Bringing the Outdoors In: Virtual Nature Walks for Depression in Multiple Sclerosis (MS) Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Virtual Reality
DeviceParticipant 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.
Standard care
Other interventionParticipants 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.
Treatment groups
40 Participants
are divided into 3 treatment groupsGroup A: Virtual reality plus standard care (SC) then SC alone - randomized groupExperimental treatment 2 interventions
Group B: Standard care alone then Virtual reality plus SC- randomized groupExperimental treatment 2 interventions
Group C: Virtual Reality - non-randomized groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Changes to the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression short form 8b scores
This is an 8-item evaluating various aspects of depression, including negative mood, anhedonia, feelings of worthlessness, and cognitive impairments. Each item is rated on a 5-point Likert scale ranging from never (1) - always (5). Scores range from 8-40 with a higher score indicating greater symptom severity.
Time frame
Baseline, 9-10 weeks and 20-21 weeks2
Virtual Reality (VR) Sessions completed over 8 weeks
A benchmark of 70% will indicate adequate feasibility and acceptability.
Time frame
8-week VR intervention3
Qualitative feedback on the VR Neuroscience Questionnaire during the intervention (groups 1 and 3)
The modified scale for this project uses 10 questions that participants will answer about the VR experience, rated from 1 (extremely low or extremely difficult) to 7 (extremely high or extremely easy). The scores range from 10 to 70, with higher scores indicating greater experience. A benchmark of 70% indicates adequate feasibility and acceptability, with participant satisfaction ratings above 80%.
Time frame
1-8 weeks (during VR)4
Qualitative feedback with Semi-structured interviews for participants that received VR
Semi-structured interviews with 20 random participants (6-7 from each group) who received the VR treatment to capture participants' subjective experiences at the midpoint and end of the intervention. The interview questions will focus on emotional changes, engagement levels, and feedback on the intervention's implementation.
Time frame
Weeks 9-10, Weeks 20- 21Secondary outcomes
1
Change to the PROMIS Anxiety short form scores of the VR experience
This consists of eight items assessing various dimensions of anxiety, including feelings of fear, worry, hyperarousal, and somatic symptoms. Each item is rated on a 5-point Likert scale ranging from never (1) - always (5). Scores range from 8-40 with a higher score indicating greater anxiety.
Time frame
Baseline, 8 weeks (after VR)2
Change to the patient perceived stress scale (PSS-10)
It comprises 10 items that assess how unpredictable, uncontrollable, and overloaded respondents find their lives. Each item is rated on a 5-point Likert scale ranging from Never (0) to Very Often (4). The total score ranges from 0 to 40, with higher scores indicating greater perceived stress. While there are no established cut-off scores, higher scores suggest higher levels of perceived stress.
Time frame
Baseline, 8 weeks (after VR)3
Change in Sleep based on the Pittsburgh Sleep Quality Index (PSQI)
It comprises 19 items, generating seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each component is scored from 0 to 3, with higher scores indicating greater dysfunction. The component scores are summed to yield a global PSQI score ranging from 0 to 21. A global score greater than 5 suggests poor sleep quality.
Time frame
Baseline, 8 weeks (after VR)4
Change in the Insomnia Severity Index (ISI)
This is a brief self-report tool that evaluates the nature, severity, and impact of insomnia. It consists of seven items, each rated on a 5-point Likert scale (0 = no problem to 4 = very severe problem), assessing areas such as difficulty falling asleep, staying asleep, satisfaction with sleep, and the extent to which sleep problems interfere with daily functioning. The total score ranges from 0 to 28, with higher scores indicating more severe insomnia. Interpretation of scores is as follows: 0-7 (no clinically significant insomnia), 8-14 (subthreshold insomnia), 15-21 (moderate insomnia), and 22-28 (severe insomnia).
Time frame
Baseline, 8 weeks (after VR)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Michigan
Lead sponsor
Apple Inc.
Collaborator
The International Organization of Multiple Sclerosis Nurses Inc
Collaborator
Source ClinicalTrials.gov