Bringing the Outdoors In: Virtual Nature Walks for Depression in Multiple Sclerosis (MS) Patients
Purpose
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 advanced technology, the Apple Vision Pro, which offers enhanced resolution, immersion, and usability compared to earlier VR systems. The study hypothesis include: - The integration of VR nature-based experiences with standard care will be feasible, and acceptable, and will result in greater reductions in depressive 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 of VR-only interventions.
Conditions
- Progressive Multiple Sclerosis
- Depression
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Confirmed diagnosis of progressive 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
Exclusion Criteria
- 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 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Intervention 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).
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Virtual reality plus standard care (SC) then SC alone - randomized group |
Participants in this group are maintained on antidepressant or psychotherapy and will receive VR nature sessions alongside participants current depression treatments. This will be followed by a washout period of 1 week and crossover to standard care only. |
|
|
Experimental Standard care alone then Virtual reality plus SC- randomized group |
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. |
|
|
Experimental Virtual Reality - non-randomized group |
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. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- University of Michigan
