Publications by authors named "Harald Baumeister"

150 Publications

Effectiveness of a Guided Web-Based Intervention to Reduce Depressive Symptoms before Outpatient Psychotherapy: A Pragmatic Randomized Controlled Trial.

Psychother Psychosom 2021 May 4:1-10. Epub 2021 May 4.

Department of Rehabilitation Psychology and Psychotherapy, University of Freiburg, Freiburg, Germany.

Introduction: Psychotherapy is a first-line treatment for depression. However, capacities are limited, leading to long waiting times for outpatient psychotherapy in health care systems. Web-based interventions (WBI) could help to bridge this treatment gap.

Objective: This study investigates the effectiveness of a guided cognitive-behavioral WBI in depressive patients seeking face-to-face psychotherapy.

Methods: A 2-arm randomized controlled trial was conducted. Depressive patients (n = 136) recruited from the waiting lists of outpatient clinics were randomly assigned to an intervention group (IG; treatment as usual [TAU] + immediate access to WBI) or a control group (CG; TAU + access to WBI after follow-up). Depressive symptoms and secondary outcomes were assessed at baseline, 7 weeks, and 5 months after randomization.

Results: Mixed-model analyses revealed a significant group × time interaction effect on depressive symptoms (F2, 121.5 = 3.91; p < 0.05). Between-group effect sizes were d = 0.55 at 7 weeks and d = 0.52 at 5 months. The IG was superior regarding psychological symptoms and mental health quality of life but not on physical health quality of life, attitudes, motivation for psychotherapy, or subjective need and uptake of psychotherapy.

Conclusions: Patients waiting for face-to-face psychotherapy can benefit from a WBI when compared to TAU. Despite the reduction of depressive symptoms in the IG, the uptake of subsequent psychotherapy was still high in both groups. The effects remained stable at the 5-month follow-up. However, this study could not determine the proportion of specific intervention effects vs. nonspecific effects, such as positive outcome expectations or attention. Future research should focus on the long-term effects and cost-effectiveness of WBI before psychotherapy.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1159/000515625DOI Listing
May 2021

Involving patients' perspective in the development of an internet- and mobile-based CBT intervention for adolescents with chronic medical conditions: Findings from a qualitative study.

Internet Interv 2021 Apr 16;24:100383. Epub 2021 Mar 16.

Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Lise-Meitner-Straße 16, 89081 Ulm, Germany.

Objective: A user-centered approach is critical for increasing the adherence to and effectiveness of an internet- and mobile-based intervention program. Therefore, potential future intervention users were involved in the development of an internet- and mobile-based cognitive behavioral therapy program (iCBT) for adolescents and young adults (AYA) with chronic medical conditions and comorbid symptoms of anxiety or depression. We aimed to identify challenges and coping strategies of the intended target group, as well as their needs and preferred intervention characteristics for an iCBT program.

Methods: Twenty AYA (aged 14-20, 60% females) with either type 1 diabetes (55%), juvenile idiopathic arthritis (25%) or cystic fibrosis (20%) were interviewed in condition-specific focus groups (4-11 participants per group) either via videoconferencing or face-to-face. Transcript verbatim data was analyzed using content analysis.

Results: Frequently reported disease-specific burdens were among others fear of disease progression, non-acceptance of disease and stressful incidents related to and aversions against medical therapy. Most frequently reported coping strategies included, seeking social support and accepting the disease. Recommendations for the content of an iCBT for comorbid symptoms of anxiety and depression comprised: dealing with disease-related fears and getting advice on health-promoting lifestyles. iCBT characteristics considered preferable by participants were: providing individual feedback by a real-person; implementation of a feature to monitor treatment progress; youthful and varied content presentation; time per session not exceeding 1 h; non-involvement of parents. A mobile-based reminder feature was considered useful, and individual tailoring and self-determination of iCBT content was considered desirable.

Conclusions: The findings highlight important patient perspectives and age-specific recommendations which can help design more optimal iCBT interventions for AYA with chronic medical conditions.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.invent.2021.100383DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8008172PMC
April 2021

Feasibility of a Software agent providing a brief Intervention for Self-help to Uplift psychological wellbeing ("SISU"). A single-group pretest-posttest trial investigating the potential of SISU to act as therapeutic agent.

Internet Interv 2021 Apr 24;24:100377. Epub 2021 Feb 24.

Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Lise Meitner Straße 16, 89081 Ulm, Germany.

Background: Software agents are computer-programs that conduct conversations with a human. The present study evaluates the feasibility of the software agent "SISU" aiming to uplift psychological wellbeing. Methods: Within a one-group pretest-posttest trial,  = 30 German-speaking participants were recruited. Assessments took place before (t1), during (t2) and after (t3) the intervention. The ability of SISU to guide participants through the intervention, acceptability, and negative effects were investigated. Data analyses are based on intention-to-treat principles. Linear mixed models will be used to investigate short-term changes over time in mood, depression, anxiety.

Intervention: The intervention consists of two sessions. Each session comprises writing tasks on autobiographical negative life events and an Acceptance- and Commitment Therapy-based exercise respectively. Participants interact with the software agent on two consecutive days for about 30 min each.

Results: All participants completed all sessions within two days. User experience was positive, with all subscales of the user experience questionnaire (UEQ) M > 0.8. Participants experienced their writings as highly self-relevant and personal. However, 57% of the participants reported at least one negative effect attributed to the intervention. Results on linear mixed models indicate an increase in anxiety over time (β = 1.33,  = .001). Qualitative User Feedback revealed that the best thing about SISU was its innovativeness (13%) and anonymity (13%). As worst thing about SISU participants indicated that the conversational style of SISU often felt unnatural (73%).

Conclusion: SISU successfully guided participants through the two-day intervention. Moreover, SISU has the potential to enter the inner world of participants. However, intervention contents have the potential to evoke negative effects in individuals. Expectable short-term symptom deterioration due to writing about negative autobiographical life events could not be prevented by acceptance and commitment therapy-based exercises. Hence, results suggest a revision of intervention contents as well as of the conversational style of SISU. The good adherence rate indicates the useful and acceptable format of SISU as a mental health chatbot. Overall, little is known about the effectiveness of software agents in the context of psychological wellbeing. Results of the present trial underline that the innovative technology bears the potential of SISU to act as therapeutic agent but should not be used with its current intervention content.

Trial-registration: The Trial is registered at the WHO International Clinical Trials Registry Platform via the German Clinical Studies Register (DRKS): DRKS00014933 (date of registration: 20.06.2018). Link: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00014933.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.invent.2021.100377DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8005771PMC
April 2021

More Light? Opportunities and Pitfalls in Digitalized Psychotherapy Process Research.

Front Psychol 2021 19;12:544129. Epub 2021 Mar 19.

Department of Clinical Psychology and Psychotherapy, Ulm University, Ulm, Germany.

While the evidence on the effectiveness of different psychotherapies is often strong, it is not settled and these therapies work. Knowledge on the causal factors and change mechanisms is of high clinical and public relevance, as it contributes to the empirically informed advancement of psychotherapeutic interventions. Here, digitalized research approaches might possess the potential to generate new insights into human behavior change, contributing to augmented interventions and mental healthcare practices with better treatment outcomes. In this perspective article, we describe recent findings of research into change mechanisms that were only feasible with digital tools and outline important future directions for this rather novel branch of research. Furthermore, we indicate several challenges and pitfalls that are to be solved, in order to advance digitalized psychotherapy process research, both methodologically and technologically.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.3389/fpsyg.2021.544129DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8017120PMC
March 2021

Lessons learned from an attempted randomized-controlled feasibility trial on "WIDeCAD" - An internet-based depression treatment for people living with coronary artery disease (CAD).

Internet Interv 2021 Apr 24;24:100375. Epub 2021 Feb 24.

Department of Clinical Psychology and Psychotherapy, University Ulm, Ulm, Germany.

Despite the high prevalence of comorbid depression in people living with coronary artery disease (CAD), uptake of psychological treatment is generally low. This study was designed to investigate the feasibility of an internet-based cognitive-behavioral (iCBT) depression intervention for people with CAD and depressive symptoms.

