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BACKGROUND: This study's aims were to compare the efficacy and negative effects of guided Internet-based cognitive behavior therapy (iCBT) and online psychoeducation (OPE) in people with major depression.METHODS: A total of 131 individuals were randomized. Assessments took place at baseline (T1), six weeks (T2), and three months (T3). The primary endpoint was change in observer-based depression severity from T1 to T2. Potential negative effects were analyzed in terms of suicidal ideations, symptom deterioration, attitudes toward seeking further help, and other adverse events.RESULTS: iCBT (n = 65) and OPE (n = 66) both reduced depressive symptoms from T1 to T2, with large changes observed for iCBT and medium for OPE (iCBT: Cohen's d = 1.09; OPE: d = 0.60). Differences between groups were significant at the primary endpoint (d = 0.36, p = 0.028). OPE continued to have a positive effect from post-treatment to follow-up, while the effect of iCBT remained stable, with differences between groups not being significant anymore at follow-up. Participants who had undergone prior psychotherapy benefited from both treatments; but for those without prior psychotherapy, iCBT was superior also at follow-up. In the iCBT group 26.2% of the participants reported at least one side-effect.LIMITATIONS: The history of psychotherapy was imbalanced between the groups. Some negative effects were assessed in the iCBT group only.CONCLUSIONS: Both iCBT and OPE were effective in reducing depressive symptoms, but with iCBT having a more rapid effect. iCBT was specifically superior in those with no prior history of psychotherapy. Negative effects occurred frequently and should be considered when implementing iCBT.TRIAL REGISTRATION: German clinical trials register: DRKS00005025.

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. © 2014 Ebert et al.; licensee BioMed Central Ltd.