sparkrxt: Feasibility and Acceptability of a Digital Therapeutic for Adolescent Depressive Symptoms
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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 < 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SparkRx
|
Device: Treatment
SparkRx is a 5-week program divided into levels intended to be completed weekly. SparkRx is a behavioral activation program. Participants are instructed to complete a weekly Patient Health Questionnaire (PHQ)-8 assessment and participant symptom check (PSC) in the mobile app. Tasks in the mobile app progress in a linear fashion (i.e., each task must be completed to progress to the next task).
Other Names:
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| Active Comparator: Psychoeducational Control
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Device: Control
The control mobile application will consist of 5 weeks of neurobiology of depression content. Participants will be instructed to complete a weekly Patient Health Questionnaire (PHQ)-8 assessment and PSC in the mobile app.
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Outcome Measures
Primary Outcome Measures
- % of potential participants eligible to participate [Screening]
Feasibility of intervention
- % of eligible participants willing to participate [Screening]
Feasibility of intervention
- adherence to program determined by % of enrolled participants completing all modules within 5 weeks and by post-treatment [5 weeks]
Feasibility of intervention
- adherence to program determined by average number of modules completed [5 weeks]
Feasibility of intervention
- adherence to program determined by engagement with program (time spent in app) [5 weeks]
Feasibility of intervention
Secondary Outcome Measures
- Change in depressive symptoms [5 weeks]
measured by the PHQ-8
Eligibility Criteria
Criteria
Inclusion Criteria:
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Between the ages of 13 and 22
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Moderate- severe self-reported symptoms of depression at baseline (PHQ-8 >= 5)
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Have a comorbid medical condition and under the care of a healthcare provider at CHST
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English fluency and literacy of adolescent and English or Spanish fluency and literacy of consenting legal guardian if under 18
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Access to an eligible mobile device (capable of installing the app) and regular internet access
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Willing to provide informed consent/assent and have legal guardian willing to provide informed consent (if required)
Exclusion Criteria:
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Concurrent psychotherapy: Have met with a psychologist for intervention (not assessment) for 30 minutes or more, more than once in the 3 weeks prior to enrollment as determined by the study team
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Change in psychotropic medication (initiation or change in dose) within the past 30 days prior to enrollment
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Suicide attempt within the past year as determined at eligibility screening
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Active suicidal ideation with intent as determined at eligibility screening
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Previously participated in user testing or clinical testing of the Spark app
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Limbix Health, Inc.
- Children's Health System, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LMX-004