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Recruiting NCT07413458

Virtual Reality (VR) NATURE - Alcohol Use Disorder (AUD)

No phase Interventional Alcohol Use Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual Reality (VR) -nature treatment, Survey completion.
Who it may be relevant to
Registry conditions: Alcohol Use Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Virtual Reality Nature Immersion to Reduce Depression in People Engaged in Intensive Outpatient Alcohol Treatment

Overview

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

Interventions

  • Device 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.).
  • Behavioral Survey completion
    All participants will complete surveys at various time-points (baseline - 9 weeks).

Primary outcome measures

  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Michigan — Ann Arbor

Identifiers

NCT: NCT07413458 · HUM00283019

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