Publications by authors named "Claudia Buntrock"

40 Publications

Editorial: How to Help Employees Returning to Work Following Depression.

Front Psychiatry 2021 25;12:714589. Epub 2021 Jun 25.

Depaatment of Psychiatry, University of Erlangen, Erlangen, Germany.

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http://dx.doi.org/10.3389/fpsyt.2021.714589DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8267170PMC
June 2021

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

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
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8185611PMC
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

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

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

@myTabu-A Placebo Controlled Randomized Trial of a Guided Web-Based Intervention for Individuals Who Sexually Abused Children and Individuals Who Consumed Child Sexual Exploitation Material: A Clinical Study Protocol.

Front Psychiatry 2020 8;11:575464. Epub 2021 Jan 8.

Clinic for Psychiatry and Psychotherapy-Forensic Psychiatry, University Medical Center Göttingen, Georg-August-University Göttingen, Göttingen, Germany.

There is a high demand for evidence-based and cost-effective treatment concepts for convicted individuals who sexually abused children (ISAC) and individuals who consumed child sexual exploitation material (ICCSEM) under community supervision (CS). The @myTabu-consortium developed a guided web-based intervention for convicted ISAC and ICCSEM under CS consisting of six online modules targeting psychological meaningful risk factors. The study aims to evaluate the effectiveness of this guided web-based intervention in reducing dynamic risk factors and the risk to re-offend compared to a placebo condition. Furthermore, these dynamic risk factors are measured before and after every module to evaluate their individual effectiveness to reduce the respective risk factor as well as risk to re-offend. This clinical trial protocol describes the planned methods as well as the intervention concept. The methodological design is a placebo controlled randomized add-on trial ( = 582) with follow-ups at 8 points in time. The placebo condition controls for attention and expectation effects and comprises the same amount of modules with a comparable temporal effort as the experimental intervention. The trial is conducted as an add-on to community supervision as usually done. Primary outcomes are dynamic risk factors assessed by self-report risk assessment tools and officially recorded re-offenses. To the best of our knowledge, the study is the first to compare the (cost-) effectiveness of a guided web-based intervention for convicted ISAC and ICCSEM under community supervision against a placebo condition. Methodological limitations (e.g., potential ceiling- or volunteers-effects) are discussed. : German Clinical Trial Register (DRKS 00021256). Prospectively registered: 24.04.2020.
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http://dx.doi.org/10.3389/fpsyt.2020.575464DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7820175PMC
January 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

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

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

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

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

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

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

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

Trial Registration Number: German Clinical Trial Registration: DRKS00014619. Registered on 16 April 2018.
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http://dx.doi.org/10.1136/bmjopen-2019-034271DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7473633PMC
September 2020

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

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

Clin Psychol Rev 2020 07 11;79:101859. Epub 2020 May 11.

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.

Psychological and psychoeducational interventions have proven to be effective in preventing depression. However, the identification of the patients that benefit the most from each type of intervention has not yet been established. A systematic review was performed of the literature on moderators of preventive psychological and psychoeducational interventions for depression in all types of population. A search was performed on PubMed, PsycINFO, Web of Science, Embase, Cochrane Central Register of Controlled Trials and OpenGrey up to July 2019. Fulfillment of eligibility criteria, data collection, and study quality assessment were assessed by two independent researchers. Outcomes were moderators of the reduction of depressive symptoms or the incidence of depression. Twenty-seven moderator effect studies performed in 19 randomized controlled trials were included. Thirty-four potential sociodemographic, clinical, interpersonal, personality and life-event moderators were evaluated. Baseline depressive symptoms, gender, age, baseline parental depression and social support were the most frequently studied potential moderators. In interventions for children and adolescents, the moderator for which evidence was strongest was having parents free of depression at baseline. Psychological and psychoeducational interventions seem to be more effective in children and adolescents who exhibit a lower use of substances and whose parents do not have symptoms of depression at baseline. In adults, a lower age was associated with greater effects of preventive interventions. ETHICS: As this systematic review is based on published data, approval from the local ethics committee was not required.
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http://dx.doi.org/10.1016/j.cpr.2020.101859DOI Listing
July 2020

Effectiveness of a Guided Web-Based Self-help Intervention to Prevent Depression in Patients With Persistent Back Pain: The PROD-BP Randomized Clinical Trial.

JAMA Psychiatry 2020 10;77(10):1001-1011

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

Importance: Depression is a frequent comorbid condition in patients with persistent back pain and is associated with substantial adverse consequences, including the risk of developing opioid use disorders. Shifting the focus from depression treatment to preventing depression might be a viable way to reduce the disease burden.

Objective: To evaluate the effectiveness of a web-based self-help intervention to reduce the incidence of major depressive episode (MDE) in patients with persistent back pain.

