Stress Management for Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- IBS symptom severity scale (IBS-SSS)
研究概览
简要总结
The primary goal of this study is to test the efficacy of emotional awareness and expression training (EAET), a novel emotional processing intervention that the investigators have developed, for people with IBS. In this randomized, controlled trial, the investigators will compare EAET to a standard intervention that teaches the conceptually opposite approach-relaxation training (RT)-and test how both of these interventions compare to a wait-list control condition. The investigators hypothesize that individuals in the EAET group will demonstrate greater improvement in their IBS symptom severity, psychological functioning, quality of life, and health care utilization at 4 and 12-week follow-up time points, compared to individuals in the wait-list control group. It is also expected that both of the active interventions (EAET and RT) will be more efficacious than the wait-list control condition.
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
- 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
- •To be eligible to participate, individuals must meet the Rome III criteria for IBS. That is, they must report that they have had:
- •recurrent abdominal pain or discomfort, or
- •a change in stool frequency or form,
- •at least three days per month, in the last three months, and
- •that they have been given this diagnosis by a physician. They must also report having pain and discomfort of at least two days per week at time of screening.
排除标准
- •Individuals who report having post-infectious IBS,
- •organic gastrointestinal diseases (e.g., inflammatory bowel disease), immunodeficiency,
- •a current psychotic disorder,
- •drug or alcohol dependence within the past two years, and
- •those who are unable to communicate in English will be excluded.
结局指标
主要结局
IBS symptom severity scale (IBS-SSS)
时间窗: Change from baseline symptom severity at 1 month and 3 months
次要结局
- Impact of Events Scale - Revised (IES-R)(Change from baseline impact of events at 1 month and 3 months)
- Toronto Alexithymia Scale -20 (TAS-20)(Change from baseline alexithymia at 1 month and 3 months)
- Bristol Stool Form Scale (BSFS)(Change from baseline stool form at 1 month and 3 months)
- Positive and Negative Affect Scale (PANAS)(Change from baseline positive affect and negative affect at 1 month and 3 months)
- Health care Utilization Scale(Change in health care utilization from baseline to 1-month and 3-month follow-ups)
- Brief Symptom Inventory(Change in psychological symptoms from baseline to 1-month and 3-month follow-ups)
- Experiences in Close Relationships Questionnaire(Change in attachment from baseline to 1-month and3-month follow-ups)
- General Social Constraints Scale(Change in social constraints from baseline to 1-month and 3-month follow-ups)
- McGill Pain Questionnaire, Short Form (SF-MPQ-2)(Change from baseline pain at 1 month and 3 months)
- Irritable Bowel Syndrome, Quality of Life (IBS-QOL)(Change from baseline quality of life at 1 month and 3 months)
- Rathus Assertiveness Schedule (RAS)(Change from baseline assertiveness at 1 month and 3 months)
- Ambivalence over Emotional Expression Scale (AEQ)(Change from baseline ambivalence over emotional expression at 1 month and 3 months)
- Clinical Global Impressions (CGI) Improvement Scale - IBS version(Change from baseline IBS symptoms at 1 month and 3 months)
- Communicating Thoughts and Feelings Questionnaire(Change from baseline ability to communicate thoughts and feelings at 1 month and 3 months)
- Medication use(Change in medication use from baseline to 1-month and 3-month follow-ups)
- IBS self-efficacy questionnaire(Change from baseline self-efficacy at 1 month and 3 months)
- Emotional Approach Coping Scale (EAC)(Change from baseline emotional approach coping at 1 month and 3 months)
- Early Trauma Inventory Self-Report Short Form(Change in Trauma reports from baseline to 1-month and 3-month follow-ups)
研究者
Mark A. Lumley
Professor
Wayne State University