Use of the Stress Management and Resilience Training (SMART) Program in the Management of Irritable Bowel Syndrome: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Change in perceived stress score from baseline
研究概览
简要总结
This is a pilot study to determine the efficacy of the Stress Management and Resilience Training (SMART) program in improving gastrointestinal and psychological symptoms, health-related quality of life, and satisfaction of care in patients with irritable bowel syndrome (IBS). Half of the participants will be enrolled in the SMART program initially. The other half will be placed in a self-management stress reduction program where they will read a popular stress reduction book over 12 weeks. Then they will have access to participate in the online SMART program.
详细描述
Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder characterized by abdominal pain related to defecation and associated with changes in stool frequency and/or form. IBS is a stress sensitive disorder and its severity has been shown to be moderated by both acute and chronic stress. Furthermore, resilience, which is defined as the ability to positively adapt and thrive in the presence of stressors and adversity, has been shown to be lower in those with IBS and associated with more severe symptoms. Therapies aimed at stress reduction in IBS have been found to be effective in the management of IBS. To our knowledge, there are no reports in the literature of a therapy to target resilience in the IBS patient population.
The Stress Management and Resilience Training (SMART) program was developed by Dr. A. Sood at the Mayo clinic to reduce stress, decrease symptoms related to stress and enhance resiliency. This is accomplished by targeting human attention and interpretation of events, people and the world. Furthermore, methods to strengthen the skills of gratitude, compassion, acceptance, forgiveness and understanding of a higher meaning are taught. Previous studies have demonstrated that this program can improve stress, anxiety, resilience and quality of life of participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Those with a diagnosis of IBS based on the Rome IV diagnostic criteria (recurrent abdominal pain at least once per week in the last 3 months associated with 2 of the following: related to defecation, associated with a change in stool frequency, associated with a change in stool form. Symptoms must have started 6 months prior to presentation)
- •Between the ages of 18 and 70
- •English speaking
- •Are able to provide written, informed consent
- •At least moderate IBS symptoms (based on an IBS symptom severity scale score [IBS-SSS] of 175 or higher)
- •At least moderate levels of perceived stress (based on a perceived stress score of 14 or higher
- •If receiving pharmacologic therapy for IBS, they must be on a stable dose for 30 days prior to enrollment
排除标准
- •History of gastrointestinal disease including celiac disease, cirrhosis, gastrointestinal malignancy, inflammatory bowel disease
- •History of gastrointestinal surgery (except appendectomy and cholecystectomy or gallbladder removal >6 months ago)
- •Poorly controlled psychiatric disease such as severe depression (with or without suicidal ideation), severe anxiety, schizophrenia, dementia
- •Currently receiving, or have received in the last 6 months, other stress reduction therapies such as mindfulness based stress reduction, meditation
- •Excessive alcohol intake (up to 1 drink per day for females and 2 drinks per day for males)
- •Illicit substance use
- •High dose opiate use
- •Pregnancy
- •Non-English speaking
- •Inability to provide written informed consent
结局指标
主要结局
Change in perceived stress score from baseline
时间窗: Week 12 (end of the SMART program)
Validated questionnaire with 10 questions regarding respondents stress levels
次要结局
- Change in perceived stress score from baseline(Week 4)
- Change from baseline in adaptive resilience score(Week 4, week 12)
- Change from baseline in resilience score as measured by the Connor-Davidson Resilience Scale(Week 4, week 12)
- Change in patient satisfaction from baseline(Week 4, week 12)
- Change in gastrointestinal symptom related anxiety from baseline(Week 4, week 12)
- Change in anxiety symptoms from baseline(Week 4, week 12)
- Change in mindfulness scores from baseline(Week 4, week 12)
- IBS symptom severity responder rate(Week 4, week 12)
- IBS related quality of life responder rate(Week 4, week 12)
- Change from baseline in resilience scores as measured by the Brief Resilience scale(Week 4, week 12)
- Change in gratitude scores from baseline(Week 4, week 12)
- Change in somatic symptom severity from baseline(Week 4, week 12)
研究者
Lin Chang, MD
Co-Director, G. Oppenheimer Center for Neurobiology of Stress and Resilience, Vatche and Tamar Manoukian Division of Digestive Diseases
University of California, Los Angeles