Design, Setting, And Participants: Prevention of Depression in Back Pain Patients (PROD-BP) was a pragmatic, observer-blinded randomized clinical trial with a parallel design conducted in Germany. Eligible adults with a diagnosis of persistent back pain and subclinical depressive symptoms, but who were depression free, were recruited either on-site or after discharge from 82 orthopedic clinics between October 1, 2015, and July 31, 2017. All analyses were conducted according to the intention-to-treat principle from October 31, 2018, to April 30, 2019.

Interventions: The intervention group received an e-coach-guided, web-based self-help intervention that was based on cognitive behavioral therapy and tailored to the needs of patients with persistent back pain. The intervention included 6 obligatory modules and 3 optional modules to be completed by participants as well as feedback from e-coaches. Both the intervention and control groups had unrestricted access to treatment as usual.

Main Outcomes And Measures: Primary outcome was time to onset of an MDE over a 12-month period as assessed by blinded diagnostic raters using the Structured Clinical Interview for DSM-5. Secondary outcomes included depression severity, quality of life, pain intensity, pain-related disability, pain self-efficacy, work capacity, and user satisfaction assessed with a variety of instruments.

Results: A total of 295 participants (mean [SD] age, 52.8 [7.7] years; 184 women [62.4%]) were recruited and randomized to either the intervention group (n = 149) or control group (n = 146). The intervention reduced the risk of MDE onset by 52% (hazard ratio, 0.48; 95% CI, 0.28-0.81; P < .001). Twenty-one participants (14.1%) in the intervention group and 41 participants (28.1%) in the control group experienced an MDE over the 12-month period. The number needed to treat to prevent 1 new case of MDE was 2.84 (95% CI, 1.79-9.44).

Conclusions And Relevance: Results of this trial showed that among patients with persistent back pain, depression can be prevented by a guided web-based self-help intervention in addition to treatment as usual. This finding suggests that using a scalable digital approach to integrate psychological treatment into routine pain management is feasible.

Trial Registration: German Clinical Trials Register Identifier: DRKS00007960.
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http://dx.doi.org/10.1001/jamapsychiatry.2020.1021DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7254449PMC
October 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

Clinical and Cost-Effectiveness of Personalized Tele-Based Coaching for Farmers, Foresters and Gardeners to Prevent Depression: Study Protocol of an 18-Month Follow-Up Pragmatic Randomized Controlled Trial (TEC-A).

Front Psychiatry 2020 4;11:125. Epub 2020 Mar 4.

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

Farmers show high levels of depressive symptoms and mental health problems in various studies. This study is part of a nationwide prevention project carried out by a German social insurance company for farmers, foresters, and gardeners (SVLFG) to implement internet- and tele-based services among others to improve mental health in this population. The aim of the present study is to evaluate the (cost-)effectiveness of personalized tele-based coaching for reducing depressive symptom severity and preventing the onset of clinical depression, compared to enhanced treatment as usual. In a two-armed, pragmatic randomized controlled trial ( = 312) with follow-ups at post-treatment (6 months), 12 and 18 months, insured farmers, foresters, and gardeners, collaborating family members and pensioners with elevated depressive symptoms (PHQ-9 ≥ 5) will be randomly allocated to personalized tele-based coaching or enhanced treatment as usual. The coaching is provided by psychologists and consists of up to 34 tele-based sessions for 25-50 min delivered over 6 months. Primary outcome is depressive symptom severity at post-treatment. Secondary outcomes include depression onset, anxiety, stress, and quality of life. A health-economic evaluation will be conducted from a societal perspective. This study is the first pragmatic randomized controlled trial evaluating the (cost-)effectiveness of a nationwide tele-based preventive service for farmers. If proven effective, the implementation of personalized tele-based coaching has the potential to reduce disease burden and health care costs both at an individual and societal level. German Clinical Trial Registration: DRKS00015655.
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http://dx.doi.org/10.3389/fpsyt.2020.00125DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7064472PMC
March 2020

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

A systematic review of trial-based economic evaluations of internet- and mobile-based interventions for substance use disorders.

Eur J Public Health 2021 Jul;31(Supplement_1):i19-i28

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

Background: Substance use disorders (SUDs) contribute significantly to global rates of morbidity and mortality. Internet- and mobile-based interventions (IMIs) have been suggested as an adjunct to face-to-face health services. However, the evidence for the cost-effectiveness of IMIs for SUDs is scant.

Methods: A comprehensive literature search in PubMed, PsycINFO, the Cochrane Central Register of Controlled Trials, NHS Economic Evaluations Database, NHS Health Technology Assessment Database, Office of Health Economics Evaluations Database and EconLit was conducted. We included economic evaluations alongside randomized controlled trials of IMIs for SUDs compared with a control group.

