Depressive SymptomsNCT05462652
Self-guided Treatment for Adolescents Navigating Depression
A study testing Active Intervention in people with Depressive Symptoms and Depression, run by Limbix Health, Inc. at 1 site in United States.
Trial summary
The goal of this study is to test whether an investigational mobile app can be a helpful treatment option for adolescents with symptoms of depression. Adolescents aged 13 to 21 with depression symptoms can be part of this study if eligible. Read more about this study
- Who is it for?
- Ages 13 to 21 years
- Conditions the study is for
- Depressive Symptoms, Depression, Depressive Disorder
- What is being tested?
- Active Intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2022to 21 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 13-21 years of age
- PHQ-8 score ≥ 5 at eligibility screening
- English fluency and literacy (participant and legal guardian, if applicable)
- 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 on study website) and regular internet access
- Participant willing and able to provide informed consent/assent and have legal guardian willing and able to provide informed consent (if required)
- Under the care of a United States (U.S.)-based licensed healthcare provider and willing to provide contact information for the provider and sign a HIPAA release that allows Limbix to contact provider
- Willing and able to provide information required for study enrollment (e.g. all responses to initial PHQ-8 assessment, and current antidepressant medication status)
- Located in the continental U.S., Hawaii, or Alaska, and not planning to leave the U.S. during the study period (through 1-month follow up assessments, up to 11 weeks after eligibility screening)
Who cannot join
- Diagnosis of (or treatment for) bipolar disorder, post traumatic stress disorder, psychotic disorder, substance use disorder, or eating disorder within the 12 months prior to eligibility screening
- Change in psychotropic medication (initiation or change in dose) within the 30 days prior to eligibility screening
- Plans to initiate or change treatment (e.g., psychotherapy, psychotropic medication, and/or other psychosocial treatment) for a mental health disorder during the study intervention period (5 weeks) as determined at eligibility screening
- Suicide attempt within the past year
- Active suicide ideation with intent
- Previous participation in user testing or clinical testing of Spark or SparkRx, or other previous use of SparkRx app
Show all 10Show fewer
- Participation in any other clinical research involving a mental health intervention or treatment within 60 days prior to eligibility screening
- Plans to participate in any other clinical research involving a mental health intervention or treatment during the study intervention period (5 weeks) as determined at eligibility screening
- 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 intervention or will prevent investigators from being able to ensure safety
- Having a sibling who is a past or current participant in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Limbix Health, Inc.
San Francisco, California, 94104
About this study
Official title: Project STAND (Self-guided Treatment for Adolescents Navigating Depression): a Randomized Controlled Trial
The goal of this study is to test whether an investigational mobile app can be a helpful treatment option for adolescents with symptoms of depression. Adolescents aged 13 to 21 with depression symptoms can be part of this study if eligible.
Eligible participants will be randomly assigned to one of two groups: one group will receive the mobile app intervention in addition to their usual care and the other group will simply continue their usual care for symptoms of depression. Both groups will have 5 weeks to use a study app, and will complete assessments during the intervention period, at post-intervention, and at one month follow-up.
Read the detailed description
The primary aim of the proposed research is to evaluate the effectiveness of a self-guided, cognitive behavioral therapy (CBT)-based mobile app + assessment-enhanced Usual Care (eUC) compared to eUC alone as an intervention for adolescents with symptoms of depression who are under the supervision of a licensed healthcare provider.
The sample size for this study is 220 subjects. Sample size calculation is based on primary outcome patient health questionnaire (PHQ-8) at post-intervention (5 weeks). Six PHQ-8 measurements will be collected from each subject (baseline and weekly during the 5-week intervention period). Using a two-sample t-test approach, assuming a two-tailed alpha set at 0.05, a total of 200 participants (100 in each study arm) will give us 80% power to detect a moderate effect size of at least d=0.4. Given an anticipated 10% rate of attrition, we aim to enroll 220 total participants in the study.
