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

Depression Clinical Trial

Official title:

Feasibility and Acceptability of a Digital Therapeutic for Adolescent Depressive Symptoms in Hematology/Oncology and Weight Management

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05351866
• Other study ID #: LMX-004
• Status: Terminated
• Phase: N/A
• Start date: January 26, 2023
• Est. completion date: June 26, 2023

Study information

• Verified date: August 2023
• Source: Limbix Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: June 26, 2023
• Est. primary completion date: June 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 22 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Device:
• 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).
• 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.

Locations

Country	Name	City	State
United States	Children's Hospital Texas	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Limbix Health, Inc.	Children's Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment-related change in depressive symptoms	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.	Change over 5 weeks
Other	Treatment-related change in anxiety	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.	Change over 5 weeks
Other	Treatment-related change in global functioning	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	Change over 5 weeks
Other	Caregiver proxy treatment-related change in depressive symptoms	Measured using caregiver proxy measures of the PHQ-8. Score range of 0 to 24 with higher scores indicating worse outcome.	Change over 5 weeks
Other	Caregiver proxy treatment-related change in global functioning	Measured using caregiver proxy measures of the SF-36. 8 subscales with scores ranging from 0-100, higher being a more favorable health state.	Change over 5 weeks
Other	Treatment-related change in hope	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.	Change over 5 weeks
Other	Healthcare utilization	Descriptive understanding of healthcare utilization. Measured by the Healthcare Utilization Questionnaire. A two-item questionnaire that assesses participants' use of healthcare resources.	Change over 5 weeks
Other	Caregiver burden	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.	Change over 5 weeks
Other	Treatment-related change in physical symptom severity	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.	Change over 5 weeks
Other	Treatment-related perceptions of experience with SparkRx	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.	5 weeks
Other	Treatment expectations	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.	5 weeks
Other	Treatment expectations: Credibility/Expectancy	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.	5 weeks
Primary	Feasibility of intervention: Eligibility	Percent of potential participants eligible to participate	Screening
Primary	Feasibility of intervention: Participant willingness	Percent of eligible participants willing to participate	Screening
Primary	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
Primary	Feasibility of intervention: Module adherence	Adherence to program determined by average number of modules completed	5 weeks
Primary	Feasibility of intervention: Time adherence	Adherence to program determined by engagement with program (time spent in app)	5 weeks
Secondary	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	5 weeks
Secondary	Adverse events	Rates of adverse events and adverse advice effects	11 weeks
Secondary	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.	5 weeks
Secondary	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.	5 weeks