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

Primary Purpose

Inflammatory Bowel Disease

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Multi-Convergent Therapy
Sponsored by
Cardiff and Vale University Health Board
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Bowel Disease focused on measuring Multi-Convergent Therapy, Mindfulness Meditation, Functional Abdominal Symptoms, Irritable Bowel Syndrome, Inflammatory Bowel Disease, Psychological Stress

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cardiff and Vale University Health Board

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Course of Multi-Convergent Thearpy

Waiting List for Multi-Convergent Therapy

Arm Description

Outcomes

Primary Outcome Measures

Change in Quality of Life in Inflammatory Bowel Disease Questionnaire

Secondary Outcome Measures

Change in Irritable Bowel Syndrome Symptom Severity Score
Change in Levenstein Perceived Stress Score
Change in Hospital Anxiety and Depression Score
Abdominal Symptoms Global Improvement Score
Relapse rate in inflammatory bowel disease
Feasibility of Treatment

Full Information

First Posted
August 26, 2011
Last Updated
January 28, 2020
Sponsor
Cardiff and Vale University Health Board
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1. Study Identification

Unique Protocol Identification Number
NCT01426568
Brief Title
A Trial of Multi-convergent Therapy for Functional Symptoms and Stress in Patients With Inflammatory Bowel Disease
Official Title
A Randomised Controlled Trial of Multi-convergent Therapy for Inflammatory Bowel Disease Patients With Functional Abdominal Symptoms and High Perceived Stress
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cardiff and Vale University Health Board

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease
Keywords
Multi-Convergent Therapy, Mindfulness Meditation, Functional Abdominal Symptoms, Irritable Bowel Syndrome, Inflammatory Bowel Disease, Psychological Stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Course of Multi-Convergent Thearpy
Arm Type
Active Comparator
Arm Title
Waiting List for Multi-Convergent Therapy
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Multi-Convergent Therapy
Other Intervention Name(s)
Mindfulness Meditation
Intervention Description
Cognitive Behavioural Therapy Relaxation Techniques Meditation Stress Management
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Change in Irritable Bowel Syndrome Symptom Severity Score
Time Frame
Assessed at baseline and at 4 months, 8 months, and 1 year
Title
Change in Levenstein Perceived Stress Score
Time Frame
2 monthly intervals over 1 year
Title
Change in Hospital Anxiety and Depression Score
Time Frame
2 monthly intervals over 1 year
Title
Abdominal Symptoms Global Improvement Score
Time Frame
4 monthly intervals over 1 year
Title
Relapse rate in inflammatory bowel disease
Time Frame
1 year
Title
Feasibility of Treatment
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Cardiff and Vale University Health Board
City
Cardiff
State/Province
South Glamorgan
ZIP/Postal Code
CF64 2XX
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24529603
Citation
Berrill JW, Sadlier M, Hood K, Green JT. Mindfulness-based therapy for inflammatory bowel disease patients with functional abdominal symptoms or high perceived stress levels. J Crohns Colitis. 2014 Sep;8(9):945-55. doi: 10.1016/j.crohns.2014.01.018. Epub 2014 Feb 13.
Results Reference
derived

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

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