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

NCT ID: NCT01426568

Last Updated: 2020-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-05-31

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.

Detailed Description

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Conditions

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Inflammatory Bowel Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Course of Multi-Convergent Thearpy

Group Type ACTIVE_COMPARATOR

Multi-Convergent Therapy

Intervention Type BEHAVIORAL

Cognitive Behavioural Therapy Relaxation Techniques Meditation Stress Management

Waiting List for Multi-Convergent Therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Multi-Convergent Therapy

Cognitive Behavioural Therapy Relaxation Techniques Meditation Stress Management

Intervention Type BEHAVIORAL

Other Intervention Names

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Mindfulness Meditation

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cardiff and Vale University Health Board

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cardiff and Vale University Health Board

Cardiff, South Glamorgan, United Kingdom

Site Status

Countries

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United Kingdom

References

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Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.

Reference Type DERIVED
PMID: 40243391 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24529603 (View on PubMed)

Other Identifiers

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10-CMC-4876

Identifier Type: -

Identifier Source: org_study_id

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