Recruiting

VR with Standard Care

Sponsor:

University of Michigan

Code:

NCT07392879

Conditions

Progressive Multiple Sclerosis

Depression

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Virtual Reality

Standard care

Study Details

Brief summary:

This trial explores the use of immersive virtual reality (VR) nature-based experiences as a supplementary treatment for depression in individuals with progressive multiple sclerosis (MS). This study will evaluate the feasibility and efficacy of at-home VR deployment using the Apple Vision Pro, an advanced device that offers enhanced resolution, immersion, and usability compared to earlier VR systems.

The study hypotheses include:

  • The integration of VR nature-based experiences with standard care will be feasible, acceptable, and will result in greater reductions in depressive symptoms compared to standard care or VR-only interventions.
  • The integration of VR nature-based experiences with standard care will result in greater reductions in stress and anxiety, better sleep, less insomnia, and improved fatigue compared to standard care alone or VR-only interventions.

Conditions

Progressive Multiple Sclerosis

Depression

Study ID

NCT07392879

Start date

Dec 15, 2025

Status verified date

Feb, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Confirmed diagnosis of progressive Multiple Sclerosis (MS, primary or secondary) by a neurologist or an MS center
  • Patient-Reported Outcomes Measurement Information System (PROMIS) Depression T-scores >55 at baseline
  • Ability to provide informed consent and participate in VR sessions at home
  • For Some Participants (Groups 1 and 2) currently receiving antidepressant or psychotherapy treatments (Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs), or psychotherapy) for the management of depression

Exclusion Criteria:

  • Severe cognitive impairments or visual deficits that may interfere with VR use, including contraindications like agoraphobia, claustrophobia, or motion sickness
  • Current participation in other clinical trials targeting depression
  • Severe psychiatric conditions that require hospitalization, or suicidal ideation, passive or active, psychosis, or active substance and alcohol abuse (score greater than 1 on CAGE (Cut down, Annoyed, Guilty, Eye-opener) Adapted to Include Drugs (CAGE-AID))
  • Another neurological or autoimmune disease per protocol
  • Participants that require vision correction, unless that vision correction is mild (± 1), or the participant has prescription contact lenses.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Virtual reality plus standard care (SC) then SC alone - randomized group

Participants in this group are maintained on antidepressants or psychotherapy and will receive VR nature sessions alongside participants' current depression treatments. This will be followed by a 1-week washout period, after which they crossover to standard care only.

experimental: Standard care alone then Virtual reality plus SC- randomized group

Participants in this group are maintained on standard depression treatments and will continue standard care for eight weeks. This will be followed by a 1-week washout period and crossover to VR plus Standard Care.

experimental: Virtual Reality - non-randomized group

Participants that are not receiving any treatment for depression will receive VR nature sessions for 8 weeks without depression treatments for eight weeks followed by 1 week washout and 8 weeks of no VR.

Interventions

Virtual Reality

Participant will have 8 weeks of immersive VR nature-based experiences. Participants are expected to use the VR headset three times per week. Headsets will contain a prototype application (app) developed by Explore POV. This app will include approximately one hour of footage showcasing 15-25 different nature experiences, that will shuffle every time participants access it. Participants will have the option to choose between 5, 10, or 15 minutes, sessions while answering weekly surveys regarding their experiences.

Standard care

Participants that are in the randomized groups will continue on antidepressants or psychotherapy during the study per their standard care. Participants in the non-randomized group don't receive any treatment for their depression and will continue not to receive anything for this during the study.

Primary outcome measure

  • Changes to the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression short form 8b scores [ Time Frame: Baseline, 9-10 weeks and 20-21 weeks ]
  • Virtual Reality (VR) Sessions completed over 8 weeks [ Time Frame: 8-week VR intervention ]
  • Qualitative feedback on the VR Neuroscience Questionnaire during the intervention (groups 1 and 3) [ Time Frame: 1-8 weeks (during VR) ]
  • Qualitative feedback with Semi-structured interviews for participants that received VR [ Time Frame: Weeks 9-10, Weeks 20- 21 ]
  • Enrollment rate [ Time Frame: Recruitment period (2 years) ]
  • Retention rates [ Time Frame: Baseline - 21 weeks ]
  • Adherence to VR intervention [ Time Frame: 8-week VR intervention ]
  • Dropout reasons [ Time Frame: Baseline - 21 weeks ]
  • Hardware/software issues [ Time Frame: During 8 weeks of VR ]

Central Contacts and Locations

Central contacts

Zee Petrie

734- 764- 5249petrieli@umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Zee Petrie

734- 764- 5249petrieli@umich.edu

Principal Investigator:

Hala Darwish, PhD

More Information

Sponsor

University of Michigan

Last update posted

Feb 12, 2026

Last verified

Feb, 2026

Keywords

  • Immersive virtual reality (VR)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-02-12.