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Background Depression in adolescents is a large and growing problem; however, access to effective mental health care continues to be a challenge. Digitally based interventions may serve to bridge this access gap for adolescents in need of care. Digital interventions that deliver components of cognitive behavioral therapy (CBT) have been shown to reduce symptoms of depression, and virtual reality (VR) may be a promising adjunctive component. However, research on these types of treatments in adolescents and young adults is limited. Objective This study aims to evaluate the feasibility, acceptability, and preliminary efficacy of Spark (v1.0), a 5-week, self-guided, CBT-based digital program using a mobile app and VR experiences to target symptoms of depression in adolescents. Methods A single-arm, open-label study of the Spark program was conducted with a community sample of 30 adolescents and young adults aged 12 to 21 years with self-reported moderate to severe depression symptoms. Participants completed a weekly depression assessment (Patient Health Questionnaire-8) in the app during the 5-week intervention period as well as web-based baseline, postintervention, and 1-month follow-up self-report assessments. The participants also completed a qualitative postintervention interview. For participants aged <18 years, caregivers completed assessments at baseline and postintervention time points. Feasibility outcomes included recruitment rate (the proportion of participants who enrolled in the study divided by the total number of participants screened for eligibility) and retention rate (the proportion of participants who completed postintervention assessments divided by the total number of participants who received the intervention). Acceptability outcomes included engagement with the program and quantitative and qualitative feedback about the program. Preliminary efficacy was evaluated based on the Patient Health Questionnaire-8. Results The study recruitment (31/66, 47%) and retention (29/30, 97%) rates were high. Participants provided higher ratings for the ease of use of the Spark program (8.76 out of 10) and their enjoyment of both the mobile app (7.00 out of 10) and VR components (7.48 out of 10) of the program, whereas they provided lower ratings for the program’s ability to improve mood (4.38 out of 10) or fit into their daily routines (5.69 out of 10). We observed a clinically and statistically significant reduction in depression scores at postintervention (mean difference 5.36; P<.001) and 1-month follow-up (mean difference 6.44; P<.001) time points. Conclusions The Spark program was found to be a feasible and acceptable way to deliver a self-guided CBT-focused intervention to adolescents and young adults with symptoms of depression. Preliminary data also indicated that the Spark program reduced the symptoms of depression in adolescents and young adults. Future studies should evaluate the efficacy of this intervention in an adequately powered randomized controlled trial. Trial Registration ClinicalTrials.gov NCT04165681; https://classic.clinicaltrials.gov/ct2/show/NCT04165681

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BACKGROUND Adolescent depression is a large and growing problem, yet access to effective mental healthcare continues to be a challenge. Digitally-based interventions may serve to bridge this access gap for adolescents in need of care. OBJECTIVE To evaluate the feasibility, acceptability, and preliminary efficacy of Spark (v1.0) , a 5-week, self-guided, cognitive-behavioral therapy (CBT)-based digital program employing mobile app and virtual reality (VR) experiences to target symptoms of depression in adolescents. METHODS A single-arm, open-label study of the Spark program with a community sample of thirty adolescents (ages 12-21) with self-reported moderate to severe depression symptoms was conducted. Participants completed a weekly depression assessment (8-item Patient Health Questionnaire, PHQ-8) in the app during the intervention period as well as web-based baseline, post-intervention, and 1-month follow-up self-report assessments. Participants also completed a post-intervention qualitative interview. Caregivers of participants under 18 completed baseline and post-intervention assessments. Feasibility outcomes included recruitment and retention rates. Acceptability outcomes included engagement with the program and quantitative and qualitative feedback about the program. Efficacy was evaluated based on the PHQ-8. RESULTS Study recruitment (47%) and retention (97%) rates were high. Participants highly rated the ease of use of the Spark program (8.76 out of 10) and their enjoyment of both the mobile app (7.00 out of 10) and VR components (7.48 out of 10) of the program, while providing more moderate ratings of the program's ability to improve mood (4.38 out of 10) or fit into their daily routines (5.69 out of 10). We observed a clinically and statistically significant reduction in depression scores at post-intervention (mean difference = 5.36, p <.001) and 1-month follow-up (mean difference = 6.44, p <.001). CONCLUSIONS Preliminary data indicated that Spark reduced symptoms of depression in adolescents. The Spark program was also found to be a feasible and acceptable way to deliver a self-guided CBT-focused intervention to adolescents with symptoms of depression. CLINICALTRIAL This study was registered on clinicaltrials.gov (NCT04165681).