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).

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.

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)