Methods: People with CAD and depressive symptoms (PHQ-9 ≥ 5) were randomly assigned to the eight modules comprising iCBT ( = 18), or waitlist-control ( = 16). Measures were taken at baseline (t1) and at post-treatment (eight weeks after randomization, t2). Feasibility-related outcomes were recruitment strategy, study attrition, intervention dropout, satisfaction, negative effects as well as the potential of the intervention to affect likely outcomes in a future full-scale trial (depression, anxiety, quality of life, fear of progression). Data analyses were based on intention-to-treat principles. Linear regression models were used to detect between group differences. Linear Mixed Models were used to model potential changes over time.

Results: This trial was terminated prior to a-priori defined sample size has been reached given low recruitment success as well as high intervention dropout (88%) and study attrition (23%). On average, participants in the intervention group completed  = 2.78 ( = 3.23) modules. Participants in the waitlist control group barely started one module ( = 0.82,  = 1.81). The satisfaction with the intervention was low ( = 20.6,  = 0.88). Participants reported no negative effects attributed to the iCBT. Differences between groups with regard to depression, anxiety, fear of progression and quality of life remained non-significant ( > 0.05).

Conclusion: This trial failed to recruit a sufficient number of participants. Future work should explore potential pitfalls with regards to the reach and persuasiveness of internet interventions for people living with CAD. The study gives important indications for future studies with regard to the need for new ideas to reach and treat people with CAD and depression.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.invent.2021.100375DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7941156PMC
April 2021

Efficacy of digital health interventions in youth with chronic medical conditions: A meta-analysis.

Internet Interv 2021 Apr 25;24:100373. Epub 2021 Feb 25.

Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Germany.

Background: Digital health interventions might extend service provisions for youth with chronic medical conditions (CC) and comorbid mental health symptoms. We aimed to comprehensively evaluate the efficacy of Internet- and mobile-based interventions (IMIs) for different psychological and disease-related outcomes in children and adolescents with CC.

Method: Studies were identified by systematic searches in CENTRAL, Embase, MEDLINE/PubMed and PsycINFO, complemented by searches in reference lists of eligible studies and other reviews. We included studies, when they were randomized controlled trials (RCTs) comparing the efficacy of an IMI to control conditions in improving psychological and disease-related outcomes in youth (mean age ≤ 18 years) with CC. Study selection, data extraction and risk of bias assessment were conducted independently by two reviewers. Meta-analyses were performed within a random-effects model, and Hedges' (with 95% confidence intervals) was calculated as effect size measure. Primary outcomes were comorbid mental health symptoms (i.e., depression, anxiety and stress), as well as quality of life and self-efficacy.

Results: A total of 19 randomized controlled trials (2410 patients) were included in this meta-analysis. IMIs were associated with improvements in self-efficacy ( = 0.38; 95% CI, 0.15 to 0.61;  = 0) and combined disease-related outcomes ( = -0.13; 95% CI, -0.25 to -0.01 = 21). Meta-analyses on other outcomes were non-significant, and some pre-planned analyses were not feasible because of a shortage of studies.

Conclusion: The available evidence on IMIs for improving mental and health-related outcomes in youth with CC is limited. Our findings point to a rather small benefit and limited efficacy. Future research is needed, to comprehensively assess the potential of IMIs to extend collaborative care, and to identify factors contributing to improved user-centered interventions with better treatment outcomes.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.invent.2021.100373DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7941178PMC
April 2021

Systematic evaluation of content and quality of English and German pain apps in European app stores.

Internet Interv 2021 Apr 24;24:100376. Epub 2021 Feb 24.

Department of Rehabilitation Psychology and Psychotherapy, Institute of Psychology, Albert-Ludwigs-University Freiburg, Engelberger Str. 41, 79106 Freiburg im Breisgau, Germany.

Background And Objective: Pain spans a broad spectrum of diseases and types that are highly prevalent and cause substantial disease burden for individuals and society. Up to 40% of people affected by pain receive no or inadequate treatment. Providing a scalable, time-, and location-independent way for pain diagnostic, management, prevention and treatment mobile health applications (MHA) might be a promising approach to improve health care for pain. However, the commercial app market is rapidly growing and unregulated, resulting in an opaque market. Studies investigating the content, privacy and security features, quality and scientific evidence of the available apps are highly needed, to guide patients and clinicians to high quality MHA.Contributing to this challenge, the present study investigates the content, quality, and privacy features of pain apps available in the European app stores.

Methods: An automated search engine was used to identify pain apps in the European Google Play and Apple App store. Pain apps were screened and checked for systematic criteria (pain-relatedness, functionality, availability, independent usability, English or German). Content, quality and privacy features were assessed by two independent reviewers using the German Mobile Application Rating Scale (MARS-G). The MARS-G assesses quality on four objectives (engagement, functionality, aesthetics, information quality) and two subjective scales (perceived impact, subjective quality).

Results: Out of 1034 identified pain apps 218 were included. Pain apps covered eight different pain types. Content included basic information, advice, assessment and tracking, and stand-alone interventions. The overall quality of the pain apps was average M = 3.13 (SD = 0.56, min = 1, max = 4.69). The effectiveness of less than 1% of the included pain apps was evaluated in a randomized controlled trial. Major problems with data privacy were present: 59% provided no imprint, 70% had no visible privacy policy.

Conclusion: A multitude of pain apps is available. Most MHA lack scientific evaluation and have serious privacy issues, posing a potential threat to users. Further research on evidence and improvements privacy and security are needed. Overall, the potential of pain apps is not exploited.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.invent.2021.100376DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7933737PMC
April 2021

Effect of an internet- and app-based stress intervention compared to online psychoeducation in university students with depressive symptoms: Results of a randomized controlled trial.

Internet Interv 2021 Apr 24;24:100374. Epub 2021 Feb 24.

Department of Clinical, Neuro, and Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.

Depression is highly prevalent among university students. Internet-based interventions have been found to be effective in addressing depressive symptoms, but it is open if this also applies to interventions directed at academic stress. It is also largely unclear if the techniques employed in such programs provide significant additional benefits when controlling for non-specific intervention effects. A sample of  = 200 students with elevated levels of depression (CES-D ≥ 16) of a large distance-learning university were randomly assigned to either an Internet- and App-based stress intervention group (IG;  = 100) or an active control group (CG;  = 100) receiving an Internet-based psychoeducational program of equal length. Self-report data was assessed at baseline, post-treatment (7 weeks) and three-month follow-up. The primary outcome was depression (CES-D) post-treatment. Secondary outcomes included mental health outcomes, modifiable risk factors, and academic outcomes. We found significant between-group effects on depressive symptom severity ( = 0.36; 95% CI: 0.08-0.64), as well as behavioral activation ( = 0.61; 95% CI: 0.30-0.91), perceived stress ( = 0.45; 95% CI: 0.18-0.73), anxiety ( = 0.35; 95% CI: 0.03-0.67) and other secondary outcomes post-treatment. Effects on depression were sustained at three-month follow-up. Response rates for depressive symptoms were significantly higher in the IG (26%) than the CG (14%) at post-test (=4.5,  = 0.04), but not at three-month follow-up ( = 0.454). We also found significant effects on relevant academic outcomes, including work impairment (follow-up;  = 0.36), work output (post-treatment;  = 0.27) and work cutback (follow-up;  = 0.36). The intervention was more effective for depressive symptoms compared to the CG, and so controlling for unspecific intervention effects. This suggests that specific techniques of the intervention may provide significant additional benefits on depressive symptoms. Trial registration: German Clinical Trial Registration (DRKS): DRKS00011800 (https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00011800).
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.invent.2021.100374DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7932886PMC
April 2021

Prevention of depression in adults with long-term physical conditions.

Cochrane Database Syst Rev 2021 03 5;3:CD011246. Epub 2021 Mar 5.

Section of Health Care Research and Rehabilitation Research, Center for Medical Biometry and Statistics, Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.

