Anxiety & Depression Association of America

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.	Device: Virtual Reality 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. Other: Standard care 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.
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.	Device: Virtual Reality 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. Other: Standard care 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.
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.	Device: Virtual Reality 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.

Recruiting Locations

More Details

Status: Recruiting
Sponsor: University of Michigan

Study Contact

Zee Petrie
734- 764- 5249
petrieli@umich.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.