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 Board1 site in 1 country66 target enrollmentJanuary 2011

ConditionsInflammatory Bowel Disease

Overview

Phase: N/A
Intervention: Not specified
Conditions: Inflammatory Bowel Disease
Sponsor: Cardiff and Vale University Health Board
Enrollment: 66
Locations: 1
Primary Endpoint: Change in Quality of Life in Inflammatory Bowel Disease Questionnaire
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

January 2011

End Date

May 2013

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Cardiff and Vale University Health Board

Responsible Party

Sponsor

Eligibility Criteria

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)