Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-02-24 @ 2:31 PM
Study NCT ID:
NCT00861393
Status:
UNKNOWN
Last Update Posted:
2009-03-13
First Post:
2009-03-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Behavioural Therapy (CBT) For Improving Emotional Well Being in Spinal Cord Injuries (SCI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2010-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-03-12', 'studyFirstSubmitDate': '2009-03-12', 'studyFirstSubmitQcDate': '2009-03-12', 'lastUpdatePostDateStruct': {'date': '2009-03-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptom checklist -90-R (SCL-90-R) Depression Anxiety Stress Scales (DASS-21) Personality Assessment Inventory (PAI) PAI measure a broad range of psychological symptoms and personality characteristics.', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'The Ways of Coping Scale- Revised (WOC-R) Community Integration Questionnaire (CIQ) Satisfaction with Life Scale (SWLS) Life satisfaction Checklist (LiSat-11) Stage of change Scales (SOC)', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Spinal Cord Injuries']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine whether or not a brief psychological treatment called cognitive behaviour therapy will help people who have suffered a spinal cord injury to cope better with their current circumstances.', 'detailedDescription': 'The goal of the current proposed research project is to investigate the potential efficacy of a group cognitive behavioural therapy (CBT) intervention aimed at improving emotional well-being, specifically mood, adjustment and quality of life (QOL), after Spinal Cord Injury(SCI). The intervention will be adapted to meet the unique needs of patients suffering from an SCI. The study objectives are:\n\n(1) to evaluate the impact of a brief CBT intervention aimed at decreasing emotional distress and improving quality of life; (2) to evaluate the sustainability of CBT therapeutic gains over time; (3) to conduct sub group analyses in order to better determine why some patients may improve post CBT, while others may not.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* between ages 18-65\n* diagnosed with spinal cord injury\n* currently endorsing significant distress as measured\n* able to provide informed consent\n* if taking psychoactive meds, on a stable dosage\n* are not currently enrolled in any other psychological treatment program\n* speak basic english with no diagnosis of communication disorder\n\nExclusion Criteria:\n\n* they endorse current suicidal ideation\n* have a Neurodegenerative disorder such as Multiple Sclerosis'}, 'identificationModule': {'nctId': 'NCT00861393', 'acronym': 'CBT', 'briefTitle': 'Cognitive Behavioural Therapy (CBT) For Improving Emotional Well Being in Spinal Cord Injuries (SCI)', 'organization': {'class': 'OTHER', 'fullName': 'Toronto Rehabilitation Institute'}, 'officialTitle': 'The Impact of a Brief Cognitive Behavior Therapy Intervention Aimed at Improving Emotional Well-Being and Quality of Life for Individuals With Spinal Cord Injuries', 'orgStudyIdInfo': {'id': 'CBT-08-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'CBT', 'interventionNames': ['Behavioral: CBT']}, {'type': 'OTHER', 'label': 'Waitlist', 'interventionNames': ['Behavioral: Waitlist CBT']}], 'interventions': [{'name': 'CBT', 'type': 'BEHAVIORAL', 'description': '12 Session CBT group', 'armGroupLabels': ['CBT']}, {'name': 'Waitlist CBT', 'type': 'BEHAVIORAL', 'description': 'Participants in the waitlist will receive CBT when first group has completed CBT and been tested.', 'armGroupLabels': ['Waitlist']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M4G 3V9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Rehabilitation Institute (Lyndhurst Center)', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Toronto Rehabilitation Institute', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Cheryl Bradbury, C.Psych', 'oldOrganization': 'Toronto Rehabilitation Institute'}}}}