Results: Of 1687 abstracts identified, 11 studies met the inclusion criteria. Targeted conditions were alcohol use disorder (four studies) and tobacco smoking (five studies) whereas two studies included any SUD. Cost-effectiveness results demonstrated that IMIs had a firm probability of being more cost-effective than TAU (e.g. less costs per additional abstinent person). Compared with (online) psycho-education, evidence towards an additional benefit of IMIs was less clear. Regarding cost-utility (e.g. costs per quality-adjusted life year gained), except for one study, results suggested that TAU and online psycho-education would probably be more preferable than IMIs. Quality of study reporting was at least adequate.

Conclusions: The likelihood of IMIs being more cost-effective than TAU looks promising but more economic evaluations are needed in order to determine the economic merit of IMIs. With an increasing pressure on health care budgets, strategies to disseminate effective interventions at affordable costs are required. This review suggests that IMIs might carry that promise and have potential as a cost-effective strategy to scale-up existing evidence-based treatments for SUDs.

Systematic Review Registration: The systematic review has been registered in the PROSPERO database (no. CRD42018099486).
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http://dx.doi.org/10.1093/eurpub/ckz022DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8266535PMC
July 2021

A systematic review of trial-based economic evaluations of internet- and mobile-based interventions for substance use disorders.

Eur J Public Health 2021 Jul;31(Supplement_1):i19-i28

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

Background: Substance use disorders (SUDs) contribute significantly to global rates of morbidity and mortality. Internet- and mobile-based interventions (IMIs) have been suggested as an adjunct to face-to-face health services. However, the evidence for the cost-effectiveness of IMIs for SUDs is scant.

Methods: A comprehensive literature search in PubMed, PsycINFO, the Cochrane Central Register of Controlled Trials, NHS Economic Evaluations Database, NHS Health Technology Assessment Database, Office of Health Economics Evaluations Database and EconLit was conducted. We included economic evaluations alongside randomized controlled trials of IMIs for SUDs compared with a control group.

Results: Of 1687 abstracts identified, 11 studies met the inclusion criteria. Targeted conditions were alcohol use disorder (four studies) and tobacco smoking (five studies) whereas two studies included any SUD. Cost-effectiveness results demonstrated that IMIs had a firm probability of being more cost-effective than TAU (e.g. less costs per additional abstinent person). Compared with (online) psycho-education, evidence towards an additional benefit of IMIs was less clear. Regarding cost-utility (e.g. costs per quality-adjusted life year gained), except for one study, results suggested that TAU and online psycho-education would probably be more preferable than IMIs. Quality of study reporting was at least adequate.

Conclusions: The likelihood of IMIs being more cost-effective than TAU looks promising but more economic evaluations are needed in order to determine the economic merit of IMIs. With an increasing pressure on health care budgets, strategies to disseminate effective interventions at affordable costs are required. This review suggests that IMIs might carry that promise and have potential as a cost-effective strategy to scale-up existing evidence-based treatments for SUDs.

Systematic Review Registration: The systematic review has been registered in the PROSPERO database (no. CRD42018099486).
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http://dx.doi.org/10.1093/eurpub/ckz022DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8266535PMC
July 2021

Economic Evaluation of an Internet-Based Stress Management Intervention Alongside a Randomized Controlled Trial.

JMIR Ment Health 2019 May 15;6(5):e10866. Epub 2019 May 15.

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

Background: Work-related stress is widespread among employees and associated with high costs for German society. Internet-based stress management interventions (iSMIs) are effective in reducing such stress. However, evidence for their cost-effectiveness is scant.

Objective: The aim of this study was to assess the cost-effectiveness of a guided iSMI for employees.

Methods: A sample of 264 employees with elevated symptoms of perceived stress (Perceived Stress Scale≥22) was assigned to either the iSMI or a waitlist control condition (WLC) with unrestricted access to treatment as usual. Participants were recruited in Germany in 2013 and followed through 2014, and data were analyzed in 2017. The iSMI consisted of 7 sessions plus 1 booster session. It was based on problem-solving therapy and emotion regulation techniques. Costs were measured from the societal perspective, including all direct and indirect medical costs. We performed a cost-effectiveness analysis and a cost-utility analysis relating costs to a symptom-free person and quality-adjusted life years (QALYs) gained, respectively. Sampling uncertainty was handled using nonparametric bootstrapping (N=5000).

Results: When the society is not willing to pay anything to get an additional symptom-free person (eg, willingness-to-pay [WTP]=€0), there was a 70% probability that the intervention is more cost-effective than WLC. This probability rose to 85% and 93% when the society is willing to pay €1000 and €2000, respectively, for achieving an additional symptom-free person. The cost-utility analysis yielded a 76% probability that the intervention is more cost-effective than WLC at a conservative WTP threshold of €20,000 (US $25,800) per QALY gained.

Conclusions: Offering an iSMI to stressed employees has an acceptable likelihood of being cost-effective compared with WLC.

