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

NCT05351866 | Terminated FDA Device

• 1 other identifier: LMX-004
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

Depression; Mental Health; Adolescent mental health

Outcome Measures

Primary Outcomes (5)

• Feasibility of intervention: Eligibility

  Percent of potential participants eligible to participate

  Screening

• Feasibility of intervention: Participant willingness

  Percent of eligible participants willing to participate

  Screening

• Feasibility of intervention: Completion adherence

  Adherence to program determined by percent of enrolled participants completing all modules within 5 weeks and by post-treatment

  5 weeks

• Feasibility of intervention: Module adherence

  Adherence to program determined by average number of modules completed

  5 weeks

• Feasibility of intervention: Time adherence

  Adherence to program determined by engagement with program (time spent in app)

  5 weeks

Secondary Outcomes (4)

• Change in depressive symptoms

  5 weeks

• Adverse events

  11 weeks

• Usability

  5 weeks

• Engagement

  5 weeks

Other Outcomes (12)

• Treatment-related change in depressive symptoms

  Change over 5 weeks

• Treatment-related change in anxiety

  Change over 5 weeks

• Treatment-related change in global functioning

  Change over 5 weeks

Study Arms (2)

SparkRx

EXPERIMENTAL

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

Device: CBT-based mobile intervention for depression

Educational Control

ACTIVE COMPARATOR

5-week mobile control with education about depression

Device: Mobile control with education about depression

Interventions

CBT-based mobile intervention for depression 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).

Also known as: SparkRx

SparkRx

Mobile control with education about depression 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.

Also known as: Educational Control

Educational Control

Eligibility Criteria

• Age: 13 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Limbix Health, Inc.: lead
• Children's Health: collaborator

Study Sites (1)

Children's Hospital Texas

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Depression; Depressive Disorder; Adolescent Behavior; Hematologic Diseases; Neoplasms; Body Weight; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mood Disorders; Mental Disorders; Hemic and Lymphatic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Personal Satisfaction

Study Officials

• Julie Germann, PhD.

  Children's Health System of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 28, 2022
• Study Start: January 26, 2023
• Primary Completion: June 26, 2023
• Study Completion: June 26, 2023
• Last Updated: August 4, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)