NCT01426568

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 31, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

January 30, 2020

Status Verified

August 1, 2013

Enrollment Period

2.3 years

First QC Date

August 26, 2011

Last Update Submit

January 28, 2020

Conditions

Inflammatory Bowel Disease

Keywords

Multi-Convergent TherapyMindfulness MeditationFunctional Abdominal SymptomsIrritable Bowel SyndromeInflammatory Bowel DiseasePsychological Stress

Outcome Measures

Primary Outcomes (1)

  • Change in Quality of Life in Inflammatory Bowel Disease Questionnaire

    Assessed at baseline and at 4 months, 8 months, and 1 year

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Course of Multi-Convergent Thearpy

ACTIVE COMPARATOR
Behavioral: Multi-Convergent Therapy

Waiting List for Multi-Convergent Therapy

NO INTERVENTION

Interventions

Multi-Convergent TherapyBEHAVIORAL

Cognitive Behavioural Therapy Relaxation Techniques Meditation Stress Management

Also known as: Mindfulness Meditation
Course of Multi-Convergent Thearpy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiff and Vale University Health Board

Cardiff, South Glamorgan, CF64 2XX, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 40243391DERIVED

  • 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.

    PMID: 24529603DERIVED

MeSH Terms

Conditions

Inflammatory Bowel DiseasesIrritable Bowel SyndromeStress, Psychological

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColonic Diseases, FunctionalColonic DiseasesBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2011

First Posted

August 31, 2011

Study Start

January 1, 2011

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

January 30, 2020

Record last verified: 2013-08

Locations

GB(1)