NCT01426568已完成不适用
A Randomised Controlled Trial of Multi-convergent Therapy for Inflammatory Bowel Disease Patients With Functional Abdominal Symptoms and High Perceived Stress
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Change in Quality of Life in Inflammatory Bowel Disease Questionnaire
研究概览
简要总结
The purpose of this study is to determine whether multi-convergent therapy is helpful to patients with inflammatory bowel disease who have functional abdominal symptoms or high perceived levels of psychological stress.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Inflammatory Bowel Disease
- •Clinical Remission of inflammatory bowel disease as defined by an adapted disease activity index and a CRP <10
- •Age 18 to 65 years
- •Evidence of irritable bowel syndrome (Rome III criteria) or high perceived stress level (Levenstein perceived stress score > 0.44)
排除标准
- •Use of steroids within 1 month of entry to study
- •Initiation or change in dose of medication within 1 month of entry to the study
- •Presence of ileostomy or colostomy
- •Diagnosis of dementia or cognitive impairment
- •Current psychosis or substance misuse
- •Change in psychotropic medication in 3 months prior to entry to study
- •Previous psychological interventions
- •Pregnancy
研究组 & 干预措施
Course of Multi-Convergent Thearpy
Active Comparator
干预措施: Multi-Convergent Therapy (Behavioral)
Waiting List for Multi-Convergent Therapy
No Intervention
结局指标
主要结局
Change in Quality of Life in Inflammatory Bowel Disease Questionnaire
时间窗: Assessed at baseline and at 4 months, 8 months, and 1 year
次要结局
- Change in Irritable Bowel Syndrome Symptom Severity Score(Assessed at baseline and at 4 months, 8 months, and 1 year)
- Abdominal Symptoms Global Improvement Score(4 monthly intervals over 1 year)
- Change in Levenstein Perceived Stress Score(2 monthly intervals over 1 year)
- Feasibility of Treatment(4 months)
- Change in Hospital Anxiety and Depression Score(2 monthly intervals over 1 year)
- Relapse rate in inflammatory bowel disease(1 year)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
3 期
Multimodality Therapy for Palliative Resectable Hepatocellular Carcinoma With Intrahepatic Vessels InvasionHepatocellular CarcinomaNCT00501813Sun Yat-sen University160
Unknown
3 期
Phase III Trial to Evaluate the Efficacy and Safety of Gemigliptin 50mg qd Added to Ongoing Glimepiride as Fix-dose Combination in Patients With Type 2 DiabetesType 2 Diabetes MellitusNCT02089126LG Life Sciences230
Unknown
1 期
Multiple Treatments for Ebola Virus Disease (EVD)Ebola Virus DiseaseNCT02380625Clinical Research Management, Inc.150
终止
2 期
M7824 With cCRT in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC)Non-small Cell Lung CancerNCT03840902EMD Serono Research & Development Institute, Inc.153
已完成
不适用
Assess the Efficacy and Safety of Multi-target Therapy in Lupus NephritisLupus NephritisNCT00876616Zhi-Hong Liu, M.D.362