JMIR Publications

ABSTRACT

Background:

Major depressive disorder (MDD) affects approximately 1 in 5 adults during their lifetime and is the leading cause of disability worldwide. Yet, a minority receive minimally adequate treatment due to person-level (e.g., geographical distance to providers) and systems-level (e.g., shortage of trained providers) barriers. Digital tools could improve this treatment gap by reducing the time and frequency of therapy sessions needed for effective treatment through provision of flexible, automated support.

Objective:

The aim of the study was to examine the feasibility, acceptability and preliminary clinical impact of Mindset for Depression, a deployment-ready 8-week smartphone-based cognitive behavior therapy (CBT) supported by brief virtual appointments with a therapist.

Methods:

This 8-week, single-arm, open trial tested the Mindset for Depression app when combined with 8 brief (16-25 min) virtual visits with a licensed doctoral-level CBT therapist (n=28). The app offers flexible, accessible psychoeducation, CBT skills practice, and support to patients with complementary clinician guidance to promote sustained engagement, monitor safety, and tailor treatment further to individual patient needs. To increase accessibility and thus generalizability, all study procedures were conducted virtually. Feasibility and acceptability were assessed via attrition, patient expectations and feedback, and treatment utilization. The primary clinical outcome measure was the clinician-rated Hamilton Depression Rating Scale (HAM-D), administered at pretreatment, mid-point, and posttreatment. Secondary measures of functional impairment and quality of life as well as maintenance of gains (3-month follow-up) were also collected.

Results:

Treatment credibility (week 4), expectancy (week 4), and satisfaction (week 8) were moderate to high and attrition was low (n=2; 7%). Participants self-reported using the app or practicing (either on or off the app) the CBT skills taught in the app for a median of 50 (week 4) or 60 (week 8) minutes per week; participants accessed the app on an average 36.8 (SD=10.0) days and completed a median of 7 out of 8 steps (interquartile range (IQR): [6, 8]) by the week 8 assessment. The app was rated positively across domains of engagement, functionality, aesthetics, and information. Participants’ depression severity scores decreased from an average HAM-D score indicating moderate depression (M=19.1, SD=5.0) at baseline to a week 8 mean score indicating mild depression (M=10.8, SD=6.1), d=1.47, P< .0001. Improvement was also observed for functional impairment and quality of life. Gains were maintained at 3-month follow-up.

Conclusions:

The results show that Mindset for Depression is a feasible and acceptable treatment option for individuals with MDD. This smartphone-led treatment holds promise to be an efficacious, scalable, and cost-effective treatment option. Next steps include testing Mindset for Depression in a fully powered randomized controlled trial as well as real world clinical settings. Clinical Trial: clinicaltrials.gov: NCT05386329