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1.  Blending Face-to-Face and Internet-Based Interventions for the Treatment of Mental Disorders in Adults: Systematic Review 
Background
Many studies have provided evidence for the effectiveness of Internet-based stand-alone interventions for mental disorders. A newer form of intervention combines the strengths of face-to-face (f2f) and Internet approaches (blended interventions).
Objective
The aim of this review was to provide an overview of (1) the different formats of blended treatments for adults, (2) the stage of treatment in which these are applied, (3) their objective in combining face-to-face and Internet-based approaches, and (4) their effectiveness.
Methods
Studies on blended concepts were identified through systematic searches in the MEDLINE, PsycINFO, Cochrane, and PubMed databases. Keywords included terms indicating face-to-face interventions (“inpatient,” “outpatient,” “face-to-face,” or “residential treatment”), which were combined with terms indicating Internet treatment (“internet,” “online,” or “web”) and terms indicating mental disorders (“mental health,” “depression,” “anxiety,” or “substance abuse”). We focused on three of the most common mental disorders (depression, anxiety, and substance abuse).
Results
We identified 64 publications describing 44 studies, 27 of which were randomized controlled trials (RCTs). Results suggest that, compared with stand-alone face-to-face therapy, blended therapy may save clinician time, lead to lower dropout rates and greater abstinence rates of patients with substance abuse, or help maintain initially achieved changes within psychotherapy in the long-term effects of inpatient therapy. However, there is a lack of comparative outcome studies investigating the superiority of the outcomes of blended treatments in comparison with classic face-to-face or Internet-based treatments, as well as of studies identifying the optimal ratio of face-to-face and Internet sessions.
Conclusions
Several studies have shown that, for common mental health disorders, blended interventions are feasible and can be more effective compared with no treatment controls. However, more RCTs on effectiveness and cost-effectiveness of blended treatments, especially compared with nonblended treatments are necessary.
doi:10.2196/jmir.6588
PMCID: PMC5622288  PMID: 28916506
mental health; Internet; psychotherapy; blended treatment
2.  Prevention of Mental Health Disorders Using Internet- and Mobile-Based Interventions: A Narrative Review and Recommendations for Future Research 
Although psychological interventions might have a tremendous potential for the prevention of mental health disorders (MHD), their current impact on the reduction of disease burden is questionable. Possible reasons include that it is not practical to deliver those interventions to the community en masse due to limited health care resources and the limited availability of evidence-based interventions and clinicians in routine practice, especially in rural areas. Therefore, new approaches are needed to maximize the impact of psychological preventive interventions. Limitations of traditional prevention programs could potentially be overcome by providing Internet- and mobile-based interventions (IMIs). This relatively new medium for promoting mental health and preventing MHD introduces a fresh array of possibilities, including the provision of evidence-based psychological interventions that are free from the restraints of travel and time and allow reaching participants for whom traditional opportunities are not an option. This article provides an introduction to the subject and narratively reviews the available evidence for the effectiveness of IMIs with regard to the prevention of MHD onsets. The number of randomized controlled trials that have been conducted to date is very limited and so far it is not possible to draw definite conclusions about the potential of IMIs for the prevention of MHD for specific disorders. Only for the indicated prevention of depression there is consistent evidence across four different randomized trial trials. The only trial on the prevention of general anxiety did not result in positive findings in terms of eating disorders (EDs), effects were only found in post hoc subgroup analyses, indicating that it might be possible to prevent ED onset for subpopulations of people at risk of developing EDs. Future studies need to identify those subpopulations likely to profit from preventive. Disorders not examined so far include substance use disorders, bipolar disorders, stress-related disorders, phobic disorders and panic disorder, obsessive–compulsive disorder, impulse-control disorders, somatic symptom disorder, and insomnia. In summary, there is a need for more rigorously conducted large scale randomized controlled trials using standard clinical diagnostic instruments for the selection of participants without MHD at baseline and the assessment of MHD onset. Subsequently, we discuss future directions for the field in order to fully exploit the potential of IMI for the prevention of MHD.
doi:10.3389/fpsyt.2017.00116
PMCID: PMC5554359
mental health; self-help; e-health; m-Health; Internet interventions; depression; anxiety; prevention
3.  The Benefit of Web- and Computer-Based Interventions for Stress: A Systematic Review and Meta-Analysis 
Background
Stress has been identified as one of the major public health issues in this century. New technologies offer opportunities to provide effective psychological interventions on a large scale.
