Digital Therapeutic for Adolescent Depressive Symptoms in Cardiology and Gastroenterology

NCT ID: NCT05461599

Last Updated: 2023-05-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-25
• Study Completion Date: 2023-05-16

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SparkRx Mobile App

The 5-week SparkRx app is divided into 5 levels intended to be completed weekly. A character called 'Limbot' is used as a guide. Limbot encourages the user in completing the behavioral activation program and provides personal examples of how they have undertaken behavioral activation therapy. Participants are instructed to complete a weekly Patient Health Questionnaire (PHQ)-8 assessment and Participant Symptom Check (PSC) questionnaire 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. Certain on-demand resources can be accessed in the app at any time, including crisis resources. Text entries that match a database of concerning words/phrases will trigger an automated pop-up suggesting participants visit the in-app crisis resources if they need additional support.

Group Type: OTHER

SparkRx Mobile App

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 13-22 years of age at time of enrollment
• Moderate-severe self-reported symptoms of depression at baseline (PHQ-8 >=5)
• Under the care of a US-based healthcare provider and willing and able to provide the name and contact information of the provider during consent
• English fluency or proficiency and literacy of adolescent and consenting legal guardian, if required
• Access to an eligible mobile device (capable of installing the app) and regular internet access
• Willing to provide informed e-consent/assent and have legal guardian willing to provide informed e consent (if required)

Exclusion Criteria

• Change in concurrent treatment (medication, and/or psychotherapy) for depression 30 days prior to study enrollment
• Suicide attempt within the past year
• Active suicide ideation with intent
• Previously participated in user testing or clinical testing of the Spark app
• Any condition, comorbidity, or event that, in the opinion of the investigator, will prevent the participant from adhering to the protocol or benefitting from the treatment (e.g., unable to perform informed assent or consent, treatment resistance as determined by investigator) or will prevent investigators from being able to ensure safety (e.g., will be leaving the country during study time period)

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital Los Angeles

OTHER

Sponsor Role: collaborator

Limbix Health, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aarthi Padmanabhan, PhD

Role: PRINCIPAL_INVESTIGATOR

Limbix Health

Locations

Limbix Health Inc.

San Francisco, California, United States

Countries

United States

Other Identifiers

LMX-003

Identifier Type: -

Identifier Source: org_study_id