Publications by authors named "Anna-Carlotta Zarski"

23 Publications

  • Page 1 of 1

Stakeholders' views on online interventions to prevent common mental health disorders in adults implemented into existing healthcare systems in Europe.

Eur J Public Health 2021 Jul;31(Supplement_1):i55-i63

Ferdinand Porsche FernFH-Distance Learning University of Applied Sciences, Wiener Neustadt 2700, Austria.

Background: Online preventive interventions can help to reduce the incidence of mental disorders. Whereas knowledge on stakeholders' attitudes and factors relevant for successfully integrating online treatment into existing healthcare systems is available, knowledge is scarce for online prevention.

Methods: Stakeholders from Germany, Switzerland, Austria and Spain were surveyed. Potential facilitators/delivery staff (e.g. psychologists, psychotherapists) completed an online questionnaire (n = 183), policy makers (i.e. from the governing sector or health insurance providers) participated in semi-structured interviews (n = 16) and target groups/potential users of mental illness prevention (n = 49) participated in ten focus groups. Thematic analysis was used to identify their experiences with and attitudes and needs regarding online programmes to prevent mental disorders. Additionally, it was examined which groups they consider underserved and which factors they consider as fostering and hindering for reach, adoption, implementation and maintenance (cf. RE-AIM model) when integrating online prevention into existing healthcare systems.

Results: Main advantages of online mental illness prevention are perceived in low structural and psychological barriers. Lack of personal contact, security, privacy and trust concerns were discussed as disadvantages. Relevant needs are high usability and target group appropriateness, evidence for effectiveness and the use of motivational tools.

Conclusions: Positive attitudes among stakeholders are the key for successful integration of online mental illness prevention into existing healthcare systems. Potential facilitators/delivery staff must receive training and support to implement these programmes; the programmes must be attractive and continuously evaluated, updated and promoted to ensure ongoing reach; and existing infrastructure and contextual factors must be considered.
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http://dx.doi.org/10.1093/eurpub/ckab043DOI Listing
July 2021

Online prevention programmes for university students: stakeholder perspectives from six European countries.

Eur J Public Health 2021 Jul;31(Supplement_1):i64-i70

King's College London, Institute of Psychiatry, Psychology and Neuroscience, London, UK.

Background: Students beginning university are at a heightened risk for developing mental health disorders. Online prevention and early intervention programmes targeting mental health have the potential to reduce this risk, however, previous research has shown uptake to be rather poor. Understanding university stakeholders' (e.g. governing level and delivery staff [DS] and students) views and attitudes towards such online prevention programmes could help with their development, implementation and dissemination within university settings.

Methods: Semi-structured interviews, focus groups and online surveys were completed with staff at a governing level, university students and DS (i.e. student health or teaching staff) from six European countries. They were asked about their experiences with, and needs and attitudes towards, online prevention programmes, as well as the factors that influence the translation of these programmes into real-world settings. Results were analyzed using thematic analysis.

Results: Participating stakeholders knew little about online prevention programmes for university settings; however, they viewed them as acceptable. The main themes to emerge were the basic conditions and content of the programmes, the awareness and engagement, the resources needed, the usability and the responsibility and ongoing efforts to increase reach.

Conclusions: Overall, although these stakeholders had little knowledge about online prevention programmes, they were open to the idea of introducing them. They could see the potential benefits that these programmes might bring to a university setting as a whole and the individual students and staff members.
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http://dx.doi.org/10.1093/eurpub/ckab040DOI Listing
July 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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Internet- and App-Based Stress Intervention for Distance-Learning Students With Depressive Symptoms: Protocol of a Randomized Controlled Trial.

Front Psychiatry 2019 21;10:361. Epub 2019 May 21.

Clinical Psychology and Psychotherapy, Institute for Psychology, Friedrich-Alexander-University Erlangen-Nuremberg, Erlangen, Germany.

