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Completed

NCT Number: NCT01426568

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

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.

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Key information

Conditions

Inflammatory Bowel Disease Behavior Behavioral Symptoms Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Irritable Bowel Syndrome Stress, Psychological

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiff and Vale University Health Board

Cardiff, South Glamorgan, CF64 2XX, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multi-Convergent Therapy

Behavioral

Cognitive Behavioural Therapy Relaxation Techniques Meditation Stress Management

Other names: Mindfulness Meditation

Primary outcomes

  1. 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 outcomes

  1. Change in Irritable Bowel Syndrome Symptom Severity Score

    Time frame: Assessed at baseline and at 4 months, 8 months, and 1 year

  2. Change in Levenstein Perceived Stress Score

    Time frame: 2 monthly intervals over 1 year

  3. Change in Hospital Anxiety and Depression Score

    Time frame: 2 monthly intervals over 1 year

  4. Abdominal Symptoms Global Improvement Score

    Time frame: 4 monthly intervals over 1 year

  5. Relapse rate in inflammatory bowel disease

    Time frame: 1 year

  6. Feasibility of Treatment

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Cardiff and Vale University Health Board

Other Gov

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 31, 2011
Registry last updated
Jan 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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