Digital Therapeutic for Adolescent Depressive Symptoms in Hematology, Oncology, and Weight Management

Limbix

Status

Terminated

Conditions

Depressive Symptoms

Oncology

Weight, Body

Adolescent - Emotional Problem

Depressive Episode

Depression

Adolescent Behavior

Depressive Disorder

Hematologic Diseases

Treatments

Device: CBT-based mobile intervention for depression

Device: Mobile control with education about depression

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05351866

LMX-004

Details and patient eligibility

About

The primary aims of the proposed research are to assess the feasibility, acceptability, and preliminary evidence of efficacy of a self-guided, cognitive behavioral therapy (CBT)-based mobile app intervention (SparkRx) for the treatment of adolescents presenting with symptoms of depression in specialty medical care settings (e.g.Hematology/Oncology, Weight Management, etc.) at Children's Health System of Texas (CHST).

Full description

These aims will be accomplished by evaluating:

Feasibility of recruiting and enrolling adolescents with mild to severe symptoms of depression from specialty care medical programs at CHST.
Retention, program adherence, completion, and withdrawal rates.
Perceived utility, usability, and enjoyment of the program by adolescents
Clinically significant changes between pre- to -post treatment and persistence of such gains at 1 month follow up.
Preliminary evidence of efficacy defined as a statistically significant difference in the eight-item Patient Health Questionnaire (PHQ-8) scores (p < 0.05) between Spark and an educational control at post-treatment.
Safety of the intervention, including rates of reported adverse events and adverse device effects

Enrollment

7 patients

Sex

All

Ages

13 to 22 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Between the ages of 13 and 22
Moderate- severe self-reported symptoms of depression at baseline (PHQ-8 >= 5)
Have a comorbid medical condition and under the care of a healthcare provider at CHST
English fluency and literacy of adolescent; English or Spanish fluency and literacy of consenting legal guardian if under 18
Access to a compatible smartphone (or other device) and operating system (i.e., capable of installing the app from the Google Play or Apple App Store; list will be provided to participants) and regular internet access
Willing to provide informed consent/assent and have legal guardian willing to provide informed consent (if required)

Exclusion criteria

Concurrent psychotherapy: Have met with a psychologist for intervention (not assessment) for 30 minutes or more, more than once in the 3 weeks prior to enrollment as determined by the study team
Change in psychotropic medication (initiation or change in dose) within the past 30 days prior to enrollment
Suicide attempt within the past year as determined at eligibility screening
Active suicidal ideation with intent as determined at eligibility screening
Previously participated in user testing or clinical testing of the Spark app
Participating in any other psychiatric or psychological treatment based clinical research at the time of enrollment and up to two months prior to enrollment or planning to participate in any other psychiatric or psychological treatment based clinical research during the study intervention period (5 weeks)
Any condition, comorbidity, or event that, in the opinion of the investigator, will prevent the participant from adhering to the protocol or benefiting from the treatment (e.g., unable to provide informed assent or consent) or will prevent investigators from being able to ensure safety (e.g., will be leaving the country during study time period)