Mental disorders are highly prevalent among university students. Distance-learning students are particularly burdened and have limited access to conventional university health services. Interventions for stress are sought after in distance learners and may help increase treatment coverage. Internet-based interventions have been shown to be effective in preventing and treating depression, but it remains unclear if interventions directed at academic stress also have this potential. The trial presented here investigates the effectiveness of an Internet- and App-based stress intervention in distance-learning students with elevated levels of depression. A sample of = 200 students of a large German distance university with elevated levels of depression [Center for Epidemiological Studies' Depression Scale (CES-D) ≥ 16] will be randomly assigned to either an Internet- and App-based stress management intervention group (IG) or a control group (CG) receiving an Internet-based psychoeducational program for academic stress. The IG consists of eight Internet-based sessions promoting stress management skills using cognitive-behavioral and problem-solving techniques. A mobile App will be employed to facilitate training transfer. Self-report data will be assessed at baseline (T0), post-treatment (T1; 7 weeks), and 3-month follow-up (T2). Potential moderators will be assessed at baseline. The primary outcome is depression (CES-D) post-treatment. Secondary outcomes include mental health outcomes, modifiable risk and protective factors, and academic outcomes. Data will be analyzed on an intention-to-treat principle along with sensitivity analyses to assess the robustness of findings. Additional health economic analyses will be conducted. Results will provide the basis to assess the acceptance and effectiveness of Internet-delivered stress interventions in distance-learning students with symptoms of depression. The study has been reviewed and approved by the University of Erlangen-Nuremberg ethics committee (Erlangen, Germany; 33_17 Bc). Results of the study will be disseminated through peer-reviewed publications. German Clinical Trial Registration (DRKS), identifier DRKS00011800.
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http://dx.doi.org/10.3389/fpsyt.2019.00361DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6537513PMC
May 2019

Efficacy and cost-effectiveness of guided and unguided internet- and mobile-based indicated transdiagnostic prevention of depression and anxiety (ICare Prevent): A three-armed randomized controlled trial in four European countries.

Internet Interv 2019 Apr 15;16:52-64. Epub 2018 Apr 15.

Department of Clinical Psychology and Psychotherapy, Nägelsbachstraße 25a, Germany.

Background: Depression and anxiety are highly prevalent and often co-occur. Several studies indicate the potential of disorder-specific psychological interventions for the prevention of each of these disorders. To treat comorbidity, transdiagnostic treatment concepts seem to be a promising approach, however, evidence for transdiagnostic concepts of prevention remains inconclusive. Internet- and mobile-based interventions (IMIs) may be an effective means to deliver psychological interventions on a large scale for the prevention of common mental disorders (CMDs) such as depression and anxiety. IMIs have been shown to be effective in treating CMDs, e.g. in reducing symptoms of depression and anxiety. However, there is a lack of studies examining the efficacy of interventions reducing the incidence of CMDs. Moreover, the comparative cost-effectiveness of guided versus unguided IMIs for the prevention of depression and anxiety has not been studied yet. Hence, this study aims at investigating the (cost-) effectiveness of guided and unguided internet- and mobile-based transdiagnostic individually tailored indicated prevention of depression and anxiety.

Methods: A multi-country three-armed randomized controlled trial will be conducted to compare a guided and unguided intervention to treatment as usual (TAU). Both active conditions are based on the same intervention, , and differ only with regard to guidance format. Altogether, 954 individuals with subclinical symptoms of depression (CES-D ≥ 16) and anxiety (GAD-7 ≥ 5) who do not have a full-blown disorder will be recruited in Germany, Switzerland, Spain and the Netherlands, and randomized to one of three conditions (guided intervention, unguided intervention, or TAU). The TAU arm will receive access to the training after a 12-month waiting period. The primary outcome will be time to CMD onset (any depression/anxiety disorder) within a follow-up period of 12 months after baseline. Secondary outcomes will include disorder-specific symptom severity (depression/anxiety) assessed by diagnostic raters blinded to intervention condition at post-intervention, self-reports, acceptability, health related quality of life, and psychosocial variables associated with developing a CMD. Assessments will take place at baseline, mid-intervention (5 weeks into the intervention), post-intervention (8 weeks after randomization) and follow-up (6 and 12 months after randomization). Data will be analyzed on an intention-to-treat basis and per protocol. Cost-effectiveness will be evaluated from a public health and a societal perspective, including both direct and indirect costs.

Discussion: The present study will further enhance the evidence-base for transdiagnostic preventive interventions and provide valuable information about optimal trade-off between treatment outcome and costs.

