Evaluation of the online-based self-help programme “Selfapy” in patients with unipolar depression: study protocol for a randomized, blinded parallel group dismantling study

Abstract Background: This study aims to evaluate the online-based self-help programme “Selfapy” on a sample of depressive subjects and, furthermore, the impact of an unaccompanied version vs. a therapeutic accompanied version. Subjects are randomly assigned to the unaccompanied course (without weekly calls from a psychologist), an accompanied course (with weekly calls from a psychologist), or the control group. Various secondary parameters related to online self-help programmes, such as life satisfaction, therapeutic relationship, social activation, self-esteem, attitude towards Internet interventions and drop-out rates, are also recorded. Methods: A sample size of 400 subjects will be included. Subjects must have at least a mild to moderate depressive episode (BDI-II and Hamilton Depression Scale) and then will be randomly assigned into one of three groups: (a) immediate access to the unaccompanied depression course of “Selfapy”, (b) immediate access to the accompanied depression course of “Selfapy”, or (c) access to “Selfapy” after a 24-week delay (waiting list). The intervention period will last for a period of 12 weeks. Diagnostic assessments will take place at four different points in time: T1 (at baseline before the treatment), T2 (6 weeks after the start of the intervention), T3 (12 weeks after the start of the intervention; end of program) and T4 (3 months after completion of the treatment follow-up). Conclusion: The effectiveness of the online self-help program "Selfapy" for depression, is to be investigated in a randomized, controlled, blinded study. Additionally, this study will utilize a “dismantled” approach to enable the comparison of the accompanied andTrial registration: Current Controlled Trial DRKS00017191Date of registration: 14.06.2019