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

RecruitingNot a drug-phase studyProgressive MSNCT07392879

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Virtual Reality
  • Standard care

What it measured

Main measures

  • Changes to the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression short form 8b scores

    Baseline, 9-10 weeks and 20-21 weeks

    Thinking and memoryMood and sleepQuality of life (reported by participants)
  • Virtual Reality (VR) Sessions completed over 8 weeks

    8-week VR intervention

    Feasibility
  • Qualitative feedback on the VR Neuroscience Questionnaire during the intervention (groups 1 and 3)

    1-8 weeks (during VR)

    Quality of life (reported by participants)Feasibility
  • Qualitative feedback with Semi-structured interviews for participants that received VR

    Weeks 9-10, Weeks 20- 21

  • Enrollment rate

    Recruitment period (2 years)

    Feasibility
  • Retention rates

    Baseline - 21 weeks

    Feasibility
  • Adherence to VR intervention

    8-week VR intervention

    Quality of life (reported by participants)Feasibility
  • Dropout reasons

    Baseline - 21 weeks

  • Hardware/software issues

    During 8 weeks of VR

Other measures (5)

  • Change to the PROMIS Anxiety short form scores of the VR experience

    Baseline, 8 weeks (after VR)

    Mood and sleep
  • Change to the patient perceived stress scale (PSS-10)

    Baseline, 8 weeks (after VR)

  • Change in Sleep based on the Pittsburgh Sleep Quality Index (PSQI)

    Baseline, 8 weeks (after VR)

    Myelin repairMood and sleep
  • Change in the Insomnia Severity Index (ISI)

    Baseline, 8 weeks (after VR)

    Mood and sleepQuality of life (reported by participants)
  • Change in the PROMIS Fatigue

    Baseline, 8 weeks (after VR)

    Fatigue

Who could take part

Progressive MS · 18 and over

Show the full 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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.

Loading reviews and guidelines…

History

    1. Started

      Dec 2025

    2. Main results due

      Apr 2027

    3. Finished

      Apr 2027

    Assembled by software from public sources.