Trial Registration: German Clinical Trial Registration (DRKS - http://www.drks.de/drks_web/): DRKS00011099.
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http://dx.doi.org/10.1016/j.invent.2018.04.002DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6364519PMC
April 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

Transdiagnostic Tailored Internet- and Mobile-Based Guided Treatment for Major Depressive Disorder and Comorbid Anxiety: Study Protocol of a Randomized Controlled Trial.

Front Psychiatry 2018 4;9:274. Epub 2018 Jul 4.

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

Depression is highly prevalent and often accompanied by comorbid anxiety disorder. Internet-based interventions have shown to be one effective treatment modality; however, comorbidities are often not targeted. Transdiagnostic tailored internet-and mobile-based interventions (IMIs) might be promising to overcome such issues. This study aims to evaluate the efficacy, moderators, and cost-effectiveness of a transdiagnostic tailored internet- and mobile-based guided intervention for depression and comorbid anxiety in individuals with major depressive disorder (MDD). Two-hundred participants with MDD will be randomly assigned to an 8-week guided self-help internet intervention (IC) or a 6-month wait-list control group (WLC). Participants of the IC will receive weekly content-focused feedback on module completion as well as monitored adherence reminders from an eCoach. The primary outcome is clinician-rated depression severity (QIDS-C) at post-assessment assessed by diagnostic raters blind to study condition. Secondary outcomes include, e.g., change in diagnostic status (MDD and anxiety disorders), remission and response rates, disorder symptom severity, health related quality of life, incongruence related to needs and values, and behavioral activation. Assessments will take place at baseline (T1), post-assessment (T2), 6-month follow-up (T3), and 12-month follow-up in the IC. Data will be analyzed on an intention-to-treat basis and per protocol. A large number of a priori defined moderators of treatment outcome will be assessed at baseline and tested in predicting treatment outcome. Cost-effectiveness will be evaluated from a societal perspective. The present study will provide evidence on the efficacy, potential cost-effectiveness, and moderators of a transdiagnostic tailored guided internet- and mobile-based treatment protocol.

Trial Registration: German Register of Clinical Studies DRKS00011690 (https://www.drks.de/drks_web/).
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http://dx.doi.org/10.3389/fpsyt.2018.00274DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6039558PMC
July 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

Severely Burdened Individuals Do Not Need to Be Excluded From Internet-Based and Mobile-Based Stress Management: Effect Modifiers of Treatment Outcomes From Three Randomized Controlled Trials.

J Med Internet Res 2018 06 19;20(6):e211. Epub 2018 Jun 19.

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

Background: Although internet-based and mobile-based stress management interventions (iSMIs) may be a promising strategy to reach employees suffering from high chronic stress, it remains unknown whether participants with high symptom severity of depression or anxiety also benefit from iSMIs or should be excluded.

Objective: This study aimed to evaluate the efficacy of iSMIs in subgroups with high symptom severity and to test whether baseline symptom severity moderates treatment outcome.

Methods: Data from three randomized controlled trials (N=791) were pooled to identify effect modifiers and to evaluate efficacy in subgroups with different levels of initial symptom severity. The outcomes perceived stress (Perceived Stress Scale, PSS), depression severity (Center for Epidemiological Depression Scale, CES-D), and anxiety (Hospital Anxiety and Depression Scale, HADS) symptom severity were assessed at baseline, 7-week postassessment, and 6-month follow-up. Potential moderators were tested in predicting differences in the change of outcome in multiple moderation analyses. Simple slope analyses evaluated efficacy of the iSMI comparing the intervention group with the waitlist control group in subgroups with low, moderate, and severe initial symptomology based on means and SDs of the study population. In addition, subgroups with clinical values of depression (CES-D≥16) and anxiety (HADS≥8) at baseline were explored, and response rates (RRs; 50% symptom reduction) and symptom-free (SF) status (CES-D<16, HADS<8) were reported.

