Clinical trial NCT05461599: Digital Therapeutic for Adolescent Depressive Symptoms in Cardiology and Gastroenterology
Official title: Feasibility and Acceptability of a Digital Therapeutic for Adolescent Depressive Symptoms in Cardiology and Gastroenterology
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
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
Lead sponsor: Limbix Health, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Children's Hospital Los Angeles
First posted: 2022-07-18
Enrollment: 2
Sex: ALL
Minimum age (years): 13
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Feasibility of intervention - Eligibility
timeFrame: Screening
measure: Feasibility of intervention - Participant willingness
timeFrame: Screening
measure: Feasibility of intervention - Adherence
timeFrame: 5 weeks
measure: Participant satisfaction with the SparkRx app
timeFrame: 5 weeks
Secondary outcomes:
measure: Change in depressive symptoms
timeFrame: Change from screening to post-intervention (5 weeks)
measure: Change in participant-reported health-related quality of life
timeFrame: Change from screening to post-intervention (5 weeks)
measure: Change in legal-guardian reported health-related quality of life
timeFrame: Change from screening to post-intervention (5 weeks)
measure: Change in participant-rated anxiety symptoms
timeFrame: Change from screening to post-intervention (5 weeks)
measure: Change in legal guardian-reported depressive symptoms
timeFrame: Change from screening to post-intervention (5 weeks)
measure: Average treatment related usability rating
timeFrame: 5 weeks
measure: Average treatment related engagement rating
timeFrame: 5 weeks
measure: Average treatment related program adherence
timeFrame: 5 weeks
measure: Average treatment related program engagement
timeFrame: 5 weeks
Other outcomes:
measure: Health care utilization
timeFrame: 5 weeks
measure: Treatment related changes by physical symptom severity
timeFrame: 5 weeks
measure: Treatment related perceptions of participants' experiences in general with SparkRx
timeFrame: 5 weeks
measure: Caregiver burden
timeFrame: 5 weeks
Locations:
city: San Francisco
country: United States
facility: Limbix Health Inc.
state: California
Study officials:
affiliation: Limbix Health
name: Aarthi Padmanabhan, PhD
role: PRINCIPAL_INVESTIGATOR
References: