Publications by authors named "David Daniel Ebert"

99 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 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

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

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

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

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

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

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

Barriers and Facilitators for Referrals of Primary Care Patients to Blended Internet-Based Psychotherapy for Depression: Mixed Methods Study of General Practitioners' Views.

JMIR Ment Health 2020 Aug 18;7(8):e18642. Epub 2020 Aug 18.

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

Background: Major depressive disorder (MDD) is highly prevalent and often managed by general practitioners (GPs). GPs mostly prescribe medication and show low referral rates to psychotherapy. Many patients remain untreated. Blended psychotherapy (bPT) combines internet-based interventions with face-to-face psychotherapy and could increase treatment access and availability. Effectively implementing bPT in routine care requires an understanding of professional users' perspectives and behavior.

Objective: This study aims to identify barriers and facilitators perceived by GPs in referring patients to bPT. Explanations for variations in referral rates were examined.

Methods: Semistructured interviews were conducted with 12 of 110 GPs participating in a German randomized controlled trial (RCT) to investigate barriers to and facilitators for referrals to bPT for MDD (10 web-based modules, app-based assessments, and 6 face-to-face sessions). The interview guide was based on the theoretical domains framework. The interviews were audio recorded and transcribed verbatim, and the qualitative content was analyzed by 2 independent coders (intercoder agreement, k=0.71). A follow-up survey with 12 interviewed GPs enabled the validation of emergent themes. The differences in the barriers and facilitators identified between groups with different characteristics (eg, GPs with high or low referral rates) were described. Correlations between referrals and characteristics, self-rated competences, and experiences managing depression of the RCT-GPs (n=76) were conducted.

Results: GPs referred few patients to bPT, although varied in their referral rates, and interviewees referred more than twice as many patients as RCT-GPs (interview-GPs: mean 6.34, SD 9.42; RCT-GPs: mean 2.65, SD 3.92). A negative correlation was found between GPs' referrals and their self-rated pharmacotherapeutic competence, r(73)=-0.31, P<.001. The qualitative findings revealed a total of 19 barriers (B) and 29 facilitators (F), at the levels of GP (B=4 and F=11), patient (B=11 and F=9), GP practice (B=1 and F=3), and sociopolitical circumstances (B=3 and F=6). Key barriers stated by all interviewed GPs included "little knowledge about internet-based interventions" and "patients' lack of familiarity with technology/internet/media" (number of statements, each k=22). Key facilitators were "perceived patient suitability, e.g. well-educated, young" (k=22) and "no conflict with GP's role" (k=16). The follow-up survey showed a very high agreement rate of at least 75% for 71% (34/48) of the identified themes. Descriptive findings indicated differences between GPs with low and high referral rates in terms of which and how many barriers (low: mean 9.75, SD 1.83; high: mean 10.50, SD 2.38) and facilitators (low: mean 18.25, SD 4.13; high: mean 21.00; SD 3.92) they mentioned.

Conclusions: This study provides insights into factors influencing GPs' referrals to bPT as gatekeepers to depression care. Barriers and facilitators should be considered when designing implementation strategies to enhance referral rates. The findings should be interpreted with care because of the small and self-selected sample and low response rates.
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http://dx.doi.org/10.2196/18642DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7463410PMC
August 2020

Psychological interventions to improve sleep in college students: A meta-analysis of randomized controlled trials.

J Sleep Res 2021 02 16;30(1):e13097. Epub 2020 Jul 16.

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

Sleep disturbances and insomnia are common in college students, and reduce their quality of life and academic performance. The aim of this meta-analysis was to evaluate the efficacy of psychological interventions aimed at improving sleep in college students. A meta-analysis was conducted with 10 randomized controlled trials with passive control conditions (N = 2,408). The overall mean effect size (Hedges' g) of all sleep-related outcomes within each trial was moderate to large (g = 0.61; 95% confidence interval: 0.41-0.81; numbers-needed-to-treat = 3). Effect sizes for global measures of sleep disturbances were g = 0.79; 95% confidence interval: 0.52-1.06; and for sleep-onset latency g = 0.65; 95% confidence interval: 0.36-0.94. The follow-up analyses revealed an effect size of g = 0.56; 95% confidence interval: 0.45-0.66 for the combined sleep-related outcomes based on three studies. No significant covariates were identified. These results should be interpreted cautiously due to an overall substantial risk of bias, and in particular with regard to blinding of participants and personnel. Nevertheless, they provide evidence that psychological interventions for improving sleep are efficacious among college students. Further research should explore long-term effects and potential moderators of treatment efficacy in college students.
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http://dx.doi.org/10.1111/jsr.13097DOI Listing
February 2021

