OBJECTIVE: To test the efficacy of smartphone-assisted online brief cognitive behavioral therapy (b-CBT) to treat maternal depression compared to online brief CBT plus an active control app. METHODS: A randomized controlled trial was conducted. Assessments were performed at baseline (T0), midpoint (T1, week 4-5), post-treatment (T2, week 8), and follow-up (T3, 2-month postnatal follow-up) by blinded interviewers. The primary outcome was depression measured by the Edinburgh Postnatal Depression Scale (EPDS) at T2. We also assessed anxiety, stress, sleep quality, well-being, physical activity, treatment response, and offspring child behavior problems. RESULTS: Eighty-one participants were randomized to the intervention (n=37) or active control (n=44) groups. Seventy-one participants completed the post-treatment assessment or reported primary outcome data. No differences were found between the intervention and active control groups regarding maternal depression or other mental health outcomes. Overall, we found large within-group effect sizes, with 80% of the total sample responding to treatment. CONCLUSIONS: Our data showed no difference between the groups, suggesting that adding apps to psychotherapy treatment may not enhance treatment effects on prenatal depression. A within-groups analysis showed that most participants with depression responded to treatment; however, future studies are needed to confirm whether this effect is related to factors other than the intervention.
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