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

INTERVENTION: 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 strategies are used: 1. Interactive psychoeducation to establish a biospychosocial symptom understanding; 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 of gut function via the autonomous nervous system and other stress circuits 3. Becoming familiar with the brain in the gut and using somatic markers as a help for orientation (?What do your gut feelings tell you??) 4. Improvement of stress management 5. Empowerment of healthy patterns of the patient?s functioning (resource activation) 6. Analysis of catastrophizing and avoidance behaviour, and developing directions of exposure and change The group intervention emphazises an interpersonal approach of psychodynamically based therapy, and in a disorder‐focused manner combines this with gut‐directed hypnotherapy and cognitive behavioural elements. In the beginning phase of the group all patients formulate concrete and realistic treatment goals that later on are evaluated to individually adjust treatment strategies. A core focus lies on the interactive group process. The group leaders pay attention to establishing a stable group setting and a supporting group cohesion. They give the basic structure following the manual to enable and support an interactive group process. Waiting‐control group: Enhanced medical care (EMC) based on the recommendations of our IBS clinic. After 3 months also the control patients get the group intervention. CONDITION: Irritable Bowel Syndrome ; Digestive System ; Irritable Bowel Syndrome PRIMARY OUTCOME: 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 OUTCOME: 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. 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% o