Efficacy and Moderators of Internet-Based Interventions in Adults with Subthreshold Depression: An Individual Participant Data Meta-Analysis of Randomized Controlled Trials.

Psychother Psychosom 2021 16;90(2):94-106. Epub 2020 Jun 16.

Department of Medical Psychology, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands,

Introduction: Evidence on effects of Internet-based interventions to treat subthreshold depression (sD) and prevent the onset of major depression (MDD) is inconsistent.

Objective: We conducted an individual participant data meta-analysis to determine differences between intervention and control groups (IG, CG) in depressive symptom severity (DSS), treatment response, close to symptom-free status, symptom deterioration and MDD onset as well as moderators of intervention outcomes.

Methods: Randomized controlled trials were identified through systematic searches via PubMed, PsycINFO, Embase and Cochrane Library. Multilevel regression analyses were used to examine efficacy and moderators.

Results: Seven trials (2,186 participants) were included. The IG was superior in DSS at all measurement points (posttreatment: 6-12 weeks; Hedges' g = 0.39 [95% CI: 0.25-0.53]; follow-up 1: 3-6 months; g = 0.30 [95% CI: 0.15-0.45]; follow-up 2: 12 months, g = 0.27 [95% CI: 0.07-0.47], compared with the CG. Significantly more participants in the IG than in the CG reached response and close to symptom-free status at all measurement points. A significant difference in symptom deterioration between the groups was found at the posttreatment assessment and follow-up 2. Incidence rates for MDD onset within 12 months were lower in the IG (19%) than in the CG (26%). Higher initial DSS and older age were identified as moderators of intervention effect on DSS.

Conclusions: Our findings provide evidence for Internet-based interventions to be a suitable low-threshold intervention to treat individuals with sD and to reduce the incidence of MDD. This might be particularly true for older people with a substantial symptom burden.
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http://dx.doi.org/10.1159/000507819DOI Listing
June 2020

A Web- and Mobile-Based Intervention for Comorbid, Recurrent Depression in Patients With Chronic Back Pain on Sick Leave (Get.Back): Pilot Randomized Controlled Trial on Feasibility, User Satisfaction, and Effectiveness.

JMIR Ment Health 2020 Apr 15;7(4):e16398. Epub 2020 Apr 15.

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

Background: Chronic back pain (CBP) is linked to a higher prevalence and higher occurrence of major depressive disorder (MDD) and can lead to reduced quality of life. Unfortunately, individuals with both CBP and recurrent MDD are underidentified. Utilizing health care insurance data may provide a possibility to better identify this complex population. In addition, internet- and mobile-based interventions might enhance the availability of existing treatments and provide help to those highly burdened individuals.

Objective: This pilot randomized controlled trial investigated the feasibility of recruitment via the health records of a German health insurance company. The study also examined user satisfaction and effectiveness of a 9-week cognitive behavioral therapy and Web- and mobile-based guided self-help intervention Get.Back in CBP patients with recurrent MDD on sick leave compared with a waitlist control condition.

Methods: Health records from a German health insurance company were used to identify and recruit participants (N=76) via invitation letters. Study outcomes were measured using Web-based self-report assessments at baseline, posttreatment (9 weeks), and a 6-month follow-up. The primary outcome was depressive symptom severity (Center for Epidemiological Studies-Depression); secondary outcomes included anxiety (Hamilton Anxiety and Depression Scale), quality of life (Assessment of Quality of Life), pain-related variables (Oswestry Disability Index, Pain Self-Efficacy Questionnaire, and pain intensity), and negative effects (Inventory for the Assessment of Negative Effects of Psychotherapy).

