Depression Clinical Trial
Official title:
Project STAND (Self-guided Treatment for Adolescents Navigating Depression): a Randomized Controlled Trial
NCT number | NCT05462652 |
Other study ID # | LMX-001 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 28, 2022 |
Est. completion date | April 21, 2023 |
Verified date | May 2024 |
Source | Limbix Health, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 223 |
Est. completion date | April 21, 2023 |
Est. primary completion date | April 21, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 13 Years to 21 Years |
Eligibility | Inclusion Criteria: - 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) Exclusion Criteria: - 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 - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Limbix Health, Inc. | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Limbix Health, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Post-intervention (5 week timepoint) | |
Secondary | 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. | Change from baseline to post-intervention (5 weeks) | |
Secondary | 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. | Post-intervention (5 week timepoint) | |
Secondary | 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. | Change from baseline to post-intervention (5 weeks) |
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