Publications by authors named "David Ebert"

274 Publications

Clinical and Cost-Effectiveness of PSYCHOnlineTHERAPY: Study Protocol of a Multicenter Blended Outpatient Psychotherapy Cluster Randomized Controlled Trial for Patients With Depressive and Anxiety Disorders.

Front Psychiatry 2021 14;12:660534. Epub 2021 May 14.

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

Internet- and mobile-based interventions (IMIs) and their integration into routine psychotherapy (i.e., blended therapy) can offer a means of complementing psychotherapy in a flexible and resource optimized way. The present study will evaluate the non-inferiority, cost-effectiveness, and safety of two versions of integrated blended psychotherapy for depression and anxiety compared to standard cognitive behavioral therapy (CBT). A three-armed multicenter cluster-randomized controlled non-inferiority trial will be conducted comparing two implementations of blended psychotherapy (PSYCHOnlineTHERAPY) compared to CBT. Seventy-five outpatient psychotherapists with a CBT-license will be randomized in a 1:1:1 ratio. Each of them is asked to include 12 patients on average with depressive or anxiety disorders resulting in a total sample size of = 900. All patients receive up to a maximum of 16 psychotherapy sessions, either as routine CBT or alternating with Online self-help sessions (fix: 8/8; flex: 0-16). Assessments will be conducted at patient study inclusion (pre-treatment) and 6, 12, 18, and 24 weeks and 12 months post-inclusion. The primary outcome is depression and anxiety severity at 18 weeks post-inclusion (post-treatment) using the Patient Health Questionnaire Anxiety and Depression Scale. Secondary outcomes are depression and anxiety remission, treatment response, health-related quality of life, patient satisfaction, working alliance, psychotherapy adherence, and patient safety. Additionally, several potential moderators and mediators including patient characteristics and attitudes toward the interventions will be examined, complemented by ecological day-to-day digital behavior variables via passive smartphone sensing as part of an integrated smart-sensing sub-study. Data-analysis will be performed on an intention-to-treat basis with additional per-protocol analyses. In addition, cost-effectiveness and cost-utility analyses will be conducted from a societal and a public health care perspective. Additionally, qualitative interviews on acceptance, feasibility, and optimization potential will be conducted and analyzed. PSYCHOnlineTHERAPY will provide evidence on blended psychotherapy in one of the largest ever conducted psychotherapy trials. If shown to be non-inferior and cost-effective, PSYCHOnlineTHERAPY has the potential to innovate psychotherapy in the near future by extending the ways of conducting psychotherapy. The rigorous health care services approach will facilitate a timely implementation of blended psychotherapy into standard care. The trial is registered in the German Clinical Trials Register (DRKS00023973; date of registration: December 28th 2020).
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http://dx.doi.org/10.3389/fpsyt.2021.660534DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8160118PMC
May 2021

Exploring the influence of testimonial source on attitudes towards e-mental health interventions among university students: Four-group randomized controlled trial.

PLoS One 2021 26;16(5):e0252012. Epub 2021 May 26.

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

Electronic mental health services (eMHSs) offer additional options for the dissemination of psychological interventions for university students. Still, many university students are reluctant to use eMHSs. Narrative messages may help increase the awareness and acceptance of quality-approved programs. However, little is known about the usefulness of narrative messages to improve attitudes towards eMHSs. In this experiment, we thus aimed to explore in how far different ways of targeting information to students affect their attitudes towards eMHSs for stress prevention and therapy, and to identify potential determinants of attitude change. N = 451 students (Mean = 32.6 years, SD = 10.2, 75% female, 7% with eMHS experience) were randomly assigned to one of four study arms involving information designed to induce different levels of perceived similarity. While the active control condition only received general information (arm 1, "information only", n = 116), the other experimental arms were additionally exposed to testimonials on specific eMHSs either addressing an unspecified audience (arm 2, n = 112), employees (arm 3, n = 115) or working university students (arm 4, n = 108). Two-way ANOVA revealed no impact of information on the alteration of attitudes towards eMHSs for stress coping (d = 0.20). Only a small effect of target-group specific testimonials on attitudes towards online therapies was identified at post-intervention (d = 0.29). Regression analyses demonstrated significant influences of source credibility and perceived similarity on attitudes for preventative eMHSs (ps<0.01), as well as a partial mediation effect of perceived similarity in favor of testimonials targeted to students (95% CI [0.22, 0.50]). Overall, this study indicated no meaningful impact of information on attitudes and limited evidence for benefits of tailored narrative messages. Since attitudes were already positive at baseline, further research with a representative student sample mimicking real-world decision scenarios is needed to gain an in-depth understanding of acceptance-facilitating message features that may contribute to promote the adoption of evidence-based eMHSs.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0252012PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8153476PMC
May 2021

Guided Internet-Based Cognitive Behavioral Therapy for Insomnia: Health-Economic Evaluation From the Societal and Public Health Care Perspective Alongside a Randomized Controlled Trial.

J Med Internet Res 2021 May 24;23(5):e25609. Epub 2021 May 24.

Department of Sport and Health Sciences, Technical University of Munich, Munich, Germany.

Background: The evidence base for internet-based cognitive behavioral therapy for insomnia (iCBT-I) is firm; however, little is known about iCBT-I's health-economic effects.

