NCT03858881: BEST-TECH

Building Evidence-Based Supports for Teens Via Technology

Status unknown NA Last updated 7 May 2019

What this trial tests

NA trial testing PROJECT PERSONALITY in Depression in 159 participants. Status unknown.

Timeline

20 March 2019

Primary endpoint
30 December 2021

30 December 2021

Quick facts

Lead sponsor	Stony Brook University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	159
Start date	20 March 2019
Primary completion	30 December 2021
Estimated completion	30 December 2021
Sites	1 location across United States

Drugs / interventions tested

• PROJECT PERSONALITY
• VR PERSONALITY PROJECT
• SHARING FEELINGS PROGRAM

Conditions studied

• Depression — all drugs for Depression →

Sponsor

Stony Brook University

Who can join

Adults 12 to 16, any sex, with Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Major depression (MD) is the leading cause of disability in youth, with a global economic burden of \>$210 billion annually. However, up to 70% of youth with MD do not receive services. Even among those who do access treatment, 30-65% fail to respond, demonstrating a significant need for more potent, accessible interventions for adolescent depressive symptoms and disorders.

The goal of this project is to assess the acceptability and effectiveness of a novel, single-session, virtual reality-based depression intervention-the VR Personality Project-teaching growth mindset: the belief that personal behaviors and characteristics, such as depressive symptoms, are malleable rather than fixed. In a previous trial, a single-session growth mindset intervention significantly reduced depressive symptoms in high symptom-adolescents; however, this intervention did not benefit all adolescents uniformly. For instance, the intervention reduced depression in adolescents who reported post-intervention increases in perceived control, but it did not lead to significant depression reductions in adolescents who reported small or no increases in perceived control. Thus, the VR Personality Project was designed to systematically target and increase adolescents' perceived control by offering a more immersive, active, and user-directed intervention experience than the web-based SSI can provide. By targeting an identified predictor of intervention response, the VR Personality Project may be lead to larger reductions in depression than the existing web-based mindset SSI.

To test this possibility, adolescents with elevated depressive symptoms or at high risk for depressive symptoms (N=159; ages 12-16) will be randomized to one of three intervention conditions: the VR Personality Project; the web-based growth mindset SSI tested previously; or an active control SSI, also tested previously. Adolescents and their parents will report on their depression symptoms, perceived control, and related domains of functioning at pre-intervention, post-intervention, and at three- and nine-month follow-ups. We predict that the VR and web-based SSIs will both lead to larger reductions in adolescent symptoms relative to the control SSI. Additionally, we predict that the VR-based SSI will lead to larger reductions in depression than the online SSI, and that these symptom reductions will be mediated by increases in adolescents' perceived control. Results may identify a particularly potent, mechanism-targeted, brief intervention for adolescent depression.

Publications & conference data

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

1. Virtual Reality and Web-Based Growth Mindset Interventions for Adolescent Depression: Protocol for a Three-Arm Randomized Trial.
   Schleider JL, Mullarkey MC, Weisz JR. · · 2019 · cited 39× · PMID 31290406 · DOI 10.2196/13368