Trial Registration: German Clinical Trials Register DRKS00004749; https://www.drks.de/DRKS00004749.

International Registered Report Identifier (irrid): RR2-10.1186/1471-2458-13-655.
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http://dx.doi.org/10.2196/10866DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6707573PMC
May 2019

Children of Mentally III Parents at Risk Evaluation (COMPARE): Design and Methods of a Randomized Controlled Multicenter Study-Part I.

Front Psychiatry 2019 26;10:128. Epub 2019 Mar 26.

Department of Special Needs Educational and Clinical Child and Adolescent Psychology, Faculty of Psychology and Sports Science, Justus-Liebig-University Gießen, Gießen, Germany.

Mental disorders are frequent, associated with disability-adjusted life years, societal, and economic costs. Children of parents with a mental illness (COPMI) are at an increased risk to develop disorders themselves. The transgenerational transmission of mental disorders has been conceptualized in a model that takes parental and family factors, the social environment (i.e., school, work, and social support), parent-child-interaction and possible child outcomes into account. The goal of the "Children of Mentally Ill Parents At Risk Evaluation" (COMPARE) study will thus be twofold: (1) to establish the efficacy and cost-effectiveness of a high-quality randomized controlled trial (RCT) with the aim of interrupting the intergenerational transmission of mental disorders in COPMI, (2) to test the components of the trans-generational transmission model of mental disorders. To implement a randomized controlled trial (RCT: comparison of parental cognitive behavioral therapy/CBT with CBT + Positive Parenting Program) that is flanked by four add-on projects that apply behavioral, psychophysiological, and neuro-imaging methods to examine potential moderators and mediators of risk transmission (projects COMPARE-emotion/-interaction/-work/-school). COMPARE-emotion targets emotion processing and regulation and its impact on the transgenerational disorder transmission; COMPARE-interaction focuses especially on the impact of maternal comorbid diagnoses of depression and anxiety disorders and will concentrate on different pathways of the impact of maternal disorders on socio-emotional and cognitive infant development, such as parent-infant interaction and the infant's stress regulation skills. COMPARE-work analyzes the transmission of strains a person experiences in one area of life to another (i.e., from family to work; spill-over), and how stress and strain are transmitted between individuals (i.e., from parent to child; cross-over). COMPARE-school focuses on the psychosocial adjustment, school performance, and subjective well-being in COPMI compared to an adequate control group of healthy children. This study protocol reports on the interdisciplinary approach of COMPARE testing the model of the transgenerational transmission of mental disorders. The combination of applied basic with clinical research will facilitate the examination of specific risk transmission mechanisms, promotion, dissemination and implementation of results into a highly important but largely neglected field. DRKS-ID: DRKS00013516 (German Clinical Trials Register, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00013516).
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http://dx.doi.org/10.3389/fpsyt.2019.00128DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6443700PMC
March 2019

A guided and unguided internet- and mobile-based intervention for chronic pain: health economic evaluation alongside a randomised controlled trial.

BMJ Open 2019 04 9;9(4):e023390. Epub 2019 Apr 9.

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

Objective: This study aims at evaluating the cost-effectiveness and cost-utility of a guided and unguided internet-based intervention for chronic pain patients (ACTonPain and ACTonPain) compared with a waitlist control group (CG) as well as the comparative cost-effectiveness of the guided and the unguided version.

Design: This is a health economic evaluation alongside a three-arm randomised controlled trial from a societal perspective. Assessments were conducted at baseline, 9 weeks and 6 months after randomisation.

Setting: Participants were recruited through online and offline strategies and in collaboration with a health insurance company.

Participants: 302 adults (≥18 years, pain for at least 6 months) were randomly allocated to one of the three groups (ACTonPain, ACTonPain, CG).

Interventions: ACTonPain consists of seven modules and is based on Acceptance and Commitment Therapy. ACTonPain and ACTonPain only differ in provision of human support.

Primary And Secondary Outcome Measures: Main outcomes of the cost-effectiveness and the cost-utility analyses were meaningful change in pain interference (treatment response) and quality-adjusted life years (QALYs), respectively. Economic evaluation estimates were the incremental cost-effectiveness and cost-utility ratio (ICER/ICUR).

Results: At 6-month follow-up, treatment response and QALYs were highest in ACTonPain (44% and 0.280; mean costs = €6,945), followed by ACTonPain (28% and 0.266; mean costs = €6,560) and the CG (16% and 0.244; mean costs = €6,908). ACTonPain vs CG revealed an ICER of €45 and an ICUR of €604.ACTonPain dominated CG. At a willingness-to-pay of €0 the probability of being cost-effective was 50% for ACTonPain (vs CG, for both treatment response and QALY gained) and 67% for ACTonPain (vs CG, for both treatment response and QALY gained). These probabilities rose to 95% when society's willingness-to-pay is €91,000 (ACTonPain) and €127,000 (ACTonPain) per QALY gained. ACTonPain vs ACTonPain revealed an ICER of €2,374 and an ICUR of €45,993.

