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).
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
7
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).
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.
Children's Hospital Texas
Dallas, Texas, United States
Feasibility of intervention: Eligibility
Percent of potential participants eligible to participate
Time frame: Screening
Feasibility of intervention: Participant willingness
Percent of eligible participants willing to participate
Time frame: 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
Time frame: 5 weeks
Feasibility of intervention: Module adherence
Adherence to program determined by average number of modules completed
Time frame: 5 weeks
Feasibility of intervention: Time adherence
Adherence to program determined by engagement with program (time spent in app)
Time frame: 5 weeks
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
Time frame: 5 weeks
Adverse events
Rates of adverse events and adverse advice effects
Time frame: 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.
Time frame: 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.
Time frame: 5 weeks
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