Results: The total enrollment rate with the recruitment strategy used was 1.26% (76/6000). Participants completed 4.8 modules (SD 2.6, range 0-7) of Get.Back. The overall user satisfaction was favorable (mean Client Satisfaction Questionnaire score=24.5, SD 5.2). Covariance analyses showed a small but statistically significant reduction in depressive symptom severity in the intervention group (n=40) at posttreatment compared with the waitlist control group (n=36; F=3.62, P=.03; d=0.28, 95% CI -0.17 to 0.74). Similar findings were noted for the reduction of anxiety symptoms (F=10.45; P=.001; d=0.14, 95% CI -0.31 to 0.60) at posttreatment. Other secondary outcomes were nonsignificant (.06≤P≤.44). At the 6-month follow-up, the difference between the groups with regard to reduction in depressive symptom severity was no longer statistically significant (F=1.50, P=.11; d=0.10, 95% CI -0.34 to 0.46). The between-group difference in anxiety at posttreatment was maintained to follow-up (F=2.94, P=.04; d=0.38, 95% CI -0.07 to 0.83). There were no statistically significant differences across groups regarding other secondary outcomes at the 6-month follow-up (.08≤P≤.42).

Conclusions: These results suggest that participants with comorbid depression and CBP on sick leave may benefit from internet- and mobile-based interventions, as exemplified with the positive user satisfaction ratings. The recruitment strategy via health insurance letter invitations appeared feasible, but more research is needed to understand how response rates in untreated individuals with CBP and comorbid depression can be increased.

Trial Registration: German Clinical Trials Register DRKS00010820; https://www.drks.de/drks_web/navigate.do? navigationId=trial.HTML&TRIAL_ID=DRKS00010820.
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http://dx.doi.org/10.2196/16398DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7191351PMC
April 2020

Design of a Guided Internet- and Mobile-Based Intervention for Internet Use Disorder-Study Protocol for a Two-Armed Randomized Controlled Trial.

Front Psychiatry 2020 17;11:190. Epub 2020 Mar 17.

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

Internet Use Disorder (IUD), characterized as the inability to control one's internet use, is emerging as an increasing societal concern as it is associated with reduced quality of life and mental health comorbidities. Evidence-based treatment options are, however, scarce due to the novelty of the diagnosis. Internet- and mobile-based interventions may be an effective means to deliver psychological treatment to individuals with IUD as they address individuals affected in their online setting. The aim of the study is to evaluate the efficacy of a newly developed, guided internet- and mobile-based intervention for IUD. In a two-armed randomized controlled trial ( = 130), individuals showing problematic internet use patterns (Internet Addiction Test ≥ 49) will be randomly allocated to the internet- and mobile-based intervention or a waiting control group. Assessments will take place at baseline, 7 weeks, 6- and 12 months after randomization. The primary outcome is internet addiction symptom severity (IAT) at 7 weeks. Secondary outcomes include quality of life, depressive symptoms, anxiety, and other psychosocial variables associated with IUD. The intervention consists of seven sessions: Goal setting and motivational interviewing, impulse control, problem solving, cognitive restructuring, self-worth, relapse prevention, and a booster session. Participants are supported by an eCoach who provides individual feedback after completion of each session. Participants can choose between several elective sessions based on individual need. This is the first study to evaluate an internet- and mobile-based intervention for IUD, which could be a promising first step to reduce individuals' disease burden. DRKS00015314. The study is currently ongoing. First participants were enrolled in the study on September 14th 2018. Recruitment will continue approximately through March 2020.
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http://dx.doi.org/10.3389/fpsyt.2020.00190DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7092751PMC
March 2020

Efficacy of a Self-Help Web-Based Recovery Training in Improving Sleep in Workers: Randomized Controlled Trial in the General Working Population.

J Med Internet Res 2020 01 7;22(1):e13346. Epub 2020 Jan 7.

Department of Health Psychology and Applied Biological Psychology, Institute of Psychology, Leuphana University of Lueneburg, Lueneburg, Germany.

