Recruiting

Observational Study

Sponsor:

Stony Brook University

Code:

NCT03858881

Conditions

Depression

Eligibility Criteria

Sex: All

Age: 12 - 16

Healthy Volunteers: Not accepted

Interventions

PROJECT PERSONALITY

VR PERSONALITY PROJECT

SHARING FEELINGS PROGRAM

Study Details

Brief summary:

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.

Conditions

Depression

Study ID

NCT03858881

Start date

Mar 20, 2019

Status verified date

May, 2019

Completion date

Dec 30, 2021

Anticipated

Primary completion date

Dec 30, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 16

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Youth is between the ages of 12-16 years (inclusive) at the time of study enrollment
  • Youth has one parent or legal guardian willing to participate in the study (i.e., to be present for the lab visit and to complete questionnaires throughout the study period)
  • Youth speaks English well enough to complete online or virtual reality-based intervention activities, which are available in English only
  • Indication of elevated risk for youth depression. This criterion may be met in one of two ways (or both ways): (a) The adolescent exhibits elevations in depressive symptoms (subclinical or greater symptom elevations, corresponding to 80th percentile or higher, based on parent-report CDI 2 conducted an initial phone screen); (b) The adolescent received treatment for depression within the previous 2 years (depression tends to recur, so past treatment receipt indicates elevated risk). Past treatment receipt will be assessed via parent report at the time of the phone screen.

Exclusion Criteria:

  • Intellectual disability, as this may undermine comprehension of intervention materials
  • Adolescent is non-English speaking, as the virtual reality and online interventions are available in English only;
  • Adolescent was hospitalized or received residential/inpatient treatment for suicide attempt or self-harming behaviors within the past 2 months, as the interventions being tested in this study are not designed for adolescents with acute medical and/or psychiatric treatment needs

Study Design

Enrollment

159 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: PROJECT PERSONALITY

experimental: VR PERSONALITY PROJECT

placebo comparator: SHARING FEELINGS PROGRAM

Interventions

PROJECT PERSONALITY

PROJECT PERSONALITY is self-administered by youth via Qualtrics and is 30 minutes in duration. The intervention includes five elements: 1. An introduction to the brain, including a lesson on neuroplasticity (how and why our behaviors are controlled by thoughts and feelings in the brains, which have potential for change); 2. Testimonials from older youths who describe their views that people's traits are malleable, given the brain's plasticity; 3. Additional vignettes written by older youths, describing times when they used "growth mindsets" to persevere through social and emotional setbacks; 4. A summary of selected scientific studies suggesting that personality can, and often does, change in positive ways over time; and 5. An exercise in which the participants write notes to younger students, drawing on scientific information to describe the malleability of people's personal traits

VR PERSONALITY PROJECT

The VR PERSONALITY PROJECT contains similar elements as PROJECT PERSONALITY, including a lesson on neuroplasticity; testimonials from older youths; information about research on the malleability of personal traits; and an exercise wherein the participant provides advice to a student in the VR environment who has experienced a peer-related setback. Content is delivered by characters in the VR environment (hired/filmed actors) who guide youths through the program, providing scientific information and personal stories. Completion time is 30-40 minutes. The key difference between the VR and web-based mindset intervention is the delivery system, and by extension the level of immersion each program offers. The VR program is designed to be immersive, fun and interactive; youth choose to speak to various scientists and students within the VR environment and navigate themselves from scene to scene. In the online program, participants automatically view a series of text-based activities.

SHARING FEELINGS PROGRAM

The web-based supportive therapy (ST) intervention, called the Sharing Feelings Program, is delivered via Qualtrics, self-administered by youth, and 30 minutes in duration. It aims to encourage youths to identify and express feelings to close others and does not teach specific skills or beliefs. It is designed to control for nonspecific aspects of intervention, including engagement in a technology-based program. It mirrors the web-based growth mindset intervention as closely as possible, including vignettes written by older youths who describe times when they benefited from sharing their feelings with friends or family.

Primary outcome measure

  • Change in Children's Depression Inventory - 2 (Youth Report) [ Time Frame: Baseline to 3- and 9-month follow-up ]
  • Change in Children's Depression Inventory - 2 (Parent Report) [ Time Frame: Baseline to 3- and 9-month follow-up ]

Central Contacts and Locations

Central contacts

Locations

Stony Brook University

Recruiting

Stony Brook, New York, United States, 11794-2500

Contacts

More Information

Sponsor

Stony Brook University

Last update posted

May 7, 2019

Last verified

May, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stony Brook University on 2019-05-07.