Digital Therapeutic for Adolescent Depressive Symptoms in Cardiology and Gastroenterology

Limbix Health, Inc.2 enrolled

Overview

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).

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Depressive Symptoms Major Depressive Disorder

Interventions

SparkRx Mobile AppDEVICE

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.

Eligibility

Sex: ALLMin age: 13 YearsMax age: 22 Years

Medical Language ↔ Plain English

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

Percent of potential participants eligible to participate

Time frame: Screening

Feasibility of intervention - Participant willingness

Percent of eligible participants willing to participate

Time frame: Screening

Feasibility of intervention - Adherence

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

Time frame: 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.

Time frame: 5 weeks

Secondary Outcomes

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