Efficacy of an internet-based self-management intervention for depression or dysthymia - a study protocol of an RCT using an active control condition

Caroline Oehler; Frauke Görges; Daniel Böttger; Juliane Hug; Nicole Koburger; Elisabeth Kohls; Christine Rummel-Kluge

doi:10.1186/s12888-019-2063-1

Efficacy of an internet-based self-management intervention for depression or dysthymia - a study protocol of an RCT using an active control condition

BMC Psychiatry. 2019 Mar 14;19(1):90. doi: 10.1186/s12888-019-2063-1.

Authors

Caroline Oehler¹, Frauke Görges¹, Daniel Böttger¹, Juliane Hug², Nicole Koburger³, Elisabeth Kohls⁴, Christine Rummel-Kluge⁵

Affiliations

¹ German Depression Foundation, Semmelweisstr. 10, 04103, Leipzig, Germany.
² European Alliance Against Depression, Semmelweisstr. 10, 04103, Leipzig, Germany.
³ Research Academy Leipzig, Wächterstraße 30, 04107, Leipzig, Germany.
⁴ Department of Psychiatry and Psychotherapy, Medical Faculty, University Leipzig, Semmelweisstr. 10, 04103, Leipzig, Germany.
⁵ Department of Psychiatry and Psychotherapy, Medical Faculty, University Leipzig, Semmelweisstr. 10, 04103, Leipzig, Germany. Christine.Rummel-Kluge@medizin.uni-leipzig.de.

Abstract

Background: The treatment of major depressive disorder, a highly prevalent disorder associated with pronounced burden, is a large challenge to healthcare systems worldwide. Internet based self-management interventions seem to be a cost effective way to complement the treatment of depressed patients, but the accumulating evidence is mainly based on the comparison to waitlist controls and treatment as usual, which might lead to an overestimation of effects. Furthermore, studies assessing long-term effects and possible negative outcomes are still rare.

Methods/design: The proposed study evaluates the efficacy of the German version of the iFightDepression® tool in comparison to an active control condition. A total of 360 patients with mild to moderate depressive symptoms are included into a two-armed randomized controlled trial. They receive one of two six week interventions; either the iFightDepression® tool or progressive muscle relaxation serving as the control condition. Both intervention groups receive information material, weekly tasks via the internet and regular phone calls as part of the intervention. The primary outcome is change in depressive symptoms after the intervention period, as measured with the Inventory of Depressive Symptomatology. Satisfaction with the program, usability, changes in perceived quality of life, and possible negative effects are assessed as secondary outcomes.

Discussion: This study represents the first randomized controlled trial on the iFightDepression® self-management tool in its German version, aiming at efficacy, but also at providing new insights into so far understudied aspects of E-mental health programs, namely the specificity of the treatment effect compared to an active control condition, it's continuity over a time course of 12 months, and possible negative effects of these internet based interventions.

Trial registration: International trial-registration took place through the "international clinical trials registry platform" (WHO) with the secondary ID 080-15-09032015. German Clinical Trial Registration: DRKS00009323 (DRKS.de, registered on 25 February 2016).

Keywords: Depression; IBI; IMI; Internet based intervention; Online self-management; Study protocol; eMentalHealth; iCBT; iFightDepression.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Depressive Disorder, Major / epidemiology
Depressive Disorder, Major / psychology*
Depressive Disorder, Major / therapy*
Dysthymic Disorder / epidemiology
Dysthymic Disorder / psychology*
Dysthymic Disorder / therapy*
Female
Humans
Internet-Based Intervention*
Male
Quality of Life / psychology
Self-Management / methods
Self-Management / psychology*
Treatment Outcome

Associated data

DRKS/DRKS00009323