Bringing the Outdoors In: Virtual Nature Walks for Depression in Multiple Sclerosis (MS) Patients

NCT07392879 | Recruiting

• 1 other identifier: HUM00267042
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Immersive virtual reality (VR)

Outcome Measures

Primary Outcomes (9)

• Changes to the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression short form 8b scores

  This is an 8-item evaluating various aspects of depression, including negative mood, anhedonia, feelings of worthlessness, and cognitive impairments. Each item is rated on a 5-point Likert scale ranging from never (1) - always (5). Scores range from 8-40 with a higher score indicating greater symptom severity.

  Baseline, 9-10 weeks and 20-21 weeks

• Virtual Reality (VR) Sessions completed over 8 weeks

  A benchmark of 70% will indicate adequate feasibility and acceptability.

  8-week VR intervention

• Qualitative feedback on the VR Neuroscience Questionnaire during the intervention (groups 1 and 3)

  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. A benchmark of 70% indicates adequate feasibility and acceptability, with participant satisfaction ratings above 80%.

  1-8 weeks (during VR)

• Qualitative feedback with Semi-structured interviews for participants that received VR

  Semi-structured interviews with 20 random participants (6-7 from each group) who received the VR treatment to capture participants' subjective experiences at the midpoint and end of the intervention. The interview questions will focus on emotional changes, engagement levels, and feedback on the intervention's implementation.

  Weeks 9-10, Weeks 20- 21

• Enrollment rate

  Feasibility will be assessed via enrollment. Recruitment will be quantified by enrollment rates relative to the number of eligibility screenings.

  Recruitment period (2 years)

• Retention rates

  Feasibility: Retention will be evaluated through the percentage of participants who complete the entire study duration, targeting a benchmark of at least 70%.

  Baseline - 21 weeks

• Adherence to VR intervention

  Feasibility: Adherence to 5-15-minute sessions 3 times per week over 8 weeks

  8-week VR intervention

• Dropout reasons

  Baseline - 21 weeks

• Hardware/software issues

  During 8 weeks of VR

Secondary Outcomes (5)

• Change to the PROMIS Anxiety short form scores of the VR experience

  Baseline, 8 weeks (after VR)

• Change to the patient perceived stress scale (PSS-10)

  Baseline, 8 weeks (after VR)

• Change in Sleep based on the Pittsburgh Sleep Quality Index (PSQI)

  Baseline, 8 weeks (after VR)

• Change in the Insomnia Severity Index (ISI)

  Baseline, 8 weeks (after VR)

• Change in the PROMIS Fatigue

  Baseline, 8 weeks (after VR)

Study Arms (3)

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

EXPERIMENTAL

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.

Device: Virtual Reality; Other: Standard care

Standard care alone then Virtual reality plus SC- randomized group

EXPERIMENTAL

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.

Device: Virtual Reality; Other: Standard care

Virtual Reality - non-randomized group

EXPERIMENTAL

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.

Device: Virtual Reality

Interventions

Virtual Reality DEVICE

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 alone then Virtual reality plus SC- randomized group; Virtual Reality - non-randomized group; Virtual reality plus standard care (SC) then SC alone - randomized group

Standard care OTHER

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.

Standard care alone then Virtual reality plus SC- randomized group; Virtual reality plus standard care (SC) then SC alone - randomized group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead
• Apple Inc.: collaborator
• The International Organization of Multiple Sclerosis Nurses Inc: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive; Depression

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Hala Darwish, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zee Petrie

CONTACT

734- 764- 5249; petrieli@umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Nursing

Model Details: There are 3 groups (2 groups that take standard care (SC) treatment for depression will be randomized) that participants are assigned to: 1) VR plus SC therapy followed by washout and SC only; 2) SC for 8 weeks washout then VR plus SC. The third group will be VR only (not on any treatment for depression and not randomized).

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 6, 2026
• Study Start: December 15, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)