The Well-being in IBS: Strengths and Happiness (WISH) Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Proportion of PP Sessions Completed by Participants
研究概览
简要总结
The purpose of this pilot study is to examine the feasibility, acceptability, and preliminary efficacy of a customized positive psychology (PP) intervention for patients with irritable bowel syndrome (IBS) compared to a wait list control group.
详细描述
Irritable bowel syndrome (IBS), a disorder of gut-brain interaction (DGBI; formerly known as functional gastrointestinal disorder) is characterized by abdominal pain and altered bowel habits, and conceptualized as resulting from complex interactions between biological, psychological, and social factors.
The treatment approach for IBS is multifaceted and focused on symptom reduction rather than cure. For mild or infrequent symptoms, lifestyle modification (e.g., diet and exercise), reassurance, and education about the disorder can at times be sufficient. For moderate to severe symptoms, a combination of pharmacotherapy and behavioral health interventions is often required. A growing body of evidence supports the use of behavioral health interventions to target the gut-brain axis in DGBI - aptly referred to as brain-gut behavior therapies (BGBT). Though highly effective, existing BGBT for IBS face important limitations including scalability and acceptability. There is also limited focus among existing BGBT on the promotion of positive psychological (PP) constructs (e.g., optimism), which are deficient in IBS, associated with fewer IBS symptoms, and associated with lower levels of distress in both clinical and non-clinical populations.
PP interventions have successfully been implemented in a variety of other chronic medical conditions to improve well-being, health-related quality of life, and health behavior engagement. PP interventions are highly acceptable and easily delivered remotely without extensive specialized training, which increases their scalability and reach.
As such, the investigators plan to do the following in this project:
- Examine the feasibility and acceptability of a 9-week, telephone-delivered PP intervention adapted to the IBS population
- Explore the impact of the PP intervention on psychological, behavioral, and health-related outcomes, compared to a wait list control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •IBS Diagnosis: Adult patients with an IBS diagnosis documented by the patient's primary care or GI clinician and meeting standardized ROME IV diagnostic criteria.
- •Language and communication: English fluency and access to a telephone.
排除标准
- •Severe psychiatric illness: Current manic episode, psychosis, or active substance use disorder diagnosed via the Mini International Neuropsychiatric Interview (MINI).
- •Cognitive impairment: Assessed using a six-item cognitive screen developed for research.
结局指标
主要结局
Proportion of PP Sessions Completed by Participants
时间窗: 9 weeks
Measured by proportion of PP sessions completed by participants in each group.
次要结局
- Ease of PP Exercises(Weeks 1-9)
- Utility of PP exercises(Weeks 1-9)
- Change in Positive Affect(Change in score from Baseline to 9 weeks)
- Change in Optimism(Change in score from Baseline to 9 weeks)
- Change in Depression(Change in score from Baseline to 9 weeks)
- Change in Anxiety(Change in score from Baseline to 9 weeks)
- Change in Gastrointestinal (GI) symptom specific anxiety(Change in score from Baseline to 9 weeks)
- Change in Ability to Bounce Back from Stress(Change in score from Baseline to 9 weeks)
- Change in Ability to Cope with Stress and Adversity(Change in score from Baseline to 9 weeks)
- Change in Response to Pain(Change in score from Baseline to 9 weeks)
- Change in Perceived Stress(Change in score from Baseline to 9 weeks)
- Change in IBS Health-related Quality of Life(Change in score from Baseline to 9 weeks)
- Change in IBS Symptom Severity(Change in score from Baseline to 9 weeks)
- Change in Self-Reported Physical Activity(Change in score from Baseline to 9 weeks)
- Change in Adherence to a Physician-Recommended Diet(Change in score from Baseline to 9 weeks)
- Change in Adherence to Medications(Change in score from Baseline to 9 weeks)
- Change in Avoidant and Restrictive Food Intake Disorder Symptoms(Change in score from Baseline to 9 weeks)
- Change in Eating Behaviors(Change in score from Baseline to 9 weeks)
- Change in IBS diagnostic criteria(Change in score from Baseline to 9 weeks)
- Immediate Impact of the Exercises: Change in Optimism Ratings(Weeks 1-9)
- Immediate Impact of the Exercises: Change in Happiness Ratings(Weeks 1-9)
研究者
Elizabeth N. Madva, M.D.
Principal Investigator
Massachusetts General Hospital