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

This study is enrolling participants by invitation only.
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 30, 2011
Last verified: August 2011
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Stress
U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Change in Levenstein Perceived Stress Score [ Time Frame: 2 monthly intervals over 1 year ] [ Designated as safety issue: No ]
  • Change in Hospital Anxiety and Depression Score [ Time Frame: 2 monthly intervals over 1 year ] [ Designated as safety issue: No ]
  • Abdominal Symptoms Global Improvement Score [ Time Frame: 4 monthly intervals over 1 year ] [ Designated as safety issue: No ]
  • Relapse rate in inflammatory bowel disease [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Feasibility of Treatment [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2011
Estimated Primary Completion Date: December 2012 (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
Genders Eligible for Study:   Both
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
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

No publications provided

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 30, 2011
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by 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:
Inflammatory Bowel Diseases
Intestinal Diseases
Stress, Psychological
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 22, 2013