Digital Therapeutic for Adolescent Depressive Symptoms in Hematology, Oncology, and Weight Management
- Conditions
- Adolescent BehaviorDepressionWeight, BodyDepressive DisorderDepressive SymptomsDepressive EpisodeAdolescent - Emotional ProblemHematologic DiseasesOncology
- Interventions
- Device: CBT-based mobile intervention for depressionDevice: Mobile control with education about depression
- Registration Number
- NCT05351866
- Lead Sponsor
- Limbix Health, Inc.
- 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).
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 7
- Between the ages of 13 and 22
- Moderate- severe self-reported symptoms of depression at baseline (PHQ-8 >= 5)
- Have a comorbid medical condition and under the care of a healthcare provider at CHST
- English fluency and literacy of adolescent; English or Spanish fluency and literacy of consenting legal guardian if under 18
- Access to a compatible smartphone (or other device) and operating system (i.e., capable of installing the app from the Google Play or Apple App Store; list will be provided to participants) and regular internet access
- Willing to provide informed consent/assent and have legal guardian willing to provide informed consent (if required)
- 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
- Change in psychotropic medication (initiation or change in dose) within the past 30 days prior to enrollment
- Suicide attempt within the past year as determined at eligibility screening
- Active suicidal ideation with intent as determined at eligibility screening
- Previously participated in user testing or clinical testing of the Spark app
- Participating in any other psychiatric or psychological treatment based clinical research at the time of enrollment and up to two months prior to enrollment or planning to participate in any other psychiatric or psychological treatment based clinical research during the study intervention period (5 weeks)
- Any condition, comorbidity, or event that, in the opinion of the investigator, will prevent the participant from adhering to the protocol or benefiting from the treatment (e.g., unable to provide informed assent or consent) or will prevent investigators from being able to ensure safety (e.g., will be leaving the country during study time period)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SparkRx CBT-based mobile intervention for depression 5-week CBT-based mobile intervention for adolescents with depressive symptoms Educational Control Mobile control with education about depression 5-week mobile control with education about depression
- Primary Outcome Measures
Name Time Method Feasibility of intervention: Module adherence 5 weeks Adherence to program determined by average number of modules completed
Feasibility of intervention: Participant willingness Screening Percent of eligible participants willing to participate
Feasibility of intervention: Eligibility Screening Percent of potential participants eligible to participate
Feasibility of intervention: Completion adherence 5 weeks Adherence to program determined by percent of enrolled participants completing all modules within 5 weeks and by post-treatment
Feasibility of intervention: Time adherence 5 weeks Adherence to program determined by engagement with program (time spent in app)
- Secondary Outcome Measures
Name Time Method Adverse events 11 weeks Rates of adverse events and adverse advice effects
Engagement 5 weeks Engagement measured with the User Engagement Scale - Short Form (UES-SF), which measures self-reported user engagement. The form has 12 items and uses a 5 point Likert scale. Scores range from 1-5, with higher scores indicating more engaging material.
Usability 5 weeks Usability measured with the System Usability Scale (SUS), which consists of 10 items, each with five response options for respondents; from Strongly agree to Strongly disagree. Scores range from 0-100, with higher scores meaning more usable.
Change in depressive symptoms 5 weeks Measured by the Patient Health Questionnaire (PHQ-8). Score range of 0 to 24 with higher scores indicating worse outcome.
* Clinically significant improvement: reduction in assessment score \>= 5
* Treatment response: 50% reduction in symptoms from pre to post-intervention
* Remission is defined as a score \< 5
Trial Locations
- Locations (1)
Children's Hospital Texas
🇺🇸Dallas, Texas, United States