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

Inflammatory Bowel Disease Clinical Trial

Official title:

A Randomised Controlled Trial of Multi-convergent Therapy for Inflammatory Bowel Disease Patients With Functional Abdominal Symptoms and High Perceived Stress

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01426568
• Other study ID #: 10-CMC-4876
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Est. completion date: May 2013

Study information

• Verified date: August 2013
• Source: Cardiff and Vale University Health Board
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Behavioral:
• Multi-Convergent Therapy
Cognitive Behavioural Therapy Relaxation Techniques Meditation Stress Management

Locations

Country	Name	City	State
United Kingdom	Cardiff and Vale University Health Board	Cardiff	South Glamorgan

Sponsors (1)

Lead Sponsor	Collaborator
Cardiff and Vale University Health Board

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Quality of Life in Inflammatory Bowel Disease Questionnaire		Assessed at baseline and at 4 months, 8 months, and 1 year
Secondary	Change in Irritable Bowel Syndrome Symptom Severity Score		Assessed at baseline and at 4 months, 8 months, and 1 year
Secondary	Change in Levenstein Perceived Stress Score		2 monthly intervals over 1 year
Secondary	Change in Hospital Anxiety and Depression Score		2 monthly intervals over 1 year
Secondary	Abdominal Symptoms Global Improvement Score		4 monthly intervals over 1 year
Secondary	Relapse rate in inflammatory bowel disease		1 year
Secondary	Feasibility of Treatment		4 months