Objective: This study aimed to evaluate the cost-effectiveness and cost-utility of iCBT-I in reducing insomnia among schoolteachers.

Methods: Schoolteachers (N=128) with clinically significant insomnia symptoms and work-related rumination were randomized to guided iCBT-I or a wait list control group, both with unrestricted access to treatment as usual. Health care use, patient and family expenditures, and productivity losses were self-assessed and used for costing from a societal and a public health care perspective. Costs were related to symptom-free status (score <8 on the insomnia severity index) and quality-adjusted life years (QALYs) gained. Sampling error was handled using nonparametric bootstrapping.

Results: Statistically significant differences favoring the intervention group were found for both health outcomes (symptom-free status yes or no: β=.30; 95% CI 0.16-0.43; QALYs: β=.019, 95% CI 0.01-0.03). From a societal perspective, iCBT-I had a 94% probability of dominating the wait list control for both health outcomes. From a public health care perspective, iCBT-I was more effective but also more expensive than the wait list control, resulting in an incremental cost-effectiveness ratio of €650 per symptom-free individual. In terms of QALYs, the incremental cost-effectiveness ratio was €11,285. At a willingness-to-pay threshold of €20,000 per QALY gained, the intervention's probability of being cost-effective was 89%.

Conclusions: Our trial indicates that iCBT could be considered as a good value-for-money intervention for insomnia.

Trial Registration: German Clinical Trial Registry: DRKS00004700; https://tinyurl.com/2nnk57jm.

International Registered Report Identifier (irrid): RR2-10.1186/1745-6215-14-169.
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http://dx.doi.org/10.2196/25609DOI Listing
May 2021

Effectiveness of a digital alcohol moderation intervention as an add-on to depression treatment for young adults: study protocol of a multicentre pragmatic randomized controlled trial.

BMC Psychiatry 2021 May 22;21(1):265. Epub 2021 May 22.

Department of Research, Arkin Mental Health Care, Amsterdam, The Netherlands.

Background: Depressive disorders and problematic drinking often co-occur, also among young adults. These co-occurring conditions are associated with various negative health outcomes compared to both conditions alone. Early intervention by addressing alcohol use and depressive symptoms simultaneously in the same treatment might improve both conditions. However, evidence on the (cost-) effectiveness of digital combined depression and alcohol interventions for young adults is currently insufficient. We therefore developed an add-on digital alcohol moderation adherence-focussed guided intervention to complement treatment as usual (TAU) for depressive disorders. The digital intervention is a web-app, including 6 modules based on motivational interviewing and cognitive behavioural therapy. This study aims to evaluate the (cost-)effectiveness of a digital alcohol moderation intervention + TAU compared to TAU on alcohol and depression outcomes among young adults with co-occurring depressive disorders and problematic alcohol use.

Methods: One hundred fifty-six participants, aged 18-35 years, with problematic alcohol use and a diagnosed depressive disorder will participate in a pragmatic multicentre two-arm randomized controlled trial. Problematic alcohol use is operationalised as scoring ≥5 for women and ≥ 8 for men on the Alcohol Use Disorder Identification Test (AUDIT). Participants will be randomized to either the experimental group (digital alcohol intervention + TAU) or control group (TAU only). Participants will be recruited at three Dutch mental health care centres and through social media. Assessments take place at baseline and after 3, 6 and 12 months post-randomization. The primary outcome is treatment response at 6-month follow-up, operationalized as a composite score that combines alcohol use and depression measures and indicates whether treatment has been successful or not. Secondary outcomes are depressive symptoms and alcohol use (i.e. number of weekly standard drinks and AUDIT score). An economic evaluation will be conducted alongside the trial.

Discussion: This study evaluates the (cost-) effectiveness of an add-on digital alcohol moderation intervention for young adults who are in treatment for depressive disorders. If proven effective, the digital intervention could be implemented in mental health care and improve treatment for people with co-occurring depressive disorders and problematic alcohol use.

Trial Registration: Pre-registered on October 29, 2019 in The Netherlands Trial Register ( NL8122 ).
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http://dx.doi.org/10.1186/s12888-021-03222-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8140318PMC
May 2021

Dismantling, optimising, and personalising internet cognitive behavioural therapy for depression: a systematic review and component network meta-analysis using individual participant data.

Lancet Psychiatry 2021 06 3;8(6):500-511. Epub 2021 May 3.

Department of Clinical Psychology, Faculty of Psychology, University of Bergen, Bergen, Norway.

Background: Internet cognitive behavioural therapy (iCBT) is a viable delivery format of CBT for depression. However, iCBT programmes include training in a wide array of cognitive and behavioural skills via different delivery methods, and it remains unclear which of these components are more efficacious and for whom.

Methods: We did a systematic review and individual participant data component network meta-analysis (cNMA) of iCBT trials for depression. We searched PubMed, PsycINFO, Embase, and the Cochrane Library for randomised controlled trials (RCTs) published from database inception to Jan 1, 2019, that compared any form of iCBT against another or a control condition in the acute treatment of adults (aged ≥18 years) with depression. Studies with inpatients or patients with bipolar depression were excluded. We sought individual participant data from the original authors. When these data were unavailable, we used aggregate data. Two independent researchers identified the included components. The primary outcome was depression severity, expressed as incremental mean difference (iMD) in the Patient Health Questionnaire-9 (PHQ-9) scores when a component is added to a treatment. We developed a web app that estimates relative efficacies between any two combinations of components, given baseline patient characteristics. This study is registered in PROSPERO, CRD42018104683.