Objective
The aim of this study is to investigate the efficacy of Web- and computer-based stress-management interventions in adults relative to a control group.
Methods
A meta-analysis was performed, including 26 comparisons (n=4226). Cohen d was calculated for the primary outcome level of stress to determine the difference between the intervention and control groups at posttest. Analyses of the effect on depression, anxiety, and stress in the following subgroups were also conducted: risk of bias, theoretical basis, guidance, and length of the intervention. Available follow-up data (1-3 months, 4-6 months) were assessed for the primary outcome stress.
Results
The overall mean effect size for stress at posttest was Cohen d=0.43 (95% CI 0.31-0.54). Significant, small effects were found for depression (Cohen d=0.34, 95% CI 0.21-0.48) and anxiety (Cohen d=0.32, 95% CI 0.17-0.47). Subgroup analyses revealed that guided interventions (Cohen d=0.64, 95% CI 0.50-0.79) were more effective than unguided interventions (Cohen d=0.33, 95% CI 0.20-0.46; P=.002). With regard to the length of the intervention, short interventions (≤4 weeks) showed a small effect size (Cohen d=0.33, 95% CI 0.22-0.44) and medium-long interventions (5-8 weeks) were moderately effective (Cohen d=0.59; 95% CI 0.45-0.74), whereas long interventions (≥9 weeks) produced a nonsignificant effect (Cohen d=0.21, 95% CI –0.05 to 0.47; P=.006). In terms of treatment type, interventions based on cognitive behavioral therapy (CBT) and third-wave CBT (TWC) showed small-to-moderate effect sizes (CBT: Cohen d=0.40, 95% CI 0.19-0.61; TWC: Cohen d=0.53, 95% CI 0.35-0.71), and alternative interventions produced a small effect size (Cohen d=0.24, 95% CI 0.12-0.36; P=.03). Early evidence on follow-up data indicates that Web- and computer-based stress-management interventions can sustain their effects in terms of stress reduction in a small-to-moderate range up to 6 months.
Conclusions
These results provide evidence that Web- and computer-based stress-management interventions can be effective and have the potential to reduce stress-related mental health problems on a large scale.
doi:10.2196/jmir.5774
PMCID: PMC5336602  PMID: 28213341
stress; mental health; internet-based interventions; review; randomized controlled trial; meta-analysis
4.  Reliability and Validity of Assessing User Satisfaction With Web-Based Health Interventions 
Background
The perspective of users should be taken into account in the evaluation of Web-based health interventions. Assessing the users’ satisfaction with the intervention they receive could enhance the evidence for the intervention effects. Thus, there is a need for valid and reliable measures to assess satisfaction with Web-based health interventions.
Objective
The objective of this study was to analyze the reliability, factorial structure, and construct validity of the Client Satisfaction Questionnaire adapted to Internet-based interventions (CSQ-I).
Methods
The psychometric quality of the CSQ-I was analyzed in user samples from 2 separate randomized controlled trials evaluating Web-based health interventions, one from a depression prevention intervention (sample 1, N=174) and the other from a stress management intervention (sample 2, N=111). At first, the underlying measurement model of the CSQ-I was analyzed to determine the internal consistency. The factorial structure of the scale and the measurement invariance across groups were tested by multigroup confirmatory factor analyses. Additionally, the construct validity of the scale was examined by comparing satisfaction scores with the primary clinical outcome.
Results
Multigroup confirmatory analyses on the scale yielded a one-factorial structure with a good fit (root-mean-square error of approximation =.09, comparative fit index =.96, standardized root-mean-square residual =.05) that showed partial strong invariance across the 2 samples. The scale showed very good reliability, indicated by McDonald omegas of .95 in sample 1 and .93 in sample 2. Significant correlations with change in depressive symptoms (r=−.35, P<.001) and perceived stress (r=−.48, P<.001) demonstrated the construct validity of the scale.
