Bringing the Outdoors In: Virtual Nature Walks for Depression in Multiple Sclerosis (MS) Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Changes to the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression short form 8b scores
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Virtual reality plus standard care (SC) then SC alone - randomized group
Participants in this group are maintained on antidepressants or psychotherapy and will receive VR nature sessions alongside participants' current depression treatments. This will be followed by a 1-week washout period, after which they crossover to standard care only.
干预措施: Virtual Reality (Device)
Virtual reality plus standard care (SC) then SC alone - randomized group
Participants in this group are maintained on antidepressants or psychotherapy and will receive VR nature sessions alongside participants' current depression treatments. This will be followed by a 1-week washout period, after which they crossover to standard care only.
干预措施: Standard care (Other)
Standard care alone then Virtual reality plus SC- randomized group
Participants in this group are maintained on standard depression treatments and will continue standard care for eight weeks. This will be followed by a 1-week washout period and crossover to VR plus Standard Care.
干预措施: Virtual Reality (Device)
Standard care alone then Virtual reality plus SC- randomized group
Participants in this group are maintained on standard depression treatments and will continue standard care for eight weeks. This will be followed by a 1-week washout period and crossover to VR plus Standard Care.
干预措施: Standard care (Other)
Virtual Reality - non-randomized group
Participants that are not receiving any treatment for depression will receive VR nature sessions for 8 weeks without depression treatments for eight weeks followed by 1 week washout and 8 weeks of no VR.
干预措施: Virtual Reality (Device)
结局指标
主要结局
Changes to the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression short form 8b scores
时间窗: Baseline, 9-10 weeks and 20-21 weeks
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.
Virtual Reality (VR) Sessions completed over 8 weeks
时间窗: 8-week VR intervention
A benchmark of 70% will indicate adequate feasibility and acceptability.
Qualitative feedback on the VR Neuroscience Questionnaire during the intervention (groups 1 and 3)
时间窗: 1-8 weeks (during VR)
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%.
Qualitative feedback with Semi-structured interviews for participants that received VR
时间窗: Weeks 9-10, Weeks 20- 21
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.
Enrollment rate
时间窗: Recruitment period (2 years)
Feasibility will be assessed via enrollment. Recruitment will be quantified by enrollment rates relative to the number of eligibility screenings.
Retention rates
时间窗: Baseline - 21 weeks
Feasibility: Retention will be evaluated through the percentage of participants who complete the entire study duration, targeting a benchmark of at least 70%.
Adherence to VR intervention
时间窗: 8-week VR intervention
Feasibility: Adherence to 5-15-minute sessions 3 times per week over 8 weeks
Dropout reasons
时间窗: Baseline - 21 weeks
Hardware/software issues
时间窗: During 8 weeks of VR
次要结局
- Change to the PROMIS Anxiety short form scores of the VR experience(Baseline, 8 weeks (after VR))
- 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))
- Change in the Insomnia Severity Index (ISI)(Baseline, 8 weeks (after VR))
- Change in the PROMIS Fatigue(Baseline, 8 weeks (after VR))
研究者
Hala Darwish
Associate Professor of Nursing
University of Michigan