Naturalistic use of a digital mental health intervention for depression and anxiety: A randomized clinical trial.

Background: Digital mental health interventions (DMHI) may offer scalable treatment for common mental health conditions. However, many commercially available apps have not been subjected to rigorous evaluation of effectiveness, particularly among users experiencing clinically significant symptomatology. We examined depression and anxiety symptom outcomes associated with a top-rated, commercially available self-guided DMHI based on cognitive behavioral therapy ("Sanvello") relative to waitlist control.

Methods: This preregistered web-based, 2-arm, parallel-group randomized trial enrolled U.S. adults with self-reported elevated symptoms of depression and/or anxiety. Those assigned to the treatment condition were provided 8 weeks of access to Sanvello. Co-primary outcomes of depression (Patient Health Questionnaire [PHQ-9]) and anxiety (Generalized Anxiety Disorder 7-item scale [GAD-7]) severity were assessed at baseline and 2, 4, 6, and 8 weeks.

Results: Intention-to-treat analyses included 280 participants (mean age 32.47 ± 9.32 years; 86.1 % women). Generalized linear mixed models showed a significant improvement in depression (F(4,779) = 6.51, p < .001) and anxiety (F(4,907) = 3.28, p = .01) associated with the DMHI over time. The intervention was also associated with a greater proportion of participants exhibiting depression response (25 [45.5 %] vs 26 [16.9 %]) and remission (10 [18.2 %] vs 7 [4.5 %]) on the PHQ-9, and anxiety response (31 [44.9 %] vs 39 [22.8 %]) and remission (20 [29.0 %] vs 27 [15.8 %]) on the GAD-7, relative to waitlist.

Limitations: Findings may not represent people with serious mental illness, suicidality, or the broader population of DMHI users.

Conclusions: A commercially available, self-guided DMHI was effective at improving symptoms in individuals experiencing depression or anxiety.

Trial Registration: ClinicalTrials.gov [NCT05373329].