Depression Clinical Trial
Official title:
Evaluating the Feasibility of Limbix Spark: a Cognitive Behavioral Therapy Based Mobile and Virtual Reality Intervention for Adolescent Depression
Verified date | July 2020 |
Source | Limbix Health, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Depression, the most common mental health disorder among adolescents, is a critical health problem within the US. In this study, the feasibility, acceptability, and preliminary efficacy of Limbix Spark, a cognitive behavioral therapy (CBT)- based mobile app + virtual reality (VR) program for helping adolescents live well with depression will be investigated. This program is specifically designed around behavioral activation theory, the idea that completing activities that make a patient feel pleasure or provide a sense of mastery are effective in reducing symptoms of depression. The program involves the use of both VR and a mobile app that include CBT components like psychological assessments, psychoeducation, and skills training. 30 participants aged 12-21 years old with mild to severe depressive symptoms and smartphone access will be enrolled in this study. The primary efficacy outcome measures will be depressive symptoms with anxiety symptoms, functional outcomes, and dimensional scales of positive and negative affect and behavioral activation serving as secondary outcome measures. Qualitative and quantitative feedback on the use of the VR + mobile app (ease of use, comfort, willingness to use again) will be assessed using questionnaires. Engagement and adherence to the program will be assessed by assessing VR and app usage.
Status | Completed |
Enrollment | 30 |
Est. completion date | April 17, 2020 |
Est. primary completion date | March 19, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 21 Years |
Eligibility |
Inclusion Criteria: 1. Score of 10 or greater on Patient Health Questionnaire (PHQ-8) 2. English fluency and literacy 3. Access to a smart phone 4. Patient willing to provide informed consent/assent and have parent/guardian willing to provide informed consent if under 18. Exclusion Criteria: 1. Seizure disorder or other neurological disorder 2. Prior diagnosis of or receiving treatment for substance use disorder, bipolar disorder, or psychosis 3. Significant vision or hearing impairment 4. Hospitalized or received residential/inpatient treatment for a suicide attempt or self-harming behaviors within the past 3 months 5. Current diagnosis of a reading/learning or intellectual disability. 6. Receiving treatment (including but not limited to medication or psychotherapy) for a cognitive disorder, including attention deficit hyperactivity disorder (ADHD). 7. Are currently participating in a treatment study. 8. Pregnancy 9. History of significant motion sickness |
Country | Name | City | State |
---|---|---|---|
United States | Limbix Health, Inc. | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Limbix Health, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adherence to program | % of enrolled participants completing all sessions at post treatment | Post treatment (5 weeks) | |
Primary | Change in depression post treatment | Change in depressive symptoms measured by Personal Health Questionnaire (PHQ-8) (min: 0; max: 24, with higher score indicating more severe depression). | Change from Baseline to Post treatment (5 weeks) | |
Secondary | Change in depression at one month follow up | Change in depressive symptoms measured by Personal Health Questionnaire (PHQ-8) (min: 0; max: 24, with higher score indicating more severe depression). | Change from Baseline to 1 month follow up (9 weeks) |
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