Digital Therapeutic for Adolescent Depressive Symptoms in Cardiology and Gastroenterology

NCT05461599 | Terminated FDA Device

• 1 other identifier: LMX-003
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

Depression; Mental Health; Adolescent Depression

Outcome Measures

Primary Outcomes (4)

• 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 - Adherence

  Adherence to program: percent of enrolled participants completing all modules by post-treatment

  5 weeks

• Participant satisfaction with the SparkRx app

  Acceptability of intervention. Measured by the User Experience (UXR) questionnaire. Includes questions from the UMUX-Lite; a two-item questionnaire that assesses the usability of the mobile application. Questions have seven response options from Strongly agree to Strongly disagree. Includes questions from the HaTs questionnaire; an open-ended questionnaire that assesses respondents' experiences with the product and provides options for feedback.

  5 weeks

Secondary Outcomes (9)

• Change in depressive symptoms

  Change from screening to post-intervention (5 weeks)

• Change in participant-reported health-related quality of life

  Change from screening to post-intervention (5 weeks)

• Change in legal-guardian reported health-related quality of life

  Change from screening to post-intervention (5 weeks)

• Change in participant-rated anxiety symptoms

  Change from screening to post-intervention (5 weeks)

• Change in legal guardian-reported depressive symptoms

  Change from screening to post-intervention (5 weeks)

Other Outcomes (4)

• Health care utilization

  5 weeks

• Treatment related changes by physical symptom severity

  5 weeks

• Treatment related perceptions of participants' experiences in general with SparkRx

  5 weeks

Study Arms (1)

SparkRx Mobile App

OTHER

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.

Device: SparkRx Mobile App

Interventions

SparkRx Mobile App 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.

SparkRx Mobile App

Eligibility Criteria

• Age: 13 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Limbix Health, Inc.: lead
• Children's Hospital Los Angeles: collaborator

Study Sites (1)

Limbix Health Inc.

San Francisco, California, 94104, United States

Location

MeSH Terms

Conditions

Depression; Depressive Disorder, Major; Gastrointestinal Diseases; Depressive Disorder; Adolescent Behavior; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mood Disorders; Mental Disorders; Digestive System Diseases; Personal Satisfaction

Study Officials

• Aarthi Padmanabhan, PhD

  Limbix Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: July 18, 2022
• Study Start: August 25, 2022
• Primary Completion: May 16, 2023
• Study Completion: May 16, 2023
• Last Updated: May 19, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)