Background: Sleep complaints are among the most prevalent health concerns, especially among workers, which may lead to adverse effects on health and work. Internet-delivered cognitive behavioral therapy for insomnia (iCBT-I) offers the opportunity to deliver effective solutions on a large scale. The efficacy of iCBT-I for clinical samples has been demonstrated in recent meta-analyses, and there is evidence that iCBT-I is effective in the working population with severe sleep complaints. However, to date, there is limited evidence from randomized controlled trials that iCBT-I could also be an effective tool for universal prevention among the general working population regardless of symptom severity. Although increasing evidence suggests that negatively toned cognitive activity may be a key factor for the development and maintenance of insomnia, little is known about how iCBT-I improves sleep by reducing presleep cognitive activity.

Objective: This study aimed to examine the efficacy of a self-help internet-delivered recovery training, based on principles of iCBT-I tailored to the work-life domain, among the general working population. General and work-related cognitive activities were investigated as potential mediators of the intervention's effect.

Methods: A sample of 177 workers were randomized to receive either the iCBT-I (n=88) or controls (n=89). The intervention is a Web-based training consisting of six 1-week modules. As the training was self-help, participants received nothing but technical support via email. Web-based self-report assessments were scheduled at baseline, at 8 weeks, and at 6 months following randomization. The primary outcome was insomnia severity. Secondary outcomes included measures of mental health and work-related health and cognitive activity. In an exploratory analysis, general and work-related cognitive activities, measured as worry and work-related rumination, were investigated as mediators.

Results: Analysis of the linear mixed effects model showed that, relative to controls, participants who received iCBT-I reported significantly lower insomnia severity scores at postintervention (between-group mean difference -4.36; 95% CI -5.59 to - 3.03; Cohen d=0.97) and at 6-month follow-up (between-group difference: -3.64; 95% CI -4.89 to -2.39; Cohen d=0.86). The overall test of group-by-time interaction was significant (P<.001). Significant differences, with small-to-large effect sizes, were also detected for cognitive activity and for mental and work-related health, but not for absenteeism. Mediation analysis demonstrated that work-related rumination (indirect effect: ab=-0.80; SE=0.34; 95% boot CI -1.59 to -0.25) and worry (indirect effect: ab=-0.37; SE=0.19; 95% boot CI -0.85 to -0.09) mediate the intervention's effect on sleep.

Conclusions: A self-help Web-based recovery training, grounded in the principles of iCBT-I, can be effective in the general working population, both short and long term. Work-related rumination may be a particularly crucial mediator of the intervention's effect, suggesting that tailoring interventions to the workplace, including components to reduce the work-related cognitive activity, might be important when designing recovery interventions for workers.

Trial Registration: German Clinical Trials Register DRKS00007142; https://www.drks.de/DRKS00007142.
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http://dx.doi.org/10.2196/13346DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6996739PMC
January 2020

A mobile application for panic disorder and agoraphobia: Insights from a multi-methods feasibility study.

Internet Interv 2020 Mar 25;19:100296. Epub 2019 Nov 25.

Friedrich-Alexander-University Nuremberg-Erlangen, Germany.

Background: Panic disorder with and without agoraphobia (PD) is a common psychological disorder. Internet-based interventions have the potential to offer highly scalable low-threshold evidence-based care to people suffering from PD. GET.ON Panic is a newly developed internet-based intervention addressing symptoms of PD. In order to transfer the training into the daily life of the individuals, we integrated mobile components in the training and created a so-called hybrid online training. The development and beta-testing of such a training requires a novel interdisciplinary approach between IT specialists and psychologists. From this point of view, we would like to share our experiences in this exploratory paper.

Methods: This initial feasibility study ( = 10) offers, on the one hand, a brief overview of the interdisciplinary development phase of the mobile application and on the other hand, provides first insights into the usage, usability and acceptance of this mobile application using qualitative interview data as well quantitative measures of 8 completing participants. For these reasons, we used a pre-posttest design without a control group. Furthermore, we present initial clinical outcomes of the intervention on e.g. panic symptom severity, depressive symptoms as well additional anxiety measures. Finally, we end with implications for further research in the relatively new field of mobile mental health.

Results: Overall, usability, user satisfaction, motivational value and technology acceptance of the app were perceived as high. The usage of app components was diverse: The use of interoceptive exposure exercises and daily summaries on anxiety and mood was highest while using in-vivo exposure exercises and monitoring panic symptoms was perceived as difficult. Furthermore, participants showed after the training less clinical symptoms as at baseline-assessment.

