Digital Therapeutic for Adolescent Depressive Symptoms in Hematology, Oncology, and Weight Management

Study Overview
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Brief Summary
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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
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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

Official Title
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Feasibility and Acceptability of a Digital Therapeutic for Adolescent Depressive Symptoms in Hematology/Oncology and Weight Management

Conditions
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Hematologic Diseases, Depression, Depressive Disorder, Depressive Symptoms, Depressive Episode, Adolescent Behavior, Adolescent - Emotional Problem, Oncology, Weight, Body

Intervention / Treatment
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* Device: CBT-based mobile intervention for depression
* Device: Mobile control with education about depression


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SparkRx<br>5-week CBT-based mobile intervention for adolescents with depressive symptoms | Device: CBT-based mobile intervention for depression<br>* 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).<br>* Other names: SparkRx;|
| Active Comparator: Educational Control<br>5-week mobile control with education about depression | Device: Mobile control with education about depression<br>* The control mobile application will consist of 5 weeks of educational content about depression. Participants will be instructed to complete a weekly Patient Health Questionnaire (PHQ)-8 assessment and PSC in the mobile app.<br>* Other names: Educational Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of intervention: Eligibility | Percent of potential participants eligible to participate | Screening | 
| Feasibility of intervention: Participant willingness | Percent of eligible participants willing to participate | Screening | 
| Feasibility of intervention: Completion adherence | Adherence to program determined by percent of enrolled participants completing all modules within 5 weeks and by post-treatment | 5 weeks | 
| Feasibility of intervention: Module adherence | Adherence to program determined by average number of modules completed | 5 weeks | 
| Feasibility of intervention: Time adherence | Adherence to program determined by engagement with program (time spent in app) | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depressive symptoms | 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 | 5 weeks | 
| Adverse events | Rates of adverse events and adverse advice effects | 11 weeks | 
| Usability | 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. | 5 weeks | 
| Engagement | 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. | 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Mental Health, Adolescent mental health