Assessing the Effectiveness of a Stress Reduction Intervention in Inflammatory Bowel Disease (IBD): a Prospective Randomized Controlled Trial (RCT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Perceived stress
研究概览
简要总结
The investigators have designed a guided, online, tri-component, stress reduction intervention for participants with inflammatory bowel diseases.
详细描述
In a randomized controlled trial, the investigators assessed the impact of an online, 3-month stress reduction intervention (yoga, breathwork, and meditation). The primary outcome was the change in Cohen's Perceived Stress Scale (PSS) between the control and intervention arms. The following secondary outcomes were also assessed: anxiety, depression, IBD disease activity (e.g., changes in CRP, fecal calprotectin, medication, hospitalization, or surgery), serum inflammatory markers, serum and salivary markers of stress, stress-resilience, and health- related quality of life. Participant satisfaction and adherence to the intervention were also evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Sealed envelopes
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years)
- •with IBD in remission (UC - partial Mayo <2 and fecal calprotectin <250 μg/g; CD regular HBI <5 or CRP <8)
- •on stable therapy for the past 3 months
- •the last flare <24 months prior to enrollment
- •PSS-10 score ≥ 7 at time of screening
- •Inclusion Criteria (Substudy):
- •Adults (≥18 years)
- •on stable therapy for the past 3 months.
排除标准
- •(RCT or Substudy):
- •Major medical co-morbidity
- •Steroid use in past 3 months
- •Clostridium difficile infection in the last 3 months
- •Unstable dose of psychiatric medications for the last 3 months
- •Inability to provide informed written consent
- •Severe psychiatric disorders (HADS scores >10 or suicidal ideation)
研究组 & 干预措施
Stress Reduction Intervention
Participants will receive the standard of care for IBD and training and access to an online stress reduction intervention.
干预措施: Stress Reduction Intervention (Other)
Control
Participants will receive the standard of care for IBD.
结局指标
主要结局
Perceived stress
时间窗: 3 months
Between group changes in the stress index from baseline to end of study using the Cohen's Perceived Stress Scale (PSS)-10 item. Summed scores range from 0-40 where lower scores are associated with less perceived stress compared to higher scores.
次要结局
- Mental health(3 months)
- Health-related quality of life(3 months)
- Markers of inflammation and stress(3 months)
- IBD levels of activity(3 months)