Depressive SymptomsNCT05461599
Digital Therapeutic for Adolescent Depressive Symptoms in Cardiology and Gastroenterology
A study testing SparkRx Mobile App in people with Depressive Symptoms and Major Depressive Disorder, run by Limbix Health, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 22 years
- Conditions the study is for
- Depressive Symptoms, Major Depressive Disorder, Depression
- What is being tested?
- SparkRx Mobile App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2022to 16 May 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
- 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)
Who cannot join
- 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)
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 Cardiology and Gastroenterology
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).
Read the 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.
- Conditions
- Depressive Symptoms, Major Depressive Disorder, Depression, Cardiology, Gastrointestinal Diseases, Depressive Disorder
- Being tested
- SparkRx Mobile App
- Keywords
- Depression, Mental Health, Adolescent Depression
- Medical subject headings
- Depression, Depressive Disorder, Major, Gastrointestinal Diseases, Depressive Disorder, Adolescent Behavior, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SparkRx Mobile AppDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| SparkRx Mobile App | Other | 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. Receives: Device: SparkRx Mobile App |
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 - Adherence
Adherence to program: percent of enrolled participants completing all modules by post-treatment
Measured: 5 weeks
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.
Measured: 5 weeks
Secondary outcomes (9)
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: Change from screening to post-intervention (5 weeks)
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.
Measured: Change from screening to post-intervention (5 weeks)
Change in legal-guardian 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.
Measured: Change from screening to post-intervention (5 weeks)
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.
Measured: Change from screening to post-intervention (5 weeks)
Change in legal guardian-reported 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: Change from screening to post-intervention (5 weeks)
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.
Measured: 5 weeks
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.
Measured: 5 weeks
Average treatment related program adherence
Measured by mobile app analytics
Measured: 5 weeks
Average treatment related program engagement
Measured by mobile app analytics
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 posted18 Jul 2022
- Study start25 Aug 2022
- Primary completion16 May 2023
- Study completion16 May 2023
Why it stopped: Enrollment too low
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Limbix Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Children's Hospital Los Angeles
- Responsible party
- Sponsor
- Investigators
- Aarthi Padmanabhan, PhD, Principal investigator, Limbix Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05461599
- Sponsor's protocol ID
- LMX-003
- Status last verified
- May 2023
- First submitted
- 29 Apr 2022
- Last updated
- 19 May 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 19 May 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 Cardiology and Gastroenterology
- ClinicalTrials.gov ID
- NCT05461599
- Acronym / sponsor ID
- LMX-003
- Conditions
- Depressive Symptoms, Major Depressive Disorder, Depression, Cardiology, Gastrointestinal Diseases, Depressive Disorder
- Keywords
- Depression, Mental Health, Adolescent Depression
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment too low
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Limbix Health, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Children's Hospital Los Angeles
- Study start
- 25 Aug 2022 (actual)
- Primary completion
- 16 May 2023 (actual)
- Study completion
- 16 May 2023 (actual)
- First posted
- 18 Jul 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SparkRx Mobile App | Other | Device: SparkRx Mobile AppThe 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. |
Who may qualify
- Ages
- 13 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
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 |
|---|---|---|
| SparkRx Mobile AppThe 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. | Device | SparkRx Mobile App |
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 - Adherence
Time frame: 5 weeks
Adherence to program: percent of enrolled participants completing all modules by post-treatment
Participant satisfaction with the SparkRx app
Time frame: 5 weeks
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.
9 secondary outcomes
Change in depressive symptoms
Time frame: Change from screening to post-intervention (5 weeks)
Change in participant-reported health-related quality of life
Time frame: Change from screening to post-intervention (5 weeks)
Change in legal-guardian reported health-related quality of life
Time frame: Change from screening to post-intervention (5 weeks)
Change in participant-rated anxiety symptoms
Time frame: Change from screening to post-intervention (5 weeks)
Change in legal guardian-reported depressive symptoms
Time frame: Change from screening to post-intervention (5 weeks)
Average treatment related usability rating
Time frame: 5 weeks
Average treatment related engagement rating
Time frame: 5 weeks
Average treatment related program adherence
Time frame: 5 weeks
Average treatment related program engagement
Time frame: 5 weeks
Results and safety
The study was stopped early (reason given: Enrollment too low). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 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.
Aarthi Padmanabhan, PhD principal investigator
Limbix Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SparkRx Mobile App in people with Depressive Symptoms and Major 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 5 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 19 May 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: Enrollment too low). 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 4 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 19 May 2023.