Background: Major depression is one of the world's leading causes of disability in adults with long-term physical conditions compared to those without physical illness. This co-morbidity is associated with a negative prognosis in terms of increased morbidity and mortality rates, increased healthcare costs, decreased adherence to treatment regimens, and a substantial decline in quality of life. Therefore, preventing the onset of depressive episodes in adults with long-term physical conditions should be a global healthcare aim. In this review, primary or tertiary (in cases of preventing recurrences in those with a history of depression) prevention are the focus. While primary prevention aims at preventing the onset of depression, tertiary prevention comprises both preventing recurrences and prohibiting relapses. Tertiary prevention aims to address a depressive episode that might still be present, is about to subside, or has recently resolved. We included tertiary prevention in the case where the focus was preventing the onset of depression in those with a history of depression (preventing recurrences) but excluded it if it specifically focused on maintaining an condition or implementing rehabilitation services (relapse prevention). Secondary prevention of depression seeks to prevent the progression of depressive symptoms by early detection and treatment and may therefore be considered a 'treatment,' rather than prevention. We therefore exclude the whole spectrum of secondary prevention.

Objectives: To assess the effectiveness, acceptability and tolerability of psychological or pharmacological interventions, in comparison to control conditions, in preventing depression in adults with long-term physical conditions; either before first ever onset of depressive symptoms (i.e. primary prevention) or before first onset of depressive symptoms in patients with a history of depression (i.e. tertiary prevention).

Search Methods: We searched the Cochrane Common Mental Disorders Controlled Trials Register, CENTRAL, MEDLINE, Embase, PsycINFO and two trials registries, up to 6 February 2020.

Selection Criteria: We included randomised controlled trials (RCTs) of preventive psychological or pharmacological interventions, specifically targeting incidence of depression in comparison to treatment as usual (TAU), waiting list, attention/psychological placebo, or placebo. Participants had to be age 18 years or older, with at least one long-term physical condition, and no diagnosis of major depression at baseline (primary prevention). In addition, we included studies comprising mixed samples of patients with and without a history of depression, which explored tertiary prevention of recurrent depression. We excluded other tertiary prevention studies. We also excluded secondary preventive interventions. Primary outcomes included incidence of depression, tolerability, and acceptability. Secondary outcomes included severity of depression, cost-effectiveness and cost-utility.

Data Collection And Analysis: We used standard methodological procedures expected by Cochrane.

Main Results: We included 11 RCTs, with one trial on psychological interventions, and 10 trials on pharmacological interventions. Data analyses on the psychological intervention (problem-solving therapy compared to TAU) included 194 participants with age-related macular degeneration. Data analyses on pharmacological interventions included 837 participants comparing citalopram (one trial), escitalopram (three trials), a mixed sample of fluoxetine/nortriptyline (one trial), melatonin (one trial), milnacipran (one trial), and sertraline (three trials), each to placebo. Included types of long-term physical conditions were acute coronary syndrome (one trial), breast cancer (one trial), head and neck cancer (two trials), stroke (five trials), and traumatic brain injury (one trial). Psychological interventions Very low-certainty evidence of one study suggests that problem solving therapy may be slightly more effective than TAU in preventing the incidence of depression, immediately post-intervention (odds ratio (OR) 0.43, 95% confidence interval (CI) 0.20 to 0.95; 194 participants). However, there may be little to no difference between groups at six months follow-up (OR 0.71, 95% CI 0.36 to 1.38; 190 participants; one study; very low-certainty evidence). No data were available regarding incidence of depression after six months. Regarding acceptability (drop-outs due to any cause), slightly fewer drop-outs occurred in the TAU group immediately post-intervention (OR 5.21, 95% CI 1.11 to 24.40; 206 participants; low-certainty evidence). After six months, however, the groups did not differ (OR 1.67, 95% CI 0.58 to 4.77; 206 participants; low-certainty evidence). This study did not measure tolerability. Pharmacological interventions Post-intervention, compared to placebo, antidepressants may be beneficial in preventing depression in adults with different types of long-term physical conditions, but the evidence is very uncertain (OR 0.31, 95% CI 0.20 to 0.49; 814 participants; nine studies; I =0%; very low-certainty evidence). There may be little to no difference between groups both immediately and at six months follow-up (OR 0.44, 95% CI 0.08 to 2.46; 23 participants; one study; very low-certainty evidence) as well as at six to 12 months follow-up (OR 0.81, 95% CI 0.23 to 2.82; 233 participants; three studies; I = 49%; very low-certainty evidence). There was very low-certainty evidence from five studies regarding the tolerability of the pharmacological intervention. A total of 669 adverse events were observed in 316 participants from the pharmacological intervention group, and 610 adverse events from 311 participants in the placebo group. There was very low-certainty evidence that drop-outs due to adverse events may be less frequent in the placebo group (OR 2.05, 95% CI 1.07 to 3.89; 561 participants; five studies; I = 0%). There was also very low-certainty evidence that drop-outs due to any cause may not differ between groups either post-intervention (OR 1.13, 95% CI 0.73 to 1.73; 962 participants; nine studies; I = 28%), or at six to 12 months (OR 1.13, 95% CI 0.69 to 1.86; 327 participants; three studies; I = 0%).

Authors' Conclusions: Based on evidence of very low certainty, our results may indicate the benefit of pharmacological interventions, during or directly after preventive treatment. Few trials examined short-term outcomes up to six months, nor the follow-up effects at six to 12 months, with studies suffering from great numbers of drop-outs and inconclusive results. Generalisation of results is limited as study populations and treatment regimes were very heterogeneous. Based on the results of this review, we conclude that for adults with long-term physical conditions, there is only very uncertain evidence regarding the implementation of any primary preventive interventions (psychological/pharmacological) for depression.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1002/14651858.CD011246.pub2DOI Listing
March 2021

Mobile Apps for Older Adults: Systematic Search and Evaluation Within Online Stores.

JMIR Aging 2021 Feb 19;4(1):e23313. Epub 2021 Feb 19.

Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, University of Ulm, Ulm, Germany.

Background: Through the increasingly aging population, the health care system is confronted with various challenges such as expanding health care costs. To manage these challenges, mobile apps may represent a cost-effective and low-threshold approach to support older adults.

Objective: This systematic review aimed to evaluate the quality, characteristics, as well as privacy and security measures of mobile apps for older adults in the European commercial app stores.

Methods: In the European Google Play and App Store, a web crawler systematically searched for mobile apps for older adults. The identified mobile apps were evaluated by two independent reviewers using the German version of the Mobile Application Rating Scale. A correlation between the user star rating and overall rating was calculated. An exploratory regression analysis was conducted to determine whether the obligation to pay fees predicted overall quality.

Results: In total, 83 of 1217 identified mobile apps were included in the analysis. Generally, the mobile apps for older adults were of moderate quality (mean 3.22 [SD 0.68]). Four mobile apps (5%) were evidence-based; 49% (41/83) had no security measures. The user star rating correlated significantly positively with the overall rating (r=.30, P=.01). Obligation to pay fees could not predict overall quality.

Conclusions: There is an extensive quality range within mobile apps for older adults, indicating deficits in terms of information quality, data protection, and security precautions, as well as a lack of evidence-based approaches. Central databases are needed to identify high-quality mobile apps.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2196/23313DOI Listing
February 2021

Predicting Symptoms of Depression and Anxiety Using Smartphone and Wearable Data.

Front Psychiatry 2021 28;12:625247. Epub 2021 Jan 28.

Department of Psychology and Logopedics, Faculty of Medicine, University of Helsinki, Helsinki, Finland.