Conclusions
The proven internal consistency, factorial structure, and construct validity of the CSQ-I indicate a good overall psychometric quality of the measure to assess the user’s general satisfaction with Web-based interventions for depression and stress management. Multigroup analyses indicate its robustness across different samples. Thus, the CSQ-I seems to be a suitable measure to consider the user’s perspective in the overall evaluation of Web-based health interventions.
doi:10.2196/jmir.5952
PMCID: PMC5023944  PMID: 27582341
Internet; mental health; evaluation; clinical effectiveness; personal satisfaction
5.  Adherence to Internet-Based Mobile-Supported Stress Management: A Pooled Analysis of Individual Participant Data From Three Randomized Controlled Trials 
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; ω2=.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)
doi:10.2196/jmir.4493
PMCID: PMC4945816  PMID: 27357528
guidance; treatment adherence; predictors; Internet intervention; work-related stress; stress management
6.  For Whom Does It Work? Moderators of Outcome on the Effect of a Transdiagnostic Internet-Based Maintenance Treatment After Inpatient Psychotherapy: Randomized Controlled Trial 
Background
Recent studies provide evidence for the effectiveness of Internet-based maintenance treatments for mental disorders. However, it is still unclear which participants might or might not profit from this particular kind of treatment delivery.
Objective
The study aimed to identify moderators of treatment outcome in a transdiagnostic Internet-based maintenance treatment (TIMT) offered to patients after inpatient psychotherapy for mental disorders in routine care.
Methods
Using data from a randomized controlled trial (N=400) designed to test the effectiveness of TIMT, we performed secondary analyses to identify factors moderating the effects of TIMT (intervention) when compared with those of a treatment-as-usual control condition. TIMT involved an online self-management module, asynchronous patient–therapist communication, a peer support group, and online-based progress monitoring. Participants in the control condition had unstructured access to outpatient psychotherapy, standardized outpatient face-to-face continuation treatment, and psychotropic management. Self-reports of psychopathological symptoms and potential moderators were assessed at the start of inpatient treatment (T1), at discharge from inpatient treatment/start of TIMT (T2), and at 3-month (T3) and 12-month follow-up (T4).
Results
Education level, positive outcome expectations, and diagnoses significantly moderated intervention versus control differences regarding changes in outcomes between T2 and T3. Only education level moderated change differences between T2 and T4. The effectiveness of the intervention (vs control) was more pronounced among participants with a low (vs high) education level (T2-T3: B=–0.32, SE 0.16, P=.049; T2-T4: B=–0.42, SE 0.21, P=.049), participants with high (vs low) positive outcome expectations (T2-T3: B=–0.12, SE 0.05, P=.02) and participants with anxiety disorder (vs mood disorder) (T2-T3: B=–0.43, SE 0.21, P=.04). Simple slope analyses revealed that despite some subgroups benefiting less from the intervention than others, all subgroups still benefited significantly.
Conclusions
This transdiagnostic Internet-based maintenance treatment might be suitable for a wide range of participants differing in various clinical, motivational, and demographic characteristics. The treatment is especially effective for participants with low education levels. These findings may generalize to other Internet-based maintenance treatments.
Trial Registration
International Standard Randomized Controlled Trial Number (ISRCTN): 28632626; http://www.controlled-trials.com/isrctn/pf/28632626 (Archived by WebCite at http://www.webcitation.org/6IqZjTLrx).
doi:10.2196/jmir.2511
PMCID: PMC3849694  PMID: 24113764
maintenance treatment; continuation treatment; Internet-based intervention; transdiagnostic treatment; mental disorders/inpatient psychotherapy; guided self-help; randomized controlled trial; relapse prevention; predictors; moderators
7.  Web-Based and Mobile Stress Management Intervention for Employees: A Randomized Controlled Trial 
Background
Work-related stress is highly prevalent among employees and is associated with adverse mental health consequences. Web-based interventions offer the opportunity to deliver effective solutions on a large scale; however, the evidence is limited and the results conflicting.
Objective
This randomized controlled trial evaluated the efficacy of guided Web- and mobile-based stress management training for employees.
Methods
A total of 264 employees with elevated symptoms of stress (Perceived Stress Scale-10, PSS-10≥22) were recruited from the general working population and randomly assigned to an Internet-based stress management intervention (iSMI) or waitlist control group. The intervention (GET.ON Stress) was based on Lazarus’s transactional model of stress, consisted of seven sessions, and applied both well-established problem solving and more recently developed emotion regulation strategies. Participants also had the opportunity to request automatic text messages on their mobile phone along with the iSMI. Participants received written feedback on every completed session from an e-coach. The primary outcome was perceived stress (PSS-10). Web-based self-report assessments for both groups were scheduled at baseline, 7 weeks, and 6 months. At 12 months, an extended follow-up was carried out for the iSMI group only.