Findings: We identified 76 RCTs, including 48 trials contributing individual participant data (11 704 participants) and 28 trials with aggregate data (6474 participants). The participants' weighted mean age was 42·0 years and 12 406 (71%) of 17 521 reported were women. There was suggestive evidence that behavioural activation might be beneficial (iMD -1·83 [95% credible interval (CrI) -2·90 to -0·80]) and that relaxation might be harmful (1·20 [95% CrI 0·17 to 2·27]). Baseline severity emerged as the strongest prognostic factor for endpoint depression. Combining human and automated encouragement reduced dropouts from treatment (incremental odds ratio, 0·32 [95% CrI 0·13 to 0·93]). The risk of bias was low for the randomisation process, missing outcome data, or selection of reported results in most of the included studies, uncertain for deviation from intended interventions, and high for measurement of outcomes. There was moderate to high heterogeneity among the studies and their components.

Interpretation: The individual patient data cNMA revealed potentially helpful, less helpful, or harmful components and delivery formats for iCBT packages. iCBT packages aiming to be effective and efficient might choose to include beneficial components and exclude ones that are potentially detrimental. Our web app can facilitate shared decision making by therapist and patient in choosing their preferred iCBT package.

Funding: Japan Society for the Promotion of Science.
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http://dx.doi.org/10.1016/S2215-0366(21)00077-8DOI Listing
June 2021

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

CANreduce 2.0 Adherence-Focused Guidance for Internet Self-Help Among Cannabis Users: Three-Arm Randomized Controlled Trial.

J Med Internet Res 2021 Apr 30;23(4):e27463. Epub 2021 Apr 30.

Swiss Research Institute for Public Health and Addiciton, University of Zurich, Zürich, Switzerland.

Background: Despite increasing demand for treatment among cannabis users in many countries, most users are not in treatment. Internet-based self-help offers an alternative for those hesitant to seek face-to-face therapy, though low effectiveness and adherence issues often arise.

Objective: Through adherence-focused guidance enhancement, we aimed to increase adherence to and the effectiveness of internet-based self-help among cannabis users.

Methods: From July 2016 to May 2019, cannabis users (n=775; male: 406/575, 70.6%, female: 169/575, 29.4%; age: mean 28.3 years) not in treatment were recruited from the general population and were randomly assigned to (1) an adherence-focused guidance enhancement internet-based self-help intervention with social presence, (2) a similar intervention with an impersonal service team, and (3) access to internet as usual. Controls who were placed on a waiting list for the full intervention after 3 months underwent an assessment and had access to internet as usual. The primary outcome measurement was cannabis-use days over the preceding 30 days. Secondary outcomes included cannabis-dependence severity, changes in common mental disorder symptoms, and intervention adherence. Differences between the study arms in primary and secondary continuous outcome variables at baseline, posttreatment, and follow-up were tested using pooled linear models.

Results: All groups exhibited reduced cannabis-use days after 3 months (social presence: -8.2 days; service team: -9.8 days; internet as usual: -4.2 days). The participants in the service team group (P=.01, d=.60) reported significantly fewer cannabis-use days than those in the internet as usual group; the reduction of cannabis use in the social presence group was not significant (P=.07, d=.40). There was no significant difference between the 2 intervention groups regarding cannabis-use reduction. The service team group also exhibited superior improvements in cannabis-use disorder, cannabis-dependence severity, and general anxiety symptoms after 3 months to those in the internet as usual group.

Conclusions: The adherence-focused guidance enhancement internet-based self-help intervention with an impersonal service team significantly reduced cannabis use, cannabis-use disorder, dependence severity, and general anxiety symptoms.

Trial Registration: ISRCTN Registry ISRCTN11086185; http://www.isrctn.com/ISRCTN11086185.
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http://dx.doi.org/10.2196/27463DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8122293PMC
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.
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http://dx.doi.org/10.3389/fpsyg.2021.544129DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8017120PMC
March 2021

Psychological treatment of depression in institutional settings: A meta-analytic review.

J Affect Disord 2021 05 12;286:340-350. Epub 2021 Mar 12.

Department of Clinical, Neuro and Developmental Psychology, Amsterdam Public Health research institute, Vrije Universiteit Amsterdam; WHO Collaborating Centre for Research and Dissemination of Psychological Interventions, Vrije Universiteit Amsterdam.

Background: Many depressed patients are treated in institutional settings. The number of studies focusing on psychotherapies for depressed patients in institutional settingsis limited, and only a few up-to-date meta-analyses have integrated the results of these studies.

Methods: We conducted a meta-analysis of 32 randomized trials with 37 comparisons between psychotherapy and control conditions, examining the effects of psychotherapy for adult patients in institutional settings with depressive disorders.

