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 sites24 target enrollmentJune 18, 2014

Overview

Phase: 未知
Intervention: Not specified
Conditions: Irritable Bowel Syndrome
Sponsor: Postdoc Programme of the Medical Faculty of the University of Heidelberg (Germany)
Enrollment: 24
Status: Completed
Last Updated: 8 years ago

Registry

who.int

Start Date

June 18, 2014

End Date

December 31, 2014

Last Updated

8 years ago

Study Type

Interventional

Sex

All

Sponsor

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

•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

•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