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

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

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

Study Overview

• Status: Recruiting
• Conditions: Alcohol Use Disorder
• Intervention / Treatment: Device: Virtual Reality (VR) -nature treatment; Behavioral: Survey completion

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zee Petrie; Phone Number: 734-647-3357; Email: petrieli@med.umich.edu
• Study Contact Backup: Name: Hala Darwish, PhD; Phone Number: 734-647-4929; Email: darwishh@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Contact: Zee Petrie; Phone Number: 734-647-3357; Email: petrieli@med.umich.edu
      • Principal Investigator: Hala Darwish, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality- (VR) nature treatment; Will use VR for 4 weeks.	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).
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).	Behavioral: Survey completion; All participants will complete surveys at various time-points (baseline - 9 weeks).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment rates	Recruitment will be quantified by enrollment rates relative to eligibility screenings.	Recruitment period (approximately 18 months)
Attendance at scheduled VR sessions	Engagement will be assessed through attendance at scheduled VR sessions	4 weeks of VR
Adherence to VR	Adherence will be measured based on participants meeting the 12-session target.	4 weeks of VR
Percentage of participants that complete the entire study duration -VR	Retention will be evaluated through the percentage of participants who complete the entire study duration, targeting a benchmark of at least 8 of the 12 sessions.	4 weeks of VR
Number of participants with documentation of informed consent completion		Recruitment period (Approximately 18 months)
The Virtual Reality Neuroscience Questionnaire (VRNQ)	The modified scale for this project uses 10 questions that participants will answer about the VR experience, rated from 1 (extremely low or extremely difficult) to 7 (extremely high or extremely easy). The scores range from 10 to 70, with higher scores indicating greater experience.	4 weeks of VR
Changes in depression measured by Patient Health Questionnaire-9 (PHQ-9)	This is a 9-item self-report measure developed to assess the presence and severity of depression symptoms aligned with the diagnostic criteria for major depressive disorder (MDD). Each item on the PHQ-9 reflects a specific depression symptom experienced over the past two weeks, including anhedonia, mood disturbances, fatigue, and suicidal ideation. Participants rate items on a 4-point Likert scale ranging from 0 ("not at all") to 3 ("nearly every day"), resulting in a total score range of 0 to 27. Clinical severity classifications include minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27). A score of ≥10 is generally used as a cutoff for moderate depression, demonstrating optimal sensitivity and specificity.	Baseline, 4 weeks, 8 weeks
Changes in anxiety measured by the Generalized Anxiety Disorder-7 (GAD-7)	This is a self-administered 7-item screening tool specifically designed to assess the frequency and severity of symptoms characteristic of generalized anxiety disorder (GAD) over the preceding two weeks. Symptoms measured include nervousness, worry, restlessness, irritability, and fearfulness, which are rated by respondents using a 4-point Likert scale ranging from 0 ("not at all") to 3 ("nearly every day"). Scores range from 0 to 21, with severity categories typically classified as minimal anxiety (0-4), mild anxiety (5-9), moderate anxiety (10-14), and severe anxiety (≥15). A cutoff score of ≥10 is commonly used to identify clinically significant anxiety.	Baseline, 4 weeks, 8 weeks
Change on the Perceived stress scale (PSS-10)	This is a widely used psychological instrument for measuring the perception of stress. It comprises 10 items that assess how unpredictable, uncontrollable, and overloaded respondents find their lives. Each item is rated on a 5-point Likert scale ranging from "Never" (0) to "Very Often" (4). Items 4, 5, 7, and 8 are positively stated and are reverse scored. The total score ranges from 0 to 40, with higher scores indicating greater perceived stress. While there are no established cut-off scores, higher scores suggest higher levels of perceived stress.	Baseline, 4 weeks, 8 weeks