Conclusions: Depending on society's willingness-to-pay, ACTonPain is a potentially cost-effective adjunct to established pain treatment. ACTonPain (vs CG) revealed lower costs at better health outcomes. However, uncertainty has to be considered. Direct comparison of the two interventions does not indicate a preference for ACTonPain.

Trial Registration Number: DRKS00006183.
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http://dx.doi.org/10.1136/bmjopen-2018-023390DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6500312PMC
April 2019

COMPARE Family (Children of Mentally Ill Parents at Risk Evaluation): A Study Protocol for a Preventive Intervention for Children of Mentally Ill Parents (Triple P, Evidence-Based Program That Enhances Parentings Skills, in Addition to Gold-Standard CBT With the Mentally Ill Parent) in a Multicenter RCT-Part II.

Front Psychiatry 2019 22;10:54. Epub 2019 Feb 22.

Department of Clinical Child and Adolescent Psychology, Philipps University Marburg, Marburg, Germany.

Mental health problems are highly frequent, as well as being associated with enormous societal and economic costs and significant disability-adjusted life years. Children of parents with a mental illness (COPMI) are at a tremendously increased risk to develop disorders themselves. According to the literature, parental mental disorders launch a wave of risk factors that in turn predict the emergence of psychological problems in the offspring, and effective treatment of the parental disorder has been associated with reduced child psychopathology (launch and grow assumption). Furthermore, studies focusing on parent-child interaction demonstrate generally poorer parenting skills in parents with mental disorders, and the enhancement of such skills has been a significant mediator in improving child outcomes (parenting assumption). To implement a preventive intervention for COPMI with the aim of interrupting the transmission of mental disorders in children of a parent with mental disorders. An RCT will compare state-of-the-art cognitive behavioral therapy (CBT) for a parent with mental disorders to CBT plus the Positive Parenting Program (Triple-P), a well-established and evidence-based program that enhances parenting skills. A total of 634 patients seeking treatment in 8 outpatient clinics in Germany and their children will be included between January 2018 and April 2021 in the study. We use (clinical) interviews and self- as well as other-report questionnaires to assess the families at four main measurement points [T1: beginning of waiting period for psychotherapy treatment (duration of waiting period depends on usual waiting period in the study center: multiple baselines), T2: begin of parental psychotherapy, T3: post-assessment, T4: 6 months follow-up]. The total observation period will be 39 months. The patients will be randomly assigned to either the control condition (25 to 45 CBT sessions) or the experimental condition (25 to 45 CBT sessions + 10 Triple-P sessions). For evaluating the treatment process, the patients and clinicians will also be assessed after each treatment session. Furthermore, there will be a continuous assessment and report of adverse events during treatment. This trial will be the first ever to address the launch and grow as well as the parenting assumption in one study and to establish effects of the two different interventions on children's health. Our study will also likely be the first one to provide data on the comparative cost-effectiveness and will therefore provide essential information relevant for the potential implementation of such programs. The structure of the RCT will allow us to establish effects of the parental disorder(s) with/without comorbidities on children's health, to test assumptions of the trans-generational transmission model of mental disorders and bi-directional influences of different treatments on the model and to analyze specific transmission mechanisms. A deeper understanding of risk mechanisms will reveal specific transmission profiles that will result in the early detection of and effective reduction in risk factors and thus improve the health of the children at risk. The study is carried out according to the Good Clinical Practice (GCP) guidelines, the Declaration of Helsinki and its later supplements and local legal requirements. The lead ethics committee at the department of psychology at Philipps-University Marburg approved the study procedure and all study documents. A positive ethics committee vote is required at a study site, before the inclusion of a first patient at the respective site. Via peer-reviewed publications in scientific journals, the results of this study will be made available to the scientific community. Using PsychData all primary data will be made available for re- and meta-analyses. Politicians, public health services, and stakeholders will be informed throughout the study and beyond, thus, improving public policy and health care decisions concerning preventive interventions and treatments for COPMI. DRKS-ID: DRKS00013516 (German Clinical Trials Register, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00013516).
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http://dx.doi.org/10.3389/fpsyt.2019.00054DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6401604PMC
February 2019

Assessing the costs and cost-effectiveness of ICare internet-based interventions (protocol).

Internet Interv 2019 Apr 27;16:12-19. Epub 2018 Feb 27.

TechnischeUniversität Dresden, School of Science, Faculty of Psychology, Chair ofClinical Psychology and E-Mental-Health, 01062 Dresden, Germany.

