NCT01426568CompletedNot Applicable
A Randomised Controlled Trial of Multi-convergent Therapy for Inflammatory Bowel Disease Patients With Functional Abdominal Symptoms and High Perceived Stress
Cardiff and Vale University Health Board2 sites in 1 country66 target enrollmentStarted: January 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 66
- Locations
- 2
- Primary Endpoint
- Change in Quality of Life in Inflammatory Bowel Disease Questionnaire
Study Overview
Brief Summary
The purpose of this study is to determine whether multi-convergent therapy is helpful to patients with inflammatory bowel disease who have functional abdominal symptoms or high perceived levels of psychological stress.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of Inflammatory Bowel Disease
- •Clinical Remission of inflammatory bowel disease as defined by an adapted disease activity index and a CRP <10
- •Age 18 to 65 years
- •Evidence of irritable bowel syndrome (Rome III criteria) or high perceived stress level (Levenstein perceived stress score > 0.44)
Exclusion Criteria
- •Use of steroids within 1 month of entry to study
- •Initiation or change in dose of medication within 1 month of entry to the study
- •Presence of ileostomy or colostomy
- •Diagnosis of dementia or cognitive impairment
- •Current psychosis or substance misuse
- •Change in psychotropic medication in 3 months prior to entry to study
- •Previous psychological interventions
- •Pregnancy
Outcomes
Primary Outcomes
Change in Quality of Life in Inflammatory Bowel Disease Questionnaire
Time Frame: Assessed at baseline and at 4 months, 8 months, and 1 year
Secondary Outcomes
- Change in Irritable Bowel Syndrome Symptom Severity Score(Assessed at baseline and at 4 months, 8 months, and 1 year)
- Abdominal Symptoms Global Improvement Score(4 monthly intervals over 1 year)
- Change in Levenstein Perceived Stress Score(2 monthly intervals over 1 year)
- Feasibility of Treatment(4 months)
- Change in Hospital Anxiety and Depression Score(2 monthly intervals over 1 year)
- Relapse rate in inflammatory bowel disease(1 year)
Investigators
Study Sites (2)
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