Results
An intention-to-treat analysis of covariance revealed significantly large effect differences between iSMI and waitlist control groups for perceived stress at posttest (F 1,261=58.08, P<.001; Cohen’s d=0.83) and at the 6-month follow-up (F 1,261=80.17, P<.001; Cohen’s d=1.02). The effects in the iSMI group were maintained at 12-month follow-up.
Conclusions
This Web- and mobile-based intervention has proven effective in reducing stress in employees in the long term. Internet-based stress management interventions should be further pursued as a valuable alternative to face-to-face interventions.
Trial Registration
German Clinical Trials Register (DRKS): 00004749; http://drks-neu.uniklinik-freiburg.de/ drks_web/setLocale_EN.do (Archived by WebCite at http://www.webcitation.org/6e8rl98nl)
doi:10.2196/jmir.5112
PMCID: PMC4749847  PMID: 26818683
Internet; randomized controlled trial; work; stress; stress management; mental health
8.  An Internet-Based Guided Self-Help Intervention for Panic Symptoms: Randomized Controlled Trial 
Background
Internet-based guided self-help is efficacious for panic disorder, but it is not known whether such treatment is effective for milder panic symptoms as well.
Objective
To evaluate the effectiveness of Don’t Panic Online, an Internet-based self-help course for mild panic symptoms, which is based on cognitive behavioral principles and includes guidance by email.
Methods
A pragmatic randomized controlled trial was conducted. Participants (N=126) were recruited from the general population and randomized to either the intervention group or to a waiting-list control group. Inclusion criteria were a Panic Disorder Severity Scale-Self Report (PDSS-SR) score between 5-15 and no suicide risk. Panic symptom severity was the primary outcome measure; secondary outcome measures were anxiety and depressive symptom severity. Measurements were conducted online and took place at baseline and 12 weeks after baseline (T1). At baseline, diagnoses were obtained by telephone interviews.
Results
Analyses of covariance (intention-to-treat) showed no significant differences in panic symptom reduction between groups. Completers-only analyses revealed a moderate effect size in favor of the intervention group (Cohen’s d=0.73, P=.01). Only 27% of the intervention group finished lesson 4 or more (out of 6). Nonresponse at T1 was high for the total sample (42.1%). Diagnostic interviews showed that many participants suffered from comorbid depression and anxiety disorders.
Conclusions
The Internet-based guided self-help course appears to be ineffective for individuals with panic symptoms. However, intervention completers did derive clinical benefits from the intervention.
Trial Registration
Nederlands Trial Register: NTR1639; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1639 (Archived by WebCite at http://www.webcitation.org/6ITZPozs9).
doi:10.2196/jmir.2362
PMCID: PMC3742403  PMID: 23896222
Internet; self-help; panic disorder; anxiety disorders; patient adherence
9.  Testing a machine-learning algorithm to predict the persistence and severity of major depressive disorder from baseline self-reports 
Molecular psychiatry  2016;21(10):1366-1371.
Heterogeneity of major depressive disorder (MDD) illness course complicates clinical decision-making. While efforts to use symptom profiles or biomarkers to develop clinically useful prognostic subtypes have had limited success, a recent report showed that machine learning (ML) models developed from self-reports about incident episode characteristics and comorbidities among respondents with lifetime MDD in the World Health Organization World Mental Health (WMH) Surveys predicted MDD persistence, chronicity, and severity with good accuracy. We report results of model validation in an independent prospective national household sample of 1,056 respondents with lifetime MDD at baseline. The WMH ML models were applied to these baseline data to generate predicted outcome scores that were compared to observed scores assessed 10–12 years after baseline. ML model prediction accuracy was also compared to that of conventional logistic regression models. Area under the receiver operating characteristic curve (AUC) based on ML (.63 for high chronicity and .71–.76 for the other prospective outcomes) was consistently higher than for the logistic models (.62–.70) despite the latter models including more predictors. 34.6–38.1% of respondents with subsequent high persistence-chronicity and 40.8–55.8% with the severity indicators were in the top 20% of the baseline ML predicted risk distribution, while only 0.9% of respondents with subsequent hospitalizations and 1.5% with suicide attempts were in the lowest 20% of the ML predicted risk distribution. These results confirm that clinically useful MDD risk stratification models can be generated from baseline patient self-reports and that ML methods improve on conventional methods in developing such models.
doi:10.1038/mp.2015.198
PMCID: PMC4935654  PMID: 26728563
10.  Evaluating the (cost-)effectiveness of guided and unguided Internet-based self-help for problematic alcohol use in employees - a three arm randomized controlled trial 
BMC Public Health  2015;15:1043.