Discussion: The current feasibility study contributes to an in-depth understanding of the potential of mobile technology in e-mental health. Overall, the GET.ON Panic app appears to be an acceptable and motivational part of a CBT-based hybrid online training for PD that has the potential to promote training success. After some suggested adjustments have been made, the efficacy should be investigated in a randomized controlled trial.
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http://dx.doi.org/10.1016/j.invent.2019.100296DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6926267PMC
March 2020

Digital Interventions for Mental Disorders: Key Features, Efficacy, and Potential for Artificial Intelligence Applications.

Adv Exp Med Biol 2019 ;1192:583-627

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

Mental disorders are highly prevalent and often remain untreated. Many limitations of conventional face-to-face psychological interventions could potentially be overcome through Internet-based and mobile-based interventions (IMIs). This chapter introduces core features of IMIs, describes areas of application, presents evidence on the efficacy of IMIs as well as potential effect mechanisms, and delineates how Artificial Intelligence combined with IMIs may improve current practices in the prevention and treatment of mental disorders in adults. Meta-analyses of randomized controlled trials clearly show that therapist-guided IMIs can be highly effective for a broad range of mental health problems. Whether the effects of unguided IMIs are also clinically relevant, particularly under routine care conditions, is less clear. First studies on IMIs for the prevention of mental disorders have shown promising results. Despite limitations and challenges, IMIs are increasingly implemented into routine care worldwide. IMIs are also well suited for applications of Artificial Intelligence and Machine Learning, which provides ample opportunities to improve the identification and treatment of mental disorders. Together with methodological innovations, these approaches may also deepen our understanding of how psychological interventions work, and why. Ethical and professional restraints as well as potential contraindications of IMIs, however, should also be considered. In sum, IMIs have a high potential for improving the prevention and treatment of mental health disorders across various indications, settings, and populations. Therefore, implementing IMIs into routine care as both adjunct and alternative to face-to-face treatment is highly desirable. Technological advancements may further enhance the variability and flexibility of IMIs, and thus even further increase their impact in people's lives in the future.
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http://dx.doi.org/10.1007/978-981-32-9721-0_29DOI Listing
November 2019

Clinical and cost-effectiveness of guided internet-based interventions in the indicated prevention of depression in green professions (PROD-A): study protocol of a 36-month follow-up pragmatic randomized controlled trial.

BMC Psychiatry 2019 09 9;19(1):278. Epub 2019 Sep 9.

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

Background: People in green professions are exposed to a variety of risk factors, which could possibly enhance the development of depression. Amongst possible prevention approaches, internet- and mobile-based interventions (IMIs) have been shown to be effective and scalable. However, little is known about the effectiveness in green professions. The aim of the present study is to examine the (cost-)effectiveness of a tailored IMI program for reducing depressive symptoms and preventing the onset of clinical depression compared to enhanced treatment as usual (TAU+).

Methods: A pragmatic randomized controlled trial (RCT) will be conducted to evaluate a tailored and therapeutically guided preventive IMI program in comparison to TAU+ with follow-ups at post-treatment (9 weeks), 6-, 12-, 24-, and 36-months. Entrepreneurs in green professions, collaborating spouses, family members and pensioners (N = 360) with sufficient insurance status and at least subthreshold depression (PHQ-9 ≥ 5) are eligible for inclusion. Primary outcome is depressive symptom severity (QIDS-SR16). Secondary outcomes include incidence of depression (QIDS-SR16), quality of life (AQoL-8D) and negative treatment effects (INEP). A health-economic evaluation will be conducted from a societal perspective. The IMI program is provided by psychologists of an external service company and consists of six guided IMIs (6-8 modules, duration: 6-8 weeks) targeting different symptoms (depressive mood, depressive mood with comorbid diabetes, perceived stress, insomnia, panic and agoraphobic symptoms or harmful alcohol use). Intervention choice depends on a screening of participants' symptoms and individual preferences. The intervention phase is followed by a 12-months consolidating phase with monthly contact to the e-coach.

