NCT04165681

A Mobile and Virtual Reality Intervention for Adolescent Depression

Completed NA Last updated 7 July 2020

What this trial tests

NA trial testing Limbix Spark in Depression in 30 participants. Completed in 17 April 2020.

Timeline

12 October 2019

Primary endpoint
19 March 2020

17 April 2020

Quick facts

Lead sponsor	Limbix Health, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	30
Start date	12 October 2019
Primary completion	19 March 2020
Estimated completion	17 April 2020
Sites	1 location across United States

Drugs / interventions tested

• Limbix Spark

Conditions studied

• Depression — all drugs for Depression →

Sponsor

Limbix Health, Inc.

Who can join

Adults 12 to 21, any sex, with Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Self-Guided Digital Intervention for Depression in Adolescents: Feasibility and Preliminary Efficacy Study.
   Miller I, Peake E, Strauss G, Vierra E, et al · · 2023 · cited 10× · PMID 37991839 · DOI 10.2196/43260