A 50% female sample will be targeted. Earlier recruitment efforts within the study demographic have resulted in majority female samples, consistent with prevalence rates within the study population. As such, recruitment efforts will be undertaken to ensure representation of male participants. Recruitment efforts will be taken to ensure adequate representation of underrepresented racial and ethnic minority groups.
Children between the ages of 13-17 will be included in this research as the program to be evaluated is specifically designed as an intervention for adolescents with symptoms of depression. Assent will be obtained from all children under 18 for study enrollment unless legally emancipated or financially independent in accordance with CA state regulations and regulations of the state in which the minor resides.
Study staff will monitor participants' symptom deterioration and questionnaire data for safety.
- Being tested
- Active Intervention
- Keywords
- Mental Health, Adolescents, Depression, Adolescent Mental Health
- Medical subject headings
- Depression, Depressive Disorder, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active InterventionDevice
The active intervention is a 5-week program divided into 5 levels intended to be completed weekly. Each level is expected to take about 60 minutes to complete. Activities in each level may include reading text on the screen, answering multiple choice style questions, swiping or clicking a button to move through screens, dragging and dropping elements on screen, and completing tasks outside of the app. Certain on-demand resources can be accessed in the apps at any time, including crisis resources. Where appropriate, text entries in the app 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. Text entries will also be monitored by study staff for safety, though not in real-time. Participants will be instructed to complete a weekly PHQ-8 assessment in the mobile app.
| Study group | Role | What they receive |
|---|---|---|
| Active Intervention | Experimental | The active intervention is a 5-week program divided into 5 levels intended to be completed weekly. Each level is expected to take about 60 minutes to complete. Activities in each level may include reading text on the screen, answering multiple choice style questions, swiping or clicking a button to move through screens, dragging and dropping elements on screen, and completing tasks outside of the app. Certain on-demand resources can be accessed in the apps at any time, including crisis resources. Where appropriate, text entries in the app 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. Text entries will also be monitored by study staff for safety, though not in real-time. Participants will be instructed to complete a weekly PHQ-8 assessment in the mobile app. Receives: Device: Active Intervention |
| Usual Care | No intervention | UC is based on a stepped care model for treatment for symptoms of depression. It can include any of the following: active monitoring of depressive symptoms and suicidality, supportive counseling by a healthcare provider, psychosocial support interventions, collaborative care (e.g. facilitation of parental and patient self-management, referral for peer support or other community or school-based behavioral health programs), psychoeducation, complementary and alternative medicine approaches, psychotherapy (e.g. behavioral treatment, interpersonal therapy, cognitive behavioral therapy), pharmacotherapy for mood problems, visit to a primary care provider, behavioral or mental health specialist or therapist, counselor or coach for mood disorder. For purposes of this study, UC will be enhanced by prompting participants to complete a weekly PHQ-8 assessment in a mobile app. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive Symptom Severity at Post-intervention
Measured by the Patient Health Questionnaire (PHQ-8), an 8-item participant-report measure for screening for depression and for establishing depression severity. The total score ranges from 0-24, with a higher score indicating greater depression symptom severity.
Measured: Post-intervention (5 week timepoint)
Secondary outcomes (3)
Intervention Response at Post-intervention
Measured by the Patient Health Questionnaire (PHQ-8) an 8-item participant-report measure for screening for depression and for establishing depression severity. The total score ranges from 0-24, with a higher score indicating greater depression symptom severity. Intervention response is defined as a 50% reduction in PHQ-8 score from baseline.
Measured: Change from baseline to post-intervention (5 weeks)
Remission at Post-intervention
Measured by the Patient Health Questionnaire (PHQ-8) an 8-item participant-report measure for screening for depression and for establishing depression severity. The total score ranges from 0-24, with a higher score indicating greater depression symptom severity. Remission is defined as a PHQ-8 score less than 5 at post-intervention.