Results: Individuals with high stress (PSS≥30), depression (CES-D≥33), anxiety (HADS≥15), and emotional exhaustion (MBI≥5.6) benefited significantly from the intervention with great reductions of stress (d=0.86-1.16, d=0.93-1.35), depression (d=0.69-1.08, d=0.91-1.19), and anxiety (d=0.79-1.19, d=1.06-1.21), and effects were sustained at 6-month follow-up. Symptom severity moderated treatment outcomes, as individuals with higher symptom severity at baseline benefited significantly more from the intervention than individuals with lower symptom severity. Furthermore, 82.9% (656/791) of individuals had clinical depression values at baseline, of which significantly more individuals in the intervention group reached at least 50% symptom reduction or fell under clinical cut-off (RR: 29.2%, 93/318; SF: 39.6%, 126/318) compared with the waitlist control group (RR: 8.0%, 27/338; SF: 18.6%, 63/338) at postassessment. Significantly more individuals with clinical anxiety values at baseline (HADS≥8, 85.3%, 675/791) in the intervention group achieved at least 50% symptom reduction or fell under clinical cut-off (RR: 27.7%, 94/339; SF: 39.8%, 135/339) compared with the WLC (RR: 4.8%, 16/336; SF: 15.5%, 52/336).

Conclusions: Highly burdened individuals benefit greatly from iSMIs and therefore should not be excluded from participation. Stress management may be a valid entry point to reach highly burdened individuals who otherwise may not seek treatment.

Trial Registration: 1) German Clinical Trials Register DRKS00005112; https://www.drks.de/DRKS00005112 (Archived by WebCite at http://www.webcitation.org/6zmIZwvdA); 2) German Clinical Trials Register DRKS00005384; https://www.drks.de/ DRKS00005384 (Archived by WebCite at http://www.webcitation.org/6zmIerdtr); and 3) German Clinical Trials Register DRKS00004749; https://www.drks.de/DRKS00004749 (Archived by WebCite at http://www.webcitation.org/6zmIjDQPx).
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http://dx.doi.org/10.2196/jmir.9387DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6030574PMC
June 2018

Effectiveness of a transdiagnostic individually tailored Internet-based and mobile-supported intervention for the indicated prevention of depression and anxiety (ICare Prevent) in Dutch college students: study protocol for a randomised controlled trial.

Trials 2018 Feb 20;19(1):118. Epub 2018 Feb 20.

Department of Clinical, Neuro-, and Developmental Psychology, Vrije Universiteit Amsterdam, Van der Boechorststraat 1, BT 1081, Amsterdam, The Netherlands.

Background: Depression and anxiety are common and co-morbid disorders that affect a significant proportion of students. Innovative prevention strategies targeting both conditions are needed to reduce their health burden and costs. ICare Prevent is such an innovative strategy and contains a transdiagnostic individually tailored Internet-based and mobile-supported intervention. It addresses common risk factors of depression and anxiety as part of a large EU-funded multi-country project* (ICare). Little is known about the clinical and cost-effectiveness of this type of intervention compared to care as usual (CAU) for college students. We hypothesize that ICare Prevent will be more (cost-)effective than CAU in the reduction of symptoms of depression and anxiety.

Methods: A three-arm, parallel, randomized controlled superiority trial will be conducted comparing a guided and an unguided version of ICare Prevent with a control group receiving CAU. The trial will be open-label but outcome assessors will be blinded. A total of 252 college students (age ≥ 16 years) with subclinical symptoms of depression defined as a score ≥ 16 on the Center for Epidemiological Studies Depression Scale (CES-D), and/or anxiety, defined as a score ≥ 5 on the Generalized Anxiety Disorder scale (GAD-7), will be included. Those meeting diagnostic criteria for a depressive or anxiety disorder will be excluded. The primary outcome is change in disorder specific symptom severity from baseline to post-intervention. Secondary endpoints include self-reported depression and anxiety symptoms as well as time to onset of a mood or anxiety disorder until 12-month follow-up. Societal costs and quality of life will be assessed to estimate the intervention's cost-effectiveness compared to CAU.

Discussion: Transdiagnostic individually tailored Internet-based prevention could be a (cost-)effective approach to tackle the disease burden of depression and anxiety among college students.

Trial Registration: Dutch trial register, NTR 6562 . Registered on 6 July 2017.
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http://dx.doi.org/10.1186/s13063-018-2477-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5819200PMC
February 2018

Efficacy of Internet-Based Guided Treatment for Genito-Pelvic Pain/Penetration Disorder: Rationale, Treatment Protocol, and Design of a Randomized Controlled Trial.

Front Psychiatry 2017 22;8:260. Epub 2018 Jan 22.

