National Center for Complementary & Alternative Medicine, The Role of Gut-Directed Hypnotherapy in Relapse Prevention for Ulcerative Colitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- feasibility
研究概览
简要总结
The UCRPT is a randomized controlled trial to determine if a type of hypnotherapy will maintain remission in patients affected by Ulcerative Colitis.
详细描述
The purpose of the study is to determine whether hypnotherapy can serve as an effective therapy for patients with Ulcerative Colitis (UC), a chronic, relapsing and remitting inflammatory bowel disease (IBD).
The goal of this study is to determine if mind-body therapy is an effective complementary therapy for IBD, meaning a therapy to be used in conjunction with your standard treatment provided by your gastroenterologist. Standard treatment for UC often includes a combination approach and may include medications such as mesalamine, corticosteroids or immunomodulators. Mind-body therapy or hypnosis has been used to reduce stress and subsequent disease activity in patients with gastrointestinal diseases including IBD and Irritable Bowel Syndrome. It has also been shown to improve immune function and reduce inflammation in other health conditions such as cancer and arthritis.
In this study, patients with inactive UC will be randomized to one of three groups. Two groups will undergo one of two mind-body therapies, which may include relaxation techniques or other techniques aimed at identifying the impact of UC on your psyche along with standard care for their UC. The other group will undergo 8 weeks of standard care without mind-body therapy. Clinical assessment measures will be repeated at 8 weeks, 12 weeks, 24 weeks and 52 weeks.
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
- 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
- •male and female patients between the ages of 18 and 70 of any ethnicity
- •endoscopy-confirmed (within the past 2 years) mild or moderately severe Ulcerative Colitis (at time of previous flare)
- •inactive disease at the time of recruitment:
- •Mayo score <2 with no subscale >1
- •no rectal bleeding
- •Physician Global Assessment Score (PGA) = 0
- •2 weeks of baseline daily symptom diaries that support criteria for inactive disease
- •documented disease flare within the past 1.5 years to enhance the opportunity to observe differences between groups in a 1-year trial .
- •no medication or a stable dose of maintenance medication (i.e. mesalamine or sulfasalazine) for at least one month prior to enrollment.
- •If taking maintenance medication: an increase in dose will be considered a relapse
- •If taking no medication: initiation of any medication will be considered a relapse
排除标准
- •active disease
- •daily rectal bleeding for past 7 days
- •Mayo Score > 2, any subscale > 1
- •PGA score >0
- •history of severe or fulminant UC
- •most recent flare included > 6 bloody stools a day
- •history of of toxicity including fever, tachycardia, anemia or an elevated Erythrocyte sedimentation rate (ESR) ∙ history of continuous bleeding, blood transfusion requirement, abdominal tenderness and distension, and colonic dilation on abdominal plain films
- •other gastrointestinal conditions
- •Crohn's Disease (CD)
- •short-bowel syndrome
- •celiac sprue
- •irritable bowel syndrome (IBS)
- •renal or hepatic disease
- •positive stool exam (bacteria, ova, parasites)
- •C-difficile
- •history of colon resection
- •steroid-dependent, patients taking oral steroids within the past 30 days, topical steroids within the past week, quit smoking in the past 30 days given the known effects of smoking cessation on UC disease flare
- •contraindications for hypnotherapy
- •unresolved history of physical or sexual abuse
- •a current or past dissociative disorder (i.e. Borderline PD, PTSD)
- •history of psychosis (including mania)
- •history of psychiatric hospitalization, including for self-harm or SI/HI
- •current substance abuse
- •severe psychiatric disorder
- •patients who are resistant to hypnosis as a result of religious or moral beliefs or any other reason
研究组 & 干预措施
Hypnotherapy
干预措施: Hypnotherapy (Behavioral)
Standard care
干预措施: Standard care (Behavioral)
Mind Body Therapy
干预措施: Mind Body Therapy (Behavioral)
结局指标
主要结局
feasibility
时间窗: 52 weeks
次要结局
- Estimated effect sizes(52 weeks)
研究者
Laurie Keefer
Associate Professor
Northwestern University