Virtual Reality for Depression in Multiple Sclerosis

Overseen By Zee Petrie

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must be taking: SSRIs, SNRIs, Psychotherapy

Disqualifiers: Severe cognitive impairments, Severe psychiatric conditions, Other neurological diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Hala Darwish, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for individuals with progressive multiple sclerosis (MS) who are experiencing depression. Participants should be able to use the Apple Vision Pro VR system at home and must currently receive standard care for MS.

Inclusion Criteria

My MS is getting worse, as confirmed by a neurologist.

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

Exclusion Criteria

I do not have any neurological or autoimmune diseases.

Participants that require vision correction, unless that vision correction is mild (± 1), or the participant has prescription contact lenses.

Severe cognitive impairments or visual deficits that may interfere with VR use, including contraindications like agoraphobia, claustrophobia, or motion sickness

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Virtual Reality Intervention

Participants receive VR nature sessions for 8 weeks

8 weeks

At-home sessions 3 times per week

Washout Period

A 1-week washout period where no VR sessions are conducted

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Midpoint and end of intervention assessments

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Nature Walks

Trial Overview

The study tests if adding virtual reality nature walks to regular treatment helps reduce depression in MS patients more than standard care alone. It uses a high-quality VR device, the Apple Vision Pro, and measures changes in mood, stress, sleep quality, and fatigue.

How Is the Trial Designed?

Group I: Virtual reality plus standard care (SC) then SC alone - randomized group Experimental Treatment 2 Interventions

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.

Group II: Virtual Reality - non-randomized group Experimental Treatment 1 Intervention

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.

Group III: Standard care alone then Virtual reality plus SC- randomized group Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Apple Inc.

Industry Sponsor

Trials

24

Recruited

1,792,000+

The International Organization of Multiple Sclerosis Nurses Inc

Collaborator