A Mobile and Virtual Reality Intervention for Adolescent Depression
Completed · Not applicable
Conditions studied: Depression
In brief
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.
Key facts
- Study ID
- NCT04165681
- Run by
- Limbix Health, Inc.
- People needed
- 30
- Starts
- 2019-10-12
- Expected to finish
- 2020-04-17
- Last updated by the study team
- 2020-07-07
Who can join
Age: 12 and older, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Score of 10 or greater on Patient Health Questionnaire (PHQ-8)
- English fluency and literacy
- Access to a smart phone
- Patient willing to provide informed consent/assent and have parent/guardian willing to provide informed consent if under 18.
You may not qualify if…
- Seizure disorder or other neurological disorder
- Prior diagnosis of or receiving treatment for substance use disorder, bipolar disorder, or psychosis
- Significant vision or hearing impairment
- Hospitalized or received residential/inpatient treatment for a suicide attempt or self-harming behaviors within the past 3 months
- Current diagnosis of a reading/learning or intellectual disability.
- Receiving treatment (including but not limited to medication or psychotherapy) for a cognitive disorder, including attention deficit hyperactivity disorder (ADHD).
- Are currently participating in a treatment study.
- Pregnancy
- History of significant motion sickness
Where it is running
- Limbix Health, Inc. — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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