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Limbix Spark: a CBT-based mobile intervention for adolescent depression in specialty care settings
Study ID: STU-2022-0185
Summary
Children between the ages of 13-22 will be included in this research as the program to be evaluated is specifically designed to treat adolescents with symptoms of depression. upon account creation and completion of the baseline self-report assessments, participants will be randomized to either the SparkRx condition or the educational control condition. eligible participants will be randomly assigned (1:1) to either complete the SparkRx program or control program. Participants will be randomized using a block randomization approach to ensure equal group sizes. Block size will range in multiples of 2 from 4-12 and be randomly generated to prevent guessing of allocation and eliminate bias. 5-Week intervention Period: Both mobile programs will be 5 weeks in duration and self-guided. The five modules in both programs are each expected to take around 60 minutes to complete. all participants will be instructed to complete one module in the mobile app per week, although they can progress through the programs at their own pace. all participants will be prompted to complete a weekly PHQ-8, participant symptom check (PSC) questionnaire, two physical symptom questionnaires, and a uXR questionnaire in the mobile application. These assessments will be assigned weekly and available for 4 days to complete. Legal guardians will also fill out a weekly PSC and physical symptom questionnaire via the secure web portal. after the 5-week intervention period, participants and their legal guardian (if required) will be emailed links to complete post-intervention self-report assessments via secure web portal. one month following the completion of post study assessments, participants and their legal guardians (if required) will be emailed links to complete follow-up self-report assessments via secure web portal. Primary outcomes (feasibility, acceptability): Feasibility outcome measures will include enrollment feasibility (i.e., proportion of recruited participants ineligible to participate and/or who decline to enroll), intervention tolerability (i.e., proportion of enrolled participants who discontinue intervention, are lost to follow-up, or experience adverse events), adherence (i.e., proportion of modules completed), and engagement (proportion of daily active users and time spent in app). adherence and engagement can be tracked via the mobile app, which will log the time and duration of usage sessions.
- Cancer Related
- No
- Healthy Volunteers
- No
- UT Southwestern Principal Investigator
- JULIE N GERMANN
LIMBIX HEALTH, INC
The current study is focused on testing the feasibility and acceptability of delivering a mobile CBT program to adolescents with concurrent medical conditions and moderate to severe self-reported depressive symptoms. To our knowledge, there are no commercially available interventions nor prescription digital therapeutics specific to adolescent depression. The primary aims of the proposed research are to assess the feasibility, acceptability, and preliminary evidence of efficacy of a self-guided, cognitive behavioral therapy (CBT)-based mobile app intervention (SparkRx) for the treatment of adolescents presenting with symptoms of depression in specialty medical care settings (e.g.Hematology/oncology, Weight Management, etc.) at Children's Health System of Texas (CHST). These aims will be accomplished by evaluating: * Feasibility of recruiting and enrolling adolescents with mild to severe symptoms of depression from specialty care medical programs at CHST. * Retention, program adherence, completion, and withdrawal rates. * Perceived utility, usability, and enjoyment of the program by adolescents * Clinically significant changes between pre- to -post treatment and persistence of such gains at 1 month follow up. * Preliminary evidence of efficacy defined as a statistically significant difference in the eight-item Patient Health Questionnaire (PHQ-8) scores (p [Less Than] 0.05) between Spark and an educational control at post-treatment. * Safety of the intervention, including rates of reported adverse events and adverse device effects * Perceived usability and feasibility of the Provider Portal in aiding providers in monitoring participants' engagement, adherence, and depression symptoms remotely.