Background: Mental health problems are common and place a burden on the individual as well as on societal resources. Despite the existence of evidence-based treatments, access to treatment is often prevented or delayed due to insufficient health care resources. Effective internet-based self-help interventions have the potential to reduce the risk for mental health problems, to successfully bridge waiting time for face-to-face treatment and to address inequities in access. However, little is known about the cost-effectiveness of such interventions. This paper describes the study protocol for the economic evaluation of the studies that form the ICare programme of internet-based interventions for the prevention and treatment of a range of mental health problems.

Methods: An overarching work package within the ICare programme was developed to assess the cost-effectiveness of the internet-based interventions alongside the clinical trials. There are two underlying tasks in the ICare economic evaluation. First, to develop schedules that generate equivalent and comparable information on use of services and supports across seven countries taking part in clinical trials of different interventions and second, to estimate unit costs for each service and support used. From these data the cost per person will be estimated by multiplying each participant's use of each service by the unit cost for that service. Additionally, productivity losses will be estimated. This individual level of cost data matches the level of outcome data used in the clinical trials. Following the analyses of service use and costs data, joint analysis of costs and outcomes will be undertaken to provide findings on the relative cost-effectiveness of the interventions, taking both a public sector and a societal perspective. These analyses use a well-established framework, the Production of Welfare approach, and standard methods and techniques underpinned by economic theory.

Discussion/conclusion: Existing research tends to support the effectiveness of internet-based interventions, but there is little information on their cost-effectiveness compared to 'treatment as usual'. The economic evaluation of ICare interventions will add considerably to this evidence base.
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http://dx.doi.org/10.1016/j.invent.2018.02.009DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6364355PMC
April 2019

Prediction of major depressive disorder onset in college students.

Depress Anxiety 2019 04 6;36(4):294-304. Epub 2018 Dec 6.

Department of Psychiatry, Harvard Medical School, Boston, MA, USA.

Background: Major depressive disorder (MDD) in college students is associated with substantial burden.

Aims: To assess 1-year incidence of MDD among incoming freshmen and predictors of MDD-incidence in a representative sample of students.

Method: Prospective cohort study of first-year college students (baseline: n = 2,519, 1-year follow-up: n = 958) RESULTS: The incidence of MDD within the first year of college was 6.9% (SE = 0.8). The most important individual-level predictors of onset were prior suicide plans and/or attempts (OR = 9.5). The strongest population-level baseline predictors were history of childhood-adolescent trauma, stressful experience in the past 12 months, parental psychopathology, and other 12-month mental disorder. Multivariate cross-validated prediction (cross-validated AUC = 0.73) suggest that 36.1% of incident MDD cases in a replication sample would occur among the 10% of students at highest predicted risk (24.5% predicted incidence in this highest-risk subgroup).

Conclusions: Screening at college entrance is a promising strategy to identify students at risk of MDD onset, which may improve the development and deployment of targeted preventive interventions.
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http://dx.doi.org/10.1002/da.22867DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6519292PMC
April 2019

Web-based intervention for depressive symptoms in adults with types 1 and 2 diabetes mellitus: a health economic evaluation.

Br J Psychiatry 2018 04;212(4):199-206

Division of Online Health Training,Innovation Incubator,Leuphana University of Lueneburg,Germany,Department of Clinical Psychology,VU University Amsterdam,The NetherlandsandInstitute of Telepsychiatry,University of Southern Denmark,Odense,Denmark.

Background: Web-based interventions are effective in reducing depression. However, the evidence for the cost-effectiveness of these interventions is scarce.AimsThe aim is to assess the cost-effectiveness of a web-based intervention (GET.ON M.E.D.) for individuals with diabetes and comorbid depression compared with an active control group receiving web-based psychoeducation.

Method: We conducted a cost-effectiveness analysis with treatment response as the outcome and a cost-utility analysis with quality-adjusted life-years (QALYs) alongside a randomised controlled trial with 260 participants.

Results: At a willingness-to-pay ceiling of €5000 for a treatment response, the intervention has a 97% probability of being regarded as cost-effective compared with the active control group. If society is willing to pay €14 000 for an additional QALY, the intervention has a 51% probability of being cost-effective.

Conclusions: This web-based intervention for individuals with diabetes and comorbid depression demonstrated a high probability of being cost-effective compared with an active control group.Declaration of interestS.N., D.D.E., D.L., M.B. and B.F. are stakeholders of the Institute for Online Health Trainings, which aims to transfer scientific knowledge related to this research into routine healthcare.
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http://dx.doi.org/10.1192/bjp.2018.10DOI Listing
April 2018

Do guided internet-based interventions result in clinically relevant changes for patients with depression? An individual participant data meta-analysis.

Clin Psychol Rev 2018 07 19;63:80-92. Epub 2018 Jun 19.

Institute of Psychology, Leuphana University Lüneburg, Germany.

