Psycho-vegetative self-regulation ? group intervention for refractory irritable bowel syndrome: RCT feasibility study with concurrent diary study

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome; Digestive System

• Registration Number: ISRCTN02977330
• Lead Sponsor: Postdoc Programme of the Medical Faculty of the University of Heidelberg (Germany)

Brief Summary

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29332637

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-18
• Study Completion: 2014-12-31
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

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)

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Portion of recruitable patients <br>2. Drop-out rates in intervention and control condition<br>3. Questionnaire completion rates <br>4. General evaluation of feasibility of randomisation and group intervention in speciality clinical care<br>5. Time series of IBS symptom severity, and of postulated psychosocial influences on the IBS symptoms: Somatization, catastrophizing, anxiety, depression, coping, stress.