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

University of Michigan

Status: Enrolling

Conditions: Depression; Progressive Multiple Sclerosis

Treatments: Other: Standard care; Device: Virtual Reality

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07392879

HUM00267042

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 3 patient groups

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

Experimental group

Description:

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.

Treatment:

Device: Virtual Reality

Other: Standard care

Standard care alone then Virtual reality plus SC- randomized group

Experimental group

Description:

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.

Treatment:

Device: Virtual Reality

Other: Standard care

Virtual Reality - non-randomized group

Experimental group

Description:

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.

Treatment:

Device: Virtual Reality