Measured: Post-intervention (5 week timepoint)
Clinically-meaningful Reduction in Severity at Post-intervention
Measured by the Patient Health Questionnaire (PHQ-8) an 8-item participant-report measure for screening for depression and for establishing depression severity. The total score ranges from 0-24, with a higher score indicating greater depression symptom severity. Clinically-meaningful reduction is defined as a ≥5 point reduction in PHQ-8 score from baseline.
Measured: Change from baseline to post-intervention (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 start28 Jul 2022
- Primary completion21 Apr 2023
- Study completion21 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Limbix Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aarthi Padmanabhan, PhD, Principal investigator, Limbix Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05462652
- Sponsor's protocol ID
- LMX-001
- Status last verified
- May 2024
- First submitted
- 14 Jul 2022
- Last updated
- 12 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Furman DJ, Hall SA, Avina C, Kulikov VN, Lake JI, Padmanabhan A. Assessing the Efficacy and Safety of a Digital Therapeutic for Symptoms of Depression in Adolescents: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Nov 16;12:e48740. doi: 10.2196/48740.
PubMed 37971800
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project STAND (Self-guided Treatment for Adolescents Navigating Depression): a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05462652
- Acronym / sponsor ID
- LMX-001
- Keywords
- Mental Health, Adolescents, Depression, Adolescent Mental Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Limbix Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Jul 2022 (actual)
- Primary completion
- 21 Apr 2023 (actual)
- Study completion
- 21 Apr 2023 (actual)
- First posted
- 18 Jul 2022 (actual)
- Results
- Posted 12 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to test whether an investigational mobile app can be a helpful treatment option for adolescents with symptoms of depression. Adolescents aged 13 to 21 with depression symptoms can be part of this study if eligible.
Eligible participants will be randomly assigned to one of two groups: one group will receive the mobile app intervention in addition to their usual care and the other group will simply continue their usual care for symptoms of depression. Both groups will have 5 weeks to use a study app, and will complete assessments during the intervention period, at post-intervention, and at one month follow-up.
Detailed description
The primary aim of the proposed research is to evaluate the effectiveness of a self-guided, cognitive behavioral therapy (CBT)-based mobile app + assessment-enhanced Usual Care (eUC) compared to eUC alone as an intervention for adolescents with symptoms of depression who are under the supervision of a licensed healthcare provider.
The sample size for this study is 220 subjects. Sample size calculation is based on primary outcome patient health questionnaire (PHQ-8) at post-intervention (5 weeks). Six PHQ-8 measurements will be collected from each subject (baseline and weekly during the 5-week intervention period). Using a two-sample t-test approach, assuming a two-tailed alpha set at 0.05, a total of 200 participants (100 in each study arm) will give us 80% power to detect a moderate effect size of at least d=0.4. Given an anticipated 10% rate of attrition, we aim to enroll 220 total participants in the study.
A 50% female sample will be targeted. Earlier recruitment efforts within the study demographic have resulted in majority female samples, consistent with prevalence rates within the study population. As such, recruitment efforts will be undertaken to ensure representation of male participants. Recruitment efforts will be taken to ensure adequate representation of underrepresented racial and ethnic minority groups.
Children between the ages of 13-17 will be included in this research as the program to be evaluated is specifically designed as an intervention for adolescents with symptoms of depression. Assent will be obtained from all children under 18 for study enrollment unless legally emancipated or financially independent in accordance with CA state regulations and regulations of the state in which the minor resides.
