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

Nolte, Sandra; Busija, Ljoudmila; Berger, Thomas; Meyer, Björn; Moritz, Steffen; Rose, Matthias; Schröder, Johanna; Späth-Nellissen, Christina; Klein, Jan Philipp (2021). 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. BMJ open, 11(1), e041389. BMJ Publishing Group 10.1136/bmjopen-2020-041389

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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.

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