A Trial of Multi-convergent Therapy for Functional Symptoms and Stress in Patients With Inflammatory Bowel Disease

Not Applicable

Completed

• Conditions: Inflammatory Bowel Disease

• Registration Number: NCT01426568
• Lead Sponsor: Cardiff and Vale University Health Board

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-08-26
• Study First Submitted QC: 2011-08-30
• Study First Posted: 2011-08-31
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2013-08
• Last Update Submitted: 2020-01-28
• Last Update Posted: 2020-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Quality of Life in Inflammatory Bowel Disease Questionnaire	Assessed at baseline and at 4 months, 8 months, and 1 year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Cardiff and Vale University Health Board; 🇬🇧 Cardiff, South Glamorgan, United Kingdom