ISRCTN02977330已完成未知

A feasibility study in a randomised controlled wait-group design to evaluate a specific group intervention to improve psycho-vegetative self-regulation in the treatment of refractory irritable bowel syndrome; concurrent diary study of interactions between symptoms, psychosocial variables, biomedical parameters, and treatment conditions

Postdoc Programme of the Medical Faculty of the University of Heidelberg (Germany)0 个研究点目标入组 24 人开始时间: 2014年6月18日最近更新: 2018年2月19日

适应症

试验速览

•1. Adult male and female patients aged 18 years or older at the time of enrolment
•2. At least one contact to the IBS clinic at Heidelberg University for making the diagnosis
•3. Documented medical diagnosis of IBS according to Rome III criteria
•4. IBS symptoms refractory to previous IBS therapies (IBS medication, antidepressants, or psychotherapies)
•4a. Without adequate relief (AR)
•4b.Subjective global assessment (SGA) at best moderately relieved on a 7-point Likert scale
•5. Entry criteria:
•5a.Abdominal Pain Intensity: Weekly average of worst abdominal pain in past 24 hours score of >3.0 on a 0 to 10 point scale and/ or
•5b. IBS-D (with diarrhea): Stool Consistency: At least 2 days per week with at least one stool that has a consistency of Type 6 or Type 7 on the Bristol Stool Scale (BSS) and/ or
•5c. IBS-C (with constipation): Stool Frequency <3 complete spontaneous bowel movements (CSBMs) per week
•5d. IBS-M (mixed): At least 25% of stools are hard or lumpy and at least 25% are loose (mushy) or watery
•5e. IBS-U (unsubtyped): Insufficient abnormality of stool consistency to meet criteria for IBS-D, IBS-C, or IBS-M.
•6. Able to read, write and speak the German language
•7. Written informed consent
•8. Residing within 45-min reachability from Heidelberg
•9. Set of problems suited for group intervention (e.g. patient is able to commit to weekly group sessions)

•1. Newly started psychotherapy or antidepressant medication (psychotherapies for at least three months or antidepressants for at least one month were allowed for admission to the study if IBS was refractory to these interventions)
•2. Evidence of alcohol or substance misuse
•3. Severe psychiatric co-morbidity (e.g. bipolar disorder, schizophrenia, dementia)
•4. Presence of suicidal ideation (current intent/ plans/ actions)
•5. Severe organic disease (operationalized by a Karnofsky index <70%)
•6. Inability to complete the questionnaires
•7. Ongoing litigation due to disability pension or compensation for personal suffering
•8. Patients with lactose intolerance and fructose malabsorption were not excluded if they had no adequate relief after an appropriate exclusion diet for more than 3 weeks

发起方

Postdoc Programme of the Medical Faculty of the University of Heidelberg (Germany)