ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01426568
Recruitment Status : Completed
First Posted : August 31, 2011
Last Update Posted : August 28, 2013
Sponsor:
Information provided by (Responsible Party):
James Berrill, 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.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Disease Behavioral: Multi-Convergent Therapy Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial of Multi-convergent Therapy for Inflammatory Bowel Disease Patients With Functional Abdominal Symptoms and High Perceived Stress
Study Start Date : January 2011
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Arm Intervention/treatment
Active Comparator: Course of Multi-Convergent Thearpy Behavioral: Multi-Convergent Therapy
Cognitive Behavioural Therapy Relaxation Techniques Meditation Stress Management
Other Name: Mindfulness Meditation
No Intervention: Waiting List for Multi-Convergent Therapy



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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01426568


Locations
United Kingdom
Cardiff and Vale University Health Board
Cardiff, South Glamorgan, United Kingdom, CF64 2XX
Sponsors and Collaborators
Cardiff and Vale University Health Board

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: James Berrill, Doctor, Cardiff and Vale University Health Board
ClinicalTrials.gov Identifier: NCT01426568     History of Changes
Other Study ID Numbers: 10-CMC-4876
First Posted: August 31, 2011    Key Record Dates
Last Update Posted: August 28, 2013
Last Verified: August 2013

Keywords provided by James Berrill, Cardiff and Vale University Health Board:
Multi-Convergent Therapy
Mindfulness Meditation
Functional Abdominal Symptoms
Irritable Bowel Syndrome
Inflammatory Bowel Disease
Psychological Stress

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis