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

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).

Study Overview

• Status: Terminated
• Conditions: Depressive Disorder; Depression; Gastrointestinal Diseases; Depressive Symptoms; Major Depressive Disorder; Adolescent Behavior; Depressive Episode; Adolescent - Emotional Problem; Cardiology
• Intervention / Treatment: Device: SparkRx Mobile App

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94104
      • Limbix Health Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 22 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Change from screening to post-intervention (5 weeks)
Change in participant-reported health-related quality of life	Measured by the Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q).A 15-item self-administered questionnaire that captures life satisfaction over the past week. Score range of 14 to 84 with a higher score indicating better outcome.	Change from screening to post-intervention (5 weeks)
Change in legal-guardian reported health-related quality of life	Measured by the Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q).A 15-item self-administered questionnaire that captures life satisfaction over the past week. Score range of 14 to 84 with a higher score indicating better outcome.	Change from screening to post-intervention (5 weeks)
Change in participant-rated anxiety symptoms	Measured by the Generalized Anxiety Disorder scale (GAD-7).The GAD-7 is a brief 7-item assessment for generalized anxiety disorder with satisfactory sensitivity and specificity. Score range of 0 to 21 with a higher score indicating worse outcome.	Change from screening to post-intervention (5 weeks)
Change in legal guardian-reported 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	Change from screening to post-intervention (5 weeks)
Average treatment related usability rating	Measured by the System Usability Scale (SUS). The SUS consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. Score range of 0 to 100 with a higher score indicating a better outcome.	5 weeks
Average treatment related engagement rating	Measured by the User Engagement Scale (UES-SF).A statistically reliable measure of self-reported user engagement. The form has 12 items and uses a 5 point Likert scale. Score range of 1-5 with a higher score indicating a better outcome.	5 weeks
Average treatment related program adherence	Measured by mobile app analytics	5 weeks
Average treatment related program engagement	Measured by mobile app analytics	5 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health care utilization	Measured by the Healthcare Utilization Questionnaire. A two-item questionnaire that asks whether participants' have used healthcare resources in the past week.	5 weeks
Treatment related changes by physical symptom severity	Measured by the Functional Disability Inventory a fifteen-item questionnaire that measures functional disability and evaluates the impact of illness on the respondents' physical and psychosocial functioning in everyday social roles. Each question is rated on a 5-point scale from 0(No Trouble) to 4 (Impossible). Score range is 0 to 60 with higher scores indicating a worse outcome.	5 weeks
Treatment related perceptions of participants' experiences in general with SparkRx	Measured by the User Experience (UXR) questionnaire. Includes questions from the Usability Metric for User Experience-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 Happiness Tracking Surveys; an open-ended questionnaire that assesses respondents' experiences with the product and provides options for feedback.	5 weeks
Caregiver burden	Measured by the work absenteeism questionnaire, containing qualitative and quantitative questions about caregiving responsibilities and related impacts on employment. Higher scores are equal to more time missed from work.	5 weeks

Collaborators and Investigators

• Sponsor: Limbix Health, Inc.
• Collaborators: Children's Hospital Los Angeles
• Investigators: Principal Investigator: Aarthi Padmanabhan, PhD, Limbix Health

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2022
• Primary Completion (Actual): May 16, 2023
• Study Completion (Actual): May 16, 2023

Study Registration Dates

• First Submitted: April 29, 2022
• First Submitted That Met QC Criteria: July 13, 2022
• First Posted (Actual): July 18, 2022

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 18, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Depression; Mental Health; Adolescent Depression
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Mood Disorders; Depression; Depressive Disorder; Disease; Gastrointestinal Diseases; Digestive System Diseases; Depressive Disorder, Major
• Other Study ID Numbers: LMX-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes