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

Overview

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.

Interventions

• 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
• 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.

Primary outcome measures

• 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]
• Virtual Reality (VR) Sessions completed over 8 weeks [Time frame: 8-week VR intervention]
• Qualitative feedback on the VR Neuroscience Questionnaire during the intervention (groups 1 and 3) [Time frame: 1-8 weeks (during VR)]
• Qualitative feedback with Semi-structured interviews for participants that received VR [Time frame: Weeks 9-10, Weeks 20- 21]
• Enrollment rate [Time frame: Recruitment period (2 years)]
• Retention rates [Time frame: Baseline - 21 weeks]
• Adherence to VR intervention [Time frame: 8-week VR intervention]
• Dropout reasons [Time frame: Baseline - 21 weeks]
• Hardware/software issues [Time frame: During 8 weeks of VR]

Secondary outcome measures (5)

• 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)]

Eligibility criteria

Inclusion criteria

• 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

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 (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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Michigan — Ann Arbor

Identifiers

NCT: NCT07392879 · HUM00267042

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