Discussion: This is the first pragmatic RCT investigating long-term effectiveness of a tailored guided IMI program for depression prevention in green professions. The present trial builds on a large-scale strategy for depression prevention in green professions. The intended implementation of the IMI program with a nationwide rollout has the potential to reduce overall depression burden and associated health care costs in case of given effectiveness.

Trial Registration: German Clinical Trial Registration: DRKS00014000 . Registered on 09 April 2018.
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http://dx.doi.org/10.1186/s12888-019-2244-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6734248PMC
September 2019

Adherence Reporting in Randomized Controlled Trials Examining Manualized Multisession Online Interventions: Systematic Review of Practices and Proposal for Reporting Standards.

J Med Internet Res 2019 08 15;21(8):e14181. Epub 2019 Aug 15.

Faculty of Psychology, School of Science, Technische Universität Dresden, Dresden, Germany.

Background: Adherence reflects the extent to which individuals experience or engage with the content of online interventions and poses a major challenge. Neglecting to examine and report adherence and its relation to outcomes can compromise the interpretation of research findings.

Objective: The aim of this systematic review is to analyze how adherence is accounted for in publications and to propose standards for measuring and reporting adherence to online interventions.

Methods: We performed a systematic review of randomized controlled trials on online interventions for the prevention and treatment of common mental disorders (depression, anxiety disorders, substance related disorders, and eating disorders) published between January 2006 and May 2018 and indexed in Medline and Web of Science. We included primary publications on manualized online treatments (more than 1 session and successive access to content) and examined how adherence was reported in these publications.

Results: We identified 216 publications that met our inclusion criteria. Adherence was addressed in 85% of full-text manuscripts, but only in 31% of abstracts. A median of three usage metrics were reported; the most frequently reported usage metric (61%) was intervention completion. Manuscripts published in specialized electronic health journals more frequently included information on the relation of adherence and outcomes.

Conclusions: We found substantial variety in the reporting of adherence and the usage metrics used to operationalize adherence. This limits the comparability of results and impedes the integration of findings from different studies. Based on our findings, we propose reporting standards for future publications on online interventions.
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http://dx.doi.org/10.2196/14181DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6713038PMC
August 2019

Unraveling the Black Box: Exploring Usage Patterns of a Blended Treatment for Depression in a Multicenter Study.

JMIR Ment Health 2019 Jul 25;6(7):e12707. Epub 2019 Jul 25.

Department of Research and Innovation, GGZ inGeest Specialized Mental Health Care, Amsterdam, Netherlands.

Background: Blended treatments, combining digital components with face-to-face (FTF) therapy, are starting to find their way into mental health care. Knowledge on how blended treatments should be set up is, however, still limited. To further explore and optimize blended treatment protocols, it is important to obtain a full picture of what actually happens during treatments when applied in routine mental health care.

Objective: The aims of this study were to gain insight into the usage of the different components of a blended cognitive behavioral therapy (bCBT) for depression and reflect on actual engagement as compared with intended application, compare bCBT usage between primary and specialized care, and explore different usage patterns.

Methods: Data used were collected from participants of the European Comparative Effectiveness Research on Internet-Based Depression Treatment project, a European multisite randomized controlled trial comparing bCBT with regular care for depression. Patients were recruited in primary and specialized routine mental health care settings between February 2015 and December 2017. Analyses were performed on the group of participants allocated to the bCBT condition who made use of the Moodbuster platform and for whom data from all blended components were available (n=200). Included patients were from Germany, Poland, the Netherlands, and France; 64.5% (129/200) were female and the average age was 42 years (range 18-74 years).

Results: Overall, there was a large variability in the usage of the blended treatment. A clear distinction between care settings was observed, with longer treatment duration and more FTF sessions in specialized care and a more active and intensive usage of the Web-based component by the patients in primary care. Of the patients who started the bCBT, 89.5% (179/200) also continued with this treatment format. Treatment preference, educational level, and the number of comorbid disorders were associated with bCBT engagement.

Conclusions: Blended treatments can be applied to a group of patients being treated for depression in routine mental health care. Rather than striving for an optimal blend, a more personalized blended care approach seems to be the most suitable. The next step is to gain more insight into the clinical and cost-effectiveness of blended treatments and to further facilitate uptake in routine mental health care.
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http://dx.doi.org/10.2196/12707DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6686640PMC
July 2019