Depression and anxiety are leading causes of disability worldwide but often remain undetected and untreated. Smartphone and wearable devices may offer a unique source of data to detect moment by moment changes in risk factors associated with mental disorders that overcome many of the limitations of traditional screening methods. The current study aimed to explore the extent to which data from smartphone and wearable devices could predict symptoms of depression and anxiety. A total of = 60 adults (ages 24-68) who owned an Apple iPhone and Oura Ring were recruited online over a 2-week period. At the beginning of the study, participants installed the data acquisition app on their smartphone. The app continuously monitored participants' location (using GPS) and smartphone usage behavior (total usage time and frequency of use). The Oura Ring provided measures related to activity (step count and metabolic equivalent for task), sleep (total sleep time, sleep onset latency, wake after sleep onset and time in bed) and heart rate variability (HRV). In addition, participants were prompted to report their daily mood (valence and arousal). Participants completed self-reported assessments of depression, anxiety and stress (DASS-21) at baseline, midpoint and the end of the study. Multilevel models demonstrated a significant negative association between the variability of locations visited and symptoms of depression (beta = -0.21, = 0.037) and significant positive associations between total sleep time and depression (beta = 0.24, = 0.023), time in bed and depression (beta = 0.26, = 0.020), wake after sleep onset and anxiety (beta = 0.23, = 0.035) and HRV and anxiety (beta = 0.26, = 0.035). A combined model of smartphone and wearable features and self-reported mood provided the strongest prediction of depression. The current findings demonstrate that wearable devices may provide valuable sources of data in predicting symptoms of depression and anxiety, most notably data related to common measures of sleep.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.3389/fpsyt.2021.625247DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7876288PMC
January 2021

Evidence on Technology-Based Psychological Interventions in Diagnosed Depression: Systematic Review.

JMIR Ment Health 2021 Feb 10;8(2):e21700. Epub 2021 Feb 10.

Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

Background: Evidence on technology-based psychological interventions (TBIs) for the treatment of depression is rapidly growing and covers a broad scope of research. Despite extensive research in this field, guideline recommendations are still limited to the general effectiveness of TBIs.

Objective: This study aims to structure evidence on TBIs by considering different application areas (eg, TBIs for acute treatment and their implementation in health care, such as stand-alone interventions) and treatment characteristics (eg, therapeutic rationale of TBIs) to provide a comprehensive evidence base and to identify research gaps in TBIs for diagnosed depression. Moreover, the reporting of negative events in the included studies is investigated in this review to enable subsequent safety assessment of the TBIs.

Methods: Randomized controlled trials on adults diagnosed with unipolar depression receiving any kind of psychotherapeutic treatment, which was at least partly delivered by a technical medium, were eligible for inclusion in our preregistered systematic review. We searched for trials in CENTRAL (Cochrane Central Register of Controlled Trials; until August 2020), MEDLINE, PsycINFO, PSYNDEX, CINAHL; until the end of January 2018), clinical trial registers, and sources of gray literature (until the end of January 2019). Study selection and data extraction were conducted by 2 review authors independently.

Results: Database searches resulted in 15,546 records, of which 241 publications were included, representing 83 completed studies and 60 studies awaiting classification (ie, preregistered studies, study protocols). Almost all completed studies (78/83, 94%) addressed the acute treatment phase, being largely either implemented as stand-alone interventions (66/83, 80%) or blended treatment approaches (12/83, 14%). Studies on TBIs for aftercare (4/83, 5%) and for bridging waiting periods (1/83, 1%) were scarce. Most TBI study arms (n=107) were guided (59/107, 55.1%), delivered via the internet (80/107, 74.8%), and based on cognitive behavioral treatment approaches (88/107, 79.4%). Almost all studies (77/83, 93%) reported information on negative events, considering dropouts from treatment as a negative event. However, reports on negative events were heterogeneous and largely unsystematic.

Conclusions: Research has given little attention to studies evaluating TBIs for aftercare and for bridging waiting periods in people with depression, even though TBIs are seen as highly promising in these application areas; thus, high quality studies are urgently needed. In addition, the variety of therapeutic rationales on TBIs has barely been represented by identified studies hindering the consideration of patient preferences when planning treatment. Finally, future studies should use specific guidelines to systematically assess and report negative events.

Trial Registration: International Prospective Register of Systematic Reviews (PROSPERO) CRD42016050413; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42016050413.

International Registered Report Identifier (irrid): RR2-10.1136/bmjopen-2018-028042.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2196/21700DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7904404PMC
February 2021

Study protocol of a randomised controlled trial on SISU, a software agent providing a brief self-help intervention for adults with low psychological well-being.

BMJ Open 2021 02 8;11(2):e041573. Epub 2021 Feb 8.

Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Ulm, Germany.

Introduction: Only a minority of people living with mental health problems are getting professional help. As digitalisation moves on, the possibility of providing internet/mobile-based interventions (IMIs) arises. One type of IMIs are fully automated conversational software agents (chatbots). Software agents are computer programs that can hold conversations with a human by mimicking a human conversational style. Software agents could deliver low-threshold and cost-effective interventions aiming at promoting psychological well-being in a large number of individuals. The aim of this trial is to evaluate the clinical effectiveness and acceptance of the brief software agent-based IMI SISU in comparison with a waitlist control group.

Methods And Analysis: Within a two-group randomised controlled trial, a total of 120 adult participants living with low well-being (Well-being Scale/WHO-5) will be recruited in Germany, Austria and Switzerland. SISU is based on therapeutic writing and acceptance and commitment therapy-based principles. The brief intervention consists of three modules. Participants work through the intervention on 3 consecutive days. Assessment takes place before (t1), during (t2) and after (t3) the interaction with SISU, as well as 4 weeks after randomisation (t4). Primary outcome is psychological well-being (WHO-5). Secondary outcomes are emotional well-being (Flourishing Scale), psychological flexibility (Acceptance and Action Questionnaire-II), quality of life (Assessment of Quality of Life -8D), satisfaction with the intervention (Client Satisfaction Questionnaire-8) and side effects (Inventory for the assessment of negative effectsof psychotherapy). Examined mediators and moderators are sociodemographic variables, personality (Big Five Inventory-10), emotion regulation (Emotion Regulation Questionnaire), alexithymia (Toronto Alexithymia Scale-20), centrality of events (Centrality of Events Scale), treatment expectancies (Credibility Expectancy Questionnaire) and technology alliance (Inventory of Technology Alliance-Online Therapy). Data analysis will be based on intention-to-treat principles. SISU guides participants through a 3-day intervention.

Ethics And Dissemination: This trial has been approved by the ethics committee of the Ulm University (No. 448/18, 18.02.2019). Results will be submitted for publication in a peer-reviewed journal and presented at conferences.

Trial Registration: The trial is registered at the WHO International Clinical Trials Registry Platform via the German Clinical Trials Register (DRKS): DRKS00016799 (date of registration: 25 April 2019). In case of important protocol modifications, trial registration will be updated. This is protocol version number 1.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1136/bmjopen-2020-041573DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7871683PMC
February 2021

Worse glycemic control, higher rates of diabetic ketoacidosis, and more hospitalizations in children, adolescents, and young adults with type 1 diabetes and anxiety disorders.

Pediatr Diabetes 2021 May 2;22(3):519-528. Epub 2021 Feb 2.

Institute for Epidemiology und Medical Biometry, ZIBMT, Universität Ulm, Ulm, Germany.

The aim of the study was to explore the metabolic characteristics and outcome parameters in youth with type 1 diabetes and anxiety disorders. HbA1c levels, rates of severe hypoglycemia, diabetic ketoacidosis (DKA), and hospital admission in children, adolescents, and young adults with type 1 diabetes and an anxiety disorder from 431 diabetes-care-centers participating in the nationwide German/Austrian/Swiss/Luxembourgian diabetes survey DPV were analyzed and compared with youth without anxiety disorders. Children, adolescents, and young adults with type 1 diabetes and anxiety disorders (n = 1325) had significantly higher HbA1c (8.5% vs. 8.2%), higher rates of DKA (4.2 vs. 2.5 per 100 patient-years), and higher hospital admission rates (63.6 vs. 40.0 per 100 patient-years) than youth without anxiety disorders (all p < 0.001). Rates of severe hypoglycemia did not differ. Individuals with anxiety disorders other than needle phobia (n = 771) had higher rates of DKA compared to those without anxiety disorders (4.2 vs. 2.5 per 100 patient-years, p = 0.003) whereas the rate of DKA in individuals with needle phobia (n = 555) was not significantly different compared to those without anxiety disorders. Children, adolescents, and young adults with anxiety disorders other than needle phobia had higher hospitalization rates (73.7 vs. 51.4 per 100 patient-years) and more inpatient days (13.2 vs. 10.1 days) compared to those with needle phobia (all p < 0.001). Children, adolescents, and young adults with type 1 diabetes and anxiety disorders had worse glycemic control, higher rates of DKA, and more hospitalizations compared to those without anxiety disorders. Because of the considerable consequences, clinicians should screen for comorbid anxiety disorders in youth with type 1 diabetes.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/pedi.13177DOI Listing
May 2021

Mediators and mechanisms of change in internet- and mobile-based interventions for depression: A systematic review.

