Clinical trial NCT05351866: Digital Therapeutic for Adolescent Depressive Symptoms in Hematology, Oncology, and Weight Management
Official title: Feasibility and Acceptability of a Digital Therapeutic for Adolescent Depressive Symptoms in Hematology/Oncology and Weight Management
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
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
Lead sponsor: Limbix Health, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Children's Health
First posted: 2022-04-28
Enrollment: 7
Sex: ALL
Minimum age (years): 13
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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)

Primary outcomes:
measure: Feasibility of intervention: Eligibility
timeFrame: Screening
measure: Feasibility of intervention: Participant willingness
timeFrame: Screening
measure: Feasibility of intervention: Completion adherence
timeFrame: 5 weeks
measure: Feasibility of intervention: Module adherence
timeFrame: 5 weeks
measure: Feasibility of intervention: Time adherence
timeFrame: 5 weeks
Secondary outcomes:
measure: Change in depressive symptoms
timeFrame: 5 weeks
measure: Adverse events
timeFrame: 11 weeks
measure: Usability
timeFrame: 5 weeks
measure: Engagement
timeFrame: 5 weeks
Other outcomes:
measure: Treatment-related change in depressive symptoms
timeFrame: Change over 5 weeks
measure: Treatment-related change in anxiety
timeFrame: Change over 5 weeks
measure: Treatment-related change in global functioning
timeFrame: Change over 5 weeks
measure: Caregiver proxy treatment-related change in depressive symptoms
timeFrame: Change over 5 weeks
measure: Caregiver proxy treatment-related change in global functioning
timeFrame: Change over 5 weeks
measure: Treatment-related change in hope
timeFrame: Change over 5 weeks
measure: Healthcare utilization
timeFrame: Change over 5 weeks
measure: Caregiver burden
timeFrame: Change over 5 weeks
measure: Treatment-related change in physical symptom severity
timeFrame: Change over 5 weeks
measure: Treatment-related perceptions of experience with SparkRx
timeFrame: 5 weeks
measure: Treatment expectations
timeFrame: 5 weeks
measure: Treatment expectations: Credibility/Expectancy
timeFrame: 5 weeks
Locations:
city: Dallas
country: United States
facility: Children's Hospital Texas
state: Texas
Study officials:
affiliation: Children's Health System of Texas
name: Julie Germann, PhD.
role: PRINCIPAL_INVESTIGATOR
References: