Abstract
BackgroundMajor depressive disorder (MDD) places a significant disease burden on individuals as well as on societies. Several web-based interventions for MDD have shown to be effective in reducing depressive symptoms. However, it is not known whether web-based interventions, when used as adjunctive treatment tools to regular psychotherapy, have an additional effect compared to regular psychotherapy for depression.Methods/designThis study is a currently recruiting pragmatic randomized controlled trial (RCT) that compares regular psychotherapy plus a web-based depression program (“deprexis”) with a control condition exclusively receiving regular psychotherapy. Adults with a depressive disorder (N = 800) will be recruited in routine secondary care from therapists over the course of their initial sessions and will then be randomized within therapists to one of the two conditions. The primary outcome is depressive symptoms measured with the Beck Depression Inventory (BDI-II) at three months post randomization. Secondary outcomes include changes on various indicators such as anxiety, somatic symptoms and quality of life. All outcomes are again assessed at the secondary endpoint six months post randomization. In addition, the working alliance and feasibility/acceptability of the treatment condition will be explored.DiscussionThis is the first randomized controlled trial to examine the feasibility/acceptability and the effectiveness of a combination of traditional face-to-face psychotherapy and web-based depression program compared to regular psychotherapeutic treatment in depressed outpatients in routine care.Trial registrationISRCTN20165665.
Highlights
Major depressive disorder (MDD) places a significant disease burden on individuals as well as on societies
This is the first randomized controlled trial to examine the feasibility/acceptability and the effectiveness of a combination of traditional face-to-face psychotherapy and web-based depression program compared to regular psychotherapeutic treatment in depressed outpatients in routine care
Objective and research questions The main objective of the present study is to further investigate combined treatment approaches for MDD by evaluating an empirically validated web-based treatment as an adjunctive tool in regular psychotherapeutic treatment in comparison with traditional psychotherapy in a sample of depressed outpatients by means of a pragmatic randomized controlled trial (RCT) in routine care
Summary
Major depression is a prevalent and debilitating disorder. Even though there is ample evidence for the efficiency and effectiveness of (guided) Internet-based interventions as well as for conventional psychotherapeutic treatments for depression, there are various strengths and limitations for both forms of treatments [11]. We will examine the effectiveness of psychotherapy plus a web-based online depression program (deprexis) versus traditional psychotherapy in routine care. A major strength of this study is that to the best of our knowledge, it will be the first study that tests whether an adjunctive web-based treatment tool in psychotherapy for depression can be successfully integrated in routine care and whether the combination will show additional effects compared to a regular psychotherapy for depression. Results of this study will provide an informative basis whether a combination of traditional face-to-face psychotherapy and web-based depression program is feasible and whether it is more effective compared to regular psychotherapeutic treatment in depressed outpatients in routine care.
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