Progressive Multiple SclerosisNCT07392879
Bringing the Outdoors In: Virtual Nature Walks for Depression in Multiple Sclerosis (MS) Patients
A study testing Virtual Reality in people with Progressive Multiple Sclerosis and Depression, run by University of Michigan at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Progressive Multiple Sclerosis, Depression
- What is being tested?
- Virtual Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2025to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Zee Petrie, 734- 764- 5249, petrieli@umich.edu
Hala Darwish, PhD
About this study
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
- Being tested
- Virtual Reality, Standard care
- Keywords
- Immersive virtual reality (VR)
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
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 careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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%.
Measured: 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.
Measured: 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.
Measured: 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%.
Measured: Baseline - 21 weeks
Adherence to VR intervention
Feasibility: Adherence to 5-15-minute sessions 3 times per week over 8 weeks
Measured: 8-week VR intervention
Dropout reasons
Measured: Baseline - 21 weeks
Hardware/software issues
Measured: During 8 weeks of VR
Secondary outcomes (5)
Change to the PROMIS Anxiety short form scores of the VR experience
This consists of eight items assessing various dimensions of anxiety, including feelings of fear, worry, hyperarousal, and somatic symptoms. 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 anxiety.
Measured: Baseline, 8 weeks (after VR)
Change to the patient perceived stress scale (PSS-10)
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).
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.
Measured: Baseline, 8 weeks (after VR)
Change in Sleep based on the Pittsburgh Sleep Quality Index (PSQI)
It comprises 19 items, generating seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each component is scored from 0 to 3, with higher scores indicating greater dysfunction. The component scores are summed to yield a global PSQI score ranging from 0 to 21. A global score greater than 5 suggests poor sleep quality.
Measured: Baseline, 8 weeks (after VR)
Change in the Insomnia Severity Index (ISI)
This is a brief self-report tool that evaluates the nature, severity, and impact of insomnia. It consists of seven items, each rated on a 5-point Likert scale (0 = no problem to 4 = very severe problem), assessing areas such as difficulty falling asleep, staying asleep, satisfaction with sleep, and the extent to which sleep problems interfere with daily functioning. The total score ranges from 0 to 28, with higher scores indicating more severe insomnia. Interpretation of scores is as follows: 0-7 (no clinically significant insomnia), 8-14 (subthreshold insomnia), 15-21 (moderate insomnia), and 22-28 (severe insomnia).
Measured: Baseline, 8 weeks (after VR)
Change in the PROMIS Fatigue
The PROMIS Fatigue Short Form 7a is a validated self-report instrument designed to assess fatigue over the past seven days. It consists of seven items that evaluate the frequency and severity of fatigue and its impact on daily activities. Each item is rated on a 5-point Likert scale ranging from "Never" (1) to "Always" (5). The raw scores are summed and converted into standardized T-scores, with a mean of 50 and a standard deviation of 10, based on the U.S. general population. Higher T-scores indicate greater fatigue severity. A change of 3 to 5 T-score points is generally considered clinically meaningful.
Measured: Baseline, 8 weeks (after VR)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start15 Dec 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Apple Inc., The International Organization of Multiple Sclerosis Nurses Inc
- Responsible party
- Principal investigator, Hala Darwish, University of Michigan
- Investigators
- Hala Darwish, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07392879
- Sponsor's protocol ID
- HUM00267042
- Status last verified
- Feb 2026
- First submitted
- 29 Jan 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bringing the Outdoors In: Virtual Nature Walks for Depression in Multiple Sclerosis (MS) Patients
- ClinicalTrials.gov ID
- NCT07392879
- Acronym / sponsor ID
- HUM00267042
- Conditions
- Progressive Multiple Sclerosis, Depression
- Keywords
- Immersive virtual reality (VR)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Apple Inc., The International Organization of Multiple Sclerosis Nurses Inc
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Virtual reality plus standard care (SC) then SC alone - randomized group | Experimental | Device: Virtual Reality, Other: Standard careParticipants 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. |
| Standard care alone then Virtual reality plus SC- randomized group | Experimental | Device: Virtual Reality, Other: Standard careParticipants 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. |
| Virtual Reality - non-randomized group | Experimental | Device: Virtual RealityParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual RealityParticipant 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. | Device | 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 careParticipants 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. | Other | Standard care alone then Virtual reality plus SC- randomized group, Virtual reality plus standard care (SC) then SC alone - randomized group |
Primary outcome
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
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.
Virtual Reality (VR) Sessions completed over 8 weeks
Time frame: 8-week VR intervention
A benchmark of 70% will indicate adequate feasibility and acceptability.
Qualitative feedback on the VR Neuroscience Questionnaire during the intervention (groups 1 and 3)
Time frame: 1-8 weeks (during VR)
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%.
Qualitative feedback with Semi-structured interviews for participants that received VR
Time frame: Weeks 9-10, Weeks 20- 21
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.
Enrollment rate
Time frame: Recruitment period (2 years)
Feasibility will be assessed via enrollment. Recruitment will be quantified by enrollment rates relative to the number of eligibility screenings.
Retention rates
Time frame: Baseline - 21 weeks
Feasibility: Retention will be evaluated through the percentage of participants who complete the entire study duration, targeting a benchmark of at least 70%.
Adherence to VR intervention
Time frame: 8-week VR intervention
Feasibility: Adherence to 5-15-minute sessions 3 times per week over 8 weeks
Dropout reasons
Time frame: Baseline - 21 weeks
Hardware/software issues
Time frame: During 8 weeks of VR
5 secondary outcomes
Change to the PROMIS Anxiety short form scores of the VR experience
Time frame: Baseline, 8 weeks (after VR)
Change to the patient perceived stress scale (PSS-10)
Time frame: Baseline, 8 weeks (after VR)
Change in Sleep based on the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, 8 weeks (after VR)
Change in the Insomnia Severity Index (ISI)
Time frame: Baseline, 8 weeks (after VR)
Change in the PROMIS Fatigue
Time frame: Baseline, 8 weeks (after VR)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hala Darwish, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality in people with Progressive Multiple Sclerosis and Depression, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zee Petrie (734- 764- 5249, petrieli@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.