Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-02-20 @ 11:25 AM
Study NCT ID:
NCT00861302
Status:
COMPLETED
Last Update Posted:
2012-06-19
First Post:
2009-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating a Chronic Pain Treatment Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-18', 'studyFirstSubmitDate': '2009-03-12', 'studyFirstSubmitQcDate': '2009-03-12', 'lastUpdatePostDateStruct': {'date': '2012-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brief Pain Inventory', 'timeFrame': 'baseline, post-treatment, 3- and 6-month follow-ups'}], 'secondaryOutcomes': [{'measure': 'Center for Epidemiologic Studies--Depression Scale', 'timeFrame': 'baseline, post-treatment, 3- and 6-month follow-ups'}, {'measure': 'Satisfaction with Life Scale', 'timeFrame': 'baseline, post-treatment, 3- and 6-month follow-ups'}, {'measure': 'McGill Pain Questionnaire', 'timeFrame': 'baseline, post-treatment, 3- and 6-month follow-ups'}, {'measure': 'Impact of Events Scale-Revised', 'timeFrame': 'baseline, post-treatment, 3- and 6-month follow-ups'}, {'measure': 'Positive Affect Negative Affect Scale-Expanded Version', 'timeFrame': 'baseline, post-treatment, 3- and 6-month follow-ups'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Musculoskeletal Pain']}, 'referencesModule': {'references': [{'pmid': '26800632', 'type': 'DERIVED', 'citation': 'Burger AJ, Lumley MA, Carty JN, Latsch DV, Thakur ER, Hyde-Nolan ME, Hijazi AM, Schubiner H. The effects of a novel psychological attribution and emotional awareness and expression therapy for chronic musculoskeletal pain: A preliminary, uncontrolled trial. J Psychosom Res. 2016 Feb;81:1-8. doi: 10.1016/j.jpsychores.2015.12.003. Epub 2015 Dec 11.'}]}, 'descriptionModule': {'briefSummary': 'This interventional study seeks to evaluate the overall outcomes of a novel, emotional awareness intervention for people with chronic musculoskeletal pain and determine which patients benefit the most from this intervention. The investigators also are evaluating the effects of brief emotional communication technique embedded in the pre-treatment assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults with chronic musculoskeletal pain, not accounted for by disease or tissue pathology, who are seeking or referred for this psychological treatment program\n\nExclusion Criteria:\n\n* Autoimmune diseases\n* Cancer pain\n* Illiterate\n* Cognitively impaired\n* Too medically ill'}, 'identificationModule': {'nctId': 'NCT00861302', 'briefTitle': 'Evaluating a Chronic Pain Treatment Program', 'organization': {'class': 'OTHER', 'fullName': 'Wayne State University'}, 'officialTitle': 'Evaluating Outcomes and Response Profiles of a Psychological Treatment for People With Chronic Pain', 'orgStudyIdInfo': {'id': 'WSU094808B3E'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': 'This is the only group in the study. It consists of patients with chronic musculoskeletal pain who are receiving the treatment program', 'interventionNames': ['Behavioral: Mind-body emotional awareness program']}], 'interventions': [{'name': 'Mind-body emotional awareness program', 'type': 'BEHAVIORAL', 'description': 'This intervention, developed and offered by Dr. Howard Schubiner of St. John Providence Health System, consists of a single individual session with him, followed by four, classroom group sessions. The intervention includes expressive writing, mindfulness, and other techniques designed to enhance awareness and acceptance of the emotional factors underlying the chronic pain problem.', 'armGroupLabels': ['Treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48075', 'city': 'Southfield', 'state': 'Michigan', 'country': 'United States', 'facility': 'St. John Providence Health System', 'geoPoint': {'lat': 42.47337, 'lon': -83.22187}}], 'overallOfficials': [{'name': 'Mark A Lumley, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wayne State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wayne State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Blue Cross Blue Shield of Michigan Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mark A. Lumley', 'investigatorAffiliation': 'Wayne State University'}}}}