Background
Problematic alcohol consumption is associated with a high disease burden for affected individuals and has a detrimental impact on companies and society due to direct and indirect health costs. This protocol describes a study design to evaluate the (cost)-effectiveness of a guided and unguided Internet-based self-help intervention for employees called “GET.ON Clever weniger trinken” (be smart – drink less) compared to a waiting list control group.
Methods
In a three-arm randomized controlled trial, 528 German adults who are currently members of the workforce will be recruited by occupational health departments of major health insurance companies. Employees aged 18 and older displaying problematic drinking patterns (>21/14 drinks per week and an AUDIT score > 8/6 for men/women) will be randomly assigned to one of three following study conditions: 1. unguided web-based self-help for problematic drinking, 2. adherence-focused guided self-help, and 3. waiting list control. Self-report data will be collected at baseline (T1), 6 weeks (T2), and 6 months (T3) after randomization. The primary outcome will be the reduction of alcohol standard units during the 7 days prior to T2, using the Timeline Followback method. Cost-effectiveness analyses to determine direct and indirect costs will be conducted from the perspectives of employers and the society. Data will be analyzed on an intention-to-treat basis and per protocol.
Discussion
There is a need to identify effective low-threshold solutions to improve ill-health and reduce the negative economic consequences due to problematic alcohol drinking in workforces. If the proposed web-based intervention proves both to be efficacious and cost-effective, it may be a useful tool to increase utilization rates of interventions for problematic drinking in occupational settings.
Trial Registration
German Register of Clinical Studies (DRKS): DRKS00006105, date of registration: 2014-07-07.
doi:10.1186/s12889-015-2375-0
PMCID: PMC4603803  PMID: 26458872
Internet intervention; Alcohol; Work-related stress; Occupational health; Cost-effectiveness; Self-help; Problematic alcohol use; Alcohol use disorders; Randomized controlled trial
11.  Preventing the onset of major depressive disorder: A meta-analytic review of psychological interventions 
Background Depressive disorders are highly prevalent, have a detrimental impact on the quality of life of patients and their relatives and are associated with increased mortality rates, high levels of service use and substantial economic costs. Current treatments are estimated to only reduce about one-third of the disease burden of depressive disorders. Prevention may be an alternative strategy to further reduce the disease burden of depression.
Methods We conducted a meta-analysis of randomized controlled trials examining the effects of preventive interventions in participants with no diagnosed depression at baseline on the incidence of diagnosed depressive disorders at follow-up. We identified 32 studies that met our inclusion criteria.
Results We found that the relative risk of developing a depressive disorder was incidence rate ratio = 0.79 (95% confidence interval: 0.69–0.91), indicating a 21% decrease in incidence in prevention groups in comparison with control groups. Heterogeneity was low (I2 = 24%). The number needed to treat (NNT) to prevent one new case of depressive disorder was 20. Sensitivity analyses revealed no differences between type of prevention (e.g. selective, indicated or universal) nor between type of intervention (e.g. cognitive behavioural therapy, interpersonal psychotherapy or other). However, data on NNT did show differences.
Conclusions Prevention of depression seems feasible and may, in addition to treatment, be an effective way to delay or prevent the onset of depressive disorders. Preventing or delaying these disorders may contribute to the further reduction of the disease burden and the economic costs associated with depressive disorders.
doi:10.1093/ije/dyt175
PMCID: PMC4023317  PMID: 24760873
Prevention; depression; RCT
12.  Internet and Computer-Based Cognitive Behavioral Therapy for Anxiety and Depression in Youth: A Meta-Analysis of Randomized Controlled Outcome Trials 
PLoS ONE  2015;10(3):e0119895.