Clin Psychol Rev 2021 02 1;83:101953. Epub 2020 Dec 1.

Department of Clinical Psychology and Psychotherapy, Ulm University, Germany.

The efficacy of Internet- and mobile-based interventions (IMIs) for depression in adults is well established. Yet, comprehensive knowledge on the mediators responsible for therapeutic change in these interventions is pending. Therefore, we conducted the first systematic review on mediators in IMIs for depression, investigating mechanisms of change in interventions with different theoretical backgrounds and delivery modes (PROSPERO CRD42019130301). Two independent reviewers screened references from five databases (i.e., Cochrane Library, Embase, MEDLINE/PubMed, PsycINFO and ICTRP), selected studies for inclusion and extracted data from eligible studies. We included 26 RCTs on mediators in IMIs for depression (6820 participants), rated their risk of bias and adherence to methodological quality criteria for psychotherapy process research. Primary studies examined 64 mediators, with cognitive variables (e.g., perceived control, rumination or interpretation bias) being the largest group of both examined (m = 28) and significant mediators (m = 22); followed by a range of other mediators, including mindfulness, acceptance and behavioral activation. Our findings might contribute to the empirically-informed advancement of interventions and mental health care practices, enabling optimized treatment outcomes for patients with depression. Furthermore, we discuss implications for future research and provide methodological recommendations for forthcoming mediation studies with more pertinent designs, allowing for inferences with higher causal specificity.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.cpr.2020.101953DOI Listing
February 2021

Effectiveness of a Guided Internet- and Mobile-Based Intervention for Patients with Chronic Back Pain and Depression (WARD-BP): A Multicenter, Pragmatic Randomized Controlled Trial.

Psychother Psychosom 2020 Dec 15:1-14. Epub 2020 Dec 15.

Department of Clinical Psychology and Psychotherapy, Friedrich-Alexander University of Erlangen-Nuremberg, Erlangen, Germany.

Introduction: There is neither strong evidence on effective treatments for patients with chronic back pain (CBP) and depressive disorder nor sufficiently available mental health care offers.

Objective: The aim is to assess the effectiveness of internet- and mobile-based interventions (IMI) as a scalable approach for treating depression in a routine care setting.

Methods: This is an observer-masked, multicenter, pragmatic randomized controlled trial with a randomization ratio of 1:1.Patients with CBP and diagnosed depressive disorder (mild to moderate severity) were recruited from 82 orthopedic rehabilitation clinics across Germany. The intervention group (IG) received a guided depression IMI tailored to CBP next to treatment-as-usual (TAU; including medication), while the control group (CG) received TAU. The primary outcome was observer-masked clinician-rated Hamilton depression severity (9-week follow-up). The secondary outcomes were: further depression outcomes, pain-related outcomes, health-related quality of life, and work capacity. Biostatistician blinded analyses using regression models were conducted by intention-to-treat and per protocol analysis.

Results: Between October 2015 and July 2017, we randomly assigned 210 participants (IG, n = 105; CG, n = 105), mostly with only a mild pain intensity but substantial pain disability. No statistically significant difference in depression severity between IG and CG was observed at the 9-week follow-up (β = -0.19, 95% CI -0.43 to 0.05). Explorative secondary depression (4/9) and pain-related (4/6) outcomes were in part significant (p < 0.05). Health-related quality of life was significantly higher in the IG. No differences were found in work capacity.

Conclusion: The results indicate that an IMI for patients with CBP and depression in a routine care setting has limited impact on depression. Benefits in pain and health-related outcomes suggest that an IMI might still be a useful measure to improve routine care.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1159/000511881DOI Listing
December 2020

Associations of depression and diabetes distress with self-management behavior and glycemic control.

Health Psychol 2021 Feb 30;40(2):113-124. Epub 2020 Nov 30.

Research Institute of the Diabetes Academy Mergentheim, Diabetes Center Mergentheim.

Objective: To analyze the independent associations of depression and diabetes distress with self-management and glycemic outcome in Type I (T1DM) and Type 2 diabetes (T2DM).

Method: Six hundred six people with T1DM or T2DM participated in a cross-sectional survey including measures of depression (PHQ-9), diabetes distress (PAID-5), self-management behavior (DSMQ), and glycemic outcome (HbA1c). Structural equation modeling was performed to analyze the independent linear associations (standardized coefficients) between these variables.

Results: In those with T1DM (n = 339), both depressive symptoms and diabetes distress were associated with lower self-management (-0.34, p < .001, and -0.16, p = .007, respectively) and thereover (indirectly) with higher HbA1c (0.20, p < .001, and 0.10, p = .016, respectively); direct associations with HbA1c were not observed. In those with T2DM (n = 267), only depressive symptoms were associated with lower self-management (-0.41, p < .001) and thus (indirectly) with higher HbA1c (0.17, p < .001). Diabetes distress, by contrast, was directly associated with higher HbA1c (0.20, p = .003) but not with self-management.

Conclusions: The results are consistent with the hypothesis that depression is linked to less optimal diabetes self-management, thus leading to less optimal glycemic outcome. The associations were relatively consistent across diabetes types. Diabetes distress was additionally associated with higher glycemic levels, suggesting that people with both depression and diabetes distress might have the least optimal outcome. The conclusions are limited by the cross-sectional study design, self-report assessment of behavior, and potential bias arising from questionnaire measures. Further research is needed to support these findings. (PsycInfo Database Record (c) 2021 APA, all rights reserved).
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1037/hea0001037DOI Listing
February 2021

StudiCare mindfulness-study protocol of a randomized controlled trial evaluating an internet- and mobile-based intervention for college students with no and "on demand" guidance.

Trials 2020 Nov 26;21(1):975. Epub 2020 Nov 26.

Department of Clinical Psychology and Psychotherapy, Institute for Psychology and Education, Ulm University, Albert-Einstein-Allee 47, 89081, Ulm, Germany.

Background: College is an exciting but also challenging time with an increased risk for mental health issues. Only a minority of the college students concerned get professional help, a problem that might be improvable by internet- and mobile-based interventions (IMIs). However, adherence of IMIs is a concern. While guidance might be a solution, it is resource-intensive, derailing potential implementation on population level. The first aim of this trial is to evaluate the efficacy of the IMI StudiCare Mindfulness (StudiCare-M) for college students with "on demand" and no guidance. The second aim is to examine potential moderators and mediators, contributing to the questions of "how" and "for whom" such interventions work.

Methods: In this three-armed randomized controlled trial, both an unguided and "guidance on demand" (GoD) condition of StudiCare-M are compared to a waitlist control group. StudiCare-M is based on principles of acceptance and commitment therapy and stress management and consists of 7 modules plus two booster sessions. Participants in the GoD condition may ask their e-coach for support whenever needed. A total of 387 college students with moderate to low mindfulness are recruited at 15+ cooperating universities in Germany, Austria, and Switzerland via circular emails. Assessments take place before as well as 1, 2, and 6 months after randomization. The primary outcome is mindfulness. Secondary outcomes include stress, depression, anxiety, interoception, presenteeism, wellbeing, intervention satisfaction, adherence, and potential side effects. Among examined moderators and mediators are sociodemographic variables, pre-treatment symptomatology, treatment expectancy, self-efficacy, cognitive fusion, emotion regulation, and alexithymia. All data will be analyzed according to intention-to-treat (ITT) principles.

Discussion: Providing effective interventions to help college students become more resilient can make a valuable contribution to the health and functionality of future society. If effective under the condition of minimal or no guidance, StudiCare-M offers a low-threshold potentially resource-efficient possibility to enhance college student mental health on a population level. Moderation- and mediation analyses will deliver further insights for optimization of target groups and intervention content.

