A Mobile and Virtual Reality Intervention for Adolescent Depression

NCT04165681 | Completed

• 1 other identifier: Limbix Spark 01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Adolescence; Cognitive Behavioral Therapy; Virtual Reality; Depression; Behavioral Activation

Outcome Measures

Primary Outcomes (2)

• Adherence to program

  % of enrolled participants completing all sessions at post treatment

  Post treatment (5 weeks)

• 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 Outcomes (1)

• Change in depression at one month follow up

  Change from Baseline to 1 month follow up (9 weeks)

Study Arms (1)

Limbix Spark

EXPERIMENTAL

A 5 week mobile + virtual reality CBT-based program

Other: Limbix Spark

Interventions

Limbix Spark OTHER

5-week, self-guided mobile + VR CBT-based program for adolescent depression

Limbix Spark

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• Limbix Health, Inc.: lead

Study Sites (1)

Limbix Health, Inc.

Los Angeles, California, 90266-2558, United States

Location

Related Publications (1)

• Miller I, Peake E, Strauss G, Vierra E, Koepsell X, Shalchi B, Padmanabhan A, Lake J. Self-Guided Digital Intervention for Depression in Adolescents: Feasibility and Preliminary Efficacy Study. JMIR Form Res. 2023 Nov 22;7:e43260. doi: 10.2196/43260.

  PMID: 37991839 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Jessica Lake, PhD

  Director of Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: November 18, 2019
• Study Start: October 12, 2019
• Primary Completion: March 19, 2020
• Study Completion: April 17, 2020
• Last Updated: July 7, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)