A CBT-based mobile intervention as an adjunct treatment for adolescents with symptoms of depression: a virtual randomized controlled feasibility trial

Frontiers in Digital Health

Digital Health

Xin L. Koepsell¹  Elise M. Vierra¹  Gabriel S. Strauss²  Aarthi Padmanabhan³  Phoebe C. Crosthwaite³  Shana A. Hall³  Vera N. Kulikov³  Jessica E. Flannery⁴  Jessica I. Lake⁴ 

[1] Content Department, Limbix Health, San Francisco, CA, United States;Product Department, Limbix Health, San Francisco, CA, United States;Research Department, Limbix Health, San Francisco, CA, United States;Science Department, Limbix Health, San Francisco, CA, United States;

关键词: cognitive behavioral therapy;    digital therapeutics;    adolescent depression;    feasibility;    mHealth;    mental health;   

DOI  :  10.3389/fdgth.2023.1062471

 received in 2022-10-05, accepted in 2023-04-27,  发布年份 2023

来源: Frontiers

【 摘 要 】

BackgroundHigh rates of adolescent depression demand for more effective, accessible treatment options. A virtual randomized controlled trial was used to assess the feasibility and acceptability of a 5-week, self-guided, cognitive behavioral therapy (CBT)-based mobile application, Spark, compared to a psychoeducational mobile application (Active Control) as an adjunct treatment for adolescents with depression during the COVID-19 pandemic.MethodsA community sample aged 13–21, with self-reported symptoms of depression, was recruited nationwide. Participants were randomly assigned to use either Spark or Active Control (NSpark = 35; NActive Control = 25). Questionnaires, including the PHQ-8 measuring depression symptoms, completed before, during, and immediately following completion of the intervention, evaluated depressive symptoms, usability, engagement, and participant safety. App engagement data were also analyzed.Results60 eligible adolescents (female = 47) were enrolled in 2 months. 35.6% of those expressing interest were consented and all enrolled. Study retention was high (85%). Spark users rated the app as usable (System Usability Scalemean = 80.67) and engaging (User Engagement Scale-Short Formmean = 3.62). Median daily use was 29%, and 23% completed all levels. There was a significant negative relationship between behavioral activations completed and change in PHQ-8. Efficacy analyses revealed a significant main effect of time, F = 40.60, p < .001, associated with decreased PHQ-8 scores over time. There was no significant Group × Time interaction (F = 0.13, p = .72) though the numeric decrease in PHQ-8 was greater for Spark (4.69 vs. 3.56). No serious adverse events or adverse device effects were reported for Spark users. Two serious adverse events reported in the Active Control group were addressed per our safety protocol.ConclusionRecruitment, enrollment, and retention rates demonstrated study feasibility by being comparable or better than other mental health apps. Spark was highly acceptable relative to published norms. The study's novel safety protocol efficiently detected and managed adverse events. The lack of significant difference in depression symptom reduction between Spark and Active Control may be explained by study design and study design factors. Procedures established during this feasibility study will be leveraged for subsequent powered clinical trials evaluating app efficacy and safety.Clinical Trial Registrationhttps://clinicaltrials.gov/ct2/show/NCT04524598

【 授权许可】

Unknown   
© 2023 Kulikov, Crosthwaite, Hall, Flannery, Strauss, Vierra, Koepsell, Lake and Padmanabhan.