Recruiting

VR Intervention

Sponsor:

University of Michigan

Code:

NCT07413458

Conditions

Alcohol Use Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Virtual Reality (VR) -nature treatment

Survey completion

Study Details

Brief summary:

This pilot randomized clinical trial will evaluate the feasibility, acceptability, and preliminary effectiveness of immersive Virtual Reality (VR) nature intervention among adults with at least moderate depression symptoms enrolled in an intensive outpatient Program (IOP) for Alcohol Use Disorder (AUD).

The study hypotheses:

  • VR-based nature immersion will be feasible, acceptable, and positively evaluated by participants
  • Participants receiving the VR intervention will report greater reductions in symptoms of depression, anxiety, and stress compared to those receiving standard care alone

Conditions

Alcohol Use Disorder

Study ID

NCT07413458

Start date

Feb 16, 2026

Status verified date

Mar, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Individuals with a documented AUD diagnosis
  • Individuals enrolled in an Intensive Outpatient Program (IOP) (First week enrollment or planned enrollment in Michigan Medicine's Addiction Treatment Services (UMATS) IOP)
  • Individuals with a Patient Health Questionnaire (PHQ-9) score (≥10, moderate or greater depression symptoms)

Exclusion Criteria:

  • Severe motion sickness or sensitivity to VR-induced nausea or dizziness (anticipated <10%), medical contraindications to VR use (e.g., seizure disorders, vestibular disorders, agoraphobia, claustrophobia, psychosis).
  • Significant cognitive impairments that prevent provision of informed consent
  • Suicidal ideation or plan after consultation with treating clinician
  • Participants who require vision correction with glasses, unless vision correction is mild (±1), or the participant does not have prescription contact lenses.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Virtual Reality- (VR) nature treatment

Will use VR for 4 weeks.

other: No VR - standard treatment - control group

Participants will receive bi-weekly email reminders about participation in this study. Participants will be offered to try the VR headsets once participation is over for the randomized period (baseline to 8 weeks).

Interventions

Virtual Reality (VR) -nature treatment

Participants assigned to the VR intervention will engage in 5 to 30-minute (gradual increase in duration as tolerated to prevent motion sickness) -3 times per week, immersive VR nature sessions over 4 weeks, using the Apple Vision Pro and Explore POV app, alongside standardintensive outpatient program (IOP) care or other treatments they are receiving (e.g., additional counseling, psychiatry, etc.).

Survey completion

All participants will complete surveys at various time-points (baseline - 9 weeks).

Primary outcome measure

  • Enrollment rates [ Time Frame: Recruitment period (approximately 18 months) ]
  • Attendance at scheduled VR sessions [ Time Frame: 4 weeks of VR ]
  • Adherence to VR [ Time Frame: 4 weeks of VR ]
  • Percentage of participants that complete the entire study duration -VR [ Time Frame: 4 weeks of VR ]
  • Number of participants with documentation of informed consent completion [ Time Frame: Recruitment period (Approximately 18 months) ]
  • The Virtual Reality Neuroscience Questionnaire (VRNQ) [ Time Frame: 4 weeks of VR ]
  • Changes in depression measured by Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Baseline, 4 weeks, 8 weeks ]
  • Changes in anxiety measured by the Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: Baseline, 4 weeks, 8 weeks ]
  • Change on the Perceived stress scale (PSS-10) [ Time Frame: Baseline, 4 weeks, 8 weeks ]
  • Change on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Positive Affect [ Time Frame: Baseline, 4 weeks, 8 weeks ]
  • Change on the PROMIS Applied Cognition Short form v.1.0 [ Time Frame: Baseline, 4 weeks, 8 weeks ]
  • Change on the Ruminative Responses Scale [ Time Frame: Baseline, 4 weeks, 8 weeks ]
  • Change on the alcohol use disorders identification test (AUDIT) [ Time Frame: Baseline, 4 weeks, 8 weeks ]
  • Hardware and software-related issues [ Time Frame: 4 weeks of VR ]
  • Change on the Drug Abuse Screening Test-10 (DAST-10) [ Time Frame: Baseline, 4 weeks, 8 weeks ]
  • Qualitative interviews [ Time Frame: 4 weeks ]
  • Study Dropout rates calculated as the proportion of enrolled participants that do not complete the Week 8 assessment visit (or the final planned study assessment) [ Time Frame: Baseline - 8 weeks ]
  • Reasons for dropouts will be summarized as count and percentaged by overall by arm [ Time Frame: Baseline - 8 weeks ]

Central Contacts and Locations

Central contacts

Zee Petrie

734-647-3357petrieli@med.umich.edu

Hala Darwish, PhD

734-647-4929darwishh@med.umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Zee Petrie

734-647-3357petrieli@med.umich.edu

Principal Investigator:

Hala Darwish, PhD

More Information

Sponsor

University of Michigan

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Keywords

  • Virtual Reality
  • Surveys

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 2026-03-27.