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

January 28, 2020 updated by: Cardiff and Vale University Health Board

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • South Glamorgan
      • Cardiff, South Glamorgan, United Kingdom, CF64 2XX
        • Cardiff and Vale University Health Board

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Course of Multi-Convergent Thearpy
Behavioral: Multi-Convergent Therapy
Cognitive Behavioural Therapy Relaxation Techniques Meditation Stress Management
Other Names:
  • Mindfulness Meditation
No Intervention: Waiting List for Multi-Convergent Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Quality of Life in Inflammatory Bowel Disease Questionnaire
Time Frame: Assessed at baseline and at 4 months, 8 months, and 1 year
Assessed at baseline and at 4 months, 8 months, and 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Irritable Bowel Syndrome Symptom Severity Score
Time Frame: Assessed at baseline and at 4 months, 8 months, and 1 year
Assessed at baseline and at 4 months, 8 months, and 1 year
Change in Levenstein Perceived Stress Score
Time Frame: 2 monthly intervals over 1 year
2 monthly intervals over 1 year
Change in Hospital Anxiety and Depression Score
Time Frame: 2 monthly intervals over 1 year
2 monthly intervals over 1 year
Abdominal Symptoms Global Improvement Score
Time Frame: 4 monthly intervals over 1 year
4 monthly intervals over 1 year
Relapse rate in inflammatory bowel disease
Time Frame: 1 year
1 year
Feasibility of Treatment
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardiff and Vale University Health Board

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

August 26, 2011

First Submitted That Met QC Criteria

August 30, 2011

First Posted (Estimate)

August 31, 2011

Study Record Updates

Last Update Posted (Actual)

January 30, 2020

Last Update Submitted That Met QC Criteria

January 28, 2020

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-CMC-4876

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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