Little is known about clinically relevant changes in guided Internet-based interventions for depression. Moreover, methodological and power limitations preclude the identification of patients' groups that may benefit more from these interventions. This study aimed to investigate response rates, remission rates, and their moderators in randomized controlled trials (RCTs) comparing the effect of guided Internet-based interventions for adult depression to control groups using an individual patient data meta-analysis approach. Literature searches in PubMed, Embase, PsycINFO and Cochrane Library resulted in 13,384 abstracts from database inception to January 1, 2016. Twenty-four RCTs (4889 participants) comparing a guided Internet-based intervention with a control group contributed data to the analysis. Missing data were multiply imputed. To examine treatment outcome on response and remission, mixed-effects models with participants nested within studies were used. Response and remission rates were calculated using the Reliable Change Index. The intervention group obtained significantly higher response rates (OR = 2.49, 95% CI 2.17-2.85) and remission rates compared to controls (OR = 2.41, 95% CI 2.07-2.79). The moderator analysis indicated that older participants (OR = 1.01) and native-born participants (1.66) were more likely to respond to treatment compared to younger participants and ethnic minorities respectively. Age (OR = 1.01) and ethnicity (1.73) also moderated the effects of treatment on remission.Moreover, adults with more severe depressive symptoms at baseline were more likely to remit after receiving internet-based treatment (OR = 1.19). Guided Internet-based interventions lead to substantial positive treatment effects on treatment response and remission at post-treatment. Thus, such interventions may complement existing services for depression and potentially reduce the gap between the need and provision of evidence-based treatments.
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http://dx.doi.org/10.1016/j.cpr.2018.06.007DOI Listing
July 2018

Efficacy and moderators of psychological interventions in treating subclinical symptoms of depression and preventing major depressive disorder onsets: protocol for an individual patient data meta-analysis of randomised controlled trials.

BMJ Open 2018 03 16;8(3):e018582. Epub 2018 Mar 16.

Department of Clinical, Neuro and Developmental Psychology, EMGO+ Institute for Health and Care Research, VU University Amsterdam, Amsterdam, The Netherlands.

Introduction: The long-term effectiveness of psychological interventions for the treatment of subthreshold depression and the prevention of depression is unclear and effects vary among subgroups of patients, indicating that not all patients profit from such interventions. Randomised clinical trials are mostly underpowered to examine adequately subgroups and moderator effects. The aim of the present study is, therefore, to examine the short-term and long-term as well as moderator effects of psychological interventions compared with control groups in adults with subthreshold depression on depressive symptom severity, treatment response, remission, symptom deterioration, quality of life, anxiety and the prevention of major depressive disorder (MDD) onsets on individual patient level and study level using an individual patient data meta-analysis approach.

Methods And Analysis: Systematic searches in PubMed, PsycINFO, Embase and the Cochrane Central Register of Controlled Trials were conducted. We will use the following types of outcome criteria: (A) onset of major depression; (B) time to major depression onset; (C) observer-reported and self-reported depressive symptom severity; (D) response; (E) remission; (F) symptom deterioration; (G) quality of life, (H) anxiety; and (I) suicidal thoughts and behaviours. Multilevel models with participants nested within studies will be used. Missing data will be handled using a joint modelling approach to multiple imputation. A number of sensitivity analyses will be conducted in order test the robustness of our findings.

Ethics And Dissemination: The investigators of the primary trials have obtained ethical approval for the data used in the present study and for sharing the data, if this was necessary, according to local requirements and was not covered from the initial ethic assessment.This study will summarise the available evidence on the short-term and long-term effectiveness of preventive psychological interventions for the treatment of subthreshold depression and prevention of MDD onset. Identification of subgroups of patients in which those interventions are most effective will guide the development of evidence-based personalised interventions for patients with subthreshold depression.

Prospero Registration Number: CRD42017058585.
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http://dx.doi.org/10.1136/bmjopen-2017-018582DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5857689PMC
March 2018

Effectiveness of Web- and Mobile-Based Treatment of Subthreshold Depression With Adherence-Focused Guidance: A Single-Blind Randomized Controlled Trial.

Behav Ther 2018 01 25;49(1):71-83. Epub 2017 May 25.

Friedrich-Alexander University Erlangen-Nuremberg; Leuphana University Lueneburg.

