DepressionNCT05351866
Digital Therapeutic for Adolescent Depressive Symptoms in Hematology, Oncology, and Weight Management
A study testing CBT-based mobile intervention for depression in people with Depression and Depressive Disorder, run by Limbix Health, Inc. at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 13 to 22 years
- Conditions the study is for
- Depression, Depressive Disorder, Depressive Symptoms
- What is being tested?
- CBT-based mobile intervention for depression
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2023to 26 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Acceptability of a Digital Therapeutic for Adolescent Depressive Symptoms in Hematology/Oncology and Weight Management
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).
Read the 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
- Conditions
- Depression, Depressive Disorder, Depressive Symptoms, Depressive Episode, Adolescent Behavior, Adolescent - Emotional Problem
- Being tested
- CBT-based mobile intervention for depression, Mobile control with education about depression
- Keywords
- Depression, Mental Health, Adolescent mental health
- Medical subject headings
- Depression, Depressive Disorder, Adolescent Behavior, Hematologic Diseases, Neoplasms, Body Weight, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-based mobile intervention for depressionDevice
Also called SparkRx
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 depressionDevice
Also called Educational Control
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.
| Study group | Role | What they receive |
|---|---|---|
| SparkRx | Experimental | 5-week CBT-based mobile intervention for adolescents with depressive symptoms Receives: Device: CBT-based mobile intervention for depression |
| Educational Control | Active comparator | 5-week mobile control with education about depression Receives: Device: Mobile control with education about depression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of intervention: Eligibility
Percent of potential participants eligible to participate
Measured: Screening
Feasibility of intervention: Participant willingness
Percent of eligible participants willing to participate
Measured: 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
Measured: 5 weeks
Feasibility of intervention: Module adherence
Adherence to program determined by average number of modules completed
Measured: 5 weeks
Feasibility of intervention: Time adherence
Adherence to program determined by engagement with program (time spent in app)
Measured: 5 weeks
Secondary outcomes (4)
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
Measured: 5 weeks
Adverse events
Rates of adverse events and adverse advice effects
Measured: 11 weeks
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.
Measured: 5 weeks
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.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start26 Jan 2023
- Primary completion26 Jun 2023
- Study completion26 Jun 2023
Why it stopped: Low Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Limbix Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Children's Health
- Responsible party
- Sponsor
- Investigators
- Julie Germann, PhD., Principal investigator, Children's Health System of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351866
- Sponsor's protocol ID
- LMX-004
- Status last verified
- Aug 2023
- First submitted
- 18 Apr 2022
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of a Digital Therapeutic for Adolescent Depressive Symptoms in Hematology/Oncology and Weight Management
- ClinicalTrials.gov ID
- NCT05351866
- Acronym / sponsor ID
- LMX-004
- Conditions
- Depression, Depressive Disorder, Depressive Symptoms, Depressive Episode, Adolescent Behavior, Adolescent - Emotional Problem
- Keywords
- Depression, Mental Health, Adolescent mental health
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low Enrollment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Limbix Health, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Children's Health
- Study start
- 26 Jan 2023 (actual)
- Primary completion
- 26 Jun 2023 (actual)
- Study completion
- 26 Jun 2023 (actual)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SparkRx | Experimental | Device: CBT-based mobile intervention for depression5-week CBT-based mobile intervention for adolescents with depressive symptoms |
| Educational Control | Active comparator | Device: Mobile control with education about depression5-week mobile control with education about depression |
Who may qualify
- Ages
- 13 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT-based mobile intervention for depressionAlso: SparkRxSparkRx 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). | Device | SparkRx |
| Mobile control with education about depressionAlso: Educational ControlThe 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. | Device | Educational Control |
Primary outcome
Feasibility of intervention: Eligibility
Time frame: Screening
Percent of potential participants eligible to participate
Feasibility of intervention: Participant willingness
Time frame: Screening
Percent of eligible participants willing to participate
Feasibility of intervention: Completion adherence
Time frame: 5 weeks
Adherence to program determined by percent of enrolled participants completing all modules within 5 weeks and by post-treatment
Feasibility of intervention: Module adherence
Time frame: 5 weeks
Adherence to program determined by average number of modules completed
Feasibility of intervention: Time adherence
Time frame: 5 weeks
Adherence to program determined by engagement with program (time spent in app)
4 secondary outcomes
Change in depressive symptoms
Time frame: 5 weeks
Adverse events
Time frame: 11 weeks
Usability
Time frame: 5 weeks
Engagement
Time frame: 5 weeks
Results and safety
The study was stopped early (reason given: Low Enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Germann, PhD. principal investigator
Children's Health System of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT-based mobile intervention for depression in people with Depression and Depressive Disorder, run by Limbix Health, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low Enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of intervention: Eligibility (time frame: Screening). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.