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

Primary Purpose

Depression, Depressive Disorder, Depressive Symptoms

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

CBT-based mobile intervention for depression

Mobile control with education about depression

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Mental Health, Adolescent mental health

Eligibility Criteria

13 Years - 22 Years (Child, Adult)All SexesDoes not accept 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)

Sites / Locations

Children's Hospital Texas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SparkRx

Educational Control

Arm Description

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

5-week mobile control with education about depression

Outcomes

Primary Outcome Measures

Feasibility of intervention: Eligibility

Percent of potential participants eligible to participate

Feasibility of intervention: Participant willingness

Percent of eligible participants willing to participate

Feasibility of intervention: Completion adherence

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

Feasibility of intervention: Module adherence

Adherence to program determined by average number of modules completed

Feasibility of intervention: Time adherence

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

Secondary Outcome Measures

Change in depressive symptoms

Measured by the Patient Health Questionnaire (PHQ-8). Score range of 0 to 24 with higher scores indicating worse outcome. Clinically significant improvement: reduction in assessment score >= 5 Treatment response: 50% reduction in symptoms from pre to post-intervention Remission is defined as a score < 5

Adverse events

Rates of adverse events and adverse advice effects

Usability

Usability measured with the System Usability Scale (SUS), which consists of 10 items, each with five response options for respondents; from Strongly agree to Strongly disagree. Scores range from 0-100, with higher scores meaning more usable.

Engagement

Engagement measured with the User Engagement Scale - Short Form (UES-SF), which measures self-reported user engagement. The form has 12 items and uses a 5 point Likert scale. Scores range from 1-5, with higher scores indicating more engaging material.

Full Information

NCT ID

NCT05351866

First Posted

April 18, 2022

Last Updated

August 2, 2023

Sponsor

Limbix Health, Inc.

Collaborators

Children's Health

1. Study Identification

Unique Protocol Identification Number

NCT05351866

Brief Title

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

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Terminated

Why Stopped

Low Enrollment

Study Start Date

January 26, 2023 (Actual)

Primary Completion Date

June 26, 2023 (Actual)

Study Completion Date

June 26, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Limbix Health, Inc.

Collaborators

Children's Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Depression, Mental Health, Adolescent mental health

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SparkRx

Arm Type

Experimental

Arm Description

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

Arm Title

Educational Control

Arm Type

Active Comparator

Arm Description

5-week mobile control with education about depression

Intervention Type

Device

Intervention Name(s)

CBT-based mobile intervention for depression

Other Intervention Name(s)

SparkRx

Intervention Description

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

Intervention Name(s)

Mobile control with education about depression

Other Intervention Name(s)

Educational Control

Intervention Description

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.

Primary Outcome Measure Information:

Title

Feasibility of intervention: Eligibility

Description

Percent of potential participants eligible to participate

Time Frame

Screening

Title

Feasibility of intervention: Participant willingness

Description

Percent of eligible participants willing to participate

Time Frame

Screening

Title

Feasibility of intervention: Completion adherence

Description

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

Time Frame

5 weeks

Title

Feasibility of intervention: Module adherence

Description

Adherence to program determined by average number of modules completed

Time Frame

5 weeks

Title

Feasibility of intervention: Time adherence

Description

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

Time Frame

5 weeks

Secondary Outcome Measure Information:

Title

Change in depressive symptoms

Description

Time Frame

5 weeks

Title

Adverse events

Description

Rates of adverse events and adverse advice effects

Time Frame

11 weeks

Title

Usability

Description

Time Frame

5 weeks

Title

Engagement

Description

Time Frame

5 weeks

Other Pre-specified Outcome Measures:

Title

Treatment-related change in depressive symptoms

Description

Difference in the change in PHQ-8 scores between the SparkRx and control arms. Score range of 0 to 24 with higher scores indicating worse outcome.

Time Frame

Change over 5 weeks

Title

Treatment-related change in anxiety

Description

Measured by the Generalized Anxiety Disorder scale (GAD-7).The GAD-7 is a brief 7-item assessment for generalized anxiety disorder with satisfactory sensitivity and specificity. Score range of 0 to 21 with a higher score indicating worse outcome.

