Do sociodemographic variables moderate effects of an internet intervention for mild to moderate depressive symptoms? An exploratory analysis of a randomised controlled trial (EVIDENT) including 1013 participants

Sandra Nolte, Ljoudmila Busija, Thomas Berger, Björn Meyer, Steffen Moritz, Matthias Rose, Johanna Schröder, Christina Späth-Nellissen, Jan Philipp Klein, Sandra Nolte, Ljoudmila Busija, Thomas Berger, Björn Meyer, Steffen Moritz, Matthias Rose, Johanna Schröder, Christina Späth-Nellissen, Jan Philipp Klein

Abstract

Objective: To explore the moderating effects of sociodemographic variables on treatment benefits received from participating in an internet intervention for depression.

Design: Randomised, assessor-blind, controlled trial.

Setting: Online intervention, with participant recruitment using multiple settings, including inpatient and outpatient medical and psychological clinics, depression online forums, health insurance companies and the media (eg, newspaper, radio).

Participants: The EVIDENT trial included 1013 participants with mild to moderate depressive symptoms.

Interventions: The intervention group subjects (n=509) received an online intervention (Deprexis) in addition to care as usual (CAU), while 504 participants received CAU alone.

Methods: To explore subgroup differences, moderating effects were investigated using linear regression models based on intention-to-treat analyses. Moderating effects included sex, age, educational attainment, employment status, relationship status and lifetime frequency of episodes.

Primary and secondary outcome measures: The primary endpoint was change in self-rated depression severity measured by the Patient Health Questionnaire-9 (PHQ-9), comparing baseline versus 12-week post-test assessment. Secondary outcome measures were the Hamilton Rating Scale for Depression and the Quick Inventory of Depressive Symptoms each at 12 weeks and at 6 and 12 months, and PHQ-9 at 6 and 12 months, respectively. In this article, we focus on the primary outcome measure only.

Results: Between-group differences were observed in post-test scores, indicating the effectiveness of Deprexis. While the effects of the intervention could be demonstrated across all subgroups, some showed larger between-group differences than others. However, after exploring the moderating effects based on linear regression models, none of the selected variables was found to be moderating treatment outcomes.

Conclusions: Our findings suggest that Deprexis is equally beneficial to a wide range of people; that is, participant characteristics were not associated with treatment benefits. Therefore, participant recruitment into web-based psychotherapeutic interventions should be broad, while special attention may be paid to those currently under-represented in these interventions.

Trial registration number: NCT01636752.

Keywords: clinical trials; depression & mood disorders; mental health; statistics & research methods.

Conflict of interest statement

Competing interests: JPK has received payments for presentations, workshops and books on psychotherapy for chronic depression and on psychiatric emergencies. BM is employed as research director at GAIA AG, the company that developed, owns and operates the internet intervention investigated in this trial. All other authors report no conflicts of interests.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Participant flow diagram. PHQ-9, Patient Health Questionnaire-9.

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