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A Mobile and Virtual Reality Intervention for Adolescent Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04165681
Recruitment Status : Completed
First Posted : November 18, 2019
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Limbix Health, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Depression Other: Limbix Spark Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluating the Feasibility of Limbix Spark: a Cognitive Behavioral Therapy Based Mobile and Virtual Reality Intervention for Adolescent Depression
Actual Study Start Date : October 12, 2019
Actual Primary Completion Date : March 19, 2020
Actual Study Completion Date : April 17, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Limbix Spark
A 5 week mobile + virtual reality CBT-based program
Other: Limbix Spark
5-week, self-guided mobile + VR CBT-based program for adolescent depression




Primary Outcome Measures :
  1. Adherence to program [ Time Frame: Post treatment (5 weeks) ]
    % of enrolled participants completing all sessions at post treatment

  2. Change in depression post treatment [ Time Frame: Change from Baseline to Post treatment (5 weeks) ]
    Change in depressive symptoms measured by Personal Health Questionnaire (PHQ-8) (min: 0; max: 24, with higher score indicating more severe depression).


Secondary Outcome Measures :
  1. Change in depression at one month follow up [ Time Frame: Change from Baseline to 1 month follow up (9 weeks) ]
    Change in depressive symptoms measured by Personal Health Questionnaire (PHQ-8) (min: 0; max: 24, with higher score indicating more severe depression).



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04165681


Locations
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United States, California
Limbix Health, Inc.
Los Angeles, California, United States, 90266-2558
Sponsors and Collaborators
Limbix Health, Inc.
Investigators
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Principal Investigator: Jessica Lake, PhD Director of Research
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Responsible Party: Limbix Health, Inc.
ClinicalTrials.gov Identifier: NCT04165681    
Other Study ID Numbers: Limbix Spark 01
First Posted: November 18, 2019    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Limbix Health, Inc.:
Adolescence
Cognitive Behavioral Therapy
Virtual Reality
Depression
Behavioral Activation
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders