NCT05351866

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Limbix Health, Inc. · Industry
• Sex: All
• Age: 13 Years – 22 Years
• Healthy volunteers: Not accepted

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

Conditions

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

Interventions

Type	Name	Description
DEVICE	CBT-based mobile intervention for depression	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).
DEVICE	Mobile control with education about depression	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.

Timeline

• Start date: 2023-01-26
• Primary completion: 2023-06-26
• Completion: 2023-06-26
• First posted: 2022-04-28
• Last updated: 2023-08-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study