NCT05461599

Digital Therapeutic for Adolescent Depressive Symptoms in Cardiology and Gastroenterology

Feasibility and Acceptability of a Digital Therapeutic for Adolescent Depressive Symptoms in Cardiology and Gastroenterology

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Limbix Health, Inc. · Industry
• Sex: All
• Age: 13 Years – 22 Years
• Healthy volunteers: Not accepted

Summary

The primary aim of this pilot study is to assess the feasibility, acceptability, and preliminary evidence of efficacy of a self-guided, cognitive behavioral therapy (CBT)-based mobile app intervention (SparkRx) for symptoms of depression among adolescents being treated in specialty medical care settings at Children's Hospital of Los Angeles (CHLA).

Detailed description

Self-report assessments will be collected at pre, post and 1-month follow up time points. Weekly PHQ-8 assessments will also be collected during the 5-week intervention as well as at pre, post and 1- month follow up time points. Study aims involve evaluating: * Feasibility of recruiting and enrolling adolescents with elevated symptoms of depression from the Cardiology and Gastroenterology programs at CHLA. * Retention, program adherence, completion, and withdrawal rates. * Safety of the intervention, including reported adverse and serious adverse events * Perceived utility, usability, and enjoyment of the SparkRx app by adolescents * Clinically significant changes in pre- to -post treatment depressive symptoms and persistence of such gains at 1 month follow up.

Conditions

• Depressive Symptoms
• Major Depressive Disorder
• Depression
• Cardiology
• Gastrointestinal Diseases
• Depressive Disorder
• Depressive Episode
• Adolescent Behavior
• Adolescent - Emotional Problem

Interventions

Type	Name	Description
DEVICE	SparkRx Mobile App	The SparkRx app will be fully self-guided and completed by participants at home. It is designed to be completed over 5 weeks but users may progress through the app at their own pace. The app progresses linearly, i.e., a task must be completed before a participant can progress to the next task. Content for a given week is not expected to take more than 60 minutes to complete.

Timeline

• Start date: 2022-08-25
• Primary completion: 2023-05-16
• Completion: 2023-05-16
• First posted: 2022-07-18
• Last updated: 2023-05-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study