Feasibility and Acceptability of a Digital Therapeutic for Adolescent Depressive Symptoms in Cardiology and Gastroenterology
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Depressive Symptoms
- Sponsor
- Limbix Health, Inc.
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Feasibility of intervention - Eligibility
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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.
Investigators
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)
Outcomes
Primary Outcomes
Feasibility of intervention - Eligibility
Time Frame: Screening
Percent of potential participants eligible to participate
Feasibility of intervention - Participant willingness
Time Frame: Screening
Percent of eligible participants willing to participate
Participant satisfaction with the SparkRx app
Time Frame: 5 weeks
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.
Feasibility of intervention - Adherence
Time Frame: 5 weeks
Adherence to program: percent of enrolled participants completing all modules by post-treatment
Secondary Outcomes
- Change in legal-guardian reported health-related quality of life(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 participant-rated anxiety symptoms(Change from screening to post-intervention (5 weeks))
- Average treatment related engagement rating(5 weeks)
- Average treatment related program adherence(5 weeks)
- Change in legal guardian-reported depressive symptoms(Change from screening to post-intervention (5 weeks))
- Average treatment related program engagement(5 weeks)
- Change in depressive symptoms(Change from screening to post-intervention (5 weeks))
- Average treatment related usability rating(5 weeks)