Time Frame

Change over 5 weeks

Title

Treatment-related change in global functioning

Description

Measured using the Short Form-36 (SF-36), a set of generic, coherent, self-reported, and easily administered quality-of-life measures used to routinely monitor and assess the care outcomes of participants. 8 subscales with scores ranging from 0-100, higher being a more favorable health state. Physical functioning Role limitations due to physical health Role limitations due to emotional problems Energy/fatigue Emotional well-being Social functioning Pain General health

Time Frame

Change over 5 weeks

Title

Caregiver proxy treatment-related change in depressive symptoms

Description

Measured using caregiver proxy measures of the PHQ-8. Score range of 0 to 24 with higher scores indicating worse outcome.

Time Frame

Change over 5 weeks

Title

Caregiver proxy treatment-related change in global functioning

Description

Measured using caregiver proxy measures of the SF-36. 8 subscales with scores ranging from 0-100, higher being a more favorable health state.

Time Frame

Change over 5 weeks

Title

Treatment-related change in hope

Description

Measured using the Hope Scale, a 12-item self-report measure, which assesses dispositional hope in adults. Each item rated from 1-8 (definitely false - definitely true). Scores range from 8-64, with higher being more hopeful. Subscales: agency and pathway.

Time Frame

Change over 5 weeks

Title

Healthcare utilization

Description

Descriptive understanding of healthcare utilization. Measured by the Healthcare Utilization Questionnaire. A two-item questionnaire that assesses participants' use of healthcare resources.

Time Frame

Change over 5 weeks

Title

Caregiver burden

Description

Descriptive understanding of caregiver burden, measured by the work absenteeism questionnaire, containing questions about caregiving responsibilities and related impacts on employment. Higher scores indicate more hours missed per week of work.

Time Frame

Change over 5 weeks

Title

Treatment-related change in physical symptom severity

Description

Measured by the Functional Disability Inventory a fifteen-item questionnaire that measures functional disability and evaluates the impact of illness on the respondents' physical and psychosocial functioning in everyday social roles. Each question is rated on a 5-point scale from 0(No Trouble) to 4 (Impossible). Score range is 0 to 60 with higher scores indicating a worse outcome.

Time Frame

Change over 5 weeks

Title

Treatment-related perceptions of experience with SparkRx

Description

Measured by the User Experience (UXR) questionnaire. Includes questions from the Usability Metric for User Experience (UMUX)-Lite; a two-item questionnaire that assesses the usability of the mobile application. Questions have seven response options from Strongly agree to Strongly disagree. Includes questions from the Happiness Tracking Surveys (HaTs); an open-ended questionnaire that assesses respondents' experiences with the product and provides options for feedback.

Time Frame

5 weeks

Title

Treatment expectations

Description

Identifying the relationship between treatment expectations and treatment outcomes. Expectations measured with the Stanford Expectations of Treatment Scale (SETS), an instrument for measuring positive and negative treatment expectancies. There are two subscales, the positive and negative expectancy. Scores range from 1-7, with higher scores indicating greater positive and negative expectancy. Outcomes measured with the PHQ-8. Score range of 0 to 24 with higher scores indicating worse outcome.

Time Frame

5 weeks

Title

Treatment expectations: Credibility/Expectancy

Description

Identifying the relationship between treatment expectations and treatment outcomes. Expectations measured with the Credibility/Expectancy Questionnaire (CEQ), a questionnaire for measuring cognitively-based credibility and relatively more affectively-based expectancy of therapy outcomes. Scores range from 6-60, with higher scores indicating a greater expectation of treatment success. Outcomes measured with the PHQ-8. Score range of 0 to 24 with higher scores indicating worse outcome.

Time Frame

5 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

22 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Julie Germann, PhD.

Organizational Affiliation

Children's Health System of Texas

Official's Role

Principal Investigator

Facility Information:

Facility Name

Children's Hospital Texas

City

Dallas

State/Province

Texas

ZIP/Postal Code

75235

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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