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

Introduction: Genito-pelvic pain/penetration disorder (GPPPD) not only adversely affects women's sexuality and sexual satisfaction but is also associated with a wide range of psychosocial consequences such as reduced quality of life and well-being, mental health comorbidities, and relationship distress. Evidence for effective treatment options is scarce.

Aim: This article describes the rationale, treatment protocol, and study design for a randomized controlled trial examining the efficacy of an Internet-based guided intervention for GPPPD.

Method: Two hundred women who meet the criteria for GPPPD and have not been able to experience sexual intercourse for at least the last 6 months will be recruited and randomly assigned either to the intervention group (IG) or a 6-month waitlist control group. Assessments take place at baseline (T1), peritreatment after completion of Session 5 in IG (T2), after completion of Session 8 or 12 weeks after randomization (T3), and after 6 months (T4). Data will be analyzed on an intention-to-treat and a completer basis.

Main Outcome Measures: The primary outcome will be sexual intercourse involving the insertion of the partner's penis at posttreatment. Secondary outcomes include, e.g., improved non-intercourse penetration, sexual functioning, dyadic stress coping, reduced fear of sexuality and negative penetration-related cognitions. Fear of sexuality, penetration-related cognitions, and exercise intensity will be assessed as mediators of intercourse in the IG. Sexual dysfunctions of partners will be measured at baseline (T1) and investigated as a potential moderator of the primary treatment outcome.

Discussion: Given the burden associated with GPPPD and the need for specialized treatment, there is a surprising lack of evidence-based treatment options. This study aims to assess whether Internet-based interventions could contribute to closing this treatment gap.

Clinical Trial Registration: German Register of Clinical Studies (DRKS): DRKS00010228.
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http://dx.doi.org/10.3389/fpsyt.2017.00260DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5786827PMC
January 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

Internet-Based Guided Self-Help for Vaginal Penetration Difficulties: Results of a Randomized Controlled Pilot Trial.

J Sex Med 2017 02;14(2):238-254

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

Introduction: Difficulties with vaginal penetration can severely affect a woman's desire to have sexual intercourse, her sexual and general well-being, or her partnership. However, treatment opportunities for vaginismus are scarce.

Aim: To evaluate the efficacy of an internet-based guided self-help intervention for vaginismus in a randomized controlled pilot trial.

Methods: Seventy-seven women with vaginismus (primary inclusion criterion = no intercourse ≥ 6 months) were randomly assigned to an intervention group (IG) and a waitlist control group (WCG). The intervention consisted of 10 sessions involving psychoeducation, relaxation exercises, sensate focus, and gradual exposure with dilators. Participants received written feedback on completed sessions from an eCoach.

Main Outcome Measures: The primary outcome was successful sexual intercourse. Secondary outcomes were non-intercourse penetration, fear of coitus, sexual functioning, and dyadic coping. Self-reported assessments were scheduled at baseline, 10 weeks, and 6 months.

Results: More participants (10 of 40, 34.48%) in the IG had intercourse compared with those in the WCG (6 of 37, 20.69%) at least once at 10 weeks or 6 months (odds ratio = 2.02). The difference was not significant (χ = 1.38, P = .38), but in the IG, there was a significant increase in intercourse penetration from baseline to 6 months (d = 0.65). No such increase was found in the WCG (d = 0.21). There were significant between-group effects concerning non-intercourse penetration (self-insertion of a finger or dilator or insertion by the partner) in favor of the IG. Fear of coitus and dyadic coping significantly decreased in the IG. Overall satisfaction with the training was high.

Conclusion: This randomized controlled trial showed promising effects of an internet-based intervention by increasing participants' ability to have intercourse and non-intercourse penetration while experiencing high treatment satisfaction. The WCG also showed improvement, although participants had vaginismus for an average duration of 6 years. Internet-based interventions could be a treatment modality to complement other methods in stepped care for vaginal penetration difficulties.
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http://dx.doi.org/10.1016/j.jsxm.2016.12.232DOI Listing
February 2017

Adherence to Internet-Based Mobile-Supported Stress Management: A Pooled Analysis of Individual Participant Data From Three Randomized Controlled Trials.

J Med Internet Res 2016 06 29;18(6):e146. Epub 2016 Jun 29.