Results: We found that psychotherapy had a significant, small to moderate effect on depressive symptoms (g=0.42; 95% CI: 0.29~0.56), with low to moderate heterogeneity (I=33; 95% CI: 0~55). The effects remained small but significant after adjustment for publication bias (g=0.27; 95% CI: 0.12~0.42) and in the studies with low risk of bias (g=0.32; 95% CI: 0.11~0.52). The effects were largely retained at 9 to 15 months follow-up and still significant, again after adjustment for publication bias and in studies with low risk of bias. We found no significant difference across types of institutional settings, including psychiatric inpatient settings and nursing homes, although no studies with a low risk of bias were available in nursing homes.

Limitations: We included different types of institutional settings, although we did not find a significant difference between settings. The number of studies was small and risk of bias was high in a considerable number of trials.

Conclusions: This meta-analysis provides evidence for a small to moderate and sustained effect of psychotherapy in patients in institutional settings with depression.
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http://dx.doi.org/10.1016/j.jad.2021.03.017DOI Listing
May 2021

An annotated checklist of the chondrichthyans of South Africa.

Zootaxa 2021 Mar 17;4947(1):zootaxa.4947.1.1. Epub 2021 Mar 17.

Pacific Shark Research Center, Moss Landing Marine Laboratories, Moss Landing, USA South African Institute for Aquatic Biodiversity, Grahamstown, South Africa Department of Ichthyology, California Academy of Sciences, San Francisco, USA.

An annotated checklist of chondrichthyan fishes (sharks, batoids, and chimaeras) occurring in South African waters is presented. The checklist is the result of decades of research and on-going systematic revisions of the regional fauna. The chondrichthyan fauna of South Africa is one of the richest in the world with 191 species, comprising 50 families and 103 genera. It consists of 30 families, 64 genera, and 111 species of sharks; 17 families, 36 genera, and 72 species of batoids; and, 3 families, 5 genera, and 8 species of chimaeras. The most species-rich shark families are the whaler sharks Carcharhinidae with 20 species followed by the deepwater catsharks Pentanchidae with 13 species. The most species-rich batoid families are the hardnose stakes Rajidae with at least 21 species followed by the stingrays Dasyatidae with 13 species. This monograph represents the first detailed annotated checklist of chondrichthyans from South Africa in over 30 years.
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http://dx.doi.org/10.11646/zootaxa.4947.1.1DOI Listing
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.
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http://dx.doi.org/10.1016/j.invent.2021.100375DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7941156PMC
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).
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http://dx.doi.org/10.1016/j.invent.2021.100374DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7932886PMC
April 2021

Transdiagnostic Internet Intervention for Indonesian University Students With Depression and Anxiety: Evaluation of Feasibility and Acceptability.

JMIR Ment Health 2021 Mar 5;8(3):e20036. Epub 2021 Mar 5.

Department of Clinical, Neuro and Developmental Psychology, Faculty of Behavioural and Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.

Background: University students with depression and anxiety do not easily receive or seek treatment; therefore, internet-based interventions have been suggested to be a promising way to improve treatment accessibility and availability. However, it has not been examined whether a guided, culturally adapted, transdiagnostic, internet-based intervention is effective for treating symptoms of depression, anxiety, or both among university students in Indonesia.

Objective: This study aims to investigate the feasibility (acceptability and satisfaction, usability, and uptake) of a guided, culturally adapted, transdiagnostic, internet-based intervention among university students with symptoms of depression, anxiety, or both in Indonesia.

Methods: Students from Universitas Gadjah Mada, Yogyakarta, Indonesia, were screened for symptoms of depression, anxiety, or both, and filled online informed consent, demographic questionnaires, and a quality of life measure at pretreatment assessment (T0). Subsequently, the participants started the intervention. Seven weeks after T0, the primary outcomes of this feasibility study were analyzed at posttreatment assessment (T1) using the 8-item Client Satisfaction Questionnaire (CSQ-8) and the System Usability Scale (SUS). Mean and SDs for the CSQ-8 and SUS were calculated to examine feasibility. Within-group secondary outcomes (depression, anxiety, and quality of life) were inspected for outliers and normal distribution. Paired-sample t tests were used to investigate differences between time points of secondary outcomes. A mixed-method approach of quantitative and qualitative analyses was adopted. Both the primary and secondary outcomes were additionally explored with an individual semistructured interview and synthesized descriptively.

Results: A total of 50 participants completed the intervention. We found a moderate to high level of satisfaction and acceptability, a slightly below-average level of desirable usability (≥70), and an adherence rate of 52% which was higher than expected given the novelty of the intervention. Results for the secondary outcomes indicated a decrease in depression and anxiety. For depression, the overall mean difference between the 2 time points for depression was 3.92 (95% CI 2.75-5.1; Hedges g 1.15; P<.001). For anxiety, the overall mean difference between the 2 time points was 3.34 (95% CI 2.06-4.61; Hedges g 1.02; P<.001). Further, a moderate effect in improving quality of life was found (g=0.50). Overall, participants were positive about the online intervention and ECoaches (online guidance), and they found the intervention to be culturally appropriate.

Conclusions: A culturally adapted, transdiagnostic, internet-based intervention appears to be acceptable and feasible for reducing symptoms of depression, anxiety, or both, and increasing quality of life in university students in Indonesia. Future studies should include a randomized controlled trial to assess the effectiveness of such interventions as they may supplement existing counseling services in universities, reduce the treatment costs, and maximize treatment accessibility in low-resourced settings.