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.
doi:10.1371/journal.pone.0119895
PMCID: PMC4364968  PMID: 25786025
13.  Efficacy of a hybrid online training for panic symptoms and agoraphobia: study protocol for a randomized controlled trial 
Trials  2014;15:427.
Background
Recently, internet-based interventions have been proposed as effective treatments for people with panic disorder (PD). However, little is known about the clinical effects of integrating mobile technology into these interventions. Because users carry their smartphones with them throughout the day, we hypothesize that this technology can be used to significantly support individuals with monitoring and overcoming their PD symptoms. The aim of the present study is to evaluate the efficacy and cost-effectiveness of a newly developed hybrid intervention that combines internet/PC with smartphone delivery to treat the symptoms of PD. The intervention is based on cognitive behavioral therapy and consists of six modules over a total of six weeks.
Methods/Design
A two-arm randomized controlled trial (RCT) will be conducted to evaluate the effects of a hybrid online training module for PD. Based on a power calculation (d =0.60; 1-β of 80%; α =0.05), 90 participants with mild to moderate panic symptoms with or without agoraphobia (as assessed by the Panic and Agoraphobia Scale) will be recruited from the general population and randomly assigned to either the intervention group or a six-month waitlist control group. The primary outcome measure will be the severity of panic symptoms. Secondary outcomes will include depression, quality of life, and an observer-based rating of panic severity. Furthermore, data regarding acceptance and the usability of the smartphone app will be assessed. Assessments will take place at baseline as well as eight weeks, three months, and six months after randomization. Moreover, a cost-effectiveness analysis will be performed from a societal perspective. Data will be analyzed on an intention-to-treat basis and per protocol.
Discussion
To our knowledge, this RCT is one of the first to examine the efficacy of a hybrid online training for adult PD. This study seeks to contribute to the emerging field of hybrid online training. If the intervention is efficacious, then research on this hybrid online training should be extended. The cost-effectiveness analysis will also indicate whether online training is an economical tool for treating PD among adults.
Trial registration
German Clinical Trial Register: DRKS00005223 (registered on 15 August 2013).
doi:10.1186/1745-6215-15-427
PMCID: PMC4233107  PMID: 25370504
Panic disorder; Agoraphobia; Sub-clinical; Internet; Mobile; Smartphone; Hybrid
14.  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;14:807.
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.
doi:10.1186/1471-2458-14-807
PMCID: PMC4153891  PMID: 25099533
Guided self-help; Unguided self-help; Occupational health; Stress management; Internet-based; Randomised controlled trial; Cost-effectiveness
15.  GET.ON Mood Enhancer: efficacy of Internet-based guided self-help compared to psychoeducation for depression: an investigator-blinded randomised controlled trial 
Trials  2014;15:39.
Background
Major depressive disorder (MDD) imposes a considerable disease burden on individuals and societies. A large number of randomised controlled trials (RCTs) have shown the efficacy of Internet-based guided self-help interventions in reducing symptoms of depression. However, study quality varies considerably. The aim of this study is to evaluate the efficacy of a new Internet-based guided self-help intervention (GET.ON Mood Enhancer) compared to online-based psychoeducation in an investigator-blinded RCT.
Methods/design
A RCT will be conducted to compare the efficacy of GET.ON Mood Enhancer with an active control condition receiving online psychoeducation on depression (OPD). Both treatment groups will have full access to treatment as usual. Adults with MDD (n = 128) will be recruited and randomised to one of the two conditions. Primary outcome will be observer-rated depressive symptoms (HRSD-24) by independent assessors blind to treatment conditions. Secondary outcomes include changes in self-reported depressive symptom severity, anxiety and quality of life. Additionally, potential negative effects of the treatments will systematically be evaluated on several dimensions (for example, symptom deteriorations, attitudes toward seeking psychological help, relationships and stigmatisation). Assessments will take place at baseline, 6 and 12 weeks after randomisation.
Discussion
This study evaluates a new Internet-based guided self-help intervention for depression using an active control condition (psychoeducation-control) and an independent, blinded outcome evaluation. This study will further enhance the evidence for Internet-based guided self-help interventions for MDD.
Trial registration
German Clinical Trial Registration (DRKS): DRKS00005025
doi:10.1186/1745-6215-15-39
PMCID: PMC3917536  PMID: 24476555
Guided self-help; Internet-based; Major depressive disorder; Randomised controlled trial; Negative effects of psychotherapy; Active control
16.  Internet-based treatment of major depression for patients on a waiting list for inpatient psychotherapy: protocol for a multi-centre randomised controlled trial 
BMC Psychiatry  2013;13:318.
Background
Major depressive disorder (MDD) is a prevalent and severe disorder. Although effective treatments for MDD are available, many patients remain untreated, mainly because of insufficient treatment capacities in the health care system. Resulting waiting periods are often associated with prolonged suffering and impairment as well as a higher risk of chronification. Web-based interventions may help to alleviate these problems. Numerous studies provided evidence for the efficacy of web-based interventions for depression. The aim of this study is to evaluate a new web-based guided self-help intervention (GET.ON-Mood Enhancer-WL) specifically developed for patients waiting to commence inpatient therapy for MDD.
Methods
In a two-armed randomised controlled trial (n = 200), the web-based guided intervention GET.ON-Mood Enhancer-WL in addition to treatment as usual (TAU) will be compared with TAU alone. The intervention contains six modules (psycho education, behavioural activation I & II, problem solving I & II, and preparation for subsequent inpatient depression therapy). The participants will be supported by an e-coach, who will provide written feedback after each module. Inclusion criteria include a diagnosis of MDD assessed with a structured clinical interview [SCID] and a waiting period of at least three weeks before start of inpatient treatment. The primary outcome is observer-rated depressive symptom severity (HRSD24). Further (explorative) questions include whether remission will be achieved earlier and by more patients during inpatient therapy because of the web-based preparatory intervention.
Discussion
If GET.ON-Mood Enhancer-WL is proven to be effective, patients may start inpatient therapy with reduced depressive symptom severity, ideally leading to higher remission rates, shortened inpatient therapy, reduced costs, and decreased waiting times.
Trial registration
German Clinical Trial Registration (DRKS): DRKS00004708.
doi:10.1186/1471-244X-13-318
PMCID: PMC4222859  PMID: 24279841
Internet therapy; Waiting time; Major depression; Inpatient treatment; Remission
17.  Efficacy and cost-effectiveness of a web-based intervention with mobile phone support to treat depressive symptoms in adults with diabetes mellitus type 1 and type 2: design of a randomised controlled trial 
BMC Psychiatry  2013;13:306.
Background
A diagnosis of diabetes mellitus types 1 or 2 doubles the odds of a comorbid depressive disorder. The combined diseases have a wide range of adverse outcomes, such as a lower quality of life, poorer diabetes outcomes and increased healthcare utilisation. Diabetes patients with depression can be treated effectively with psychotherapy, but access to psychological care is limited. In this study we will examine the efficacy and cost-effectiveness of a newly developed web-based intervention (GET.ON Mood Enhancer Diabetes) for people with diabetes and comorbid depressive symptoms.
Methods/Design
A two-arm randomised controlled trial will be conducted. Adults with diabetes (type 1 or type 2) with increased depression scores (> 22 on the German version of the Center for Epidemiological Studies Depression Scale (CES-D)) will be included. Eligible participants will be recruited through advertisement in diabetes patient journals and via a large-scale German health insurance company. The participants will be randomly assigned to either a 6-week minimally guided web-based self-help program or an online psychoeducation program on depression. The study will include 260 participants, which will enable us to detect a statistically significant difference with a group effect size of d = 0.35 at a power of 80% and a significance level of p = 0.05. The primary outcome measure will be the level of depression as assessed by the CES-D. The secondary outcome measures will be: diabetes-specific emotional distress, glycaemic control, self-management behaviour and the participants’ satisfaction with the intervention. Online self-assessments will be collected at baseline and after a 2 months period, with additional follow-up measurements 6 and 12 months after randomisation. The data will be analysed on an intention-to-treat basis and per protocol. In addition, we will conduct an economic evaluation from a societal perspective.
Discussion
If this intervention is shown to be cost-effective, it has considerable potential for implementing psychological care for large numbers of people with diabetes and comorbid depression in routine practice and improve health outcomes.
Trial registration
German Clinical Trial Register (DRKS): DRKS00004748.
doi:10.1186/1471-244X-13-306
PMCID: PMC4225701  PMID: 24238346
Diabetes; Depression; Guided web-based self-help; Internet; Randomised controlled trial; Efficacy; Cost-effectiveness
18.  Efficacy and cost-effectiveness of a web-based and mobile stress-management intervention for employees: design of a randomized controlled trial 
BMC Public Health  2013;13:655.