Trial Registration: WHO International Clinical Trials Registry Platform via the German Clinical Studies Trial Register DRKS00014774 . Registered on 18 May 2018.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1186/s13063-020-04868-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7691111PMC
November 2020

Stay Present with Your Phone: A Systematic Review and Standardized Rating of Mindfulness Apps in European App Stores.

Int J Behav Med 2020 Nov 20. Epub 2020 Nov 20.

Institute of Psychology, Department of Rehabilitation Psychology and Psychotherapy, Albert-Ludwigs-University of Freiburg, Engelbersger Str. 41, 79085, Freiburg, Germany.

Background: Mindfulness-based interventions show positive effects on physical and mental health. For a better integration of mindfulness techniques in daily life, the use of apps may be promising. However, only a few studies have examined the quality of mindfulness apps using a validated standardized instrument. This review aims to evaluate the content, quality, and privacy features of mindfulness-focused apps from European commercial app stores.

Methods: An automated search engine (webcrawler) was used to identify mindfulness-focused apps in the European Apple App- and Google Play store. Content, quality, and privacy features were evaluated by two independent reviewers using the Mobile Application Rating Scale (MARS). The MARS assesses the subscales engagement, functionality, aesthetics, and information quality.

Results: Out of 605 identified apps, 192 met the inclusion criteria. The overall quality was moderate (M = 3.66, SD = 0.48). Seven apps were tested in a randomized controlled trial (RCT). Most of the apps showed a lack of data security and no privacy policy. The five apps with the highest ratings are from a credible source, include a privacy policy, and are also based on standardized mindfulness and behavior change techniques.

Conclusions: The plethora of often low-quality apps in commercial app stores makes it difficult for users to identify a suitable app. Above that, the lack of scientific verification of effectiveness and shortcomings in privacy protection and security poses potential risks. So far, the potential of mindfulness-focused apps is not exploited in commercial app stores.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1007/s12529-020-09944-yDOI Listing
November 2020

Protocol for a systematic review and meta-analysis of culturally adapted internet- and mobile-based health promotion interventions.

BMJ Open 2020 11 9;10(11):e037698. Epub 2020 Nov 9.

Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, University of Ulm, Ulm, Germany.

Introduction: High rates of immigration pose challenges for the healthcare systems of many countries to offer high-quality care to diverse populations. Advancing health interventions with incorporating the cultural background of diverse populations can be helpful to overcome this challenge. First studies suggest that culturally diverse populations might benefit from culturally adapted internet-based and mobile-based interventions (IMI) to promote health behaviours. However, the effectiveness of culturally adapted IMIs for health promotion interventions has not been evaluated systematically. Therefore, the aim of this review is to assess the effectiveness of culturally adapted IMIs regarding health promotion. Additionally, the cultural adaptation features of these interventions will be outlined.

Methods And Analysis: Randomised controlled trials (RCTs) investigating the effectiveness of culturally adapted IMIs to promote health behaviours in the field of healthy eating, smoking cessation, alcohol consumption, physical activity and sexual health behaviour will be identified via a systematic search of the databases MEDLINE, Embase, PsycINFO, CENTRAL. The preliminary search has been conducted on the 26 August 2019 and will be updated in the process. Data will be pooled meta-analytically in case of at least three included studies reporting on the same outcome. Moreover, a narrative synthesis of the included studies will be conducted. The risk of bias will be assessed using the Cochrane Collaboration's tool for the Quality Assessment of RCTs V. 2.0. Publication bias will be assessed using funnel plots.

Ethics And Dissemination: Ethical approval is not required for this study. The results of this study will be published in a peer-reviewed international journal.

Prospero Registration Number: PROSPERO; CRD42020152939.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1136/bmjopen-2020-037698DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7654131PMC
November 2020

Validation of the Mobile Application Rating Scale (MARS).

PLoS One 2020 2;15(11):e0241480. Epub 2020 Nov 2.

Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, University Ulm, Ulm, Germany.

Background: Mobile health apps (MHA) have the potential to improve health care. The commercial MHA market is rapidly growing, but the content and quality of available MHA are unknown. Instruments for the assessment of the quality and content of MHA are highly needed. The Mobile Application Rating Scale (MARS) is one of the most widely used tools to evaluate the quality of MHA. Only few validation studies investigated its metric quality. No study has evaluated the construct validity and concurrent validity.

Objective: This study evaluates the construct validity, concurrent validity, reliability, and objectivity, of the MARS.

Methods: Data was pooled from 15 international app quality reviews to evaluate the metric properties of the MARS. The MARS measures app quality across four dimensions: engagement, functionality, aesthetics and information quality. Construct validity was evaluated by assessing related competing confirmatory models by confirmatory factor analysis (CFA). Non-centrality (RMSEA), incremental (CFI, TLI) and residual (SRMR) fit indices were used to evaluate the goodness of fit. As a measure of concurrent validity, the correlations to another quality assessment tool (ENLIGHT) were investigated. Reliability was determined using Omega. Objectivity was assessed by intra-class correlation.

Results: In total, MARS ratings from 1,299 MHA covering 15 different health domains were included. Confirmatory factor analysis confirmed a bifactor model with a general factor and a factor for each dimension (RMSEA = 0.074, TLI = 0.922, CFI = 0.940, SRMR = 0.059). Reliability was good to excellent (Omega 0.79 to 0.93). Objectivity was high (ICC = 0.82). MARS correlated with ENLIGHT (ps<.05).

Conclusion: The metric evaluation of the MARS demonstrated its suitability for the quality assessment. As such, the MARS could be used to make the quality of MHA transparent to health care stakeholders and patients. Future studies could extend the present findings by investigating the re-test reliability and predictive validity of the MARS.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0241480PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7605637PMC
December 2020

Effectiveness of guided internet-based interventions in the indicated prevention of depression in green professions (PROD-A): Results of a pragmatic randomized controlled trial.

J Affect Disord 2021 01 15;278:658-671. Epub 2020 Sep 15.

Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, University of Ulm, Ulm, Germany.

Background: Major Depressive Disorder (MDD) has a major impact on public health. Reduction of depression burden in general population is of greatest importance and might be achieved by implementation of depression prevention measures into routine care. We evaluate an online prevention measure as part of a national project aiming to reduce depression in the occupational group of green professions.

Methods: This two-armed pragmatic RCT (n = 360) evaluates the effectiveness of a tailored internet-based intervention (IMI) program compared to enhanced treatment as usual. The IMI program entailed access to one of six guided IMIs each focusing on different symptom areas (depressive mood with optional comorbid diabetes, perceived stress, insomnia, panic and agoraphobia and harmful alcohol consumption). Eligible were entrepreneurs, spouses, family members and pensioners in green professions with adequate insurance status and at least subthreshold depression (PHQ≥5). Primary outcome was depressive symptom severity (QIDS-SR16) at 9-weeks post-treatment (T1). Various secondary outcomes were assessed at T1.

Results: A small effect of depression reduction (d=-0.28, 95%-CI: -0.50 to -0.07) was found at T1 favouring the IMI program (β=-0.22, 95%-CI: -0.41 to -0.02, p=.033). Categorical analysis indicated a reduced risk of potential MDD with NNTB=28.11. Adherence to the IMI program at T1 was exceptionally low.

Limitations: Results are limited to green professions and representativeness might be restricted by self-selection of participants.

Conclusion: Depression burden in green professions can be reduced by this online prevention measure. Yet, short-term effectiveness is restricted by low adherence rates.

Trial Registration: German Clinical Trial Registration: DRKS00014000. Registered: 09 April 2018.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jad.2020.09.066DOI Listing
January 2021

PartnerCARE-a psycho-oncological online intervention for partners of patients with cancer: study protocol for a randomised controlled feasibility trial.

BMJ Open 2020 10 5;10(10):e035599. Epub 2020 Oct 5.

Department of Psychosomatic Medicine and Psychotherapy, University Ulm Medical Center, Ulm, Germany.

