Accepted for/Published in: JMIR Formative Research
Date Submitted: Oct 21, 2021
Open Peer Review Period: Oct 21, 2021 - Oct 28, 2021
Date Accepted: Feb 1, 2022
Date Submitted to PubMed: Feb 2, 2022
(closed for review but you can still tweet)
Efficacy of an online intervention for treatment of depressive disorders: a three-arm randomized controlled trial comparing guided and unguided self-help with waitlist control
ABSTRACT
Background:
Digital health applications are efficacious treatment options for mild-to-moderate depressive disorders. However, the extent to which psychological guidance increases the efficacy of these applications is controversial.
Objective:
We evaluated the efficacy of the online intervention “Selfapy” for unipolar depression. We also investigated differences between a psychotherapist-guided vs. unguided version compared with those from a control group.
Methods:
A cohort of 401 participants with mild-to-severe depressive disorders were assigned randomly to either participate in a guided version of Selfapy (involving weekly telephone calls of 25-minute duration), an unguided version of Selfapy, or to the waiting list (control group). Selfapy is a cognitive behavioral therapy-based intervention for depressive disorders of duration 12 weeks. Symptom assessment was undertaken at T1 (before study entrance), T2 (after 6 weeks), T3 (post-treatment, after 12 weeks), and T4 (follow-up, after 6 months). The main outcome was reduction in depressive symptoms in the Beck Depression Inventory (BDI-II) from T1 to T3. Secondary-outcome parameters were the Quick Inventory of Depressive Symptomatology – Self Report (QIDS-SR 16) and Beck Anxiety Inventory (BAI).
Results:
A total of 297 out of 401 participants (74.06%) completed the post-measurement at T3. In the ITT-analysis, both intervention groups showed a significantly higher reduction in depressive symptoms (BDI-II) from T1 to T3 compared with the control group, with high within-group effect sizes (guided: d = 1.46; unguided: d = 1.36). No significant differences were found for guided vs. unguided treatment groups. The response rate (BDI-II) was 46.4% for the guided version, 40.0% for the unguided version, and 2.0% in the control group. After 6 months (T4), treatment effects could be maintained for both intervention groups (BDI-II) without differences between either intervention group.
Conclusions:
Selfapy can help to reduce depressive symptoms in guided or unguided versions. Follow-up data suggest that these effects could be maintained. The guided version was not superior to the unguided version. Clinical Trial: Current Controlled Trial DRKS00017191; Date of registration: 14 May 2019.
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