Efficacy of a Web-Based Intervention for Depressive Disorders: Three-Arm Randomized Controlled Trial Comparing Guided and Unguided Self-Help With Waitlist Control

Abstract

Background Digital health apps are efficacious treatment options for mild-to-moderate depressive disorders. However, the extent to which psychological guidance increases the efficacy of these apps is controversial. Objective We evaluated the efficacy of a web-based intervention, called Selfapy, for unipolar depression. We also investigated differences between psychotherapist-guided and unguided versions. Methods Selfapy is a cognitive behavioral therapy–based intervention for depressive disorders. Participants with mild-to-severe depressive disorders were assigned randomly to participate in either guided (weekly 25-minute duration telephone calls) intervention, unguided version, or waiting list (control group) for 12 weeks. We assessed depressive symptoms at the start of the study, midway through the intervention (6 weeks), at the end of the intervention (12 weeks), and at follow-up (6 months). The main outcome was difference in the Beck Depression Inventory score between the start of the study and the end of the intervention. Secondary outcomes were the Quick Inventory of Depressive Symptomatology—Self Report, the Hamilton Rating Depression Scale, and the Beck Anxiety Inventory. Results Of 401 participants, 301 participants (75.1%) completed the intervention. Changes in the Beck Depression Inventory from baseline differed significantly between groups at the postintervention (F2,398=37.20, P<.001). The reductions in scores for both guided and unguided intervention groups were greater than that for the control group, with large between-group effect sizes (guided vs control: d=1.63, 95% CI 1.37 to 1.93; unguided vs control: d=1.47, 95% CI 1.22 to 1.73) at postintervention. No significant differences were found between guided and unguided intervention groups (P=.18). At follow-up (6 months), treatment effects on the primary outcome were maintained for both intervention groups (guided: F1,194=0.62, P>.999; unguided: F1,176=0.13, P>.999). Conclusions Both guided and unguided versions of the intervention were highly effective in reducing depressive symptoms. Follow-up data suggest that these effects could be maintained. The guided version was not superior to the unguided version. Trial Registration German Clinical Trials Register DRKS00017191; https://tinyurl.com/2p9h5hnx International Registered Report Identifier (IRRID) RR2-10.1186/s13063-021-05218-4

Guided Internet-Delivered Treatment for Depression: Scoping Review

“…In guided treatment programs, a therapist often plays an active role in the treatment and guides the patient (or research participant) through the program. Studies have shown that both treatment formats could be effective and that a guided program is not necessarily superior to an unguided program [ 17 , 18 ] but that the inclusion of guidance could have an impact on treatment adherence [ 19 ].…”

Barriers to and Facilitators of a Blended Cognitive Behavioral Therapy Program for Depression and Anxiety Based on Experiences of University Students: Qualitative Interview Study

“…Moreover, our study provides the first qualitative insights into the facilitators and barriers that might influence the uptake of an app in a bCBT program among students with mild to moderate depression or anxiety symptoms. Furthermore, almost all participants completed the bCBT program; hence, the therapy adherence seems to be substantially higher than that in study designs using either only face-to-face therapy sessions or DTx alone [ 41 , 65 ]. This leads to the assumption that the combination of individual face-to-face therapy sessions with personalized digital components could contribute to students’ motivation and engagement.…”

The efficacy, acceptability and satisfaction of internet-based cognitive behavioral therapy with the absence of professional guidance for depression in adults: a systematic review and meta-analysis

“…They were published between 2004[64] and 2022 [35]. There were 10 659 participants in systematic review, 5 615 in intervention group and 5044 in control group.…”

“…The risk of bias of 30 studies included were presented in Figure 2 and Figure 3. 22 studies [35,36,39,40,[42][43][44]46-48, 50-54, 56-59, 61, 63, 64] explicitly described the process of randomization and concealed the allocation sequences until the participants were assigned to interventions. Unlike the above studies, the detailed information about the allocation sequence concealment cannot be found in the remaining 8 studies [37,38,41,45,49,55,60,62].…”