Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-01-01 @ 5:00 PM
Study NCT ID:
NCT01426568
Status:
COMPLETED
Last Update Posted:
2020-01-30
First Post:
2011-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of Multi-convergent Therapy for Functional Symptoms and Stress in Patients With Inflammatory Bowel Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}, {'id': 'D013315', 'term': 'Stress, Psychological'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064866', 'term': 'Mindfulness'}], 'ancestors': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-28', 'studyFirstSubmitDate': '2011-08-26', 'studyFirstSubmitQcDate': '2011-08-30', 'lastUpdatePostDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Quality of Life in Inflammatory Bowel Disease Questionnaire', 'timeFrame': 'Assessed at baseline and at 4 months, 8 months, and 1 year'}], 'secondaryOutcomes': [{'measure': 'Change in Irritable Bowel Syndrome Symptom Severity Score', 'timeFrame': 'Assessed at baseline and at 4 months, 8 months, and 1 year'}, {'measure': 'Change in Levenstein Perceived Stress Score', 'timeFrame': '2 monthly intervals over 1 year'}, {'measure': 'Change in Hospital Anxiety and Depression Score', 'timeFrame': '2 monthly intervals over 1 year'}, {'measure': 'Abdominal Symptoms Global Improvement Score', 'timeFrame': '4 monthly intervals over 1 year'}, {'measure': 'Relapse rate in inflammatory bowel disease', 'timeFrame': '1 year'}, {'measure': 'Feasibility of Treatment', 'timeFrame': '4 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Multi-Convergent Therapy', 'Mindfulness Meditation', 'Functional Abdominal Symptoms', 'Irritable Bowel Syndrome', 'Inflammatory Bowel Disease', 'Psychological Stress'], 'conditions': ['Inflammatory Bowel Disease']}, 'referencesModule': {'references': [{'pmid': '40243391', 'type': 'DERIVED', 'citation': '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': '24529603', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Inflammatory Bowel Disease\n* Clinical Remission of inflammatory bowel disease as defined by an adapted disease activity index and a CRP \\<10\n* Age 18 to 65 years\n* Evidence of irritable bowel syndrome (Rome III criteria) or high perceived stress level (Levenstein perceived stress score \\> 0.44)\n\nExclusion Criteria:\n\n* Use of steroids within 1 month of entry to study\n* Initiation or change in dose of medication within 1 month of entry to the study\n* Presence of ileostomy or colostomy\n* Diagnosis of dementia or cognitive impairment\n* Current psychosis or substance misuse\n* Change in psychotropic medication in 3 months prior to entry to study\n* Previous psychological interventions\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT01426568', 'briefTitle': 'A Trial of Multi-convergent Therapy for Functional Symptoms and Stress in Patients With Inflammatory Bowel Disease', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Cardiff and Vale University Health Board'}, 'officialTitle': 'A Randomised Controlled Trial of Multi-convergent Therapy for Inflammatory Bowel Disease Patients With Functional Abdominal Symptoms and High Perceived Stress', 'orgStudyIdInfo': {'id': '10-CMC-4876'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Course of Multi-Convergent Thearpy', 'interventionNames': ['Behavioral: Multi-Convergent Therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Waiting List for Multi-Convergent Therapy'}], 'interventions': [{'name': 'Multi-Convergent Therapy', 'type': 'BEHAVIORAL', 'otherNames': ['Mindfulness Meditation'], 'description': 'Cognitive Behavioural Therapy Relaxation Techniques Meditation Stress Management', 'armGroupLabels': ['Course of Multi-Convergent Thearpy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CF64 2XX', 'city': 'Cardiff', 'state': 'South Glamorgan', 'country': 'United Kingdom', 'facility': 'Cardiff and Vale University Health Board', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardiff and Vale University Health Board', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}