International Registered Report Identifier (irrid): RR2-10.1016/j.invent.2018.11.002.
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http://dx.doi.org/10.2196/20036DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7980121PMC
March 2021

Evaluating a Hybrid Web-Based Training Program for Panic Disorder and Agoraphobia: Randomized Controlled Trial.

J Med Internet Res 2021 Mar 4;23(3):e20829. Epub 2021 Mar 4.

Friedrich-Alexander-University Nuremberg-Erlangen, Nuremberg-Erlangen, Germany.

Background: Previous studies provide evidence for the effectiveness of web-based interventions for panic disorder with and without agoraphobia. Smartphone-based technologies hold significant potential for further enhancing the accessibility and efficacy of such interventions.

Objective: This randomized controlled trial aims to evaluate the efficacy of a guided, hybrid web-based training program based on cognitive behavioral therapy for adults with symptoms of panic disorder.

Methods: Participants (N=92) with total scores in the Panic and Agoraphobia Scale ranging from 9 to 28 were recruited from the general population and allocated either to a hybrid intervention (GET.ON Panic) or to a wait-list control group. The primary outcome was the reduction in panic symptoms, as self-assessed using a web-based version of the Panic and Agoraphobia Scale.

Results: Analysis of covariance-based intention-to-treat analyses revealed a significantly stronger decrease in panic symptoms posttreatment (F=9.77; P=.002; Cohen d=0.66; 95% CI 0.24-1.08) in the intervention group than in the wait-list control group. Comparisons between groups of the follow-up measures at 3 and 6 months yielded even stronger effects (3-month follow-up: F=17.40, P<.001, Cohen d=0.89, 95% CI 0.46-1.31; 6-month follow-up: F=14.63, P<.001, Cohen d=0.81, 95% CI 0.38-1.24).

Conclusions: Hybrid web-based training programs may help reduce the symptoms of panic disorder and hence play an important role in improving health care for patients with this debilitating disorder.

Trial Registration: German Clinical Trial Register DRKS00005223; https://tinyurl.com/f4zt5ran.

International Registered Report Identifier (irrid): RR2-10.1186/1745-6215-15-427.
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http://dx.doi.org/10.2196/20829DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7974752PMC
March 2021

How can we estimate QALYs based on PHQ-9 scores? Equipercentile linking analysis of PHQ-9 and EQ-5D.

Evid Based Ment Health 2021 Mar 2. Epub 2021 Mar 2.

Department of Clinical, Neuro and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.

Background: Quality-adjusted life years (QALYs) are widely used to measure the impact of various diseases on both the quality and quantity of life and in their economic valuations. It will be clinically important and informative if we can estimate QALYs based on measurements of depression severity.

Objective: To construct a conversion table from the Patient Health Questionnaire-9 (PHQ-9), the most frequently used depression scale in recent years, to the Euro-Qol Five Dimensions Three Levels (EQ-5D-3L), one of the most commonly used instruments to assess QALYs.

Methods: We obtained individual participant data of randomised controlled trials of internet cognitive-behavioural therapy which had administered depression severity scales and the EQ-5D-3L at baseline and at end of treatment. Scores from depression scales were all converted into the PHQ-9 according to the validated algorithms. We used equipercentile linking to establish correspondences between the PHQ-9 and the EQ-5D-3L.

Findings: Individual-level data from five trials (total N=2457) were available. Subthreshold depression (PHQ-9 scores between 5 and 10) corresponded with EQ-5D-3L index values of 0.9-0.8, mild major depression (10-15) with 0.8-0.7, moderate depression (15-20) with 0.7-0.5 and severe depression (20 or higher) with 0.6-0.0. A five-point improvement in PHQ-9 corresponded approximately with an increase in EQ-5D-3L score by 0.03 and a ten-point improvement by approximately 0.25.

Conclusions And Clinical Implications: The conversion table between the PHQ-9 and the EQ-5D-3L scores will enable fine-grained assessment of burden of depression at its various levels of severity and of impacts of its various treatments.
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http://dx.doi.org/10.1136/ebmental-2020-300240DOI Listing
March 2021

Patient alliance with the program predicts treatment outcomes whereas alliance with the therapist predicts adherence in internet-based therapy for panic disorder.

Psychother Res 2021 Feb 10:1-14. Epub 2021 Feb 10.

Department of Psychology, The Hebrew University of Jerusalem, Jerusalem, Israel.

Objective: This study examines relationships among different aspects of therapeutic alliance with treatment outcome, adherence and attrition in internet delivered cognitive behavioral therapy (ICBT) for panic disorder. We examined alliance-outcome relationships in ICBT ( = 74) using a newly developed self-report alliance measure that disentangles alliance with program content (Internet Patient's Experience of Attunement and Responsiveness with the program; I-PEARp) and with the therapist (I-PEARt). We compared ICBT outcomes of patient rated and therapist-rated alliance with conventional alliance scales (WAI-6 and WAI-T). Consistent with our hypothesis, I-PEARp and I-PEARt distinguished between different aspects of the alliance and predicted outcomes better than standard alliance scales. Furthermore, higher ratings of I-PEARp were associated with subsequent lower symptoms and lower symptoms were associated with higher subsequent alliance. In contrast, I-PEARt predicted adherence, but not symptoms. Although therapists' ratings of alliance (thI-PEAR) improved significantly during treatment, they did not predict subsequent symptoms, adherence, or dropout. Results indicate that the patient experience of the alliance in ICBT includes two aspects, each of which uniquely contributes to outcomes; patient connection to the program is related to symptom outcomes whereas the dyadic relationship with the therapist serves as the glue to allow the treatment to hold.
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http://dx.doi.org/10.1080/10503307.2021.1882712DOI Listing
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.
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http://dx.doi.org/10.1136/bmjopen-2020-041573DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7871683PMC
February 2021

Internet-Based Cognitive Behavioral Therapy for Depression: A Systematic Review and Individual Patient Data Network Meta-analysis.