Introduction: Cancer burdens not only the patient but also the partner to a comparable extent. Partners of patients with cancer are highly involved in the caring process and therefore often experience distress and report a low quality of life. Interventions for supporting partners are scarce. Existing ones are rarely used by partners because they are often time-consuming per se and offer only limited flexibility with regard to schedule and location. The online intervention PartnerCARE has been developed on the basis of caregiver needs and consists of six consecutive sessions and four optional sessions, which are all guided by an e-coach. The study aims to evaluate feasibility and acceptance of the online intervention PartnerCARE and the related trial process. In addition, first insights of the putative efficacy of PartnerCARE should be gained.

Methods And Analysis: A two-arm parallel-group randomised controlled trial will be conducted to compare the PartnerCARE online intervention with a waitlist control group. The study aims to recruit in total n=60 partners of patients with any type of cancer across different access paths (eg, university medical centres, support groups, social media). Congruent with feasibility study objectives, the primary outcome comprises recruitment process, study procedure, acceptance and satisfaction with the intervention (Client Satisfaction Questionnaire adapted to Internet-based interventions), possible negative effects (Inventory of Negative Effects in Psychotherapy) and dropout rates. Secondary outcomes include quality of life, distress, depression, anxiety, caregiver burden, fear of progression, social support, self-efficacy, coping and loneliness. Online measurements will be performed by self-assessment at three time points (baseline/pre-randomisation, 2 months and 4 months after randomisation). Data analyses will be based on intention-to-treat principle.

Ethics And Dissemination: Ethics approval has been granted by the Ethics Committee of the University of Ulm (No 390/18). Results from this study will be disseminated to relevant healthcare communities, in peer-reviewed journals and at scientific and clinical conferences.

Trial Registration Number: DRKS00017019.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1136/bmjopen-2019-035599DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7537440PMC
October 2020

Clinical and cost-effectiveness of a guided internet-based Acceptance and Commitment Therapy to improve chronic pain-related disability in green professions (PACT-A): study protocol of a pragmatic randomised controlled trial.

BMJ Open 2020 09 3;10(9):e034271. Epub 2020 Sep 3.

Clinical Psychology and Psychotherapy, Ulm University, Ulm, Baden-Württemberg, Germany.

Introduction: Chronic pain is highly prevalent, associated with substantial personal and economic burdens, and increased risk for mental disorders. Individuals in green professions (agriculturists, horticulturists, foresters) show increased prevalence of chronic pain and other risk factors for mental disorders. Available healthcare services in rural areas are limited. Acceptance towards face-to-face therapy is low. Internet and mobile-based interventions (IMIs) based on Acceptance and Commitment Therapy (ACT) might be a promising alternative for this population and may enable effective treatment of chronic pain. The present study aims to evaluate the clinical and cost-effectiveness of an ACT-based IMI for chronic pain in green professions in comparison with enhanced treatment as usual (TAU+).

Methods And Analysis: A two-armed pragmatic randomised controlled trial will be conducted. Two hundred eighty-six participants will be randomised and allocated to either an intervention or TAU+ group. Entrepreneurs in green professions, collaborating spouses, family members and pensioners with chronic pain are eligible for inclusion. The intervention group receives an internet-based intervention based on ACT (7 modules, over 7 weeks) guided by a trained e-coach to support adherence (eg, by positive reinforcement). Primary outcome is pain interference (Multidimensional Pain Interference scale; MPI) at 9 weeks post-randomisation. Secondary outcomes are depression severity (Quick Inventory Depressive Symptomology; QIDS-SR16), incidence of major depressive disorder, quality of life (Assessment of Quality of Life; AQoL-8D) and possible side effects associated with the treatment (Inventory for the Assessment of Negative Effects of Psychotherapy; INEP). Psychological flexibility (Chronic Pain Acceptance Questionnaire, Committed Action Questionnaire, Cognitive Fusion Questionnaire) will be evaluated as a potential mediator of the treatment effect. Furthermore, mediation, moderation and health-economic analyses from a societal perspective will be performed. Outcomes will be measured using online self-report questionnaires at baseline, 9-week, 6-month, 12-month, 24-month and 36-month follow-ups.

Ethics And Dissemination: This study was approved by the Ethics Committee of the University of Ulm, Germany (file no. 453/17-FSt/Sta; 22 February 2018). Results will be submitted for publication in peer-reviewed journals and presented at conferences.

Trial Registration Number: German Clinical Trial Registration: DRKS00014619. Registered on 16 April 2018.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1136/bmjopen-2019-034271DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7473633PMC
September 2020

Cultural adaptation of Internet- and mobile-based interventions for mental disorders: a systematic review protocol.

Syst Rev 2020 09 3;9(1):207. Epub 2020 Sep 3.

Department of Rehabilitation Psychology and Psychotherapy, Institute of Psychology, University of Freiburg, Engelbergerstr. 41, 79085, Freiburg, Germany.

Background: Internet- and mobile-based interventions (IMI) are an effective and scalable low-threshold solution to reach people who are undersupplied by current healthcare. Adapting interventions to the cultural and ethnic background of the target group enhances their acceptance and effectiveness. However, no systematic approach to cultural adaptation of IMI has been established so far. Therefore, this review aims to summarise components and procedures commonly used in the cultural adaptation of IMI for mental disorders, as well as the current evidence base on whether such a cultural adaptation leads to an increased acceptance, adherence, and effectiveness of IMI for mental disorders.

Methods: A systematic literature search will be performed using the following databases: MEDLINE, Embase, PsycINFO, CENTRAL, and WoS. The search term will include keywords related to cultural adaptation, IMI, and mental disorders/disturbances. Two independent reviewers will evaluate studies against inclusion and exclusion criteria and extract study and intervention characteristics, details on the cultural adaptation approach, and outcome data. Quality of evidence will be assessed using the Quality Assessment Tool for Reviewing Studies with Diverse Designs, and results will be synthesised qualitatively.

Discussion: Providing adequate mental healthcare regardless of cultural backgrounds is a major global health challenge. The planned systematic review will lay the foundation for the further development of the cultural adaptation of IMI for mental disorders by summarising the current state and providing recommendations for future research.

Systematic Review Registration: PROSPERO CRD42019142320.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1186/s13643-020-01438-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7472576PMC
September 2020

Effects of Internet-Based Cognitive Behavioral Therapy in Routine Care for Adults in Treatment for Depression and Anxiety: Systematic Review and Meta-Analysis.

J Med Internet Res 2020 08 31;22(8):e18100. Epub 2020 Aug 31.

Department of Clinical Psychology and Psychotherapy, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany.

Background: Although there is evidence for the efficacy of internet-based cognitive behavioral therapy (iCBT), the generalizability of results to routine care is limited.

Objective: This study systematically reviews effectiveness studies of guided iCBT interventions for the treatment of depression or anxiety.

Methods: The acceptability (uptake, participants' characteristics, adherence, and satisfaction), effectiveness, and negative effects (deterioration) of nonrandomized pre-post designs conducted under routine care conditions were synthesized using systematic review and meta-analytic approaches.

Results: A total of 19 studies including 30 groups were included in the analysis. Despite high heterogeneity, individual effect sizes of investigated studies indicate clinically relevant changes, with effect sizes ranging from Hedges' g=0.42-1.88, with a pooled effect of 1.78 for depression and 0.94 for anxiety studies. Uptake, participants' characteristics, adherence, and satisfaction indicate a moderate to high acceptability of the interventions. The average deterioration across studies was 2.9%.

Conclusions: This study provides evidence supporting the acceptability and effectiveness of guided iCBT for the treatment of depression and anxiety in routine care. Given the high heterogeneity between interventions and contexts, health care providers should select interventions that have been proven in randomized controlled clinical trials. The successful application of iCBT may be an effective way of increasing health care in multiple contexts.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2196/18100DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7490682PMC
August 2020

Implementing internet- and tele-based interventions to prevent mental health disorders in farmers, foresters and gardeners (ImplementIT): study protocol for the multi-level evaluation of a nationwide project.

BMC Psychiatry 2020 08 27;20(1):424. Epub 2020 Aug 27.

Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Friedrich-Alexander University of Erlangen-Nürnberg, Erlangen, Germany.

Background: Farmers are a vulnerable population for developing depression or other mental health disorders due to a variety of risk factors in their work context. Beyond face-to-face resources, preventive internet- and tele-based interventions could extend available treatment options to overcome barriers to care. The German Social Insurance Company for Agriculture, Forestry and Horticulture (SVLFG) implements several guided internet- and mobile-based interventions and personalised tele-based coaching for this specific target group provided by external companies within a nation-wide prevention project for their insured members. The current study aims to evaluate the implementation process and to identify determinants of successful implementation on various individual and organisational levels.

Methods: The current study includes two groups of participants: 1) insured persons with an observable need for prevention services, and 2) staff-participants who are involved in the implementation process. The Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework and the Consolidated Framework for Implementation Research (CFIR) will be used to track and evaluate the implementation process. A mixed-method approach will provide insights on individual and organizational level (e.g. degree of normalization, readiness for change) and helps to identify determinants of successful implementation. In-depth insights on experiences of the participants (e.g. acceptance, satisfaction, barriers and facilitating factors of intervention use) will be yielded through qualitative interviews. Focus groups with field workers provide insights into barriers and facilitators perceived during their consultations. Furthermore, intervention as well as implementation costs will be evaluated. According to the stepwise, national rollout, data collection will occur at baseline and continuously across 24 months.

Discussion: The results will show to what extent the implementation of the internet- and tele-based services as a preventive offer will be accepted by the participants and involved employees and which critical implementation aspects will occur within the process. If the implementation of the internet- and tele-based services succeeds, these services may be feasible in the long-term.

Trial Registration: German Clinical Trial Registration: DRKS00017078 . Registered on 18.04.2019.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1186/s12888-020-02800-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7450981PMC
August 2020

Impact of an acceptance facilitating intervention on psychotherapists' acceptance of blended therapy.

PLoS One 2020 12;15(8):e0236995. Epub 2020 Aug 12.

Faculty of Behavioural and Movement Sciences, Clinical, Neuro- & Developmental Psychology, VU Amsterdam, Amsterdam, The Netherlands.

Blended therapy is a new approach combining advantages of face-to-face psychotherapy and Internet- and mobile-based interventions. Acceptance is a fundamental precondition for its implementation. The aim of this study was to assess 1) the acceptance of psychotherapists towards blended therapy, 2) the effectiveness of an acceptance facilitating intervention (AFI) on psychotherapists' acceptance towards blended therapy and 3) to identify potential effect moderators. Psychotherapists (N = 284) were randomly assigned to a control (CG) or an intervention group (IG). The IG received a short video showing an example of blended therapy, the CG an attention placebo video. Both groups received a reliable online questionnaire assessing acceptance, effort expectancy, performance expectancy, facilitating conditions, social influence and internet anxiety. Between group differences were examined using t-tests and Mann-Whitney tests. Exploratory analysis was conducted to identify moderators. Psychotherapists in CG showed mixed baseline acceptance towards blended therapy (low = 40%, moderate = 33%, high = 27%). IG showed significantly higher acceptance compared to CG (d = .27, pone-sided = .029; low = 24%, moderate = 47%, high = 30%). Bootstrapped confidence intervals were overlapping. Performance expectancy (d = .35), effort expectancy (d = .44) and facilitating conditions (d = .28) were significantly increased (p < .05). No effects on social influence and internet anxiety were found (p>.05). Exploratory analysis indicated psychodynamic oriented psychotherapists profiting particularly from the AFI. Blended therapy is a promising approach to improve healthcare. Psychotherapists show mixed acceptance, which might be improvable by AFIs, particularly in subpopulations of initially rather skeptical psychotherapists. Forthcoming studies should extend the present study by shifting focus from attitudes to the impact of different forms of AFIs on uptake.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0236995PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7423074PMC
October 2020

Further development in the assessment of psychological flexibility: validation of the German committed action questionnaire.

Health Qual Life Outcomes 2020 Aug 3;18(1):260. Epub 2020 Aug 3.

Institute of Sport and Sport Science, University Freiburg, Schwarzwaldstraße 175, 79117, Freiburg, Germany.

Background: Psychological flexibility is considered a fundamental aspect of health. It includes six interrelated facets: 1) cognitive defusion, 2) acceptance, 3) contact with the present moment, 4) self-as-context, 5) values, and 6) committed action. To gain further insight into psychological flexibility and its effects on health, reliable and valid instruments to assess all facets are needed. Committed action is one facet that is understudied. A long and short version of a validated measure (CAQ and CAQ-8) have been developed in English. Currently, there are no German versions of the CAQ. Aim of this study is to validate German-language versions of these in a chronic pain population.

Methods: The CAQ instructions and items were translated and evaluated in a chronic pain population (N = 181). Confirmatory factor analysis and Mokken scale analysis were conducted to evaluate the German questionnaires. Correlations with health outcomes, including quality of life (SF-12), physical and emotional functioning (MPI, BPI, PHQ-9, GAD-7), pain intensity, and with other facets of psychological flexibility (CPAQ, FAH-II) were investigated for convergent validity purposes. Scale reliability was assessed by the alpha, MS, lambda-2, LCRC, and omega coefficient.

Results: A bifactor model consisting of one general factor and two methodological factors emerged from the analysis. Criteria for reliability and validity were met. Medium to strong correlations to health outcomes and other facets of psychological flexibility were found. Results were similar to the original English version.

Conclusions: The present study presents a valid and reliable instrument to investigate committed action in German populations. Future studies could expand the present findings by evaluating the German CAQ versions in non-pain populations. The role of committed action and the wider psychological flexibility model in pain and other conditions deserves further investigation.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1186/s12955-020-01497-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7397648PMC
August 2020

Are Internet- and mobile-based interventions effective in adults with diagnosed panic disorder and/or agoraphobia? A systematic review and meta-analysis.

J Affect Disord 2020 11 15;276:169-182. Epub 2020 Jul 15.

Department of Clinical Psychology and Psychotherapy, Ulm University, Albert-Einstein-Allee-47, 89081 Ulm, Germany.

Background: There is no meta-analysis that specifically evaluates the effectiveness of Internet- and mobile-based interventions (IMIs) in adults with diagnosed panic disorder and/or agoraphobia (PD/A) so far. The current meta-analysis aims to fill this gap (PROSPERO CRD 42016034016).

Methods: Systematic literature searches in six databases for randomised and controlled clinical trials investigating IMIs in adults, who met diagnostic criteria for PD/A. Study selection and data extraction were conducted independently by two reviewers. Random-effects meta-analyses, pre-planned subgroup and sensitivity analyses were conducted when appropriate. Primary outcomes were PD and A symptom severity. In addition, adherence, response, remission, quality of life, anxiety and depression symptom severity were examined.

Results: A total of 16 trials (1015 patients), with 21 comparisons (9 IMI vs. waitlist; 7 IMI vs. IMI; 5 IMI vs. active treatment condition), were included. IMIs revealed beneficial effects on panic (Hedges' g range -2.61 to -0.25) and agoraphobia symptom severity when compared to waitlist (pooled g = -1.15, [95%-CI = -1.56; -0.74]). Studies comparing IMIs to active controls (i.e., face-to-face CBT and applied relaxation) did not find significant differences for reductions in panic (g = -0.02, [95%-CI = -0.25; 0.21]) and agoraphobia symptom severity (g = -0.10, [95%-CI = -0.39; 0.19]). Furthermore, IMIs were superior to waitlist controls regarding anxiety and depression symptom severity and quality of life.

Limitations: Tests for publication bias were not feasible due to the limited number of trials per comparison, and the risk of bias assessment indicated some methodological shortcomings.

Conclusions: Findings from this meta-analytic review provide support for the effectiveness of IMIs in patients with verified PD/A. However, before IMIs can be included in treatment guidelines for PD/A, future high quality research is needed that substantiates and extends the evidence base, especially in regard to intervention safety.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jad.2020.06.059DOI Listing
November 2020