Study staff will monitor participants' symptom deterioration and questionnaire data for safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Intervention | Experimental | Device: Active InterventionThe active intervention is a 5-week program divided into 5 levels intended to be completed weekly. Each level is expected to take about 60 minutes to complete. Activities in each level may include reading text on the screen, answering multiple choice style questions, swiping or clicking a button to move through screens, dragging and dropping elements on screen, and completing tasks outside of the app. Certain on-demand resources can be accessed in the apps at any time, including crisis resources. Where appropriate, text entries in the app 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. Text entries will also be monitored by study staff for safety, though not in real-time. Participants will be instructed to complete a weekly PHQ-8 assessment in the mobile app. |
| Usual Care | No intervention | –UC is based on a stepped care model for treatment for symptoms of depression. It can include any of the following: active monitoring of depressive symptoms and suicidality, supportive counseling by a healthcare provider, psychosocial support interventions, collaborative care (e.g. facilitation of parental and patient self-management, referral for peer support or other community or school-based behavioral health programs), psychoeducation, complementary and alternative medicine approaches, psychotherapy (e.g. behavioral treatment, interpersonal therapy, cognitive behavioral therapy), pharmacotherapy for mood problems, visit to a primary care provider, behavioral or mental health specialist or therapist, counselor or coach for mood disorder. For purposes of this study, UC will be enhanced by prompting participants to complete a weekly PHQ-8 assessment in a mobile app. |
Who may qualify
- Ages
- 13 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 13-21 years of age
- PHQ-8 score ≥ 5 at eligibility screening
- English fluency and literacy (participant and legal guardian, if applicable)
- 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 on study website) and regular internet access
- Participant willing and able to provide informed consent/assent and have legal guardian willing and able to provide informed consent (if required)
Key exclusion criteria (10 listed)
- Diagnosis of (or treatment for) bipolar disorder, post traumatic stress disorder, psychotic disorder, substance use disorder, or eating disorder within the 12 months prior to eligibility screening
- Change in psychotropic medication (initiation or change in dose) within the 30 days prior to eligibility screening
- Plans to initiate or change treatment (e.g., psychotherapy, psychotropic medication, and/or other psychosocial treatment) for a mental health disorder during the study intervention period (5 weeks) as determined at eligibility screening
- Suicide attempt within the past year
- Active suicide ideation with intent
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 |
|---|---|---|
| Active InterventionThe active intervention is a 5-week program divided into 5 levels intended to be completed weekly. Each level is expected to take about 60 minutes to complete. Activities in each level may include reading text on the screen, answering multiple choice style questions, swiping or clicking a button to move through screens, dragging and dropping elements on screen, and completing tasks outside of the app. Certain on-demand resources can be accessed in the apps at any time, including crisis resources. Where appropriate, text entries in the app 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. Text entries will also be monitored by study staff for safety, though not in real-time. Participants will be instructed to complete a weekly PHQ-8 assessment in the mobile app. | Device | Active Intervention |
Primary outcome
Depressive Symptom Severity at Post-intervention
Time frame: Post-intervention (5 week timepoint)
Measured by the Patient Health Questionnaire (PHQ-8), an 8-item participant-report measure for screening for depression and for establishing depression severity. The total score ranges from 0-24, with a higher score indicating greater depression symptom severity.
3 secondary outcomes
Intervention Response at Post-intervention
Time frame: Change from baseline to post-intervention (5 weeks)
Remission at Post-intervention
Time frame: Post-intervention (5 week timepoint)
Clinically-meaningful Reduction in Severity at Post-intervention
Time frame: Change from baseline to post-intervention (5 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37971800Furman DJ, Hall SA, Avina C, Kulikov VN, Lake JI, Padmanabhan A. Assessing the Efficacy and Safety of a Digital Therapeutic for Symptoms of Depression in Adolescents: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Nov 16;12:e48740. doi: 10.2196/48740.
- 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, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Intervention in people with Depressive Symptoms and Depression, 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 8 inclusion and 10 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: finished, as of the sponsor's last update on 12 Jun 2024. 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?
Yes. Results are posted in the registry (first posted 12 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Depressive Symptom Severity at Post-intervention (time frame: Post-intervention (5 week timepoint)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05462652, which also lists 1 linked publication.
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 12 Jun 2024; AzTrials last refreshed its copy on 31 Oct 2026.