JAMA Psychiatry 2021 Apr;78(4):361-371

Benson Henry Institute for Mind Body Medicine, Massachusetts General Hospital, Harvard University, Boston, Massachusetts.

Importance: Personalized treatment choices would increase the effectiveness of internet-based cognitive behavioral therapy (iCBT) for depression to the extent that patients differ in interventions that better suit them.

Objective: To provide personalized estimates of short-term and long-term relative efficacy of guided and unguided iCBT for depression using patient-level information.

Data Sources: We searched PubMed, Embase, PsycInfo, and Cochrane Library to identify randomized clinical trials (RCTs) published up to January 1, 2019.

Study Selection: Eligible RCTs were those comparing guided or unguided iCBT against each other or against any control intervention in individuals with depression. Available individual patient data (IPD) was collected from all eligible studies. Depression symptom severity was assessed after treatment, 6 months, and 12 months after randomization.

Data Extraction And Synthesis: We conducted a systematic review and IPD network meta-analysis and estimated relative treatment effect sizes across different patient characteristics through IPD network meta-regression.

Main Outcomes And Measures: Patient Health Questionnaire-9 (PHQ-9) scores.

Results: Of 42 eligible RCTs, 39 studies comprising 9751 participants with depression contributed IPD to the IPD network meta-analysis, of which 8107 IPD were synthesized. Overall, both guided and unguided iCBT were associated with more effectiveness as measured by PHQ-9 scores than control treatments over the short term and the long term. Guided iCBT was associated with more effectiveness than unguided iCBT (mean difference [MD] in posttreatment PHQ-9 scores, -0.8; 95% CI, -1.4 to -0.2), but we found no evidence of a difference at 6 or 12 months following randomization. Baseline depression was found to be the most important modifier of the relative association for efficacy of guided vs unguided iCBT. Differences between unguided and guided iCBT in people with baseline symptoms of subthreshold depression (PHQ-9 scores 5-9) were small, while guided iCBT was associated with overall better outcomes in patients with baseline PHQ-9 greater than 9.

Conclusions And Relevance: In this network meta-analysis with IPD, guided iCBT was associated with more effectiveness than unguided iCBT for individuals with depression, benefits were more substantial in individuals with moderate to severe depression. Unguided iCBT was associated with similar effectiveness among individuals with symptoms of mild/subthreshold depression. Personalized treatment selection is entirely possible and necessary to ensure the best allocation of treatment resources for depression.
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http://dx.doi.org/10.1001/jamapsychiatry.2020.4364DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8027916PMC
April 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.
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http://dx.doi.org/10.1016/j.cpr.2020.101953DOI Listing
February 2021

BEST FOR CAN - bringing empirically supported treatments to children and adolescents after child abuse and neglect: study protocol.

Eur J Psychotraumatol 2020 Nov 26;11(1):1837531. Epub 2020 Nov 26.

Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Goethe University Frankfurt, Frankfurt/Main, Germany.

Despite a large body of evidence demonstrating the effectiveness of psychotherapy for posttraumatic stress for children and adolescents, the adoption of empirically supported treatments (ESTs) in routine care is low. This implementation study aims to evaluate the dissemination of Trauma-Focused Cognitive Behavioural Therapy (TF-CBT) for children and adolescents with posttraumatic stress symptoms (PTSS) after child abuse and neglect (CAN) with a focus on supervision. In a cluster-randomized controlled trial, the study will evaluate the implementation of TF-CBT focussing on the training of therapists including the provision of supervision. The effectiveness of specialized trauma-focused supervision will be compared to supervision as usual with respect to the successful implementation of TF-CBT for youths with PTSS administered by psychotherapists with different levels of professional experience. The primary outcome is whether the patient receives a treatment with sufficient adherence to the TF-CBT manual. The unit of randomization will be the therapists. The main outcome will be analysed using multilevel logistic regressions. Secondary outcomes will concern further patient-related (reduction of PTSS and depressive symptoms) and therapist-related (professional quality of life) variables. Additional exploratory analyses are planned. Since the trial is designed as an implementation study, it permits naturalistic referrals to the participating therapists by patients, caregivers, child and youth welfare agencies and paediatricians. The strict primary outcome will help evaluating the role of model-based supervision in the implementation process. The explorative outcomes will evaluate whether implementation success translates into better patient outcomes. We expect that the dissemination measures will lead to a successful implementation of TF-CBT and promote sustainable structures in routine care that will remain in place after study completion and offer access to ESTs for future children and youths with a history of CAN.
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http://dx.doi.org/10.1080/20008198.2020.1837531DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7747933PMC
November 2020

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

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

The effects of patients' expectations on surgery outcome in total hip and knee arthroplasty: a prognostic factor meta-analysis.

