Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2025-12-30 @ 11:37 PM
Study NCT ID:
NCT01240395
Status:
COMPLETED
Last Update Posted:
2014-02-19
First Post:
2010-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mindfulness-based Cognitive Therapy for Individuals With Multiple Chemical Sensitivity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018777', 'term': 'Multiple Chemical Sensitivity'}], 'ancestors': [{'id': 'D018876', 'term': 'Environmental Illness'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D007280', 'term': 'Disorders of Environmental Origin'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000099025', 'term': 'Mindfulness-Based Cognitive Therapy'}], 'ancestors': [{'id': 'D064866', 'term': 'Mindfulness'}, {'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': 'ESTIMATED', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-17', 'studyFirstSubmitDate': '2010-11-10', 'studyFirstSubmitQcDate': '2010-11-12', 'lastUpdatePostDateStruct': {'date': '2014-02-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Quick Environmental Exposure and Sensitivity Inventory (QEESI)', 'timeFrame': '8 weeks, 1 year follow up', 'description': 'QEESI is a screening instrument for MCS.'}], 'secondaryOutcomes': [{'measure': 'The brief illness perception questionnaire (Brief IPQ)', 'timeFrame': '8 weeks, 1 year follow up'}, {'measure': 'The Five Facet Mindfulness Questionnaire (FFMQ)', 'timeFrame': '8 weeks, 1 year follow up'}, {'measure': 'Symptom Check List 92 (SCL-92)', 'timeFrame': '8 weeks, 1 year follow up'}, {'measure': 'The Perceived Stress Scale (PSS-10)', 'timeFrame': '8 weeks, 1 year follow up'}, {'measure': 'The World Health Organization Quality of Life (WHOQOL-BREF)', 'timeFrame': '8 weeks, 1 year follow-up'}, {'measure': 'Rumination-reflection questionnaire (RRQ)', 'timeFrame': '8 weeks, 1 year follow-up'}, {'measure': 'Self compassion scale short form', 'timeFrame': '8 weeks, 1 year follow up'}, {'measure': 'The role work functioning index', 'timeFrame': '8 weeks, 1 year follow-up'}]}, 'conditionsModule': {'keywords': ['Multiple chemical sensitivities', 'MCS', 'Mindfulness-based cognitive therapy', 'MBCT'], 'conditions': ['Multiple Chemical Sensitivity']}, 'referencesModule': {'references': [{'pmid': '23016822', 'type': 'DERIVED', 'citation': 'Hauge CR, Bonde PJ, Rasmussen A, Skovbjerg S. Mindfulness-based cognitive therapy for multiple chemical sensitivity: a study protocol for a randomized controlled trial. Trials. 2012 Sep 27;13:179. doi: 10.1186/1745-6215-13-179.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the effect of mindfulness-based cognitive therapy (MBCT) on physical symptoms attributed to chemical exposures, psychological distress, illness worry, quality of life, and illness perceptions in patients suffering from multiple chemical sensitivity (MCS). Furthermore, a secondary objective is to evaluate whether a possible symptom reduction is mediated by an increased level of mindfulness.\n\nThe primary hypothesis is that the self-reported severity of MCS symptoms and the degree to which chemical exposures causes symptoms and the impact on daily life will be significantly improved in the MBCT treatment group as compared to the control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Fulfil Lacour's criteria for Multiple Chemical Sensitivity\n* Sign a written informed consent form\n\nExclusion Criteria:\n\n* A psychotic or bipolar disorder\n* An acute psychiatric disorder requiring other treatment\n* Suicidal ideations\n* Current alcohol or drug abuse\n* Previously engaged in a mindfulness programme"}, 'identificationModule': {'nctId': 'NCT01240395', 'briefTitle': 'Mindfulness-based Cognitive Therapy for Individuals With Multiple Chemical Sensitivity', 'organization': {'class': 'OTHER', 'fullName': 'The Danish Research Centre for Chemical Sensitivities'}, 'orgStudyIdInfo': {'id': 'MBCT-MCS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MBCT intervention', 'interventionNames': ['Behavioral: Mindfulness-based Cognitive Therapy (MBCT)']}, {'type': 'NO_INTERVENTION', 'label': 'Control group'}], 'interventions': [{'name': 'Mindfulness-based Cognitive Therapy (MBCT)', 'type': 'BEHAVIORAL', 'description': 'MBCT is partly based on the mindfulness-based stress reduction program (MBSR), developed by Jon Kabat-Zinn and colleagues, and partly on cognitive therapy for depression, the latter influence particularly expressed through the aspect of "decentering", meaning not accepting the content of thoughts as facts and not identifying with the thought. The MBCT programme in this study includes 2½ hours of training once a week for 9 weeks. In addition, participants are encouraged to practice at home for up to 45 min per day, 6 days a week during the entire course.', 'armGroupLabels': ['MBCT intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2820', 'city': 'Ledreborg Allé 40, 2.', 'state': 'Gentofte', 'country': 'Denmark', 'facility': 'The Danish Research Centre for Chemical Sensitivities'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Danish Research Centre for Chemical Sensitivities', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MSc psychology', 'investigatorFullName': 'Christian Riise Hauge', 'investigatorAffiliation': 'The Danish Research Centre for Chemical Sensitivities'}}}}