Background
Work-related stress is associated with a variety of mental and emotional problems and can lead to substantial economic costs due to lost productivity, absenteeism or the inability to work. There is a considerable amount of evidence on the effectiveness of traditional face-to-face stress-management interventions for employees; however, they are often costly, time-consuming, and characterized by a high access threshold. Web-based interventions may overcome some of these problems yet the evidence in this field is scarce. This paper describes the protocol for a study that will examine the efficacy and cost-effectiveness of a web-based guided stress-management training which is based on problem solving and emotion regulation and aimed at reducing stress in adult employees.
Methods
The study will target stressed employees aged 18 and older. A randomized controlled trial (RCT) design will be applied. Based on a power calculation of d=.35 (1-β of 80%, α = .05), 264 participants will be recruited and randomly assigned to either the intervention group or a six-month waitlist control group. Inclusion criteria include an elevated stress level (Cohen’s Perceived Stress Scale-10 ≥ 22) and current employment. Exclusion criteria include risk of suicide or previously diagnosed psychosis or dissociative symptoms. The primary outcome will be perceived stress, and secondary outcomes include depression and anxiety. Data will be collected at baseline and seven weeks and six months after randomization. An extended follow up at 12 months is planned for the intervention group. Moreover, a cost-effectiveness analysis will be conducted from a societal perspective and will include both direct and indirect health care costs. Data will be analyzed on an intention-to-treat basis and per protocol.
Discussion
The substantial negative consequences of work-related stress emphasize the necessity for effective stress-management trainings. If the proposed internet intervention proves to be (cost-) effective, a preventative, economical stress-management tool will be conceivable. The strengths and limitations of the present study are discussed.
Trial registration
German Register of Clinical Studies (DRKS): DRKS00004749
doi:10.1186/1471-2458-13-655
PMCID: PMC3717042  PMID: 23855376
Internet intervention; Efficacy; Prevention; Work-related stress; Stress management; Depression; Occupational health; Cost-effectiveness
19.  Log in and breathe out: efficacy and cost-effectiveness of an online sleep training for teachers affected by work-related strain - study protocol for a randomized controlled trial 
Trials  2013;14:169.
Background
Insomnia and work-related stress often co-occur. Both are associated with personal distress and diminished general functioning, as well as substantial socio-economic costs due to, for example, reduced productivity at the work place and absenteeism. Insomnia complaints by people experiencing work-related stress are correlated with a deficient cognitive detachment from work. Diffuse boundaries between work and private life can additionally complicate the use of recreational activities that facilitate cognitive detachment.
Cognitive behavioral therapy for insomnia is effective but rarely implemented. Internet-based cognitive behavioral therapy for insomnia could potentially reduce this deficit given its demonstrated effectiveness. Less is known, however, about the efficacy of internet-based cognitive behavioral therapy for insomnia in populations affected by high work stress. Thus, the aim of the present study is to evaluate the efficacy and cost-effectiveness of a newly developed, guided online training which is based on Cognitive Behavioral Therapy for insomnia and tailored to teachers affected by occupational stress.
Methods/Design
In a two-arm randomized controlled trial (N = 128), the effects of a guided online sleep training will be compared to a waitlist-control condition. German teachers with significant clinical insomnia complaints (Insomnia Severity Index ≥15) and work-related rumination (Irritation Scale, subscale Cognitive Irritation ≥15) will be included in the study. The primary outcome measure will be insomnia severity. Additionally, an economic evaluation from a societal perspective will be conducted. Data from the intention-to-treat sample will be analyzed two and six months after randomization.
Discussion
To the best of our knowledge, this is the first study to evaluate an online sleep training tailored to a specific population with work stress, that is, teachers. If this type of intervention is effective, it could reduce the paucity of cognitive behavioral therapy for insomnia and augment the support for teachers in coping with their insomnia problems.
Trial registration
German Clinical Trial Register (DRKS): DRKS00004700
doi:10.1186/1745-6215-14-169
PMCID: PMC3703267  PMID: 23759035
Insomnia; Internet; CBT-I; Cost-effectiveness; Occupational health; Stress; Teachers

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