Change on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Positive Affect	This is a psychometrically robust, 15-item measure specifically developed to assess positive emotional experiences or affective states over the past seven days. This PROMIS instrument focuses on capturing positive psychological constructs such as feelings of happiness, contentment, enthusiasm, and engagement with life. Participants rate each item using a 5-point Likert scale from 1 ("Not at All") to 5 ("Very Much"), with higher scores indicating greater levels of positive affect.	Baseline, 4 weeks, 8 weeks
Change on the PROMIS Applied Cognition Short form v.1.0	This is a concise, validated 8-item measure designed to assess participants' perceived cognitive deficits, regardless of disease type. This PROMIS instrument focuses on participants' perceptions of their mental acuity, concentration, verbal and nonverbal memory, verbal fluency, and perceived changes in their cognitive functions. Participants rate each item on a 5-point Likert scale from 1 ("Not At All") to 5 ("Very Much"), with higher scores indicating greater cognitive dysfunction.	Baseline, 4 weeks, 8 weeks
Change on the Ruminative Responses Scale	This is a validated and reliable 10-item scale that measures a participant's way of coping with repetitive and self-reflective moods. This is a shortened version of the Response Style Questionnaire and has been shortened to focus more on reflection and brooding, as compared to general depression. Participants rate each item from 1 ("Almost Never") to 4 ("Almost Always"), with higher scores indicating a greater level of rumination.	Baseline, 4 weeks, 8 weeks
Change on the alcohol use disorders identification test (AUDIT)	This is a well-validated, standardized instrument developed by the World Health Organization for screening hazardous alcohol consumption, harmful drinking patterns, and potential alcohol dependence. This tool consists of 10 items assessing alcohol consumption frequency, quantity, binge drinking behaviors, dependence symptoms, and related negative consequences. Scores range from 0 to 40, with higher scores indicating greater alcohol use severity: scores of 8 or higher suggest hazardous drinking patterns, while scores of 20 or more indicate probable dependence.	Baseline, 4 weeks, 8 weeks
Hardware and software-related issues	The technical feasibility will be measured by tracking hardware and software-related issues, with acceptability ratings of ≥75%.	4 weeks of VR
Change on the Drug Abuse Screening Test-10 (DAST-10)	This is a brief, validated self-report measure designed to identify problematic use of substances other than alcohol. It consists of 10 items assessing drug use frequency, associated consequences, interpersonal difficulties, and impairment resulting from substance use behaviors. Total scores range from 0 to 10, with higher scores indicating a greater severity of drug-related problems: scores of 3-5 suggest moderate risk, and scores of 6 or higher indicate substantial drug abuse risk warranting further clinical evaluation.	Baseline, 4 weeks, 8 weeks
Qualitative interviews	Semi-structured qualitative interviews will be conducted individually with 10 randomly selected participants at 4 weeks to explore subjective experiences with the VR intervention. Each interview is anticipated to take approximately 30-40 minutes.	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)	Dropout rate will be calculated as the proportion of enrolled participants who do not complete the Week 8 assessment visit (or the final planned study assessment) for any reason. The numerator is the number of participants who withdraw, are lost to follow-up, are discontinued by the study team, or otherwise fail to complete the Week 8 assessment. The denominator is the total number of participants enrolled and consented at baseline. Dropout will also be summarized by randomized arm. Higher values indicate worse retention (higher attrition).	Baseline - 8 weeks
Reasons for dropouts will be summarized as count and percentaged by overall by arm	Drop-out reasons will be collected at the time of withdrawal, if possible, using a brief standardized exit reason will be coded into predefined categories and summarized as count and percentaged overall by arm [ VR- tolerability, time demands, other treatment factors, technology issues, safety concerns, cybersickness, lost to follow up, other] If multiple reasons are provided, the study team will identify a primary reason.	Baseline - 8 weeks

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Hala Darwish, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: January 29, 2026
• First Submitted That Met QC Criteria: February 13, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Virtual Reality; Surveys
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Alcoholism
• Other Study ID Numbers: HUM00283019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No