Irritable Bowel Syndrome Digestive System Irritable Bowel Syndrome
Conditions
Interventions
Intervention group: 12 weekly IBS specific outpatient group sessions. The main aim of the group intervention is to improve the patients? psycho-vegetative self-regulation. The following intervention s
the main focus are brain-gut interactions
2. Gut-directed hypnotherapy following the Manchester protocol (Gonsalkorale 2006) for regulating the brain-gut interactions, i.e. control and normalization o
Sponsors
Postdoc Programme of the Medical Faculty of the University of Heidelberg (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Portion of recruitable patients 2. Drop-out rates in intervention and control condition 3. Questionnaire completion rates 4. General evaluation of feasibility of randomisation and group intervention in speciality clinical care 5. Time series of IBS symptom severity, and of postulated psychosocial influences on the IBS symptoms: Somatization, catastrophizing, anxiety, depression, coping, stress. | — |
Secondary
| Measure | Time frame |
|---|---|
| IBS physical symptom experience: 1. Irritable bowel symptom severity scale (IBS-SSS) 2. Bristol stool scale (BSS) Psychosocial factors: 1. Patient Health Questionnaire: somatic symptom severity (PHQ-15), depressive symptom scale (PHQ-9), generalised anxiety (GAD-7) 2. Illness anxiety (WI-7) 3. Perceived Stress Questionnaire PSQ-D (subscale ?demands?) 4. Coping Strategies Questionnaire (CSQ) 5. Short Scale for Measuring General Self-efficacy Beliefs (Allgemeine Selbstwirksamkeit Kurzskala, ASKU) 6. Functional Digestive Diseases Quality of Life Questionnaire (FDDQOL) (subscale ?daily activities?) 7. Experience of Close Relationships-Revised, German Version (ECR-RD12) 8. Evaluation of social systems (EVOS) Group process: 1. Group questionnaire, German version (GQ-D) Biomedical markers: 1. Stress circuits: 1a. HPA axis: ACTH, Cortisol 1b.Epigenetic programming of stress responses: Methylation of Cytosin-phosphatidyl-Guanin (CpG) islands within the promoter region of the neuron-specific glucocorticoid receptor gene NR3C1, and of the corticotrophin releasing factor (CRF) gene 2. Serotonergic system: Serotonin; Typing of functional SNPs (Single Nucleotide Polymorphism) in HTR3- and HTR4-genes, and in the serotonin transporter (SERT) gene SLC6A4 at baseline 3. Inflammatory processes: Calprotectin Patient-Reported Outcomes (PRO): 1. Adequate relief (AR) 2. Subjective global assessment (SGA) measured on a 7-point Likert scale Measures are assessed at baseline, 3 months and 6 months post randomisation. | — |
Countries
Germany
Outcome results
None listed