Evidence for the impact of psychological Interventions for subthreshold depression (sD) is conflicting. Moreover, human resources to deliver such treatments are limited. This study aimed to evaluate the effectiveness of a web-based intervention with adherence-focused guidance in the treatment of sD. Participants with sD (CES-D≥ 16, no Major Depressive Disorder according to DSM-IV criteria, N = 204) recruited via a large health insurance were randomly allocated to a web-based mobile-supported cognitive-behavioral intervention or to a waitlist control condition with unrestricted access to usual care. The primary outcome was the reduction in depressive symptom severity as measured by blind diagnostic raters using the Quick Inventory of Depressive Symptomatology (QIDS) at posttreatment. There was a statistically significant between-group difference in QIDS scores at posttreatment in favor of the intervention group, F(1, 201) = 11.31, p = .001, corresponding to a medium effect size of d = 0.37 (95% CI 0.09-0.64) and a NNT of 7 (95%-CI 3.7-41.2). Significant effects in favour of the intervention group were also found for secondary outcomes such as quality of life, anxiety, and insomnia severity. Web-based self-help interventions with adherence-focused guidance could be an acceptable and effective approach to reduce a range of negative consequences associated with subclinical depression.
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http://dx.doi.org/10.1016/j.beth.2017.05.004DOI Listing
January 2018

Cost effectiveness of guided Internet-based interventions for depression in comparison with control conditions: An individual-participant data meta-analysis.

Depress Anxiety 2018 03 12;35(3):209-219. Epub 2018 Jan 12.

Department of Health Sciences, Faculty of Earth and Life Sciences, Amsterdam Public Health Research Institute, VU University Amsterdam, Amsterdam, The Netherlands.

Background: There is limited evidence on the cost effectiveness of Internet-based treatments for depression. The aim was to evaluate the cost effectiveness of guided Internet-based interventions for depression compared to controls.

Methods: Individual-participant data from five randomized controlled trials (RCT), including 1,426 participants, were combined. Cost-effectiveness analyses were conducted at 8 weeks, 6 months, and 12 months follow-up.

Results: The guided Internet-based interventions were more costly than the controls, but not statistically significant (12 months mean difference = €406, 95% CI: - 611 to 1,444). The mean differences in clinical effects were not statistically significant (12 months mean difference = 1.75, 95% CI: - .09 to 3.60 in Center for Epidemiologic Studies Depression Scale [CES-D] score, .06, 95% CI: - .02 to .13 in response rate, and .00, 95% CI: - .03 to .03 in quality-adjusted life-years [QALYs]). Cost-effectiveness acceptability curves indicated that high investments are needed to reach an acceptable probability that the intervention is cost effective compared to control for CES-D and response to treatment (e.g., at 12-month follow-up the probability of being cost effective was .95 at a ceiling ratio of 2,000 €/point of improvement in CES-D score). For QALYs, the intervention's probability of being cost effective compared to control was low at the commonly accepted willingness-to-pay threshold (e.g., at 12-month follow-up the probability was .29 and. 31 at a ceiling ratio of 24,000 and 35,000 €/QALY, respectively).

Conclusions: Based on the present findings, guided Internet-based interventions for depression are not considered cost effective compared to controls. However, only a minority of RCTs investigating the clinical effectiveness of guided Internet-based interventions also assessed cost effectiveness and were included in this individual-participant data meta-analysis.
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http://dx.doi.org/10.1002/da.22714DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5888145PMC
March 2018

Turning Good Intentions Into Actions by Using the Health Action Process Approach to Predict Adherence to Internet-Based Depression Prevention: Secondary Analysis of a Randomized Controlled Trial.

J Med Internet Res 2018 01 11;20(1):e9. Epub 2018 Jan 11.

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

Background: Many individuals engaging in Internet-based interventions fail to complete these treatments as intended. The processes responsible for treatment adherence in Internet-based interventions are still poorly understood.

Objective: The aim of this study was to investigate to what extent adherence in an Internet-based intervention can be predicted by motivational and volitional factors outlined in the health action process approach (HAPA).

Methods: This study investigated motivational and volitional factors included in HAPA in a randomized controlled trial to predict treatment adherence of N=101 individuals with subclinical depression in the intervention group of a depression prevention intervention (GET.ON Mood Enhancer). Adherence was operationalized as the number of completed treatment modules. Using longitudinal structural equation modeling, HAPA variables (motivational, maintenance, and recovery self-efficacy, outcome expectancies, intention, and planning) were assessed at baseline and their associations with adherence 7 weeks later.

Results: Planning predicted adherence. Better planning was, in turn, associated with higher levels of maintenance self-efficacy, and the latter significantly affected treatment adherence via planning. The other hypothesized direct associations were not significant. In total, the HAPA variables accounted for 14% of variance in treatment adherence.

Conclusions: Planning emerged as the strongest predictor of treatment adherence in highly motivated participants in an Internet-based intervention out of all HAPA variables investigated. Findings are in line with the hypothesis that planning facilitates the translation of good intentions into actions. The findings imply that systematically fostering planning skills and maintenance self-efficacy prior to or during Internet-based interventions would help participants to successfully complete these treatments.

Trial Registration: German Clinical Trials Register DRKS00005973; https://www.drks.de/drks_web/navigate.do? navigationId=trial.HTML&TRIAL_ID=DRKS00005973 (Archived by WebCite at http://www.webcitation.org/6uxCy64sy).
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http://dx.doi.org/10.2196/jmir.8814DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5785685PMC
January 2018