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Digital Therapeutic for Adolescent Depressive Symptoms in Cardiology and Gastroenterology

Primary Purpose

Depressive Symptoms, Major Depressive Disorder, Depression

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

SparkRx Mobile App

About this trial

This is an interventional treatment trial for Depressive Symptoms focused on measuring Depression, Mental Health, Adolescent Depression

Eligibility Criteria

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

Inclusion Criteria:

13-22 years of age at time of enrollment
Moderate-severe self-reported symptoms of depression at baseline (PHQ-8 >=5)
Under the care of a US-based healthcare provider and willing and able to provide the name and contact information of the provider during consent
English fluency or proficiency and literacy of adolescent and consenting legal guardian, if required
Access to an eligible mobile device (capable of installing the app) and regular internet access
Willing to provide informed e-consent/assent and have legal guardian willing to provide informed e consent (if required)

Exclusion Criteria:

Change in concurrent treatment (medication, and/or psychotherapy) for depression 30 days prior to study enrollment
Suicide attempt within the past year
Active suicide ideation with intent
Previously participated in user testing or clinical testing of the Spark app
Any condition, comorbidity, or event that, in the opinion of the investigator, will prevent the participant from adhering to the protocol or benefitting from the treatment (e.g., unable to perform informed assent or consent, treatment resistance as determined by investigator) or will prevent investigators from being able to ensure safety (e.g., will be leaving the country during study time period)

Sites / Locations

Limbix Health Inc.

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

SparkRx Mobile App

Arm Description

The 5-week SparkRx app is divided into 5 levels intended to be completed weekly. A character called 'Limbot' is used as a guide. Limbot encourages the user in completing the behavioral activation program and provides personal examples of how they have undertaken behavioral activation therapy. Participants are instructed to complete a weekly Patient Health Questionnaire (PHQ)-8 assessment and Participant Symptom Check (PSC) questionnaire 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. Certain on-demand resources can be accessed in the app at any time, including crisis resources. Text entries that match a database of concerning words/phrases will trigger an automated pop-up suggesting participants visit the in-app crisis resources if they need additional support.

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 - Adherence

Adherence to program: percent of enrolled participants completing all modules by post-treatment

Participant satisfaction with the SparkRx app

Acceptability of intervention. Measured by the User Experience (UXR) questionnaire. Includes questions from the 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 HaTs questionnaire; an open-ended questionnaire that assesses respondents' experiences with the product and provides options for feedback.

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

Change in participant-reported health-related quality of life

Measured by the Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q).A 15-item self-administered questionnaire that captures life satisfaction over the past week. Score range of 14 to 84 with a higher score indicating better outcome.

Change in legal-guardian reported health-related quality of life

Change in participant-rated anxiety symptoms

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 in legal guardian-reported depressive symptoms

Average treatment related usability rating

Measured by the System Usability Scale (SUS). The SUS consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. Score range of 0 to 100 with a higher score indicating a better outcome.

Average treatment related engagement rating

Measured by the User Engagement Scale (UES-SF).A statistically reliable measure of self-reported user engagement. The form has 12 items and uses a 5 point Likert scale. Score range of 1-5 with a higher score indicating a better outcome.

Average treatment related program adherence

Measured by mobile app analytics

Average treatment related program engagement

Measured by mobile app analytics

Full Information

NCT ID

NCT05461599

First Posted

April 29, 2022

Last Updated

May 18, 2023

Sponsor

Limbix Health, Inc.

Collaborators

Children's Hospital Los Angeles

1. Study Identification

Unique Protocol Identification Number

NCT05461599

Brief Title

Digital Therapeutic for Adolescent Depressive Symptoms in Cardiology and Gastroenterology

Official Title

Feasibility and Acceptability of a Digital Therapeutic for Adolescent Depressive Symptoms in Cardiology and Gastroenterology

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Terminated

Why Stopped

Enrollment too low

Study Start Date

August 25, 2022 (Actual)

Primary Completion Date

May 16, 2023 (Actual)

Study Completion Date

May 16, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Limbix Health, Inc.

Collaborators

Children's Hospital Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

The primary aim of this pilot study is to assess the feasibility, acceptability, and preliminary evidence of efficacy of a self-guided, cognitive behavioral therapy (CBT)-based mobile app intervention (SparkRx) for symptoms of depression among adolescents being treated in specialty medical care settings at Children's Hospital of Los Angeles (CHLA).

Detailed Description

Self-report assessments will be collected at pre, post and 1-month follow up time points. Weekly PHQ-8 assessments will also be collected during the 5-week intervention as well as at pre, post and 1- month follow up time points. Study aims involve evaluating: Feasibility of recruiting and enrolling adolescents with elevated symptoms of depression from the Cardiology and Gastroenterology programs at CHLA. Retention, program adherence, completion, and withdrawal rates. Safety of the intervention, including reported adverse and serious adverse events Perceived utility, usability, and enjoyment of the SparkRx app by adolescents Clinically significant changes in pre- to -post treatment depressive symptoms and persistence of such gains at 1 month follow up.

6. Conditions and Keywords

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

Depressive Symptoms, Major Depressive Disorder, Depression, Cardiology, Gastrointestinal Diseases, Depressive Disorder, Depressive Episode, Adolescent Behavior, Adolescent - Emotional Problem

Keywords

Depression, Mental Health, Adolescent Depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SparkRx Mobile App

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

SparkRx Mobile App

Intervention Description

The SparkRx app will be fully self-guided and completed by participants at home. It is designed to be completed over 5 weeks but users may progress through the app at their own pace. The app progresses linearly, i.e., a task must be completed before a participant can progress to the next task. Content for a given week is not expected to take more than 60 minutes to complete.

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 - Adherence

Description

Adherence to program: percent of enrolled participants completing all modules by post-treatment

Time Frame

5 weeks

Title

Participant satisfaction with the SparkRx app

Description

Time Frame

5 weeks

Secondary Outcome Measure Information:

Title

Change in depressive symptoms

Description

Time Frame