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

Background: Nonadherence to treatment is a prevalent issue in Internet interventions. Guidance from health care professionals has been found to increase treatment adherence rates in Internet interventions for a range of physical and mental disorders. Evaluating different guidance formats of varying intensity is important, particularly with respect to improvement of effectiveness and cost-effectiveness. Identifying predictors of nonadherence allows for the opportunity to better adapt Internet interventions to the needs of participants especially at risk for discontinuing treatment.

Objective: The goal of this study was to investigate the influence of different guidance formats (content-focused guidance, adherence-focused guidance, and administrative guidance) on adherence and to identify predictors of nonadherence in an Internet-based mobile-supported stress management intervention (ie, GET.ON Stress) for employees.

Methods: The data from the groups who received the intervention were pooled from three randomized controlled trials (RCTs) that evaluated the efficacy of the same Internet-based mobile-supported stress management intervention (N=395). The RCTs only differed in terms of the guidance format (content-focused guidance vs waitlist control, adherence-focused guidance vs waitlist control, administrative guidance vs waitlist control). Adherence was defined by the number of completed treatment modules (0-7). An ANOVA was performed to compare the adherence rates from the different guidance formats. Multiple hierarchical linear regression analysis was conducted to evaluate predictors of nonadherence, which included gender, age, education, symptom-related factors, and hope for improvement.

Results: In all, 70.5% (93/132) of the content-focused guidance sample, 68.9% (91/132) of the adherence-focused guidance sample, and 42.0% (55/131) of the participants in the administrative guidance sample completed all treatment modules. Guidance had a significant effect on treatment adherence (F2,392=11.64, P<.001; ω(2)=.05). Participants in the content-focused guidance (mean 5.70, SD 2.32) and adherence-focused guidance samples (mean 5.58, SD 2.33) completed significantly more modules than participants in the administrative guidance sample (mean 4.36, SD 2.78; t223=4.53, P<.001; r=.29). Content-focused guidance was not significantly associated with higher adherence compared to adherence-focused guidance (t262=0.42, P=.67; r=.03). The effect size of r=.03 (95% CI -0.09 to 0.15) did not pass the equivalence margin of r=.20 and the upper bound of the 95% CI lay below the predefined margin, indicating equivalence between adherence-focused guidance and content-focused guidance. Beyond the influence of guidance, none of the predictors significantly predicted nonadherence.

Conclusions: Guidance has been shown to be an influential factor in promoting adherence to an Internet-based mobile-supported stress management intervention. Adherence-focused guidance, which included email reminders and feedback on demand, was equivalent to content-focused guidance with regular feedback while requiring only approximately a quarter of the coaching resources. This could be a promising discovery in terms of cost-effectiveness. However, even after considering guidance, sociodemographic, and symptom-related characteristics, most interindividual differences in nonadherence remain unexplained.

Clinical Trial: DRKS00004749; http://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL _ID=DRKS00004749 (Archived by WebCite at http://www.webcitation.org/6QiDk9Zn8); DRKS00005112; http://drks-neu.uniklinik-freiburg. de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00005112 (Archived by WebCite at http://www.webcitation.org/6QiDysvev); DRKS00005384; http://drks-neu.uniklinik-freiburg.de/ drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00005384 (Archived by WebCite at http://www.webcitation.org/6QiE0xcpE).
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http://dx.doi.org/10.2196/jmir.4493DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4945816PMC
June 2016

Internet and computer-based cognitive behavioral therapy for anxiety and depression in youth: a meta-analysis of randomized controlled outcome trials.

PLoS One 2015 18;10(3):e0119895. Epub 2015 Mar 18.

Leuphana University, Innovation Incubator, Division Health Trainings Online, Lueneburg, Germany; GGZ inGeest, Regional Mental Health Service Centre, VU University Medical Centre, Amsterdam, the Netherlands; Department of Clinical Psychology and EMGO Institute for Health and Care Research, VU University, Amsterdam, the Netherlands.

Background: Anxiety and depression in children and adolescents are undertreated. Computer- and Internet-based cognitive behavioral treatments (cCBT) may be an attractive treatment alternative to regular face-to-face treatment.This meta-analysis aims to evaluate whether cCBT is effective for treating symptoms of anxiety and depression in youth.