Health Psychol Rev 2020 Dec 21:1-17. Epub 2020 Dec 21.

Department of Psychology, University of Zurich, Zurich, Switzerland.

Patients' expectations are among the most frequently studied psychological prognostic factors in total knee and hip arthroplasty (TKA/THA). So far, however, evidence on the effect of patients' preoperative expectations on surgery outcome is inconclusive. Heterogeneity of expectation constructs and the use of psychometrically not evaluated measurement instruments have constituted major obstacles for the integration of the current literature. Using a theory-based model of expectation constructs , this meta-analysis set out to disentangle the conflicting results in the current literature. Systematic literature searches yielded  = 46 studies (= 10,465) that reported associations of preoperative expectations with postoperative pain, functioning and disability, and satisfaction. Random effects meta-analysis revealed a robust small association ( = .16; 95% CI .13, .19) between patients' positive preoperative expectations and better postoperative outcomes. This effect did not differ between THA and TKA, different outcome categories and different follow-up periods. Studies using psychometrically evaluated expectation measures reported significantly higher effects (= .19 95% CI .16, .22). Whether this effect varies among different expectation constructs remains unclear. High-quality studies using validated, multidimensional expectation measures are needed to further understand the role of different expectation constructs in THA and TKA surgery.
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http://dx.doi.org/10.1080/17437199.2020.1854051DOI Listing
December 2020

Psychological interventions as an alternative and add-on to antidepressant medication to prevent depressive relapse: systematic review and meta-analysis.

Br J Psychiatry 2020 Nov 18:1-8. Epub 2020 Nov 18.

Amsterdam University Medical Centers, Department of Psychiatry, University of Amsterdam; and Institute for Advanced Study, Amsterdam, The Netherlands.

Background: After remission, antidepressants are often taken long term to prevent depressive relapse or recurrence. Whether psychological interventions can be a viable alternative or addition to antidepressants remains unclear.

Aims: To compare the effectiveness of psychological interventions as an alternative (including delivered when tapering antidepressants) or addition to antidepressants alone for preventing depressive relapse.

Method: Embase, PubMed, the Cochrane Library and PsycINFO were searched from inception until 13 October 2019. Randomised controlled trials (RCTs) with previously depressed patients in (partial) remission where preventive psychological interventions with or without antidepressants (including tapering) were compared with antidepressant control were included. Data were extracted independently from published trials. A random-effects meta-analysis on time to relapse (hazard ratio, HR) and risk of relapse (risk ratio, RR) at the last point of follow-up was conducted. PROSPERO ID: CRD42017055301.

Results: Among 11 included trials (n = 1559), we did not observe an increased risk of relapse for participants receiving a psychological intervention while tapering antidepressants versus antidepressants alone (RR = 1.02, 95% CI 0.84-1.25; P = 0.85). Psychological interventions added to antidepressants significantly reduced the risk of relapse (RR = 0.85, 95% CI 0.74-0.97; P = 0.01) compared with antidepressants alone.

Conclusions: This study found no evidence to suggest that adding a psychological intervention to tapering increases the risk of relapse when compared with antidepressants alone. Adding a psychological intervention to antidepressant use reduces relapse risk significantly versus antidepressants alone. As neither strategy is routinely implemented these findings are relevant for patients, clinicians and guideline developers.
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http://dx.doi.org/10.1192/bjp.2020.198DOI Listing
November 2020

Tailored implementation of internet-based cognitive behavioural therapy in the multinational context of the ImpleMentAll project: a study protocol for a stepped wedge cluster randomized trial.

Trials 2020 Oct 28;21(1):893. Epub 2020 Oct 28.

University Medical Center Groningen, Interdisciplinary Center for Psychopathology and Emotion Regulation, University of Groningen, Groningen, The Netherlands.

Background: Internet-based Cognitive Behavioural Therapy (iCBT) is found effective in treating common mental disorders. However, the use of these interventions in routine care is limited. The international ImpleMentAll study is funded by the European Union's Horizon 2020 programme. It is concerned with studying and improving methods for implementing evidence-based iCBT services for common mental disorders in routine mental health care. A digitally accessible implementation toolkit (ItFits-toolkit) will be introduced to mental health care organizations with the aim to facilitate the ongoing implementation of iCBT services within local contexts. This study investigates the effectiveness of the ItFits-toolkit by comparing it to implementation-as-usual activities.

Methods: A stepped wedge cluster randomized controlled trial (SWT) design will be applied. Over a trial period of 30 months, the ItFits-toolkit will be introduced sequentially in twelve routine mental health care organizations in primary and specialist care across nine countries in Europe and Australia. Repeated measures are applied to assess change over time in the outcome variables. The effectiveness of the ItFits-toolkit will be assessed in terms of the degree of normalization of the use of the iCBT services. Several exploratory outcomes including uptake of the iCBT services will be measured to feed the interpretation of the primary outcome. Data will be collected via a centralized data collection system and analysed using generalized linear mixed modelling. A qualitative process evaluation of routine implementation activities and the use of the ItFits-toolkit will be conducted within this study.

