No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
University of Michigan · Other
Who this trial is looking for
This trial is looking for people with progressive multiple sclerosis who experience depression. Participants will use virtual reality nature experiences at home as a supplement to their current depression treatment.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with progressive multiple sclerosis.
I have a depression score above 55.
I can provide consent and participate in virtual reality sessions.
I am currently receiving antidepressant or psychotherapy treatments.
You may not be able to join if
I have severe cognitive impairments or visual deficits that affect my VR use.
I am currently in another clinical trial for depression.
I have severe psychiatric conditions that may need hospitalization.
I have active substance or alcohol abuse issues.
I have another neurological or autoimmune disease.
I require vision correction that is not mild.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 syste…
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.
Trial Locations
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Status
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 V…
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.
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