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

Study Overview
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Brief Summary
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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.

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

Conditions
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Inflammatory Bowel Disease

Intervention / Treatment
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* Behavioral: Multi-Convergent Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Course of Multi-Convergent Thearpy<br> | Behavioral: Multi-Convergent Therapy<br>* Cognitive Behavioural Therapy Relaxation Techniques Meditation Stress Management<br>* Other names: Mindfulness Meditation;|
| No Intervention: Waiting List for Multi-Convergent Therapy<br> | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multi-Convergent Therapy, Mindfulness Meditation, Functional Abdominal Symptoms, Irritable Bowel Syndrome, Inflammatory Bowel Disease, Psychological Stress