Discussion: The ImpleMentAll study is a large-scale international research project designed to study the effectiveness of tailored implementation. Using a SWT design that allows to examine change over time, this study will investigate the effect of tailored implementation on the normalization of the use of iCBT services and their uptake. It will provide a better understanding of the process and methods of tailoring implementation strategies. If found effective, the ItFits-toolkit will be made accessible for mental health care service providers, to help them overcome their context-specific implementation challenges.

Trial Registration: ClinicalTrials.gov NCT03652883 . Retrospectively registered on 29 August 2018.
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http://dx.doi.org/10.1186/s13063-020-04686-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7592568PMC
October 2020

Moderators of psychological and psychoeducational interventions for the prevention of anxiety: A systematic review.

J Anxiety Disord 2020 12 28;76:102317. Epub 2020 Sep 28.

Biomedical Research Institute of Malaga (IBIMA), C/ Sevilla 23, 29009, Málaga, Spain; Prevention and Health Promotion Research Network (redIAPP), ISCIII, Gran Via de les Corts Catalanes, 587, 08007, Barcelona, Spain.

The aim of this study was to assess the available evidence on potential moderators of psychological and psychoeducational interventions for the prevention of anxiety. A systematic review using PubMed, PsycINFO, Web of Science, Embase, OpenGrey, and CENTRAL was performed up to October 2019. Two independent researchers assessed the fulfillment of eligibility criteria, extracted the data and performed a quality assessment of the included studies. Outcomes were moderators of the reduction of anxious symptoms or the incidence of anxiety disorders. Fourteen studies reporting results on moderator analyses performed in 13 randomized controlled trials were included. Twenty-seven potential moderators were organized into six categories: sociodemographic, clinical characteristics, cognitive variables, life events, interpersonal functioning and intervention characteristics. The most frequently examined variables were gender, age and baseline anxiety. We found insufficient evidence for all moderator categories studied. In children and adolescents, we found some studies with significant results for the low family support variable and higher levels of anxiety symptoms at baseline, which were both associated with higher effectiveness. Limited conclusions can be drawn about for whom and under what conditions interventions work in the prevention of anxiety. A strong need to improve the methodological quality and the number of moderator studies was identified.
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http://dx.doi.org/10.1016/j.janxdis.2020.102317DOI Listing
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.
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http://dx.doi.org/10.1016/j.jad.2020.09.066DOI Listing
January 2021

User Experience and Effects of an Individually Tailored Transdiagnostic Internet-Based and Mobile-Supported Intervention for Anxiety Disorders: Mixed-Methods Study.

J Med Internet Res 2020 09 16;22(9):e16450. Epub 2020 Sep 16.

Clinical, Neuro- & Development Psychology, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.

Background: Internet interventions have been shown to be effective in treating anxiety disorders. Most interventions to date focus on single disorders and disregard potential comorbidities.

Objective: The aim of this mixed-methods study was to investigate feasibility, user experience, and effects of a newly developed individually tailored transdiagnostic guided internet intervention for anxiety disorders.

Methods: This study is an uncontrolled, within-group, baseline, postintervention pilot trial with an embedded qualitative and quantitative process and effect evaluation. In total, 49 adults with anxiety disorders (generalized anxiety disorder n=20, social phobia n=19, agoraphobia without panic n=12, panic with agoraphobia n=6, panic without agoraphobia n=4, subclinical depression n=41) received access to the 7-session intervention. We examined motivation and expectations, intervention use, user experience, impact, and modification requests. Qualitative data were assessed using semistructured interviews and analyzed by qualitative content analysis. Quantitative outcomes included symptom severity of anxiety and depression (Hamilton Anxiety Rating Scale [HAM-A], Quick Item Inventory of Depressive Symptomatology clinician rating [QIDS-C]), diagnostic status in clinical interviews (Mini International Neuropsychiatric Interview [MINI]), and web-based self-reports (Generalized Anxiety Disorder-7 [GAD-7], Center for Epidemiological Studies Depression Scale [CES-D], Beck Anxiety Inventory [BAI], Panic and Agoraphobia Scale [PAS], Social Phobia Scale [SPS], Patient Health Questionnaire-9 [PHQ-9]) at baseline and postassessment. Quantitative data was analyzed by comparing within-group means expressed as Cohen d.

Results: Anxiety symptom severity (HAM-A d=1.19) and depressive symptoms (QIDS-C d=0.42) improved significantly, and 54% (21/39) no longer were diagnosed as having any anxiety disorder. The main positive effects were the general improvement of disease burden and attentiveness to feelings and risk situations while the main negative effects experienced were lack of change in disease burden and symptom deterioration. The most prevalent reasons for participation were the advantages of online treatment, symptom burden, and openness toward online treatment. Helpful factors included support, psychoeducation and practicing strategies in daily life; the main hindering factors were too little individualization and being overwhelmed by the content and pace.

Conclusions: The intervention was found to be feasible and results show preliminary data indicating potential efficacy for improving anxiety and depression. The next step should be the evaluation within a randomized controlled trial. Concerning intervention development, it was found that future interventions should emphasize individualization even more in order to further improve the fit to individual characteristics, preferences, and needs.
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http://dx.doi.org/10.2196/16450DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7527916PMC
September 2020