Accepted for/Published in: JMIR Mental Health
Date Submitted: Jan 14, 2025
Date Accepted: Apr 25, 2025
Treatment without cost? Effects and side effects of an internet-based intervention for depression in a randomized controlled trial
ABSTRACT
Background:
Internet-based interventions for depression are increasingly integrated into health care due to their effectiveness, availability, and cost-effectiveness. However, negative effects have largely been overlooked.
Objective:
This study evaluated both positive and negative effects.
Methods:
303 participants were analyzed using mixed model for repeated measures to assess changes in depressive symptoms via Beck Depression Inventory-II (primary outcome) after 12 weeks. Secondary endpoints included depressive symptoms (PHQ-9), self-esteem, and quality of life. Negative effects were evaluated using the Positive and Negative Effects of Psychotherapy Scale for internet-based interventions (PANEPS-I). Moderation analyses were conducted to explore influential effects on treatment outcomes.
Results:
The intervention group showed greater reduction in depressive symptoms compared to controls, with small to medium effect sizes (g = 0.30–0.42). Although improvements in self-esteem and quality of life were not observed in intention-to-treat analyses, the completer sample indicated higher self-esteem in the intervention group. Negative effects were reported by 22–68%, with the highest rates for program-related effects (e.g., not addressing personal problems). No moderation effects were identified.
Conclusions:
The intervention effectively reduces depressive symptoms. Although negative effects were present, they did not impact treatment outcome, tentatively suggesting that overall benefits may outweigh the negative effects for users. Clinical Trial: German Clinical Trial Register, drks.de, ID: DRKS00027459
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