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

NCT ID: NCT05351866

Last Updated: 2023-08-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-26
• Study Completion Date: 2023-06-26

Brief Summary

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).

Detailed Description

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).

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

Conditions

Depression; Depressive Disorder; Depressive Symptoms; Depressive Episode; Adolescent Behavior; Adolescent - Emotional Problem; Hematologic Diseases; Oncology; Weight, Body

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SparkRx

5-week CBT-based mobile intervention for adolescents with depressive symptoms

Group Type: EXPERIMENTAL

CBT-based mobile intervention for depression

Intervention Type: DEVICE

SparkRx is a 5-week program divided into levels intended to be completed weekly. SparkRx is a behavioral activation program. Participants are instructed to complete a weekly Patient Health Questionnaire (PHQ)-8 assessment and participant symptom check (PSC) in the mobile app. Tasks in the mobile app progress in a linear fashion (i.e., each task must be completed to progress to the next task).

Educational Control

5-week mobile control with education about depression

Group Type: ACTIVE_COMPARATOR

Mobile control with education about depression

Intervention Type: DEVICE

The control mobile application will consist of 5 weeks of educational content about depression. Participants will be instructed to complete a weekly Patient Health Questionnaire (PHQ)-8 assessment and PSC in the mobile app.

Interventions

CBT-based mobile intervention for depression

SparkRx is a 5-week program divided into levels intended to be completed weekly. SparkRx is a behavioral activation program. Participants are instructed to complete a weekly Patient Health Questionnaire (PHQ)-8 assessment and participant symptom check (PSC) in the mobile app. Tasks in the mobile app progress in a linear fashion (i.e., each task must be completed to progress to the next task).

Intervention Type: DEVICE

Mobile control with education about depression

The control mobile application will consist of 5 weeks of educational content about depression. Participants will be instructed to complete a weekly Patient Health Questionnaire (PHQ)-8 assessment and PSC in the mobile app.

Intervention Type: DEVICE

Other Intervention Names

SparkRx; Educational Control

Eligibility Criteria

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)

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Health

OTHER

Sponsor Role: collaborator

Limbix Health, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julie Germann, PhD.

Role: PRINCIPAL_INVESTIGATOR

Children's Health System of Texas

Locations

Children's Hospital Texas

Dallas, Texas, United States

Countries

United States

Other Identifiers

LMX-004

Identifier Type: -

Identifier Source: org_study_id