Cognitive behavioural therapy - irritable bowel syndrome feasibility study

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2014
INTERVENTION: Participants in each of the study conditions will have measures taken at baseline and at 12 and 26 weeks post randomisation. Participants will be randomly allocated to one of four treatment conditions as described below. 1. High‐intensity cognitive behavioural therapy consisting of 12 hours of weekly treatment sessions with a cognitive psychotherapist. Therapy will be delivered in accordance with the methods developed by Toner et al. (2000). 2. Low‐intensity cognitive behavioural therapy delivered by a registered nurse consisting of a 1‐hour initial assessment session and five 30‐minute sessions of therapy. Participants will work through six treatment modules supported by self‐help materials consisting of: psychoeducation, relaxation techniques, the cognitive model of stress, applying the cognitive model to IBS, avoidance and exposure, diet and IBS. The six treatment modules used within this arm of the study are an adapted version of the treatment protocol originally developed by Hunt et al. (2009) at the University of Pennsylvania, USA. 3. Self‐help. Participants will work through six modules of self‐help materials consisting of: psychoeducation, relaxation techniques, the cognitive model of stress, applying the cognitive model to IBS, avoidance and exposure, diet and IBS. The six treatment modules used within this arm of the study are an adapted version of the treatment protocol originally developed by Hunt et al. (2009) at the University of Pennsylvania, USA. Participants in this treatment condition will not receive therapist support. 4. Treatment as usual control. Participants in this treatment condition will receive the usual care of their hospital gastroenterologist and general practitioner as indicated by current best practice guidance. Hunt, M., Moshier, S. and Milonova, M. (2009) Brief cognitive‐behavioral internet therapy for irritable bowel syndrome. Behaviour Research and Therapy 47(9): pp. 797‐802. Toner, B., Segal, Z., Emmott, S. and Myran, D. (2 CONDITION: Irritable Bowel Syndrome ; Digestive System ; Irritable bowel syndrome PRIMARY OUTCOME: Gastrointestinal Symptom Rating Scale for IBS (IBS‐GSRS) measured at baseline, 12 weeks and 26 weeks post randomisation. SECONDARY OUTCOME: 1. Irritable Bowel Syndrome Quality of Life Instrument (IBS‐QOL); 2. Generalised Anxiety Disorder Assessment (GAD 7); 3. Patient Health Questionnaire (PHQ‐9); ; Measured at baseline, 12 weeks and 26 weeks post randomisation. INCLUSION CRITERIA: 1. Adult male and female patients aged 18 years or older at the time of enrolment 2. Documented medical diagnosis of IBS with symptom onset at least six months prior to recruitment (in order to fulfil Rome criteria at screening) 3. Able to read, write and speak the English language 4. Able to provide written informed consent 5. Patients with and without concomitant antidepressant use 6. Not currently taking part in other research studies 7. Able to commit to weekly treatment sessions within the intervention arms of the study
Epistemonikos ID: 53076ac14e0c03425f04207486aa92e292c068dc
First added on: Aug 22, 2024