Methods And Findings: We conducted systematic searches in bibliographical databases (Pubmed, Cochrane controlled trial register, PsychInfo) up to December 4, 2013. Only randomized controlled trials in which a computer-, Internet- or mobile-based cognitive behavioral intervention targeting either depression, anxiety or both in children or adolescents up to the age of 25 were compared to a control condition were selected. We employed a random-effects pooling model in overall effect analyses and a mixed effect model for sub-group analyses. Searches resulted in identifying 13 randomized trials, including 796 children and adolescents that met inclusion criteria. Seven studies were directed at treating anxiety, four studies at depression, and two were of a transdiagnostic nature, targeting both anxiety and depression. The overall mean effect size (Hedges' g) of cCBT on symptoms of anxiety or depression at post-test was g=0.72 (95% CI:0.55-0.90, numbers needed to be treated (NNT)=2.56). Heterogeneity was low (I²=20.14%, 95% CI: 0-58%). The superiority of cCBT over controls was evident for interventions targeting anxiety (g=0.68; 95% CI: 0.45-0.92; p < .001; NNT=2.70) and for interventions targeting depression (g=0.76; 95% CI: 0.41-0.12; p < .001; NNT=2.44) as well as for transdiagnostic interventions (g=0.94; 95% CI: 0.23-2.66; p < .001; NNT=2.60).

Conclusions: Results provide evidence for the efficacy of cCBT in the treatment of anxiety and depressive symptoms in youth. Hence, such interventions may be a promising treatment alternative when evidence based face-to-face treatment is not feasible. Future studies should examine long-term effects of treatments and should focus on obtaining patient-level data from existing studies, to perform an individual patient data meta-analysis.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0119895PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4364968PMC
February 2016

Efficacy and cost-effectiveness of minimal guided and unguided internet-based mobile supported stress-management in employees with occupational stress: a three-armed randomised controlled trial.

BMC Public Health 2014 Aug 7;14:807. Epub 2014 Aug 7.

Innovation Incubator, Division Health Trainings online, Leuphana University, Rotenbleicher Weg 67, 21335 Lüneburg, Germany.

Background: Internet- and mobile based stress-management interventions (iSMI) may be an effective means to address the negative consequences of occupational stress. However, available results from randomised controlled trials are conflicting. Moreover, it is yet not clear whether guided or unguided self-help iSMI provide better value for money. Internet-based mental health interventions without guidance are often much less effective than interventions including at least some guidance from a professional. However, direct comparisons in randomised controlled trials are scarce and, to the best of our knowledge, the comparative (cost)-effectiveness of guided vs. unguided iSMI has not yet been studied. Hence, this study investigates the acceptability and (cost-) effectiveness of minimal guided and unguided iSMI in employees with heightened levels of perceived stress.

Methods: A three-armed randomised controlled trial (RCT) will be conducted to compare a minimal guided and unguided iSMI with a waiting list control condition (WLC). Both active conditions are based on the same iSMI, i.e. GET.ON Stress, and differ only with regard to the guidance format. Employees with heightened levels of perceived stress (PSS ≥ 22) will be randomised to one of three conditions. Primary outcome will be comparative changes in perceived stress (PSS). Secondary outcomes include changes in self-reported depression, work-engagement, presenteeism and absenteeism. Moreover, a cost-effectiveness analysis will be conducted from a societal perspective, including both direct medical costs and costs related to productivity losses. In addition, a cost-benefit analysis will be conducted from the employer's perspective. Incremental net-benefit regression analyses will address the question if there are any baseline factors (i.e. subgroups of employees) associated with particularly favorable cost-effectiveness when the experimental intervention is offered. Assessments take place at baseline, 7 weeks post-treatment and 6 months after randomisation.

Discussion: Online-based (guided) self-help interventions could be an acceptable, effective and economically sustainable approach to offer evidence-based intervention alternatives to reduce the negative consequences associated with work-related stress. This study evaluates the (cost-) effectiveness of two versions of an iSMI, minimal guided and unguided iSMI. Thus, the present study will further enhance the evidence-base for iSMI and provide valuable information about the optimal balance between outcome and economic costs.

Trial Registration: German Clinical Trial Registration (DRKS): DRKS00005687.
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http://dx.doi.org/10.1186/1471-2458-14-807DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4153891PMC
August 2014
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