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 (Preprint)

Abstract

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.

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.

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 with a duration of 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), the Hamilton Rating Depression Scale (HRSD-24) and the Beck Anxiety Inventory (BAI).

A total of 301 out of 401 participants (75.1%) completed the post-measurement at T3. Changes in BDI-II from baseline differed significantly between groups at post-treatment with a significant effect of group (F(2,398) = 37.20, P<.001). Post-hoc analyses revealed a higher reduction for both intervention groups compared to the control group, with large between group effect sizes (guided vs. control: d=1.63 (95% CI 1.37-1.93); unguided vs. control: d=1.47 (95% CI 1.22-1.73)) at post-treatment. No significant differences were found between the two treatment groups. Same results were established for all secondary outcomes. At follow-up (6 months), treatment effects on the primary outcome could be maintained for both intervention groups in the completer sample.

Selfapy is highly effective 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.

Current Controlled Trial DRKS00017191; Date of registration: 14 May 2019.

RR2-10.1186/s13063-021-05218-4