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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
James Berrill, Cardiff and Vale University Health Board
ClinicalTrials.gov Identifier:
NCT01426568
First received: August 26, 2011
Last updated: August 27, 2013
Last verified: August 2013
  Purpose
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 Intervention Phase
Inflammatory Bowel Disease Behavioral: Multi-Convergent Therapy Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by James Berrill, Cardiff and Vale University Health Board:

Primary Outcome Measures:
  • 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:
  • Change in Irritable Bowel Syndrome Symptom Severity Score [ Time Frame: 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 ]
  • Change in Hospital Anxiety and Depression Score [ Time Frame: 2 monthly intervals over 1 year ]
  • Abdominal Symptoms Global Improvement Score [ Time Frame: 4 monthly intervals over 1 year ]
  • Relapse rate in inflammatory bowel disease [ Time Frame: 1 year ]
  • Feasibility of Treatment [ Time Frame: 4 months ]

Enrollment: 66
Study Start Date: January 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: August 26, 2011
Last Updated: August 27, 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

ClinicalTrials.gov processed this record on June 23, 2017