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

Обзор

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.

Вмешательства

• Устройство 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
• Другое 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.

Первичные конечные точки

• Changes to the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression short form 8b scores [Срок оценки: Baseline, 9-10 weeks and 20-21 weeks]
• Virtual Reality (VR) Sessions completed over 8 weeks [Срок оценки: 8-week VR intervention]
• Qualitative feedback on the VR Neuroscience Questionnaire during the intervention (groups 1 and 3) [Срок оценки: 1-8 weeks (during VR)]
• Qualitative feedback with Semi-structured interviews for participants that received VR [Срок оценки: Weeks 9-10, Weeks 20- 21]
• Enrollment rate [Срок оценки: Recruitment period (2 years)]
• Retention rates [Срок оценки: Baseline - 21 weeks]
• Adherence to VR intervention [Срок оценки: 8-week VR intervention]
• Dropout reasons [Срок оценки: Baseline - 21 weeks]
• Hardware/software issues [Срок оценки: During 8 weeks of VR]

Вторичные конечные точки (5)

• Change to the PROMIS Anxiety short form scores of the VR experience [Срок оценки: Baseline, 8 weeks (after VR)]
• Change to the patient perceived stress scale (PSS-10) [Срок оценки: Baseline, 8 weeks (after VR)]
• Change in Sleep based on the Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Baseline, 8 weeks (after VR)]
• Change in the Insomnia Severity Index (ISI) [Срок оценки: Baseline, 8 weeks (after VR)]
• Change in the PROMIS Fatigue [Срок оценки: Baseline, 8 weeks (after VR)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Michigan — Ann Arbor

Идентификаторы

NCT: NCT07392879 · HUM00267042

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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