The WISH Intervention for IBS: Feasibility, Preliminary Effects, and Candidate Gut-Brain Mechanisms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Proportion of Intervention Sessions Completed by Participants
研究概览
简要总结
The purpose of this study is to examine the feasibility, acceptability, preliminary effects, and candidate gut-brain mechanisms of an optimized positive psychology (PP) intervention for patients with irritable bowel syndrome (IBS), entitled "WISH," compared to an educational control intervention.
详细描述
Irritable bowel syndrome (IBS), a disorder of gut-brain interaction (DGBI; also known as functional gastrointestinal (GI) disorder) is characterized by abdominal pain and altered bowel habits, and conceptualized as resulting from complex interactions between biological, psychological, and social factors. Compared to healthy populations, individuals with IBS have reduced positive psychological well-being, which in turn has been associated with impaired physical health, greater depression and anxiety, and worse health-related quality of life. A growing body of evidence supports the use of behavioral health interventions, referred to as brain-gut behavior therapies (BGBTs), as part of a comprehensive treatment approach for IBS. There is a critical need for new BGBTs for IBS that are scalable, acceptable, and mechanistically targeted.
Positive psychology (PP) interventions have successfully been implemented in a variety of other chronic medical conditions to improve well-being, health-related quality of life, health behavior engagement, and health outcomes. PP interventions are typically highly acceptable and easily delivered remotely without extensive specialized training, which increases their scalability and reach. Aside from the investigator's preliminary proof-of-concept work, however, PP interventions have not been evaluated in IBS.
Accordingly, the purpose of this study is to examine the feasibility, acceptability, preliminary efficacy, and candidate gut-brain mechanisms of an optimized, 9-week, phone-delivered, PP intervention for patients with IBS, entitled "Well-being in IBS: Strengths and Happiness (WISH)," compared to a time-and attention-matched educational control intervention.
The primary aims of this randomized controlled trial (RCT) are to determine feasibility (at least 50% of participants completing at least 6/9 PP sessions) and acceptability (mean ease and utility ratings for each session of at least 7/10).
The exploratory aims of this RCT are to examine: (1) preliminary effects of the PP intervention in improving health-related (IBS symptom severity, health-related quality of life, and IBS diagnostic criteria), psychological (positive affect, optimism, resilience, self-efficacy, depression, anxiety, GI symptom-specific anxiety, response to pain, and perceived stress), and health behavior (physical activity, avoidant/restrictive eating) outcomes; and (2) candidate gut-brain mechanisms of the PP intervention including changes in autonomic function (as measured by heart-rate variability), interoception, stress-mediated gene expression, and immune system activity.
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
- Double (Participant, 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 meeting standardized Rome IV diagnostic criteria.
- •Language and communication: English fluency and access to a phone.
排除标准
- •Presence of inflammatory bowel disease or other structural/biochemical primary gastrointestinal illness that better explains IBS-like symptoms: As reported by the patient, their physician, and/or documented in the medical record.
- •Severe psychiatric illness: Current manic episode, psychosis, or active substance use disorder diagnosed via the Mini International Neuropsychiatric Interview (MINI) or Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND).
- •Cognitive impairment: Assessed using a six-item cognitive screen developed for research.
- •Presence of atrial fibrillation or a cardiac pacemaker, or daily use of beta blocking medication: As reported by the patient and/or documented in the medical record.
- •Plans to start or participate in another new behavioral health intervention or psychotherapy during the study period.
研究组 & 干预措施
Positive Psychology (PP) Intervention
Participants will complete an adapted, optimized, phone-based, 9-week positive psychology (PP) intervention.
干预措施: Positive Psychology (PP) Intervention (Behavioral)
Educational Intervention
Participants will complete a 9-week, phone-based educational intervention that matches the PP intervention in terms of both time and attention.
干预措施: Educational Intervention (Behavioral)
结局指标
主要结局
Proportion of Intervention Sessions Completed by Participants
时间窗: Post-intervention at 9 weeks
Feasibility will be measured by the proportion of intervention sessions completed by participants. The intervention will be considered feasible if at least 50% of participants complete at least 6/9 sessions.
Ease of Weekly Exercises
时间窗: Weekly during intervention (weeks 1-8) and post-intervention (week 9)
Participants will provide ratings of ease after each weekly exercise, measured on a 10-point Likert scale (0=very difficult, 10=very easy).
Utility of Weekly Exercises
时间窗: Weekly during intervention (weeks 1-8) and post-intervention (week 9)
Participants will provide ratings of utility after each weekly exercise, measured on a 10-point Likert scale (0=not at all helpful; 10=very helpful).
次要结局
- Treatment Expectancy(Week 1 (after first phone session))
- Immediate Impact of the Exercises: Change in Optimism Ratings(Weeks 1-9)
- Immediate Impact of the Exercises: Change in Happiness Ratings(Weeks 1-9)
- Immediate Impact of the Exercises: Change in IBS Knowledge Ratings(Weeks 1-9)
- Change in IBS Symptom Severity(At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21))
- Change in IBS Health-Related Quality of Life(At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21))
- Change in Positive Affect(At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21))
- Change in Dispositional Optimism(At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21))
- Change in State Optimism(At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21))
- Change in Resilience(At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21))
- Change in Self-Efficacy(At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21))
- Change in Depression(At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21))
- Change in Anxiety(At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21))
- Change in Gastrointestinal (GI) Symptom-Specific Anxiety(At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21))
- Change in Response to Pain(At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21))
- Change in Perceived Stress(At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21))
- Change in Self-Reported Physical Activity(At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21))
- Change in Avoidant and Restrictive Eating(At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21))
- Change in Interoception(At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21))
- Change in Autonomic Function(At baseline (week 1) and post-intervention (week 9))
- Change in Stress-Mediated Gene Expression(At baseline (week 1) and post-intervention (week 9))
- Treatment Credibility(Week 1 (after first phone session))
- Change in Blood Inflammatory Biomarker Levels(At baseline (week 1) and post-intervention (week 9))
- Immediate Impact of the Exercises: Change in Optimism Ratings(Weeks 1-9)
- Immediate Impact of the Exercises: Change in Happiness Ratings(Weeks 1-9)
- Immediate Impact of the Exercises: Change in IBS Knowledge Ratings(Weeks 1-9)
- Change in IBS Symptom Severity(At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21))
- Change in IBS Health-Related Quality of Life(At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21))
- Change in Rome IV Diagnostic Criteria for IBS(At prescreening (prior to baseline), post-intervention (week 9), and 3-months post-intervention (week 21))
- Change in Positive Affect(At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21))
- Change in Dispositional Optimism(At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21))
- Change in State Optimism(At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21))
- Change in Resilience(At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21))
- Change in Self-Efficacy(At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21))
- Change in Depression(At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21))
- Change in Anxiety(At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21))
- Change in Gastrointestinal (GI) Symptom-Specific Anxiety(At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21))
- Change in Response to Pain(At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21))
- Change in Perceived Stress(At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21))
- Change in Self-Reported Physical Activity(At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21))
- Change in Avoidant and Restrictive Eating(At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21))
- Change in Interoception(At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21))
- Change in Autonomic Function(At baseline (week 1) and post-intervention (week 9))
- Change in Stress-Mediated Gene Expression(At baseline (week 1) and post-intervention (week 9))
- Change in Serum Cytokine Levels(At baseline (week 1) and post-intervention (week 9))
- Treatment Credibility(Week 1 (after first phone session))
- Treatment Expectancy(Week 1 (after first phone session))
研究者
Elizabeth N. Madva, M.D.
Assistant Professor of Psychiatry
Massachusetts General Hospital