Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2026-01-13 @ 10:49 AM
Study NCT ID:
NCT00495261
Status:
COMPLETED
Last Update Posted:
2008-01-16
First Post:
2007-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development and Validation of a Mindfulness Intervention for Problem Gambling: An Exploratory Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005715', 'term': 'Gambling'}], 'ancestors': [{'id': 'D012309', 'term': 'Risk-Taking'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D007174', 'term': 'Disruptive, Impulse Control, and Conduct Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-01-14', 'studyFirstSubmitDate': '2007-06-29', 'studyFirstSubmitQcDate': '2007-06-29', 'lastUpdatePostDateStruct': {'date': '2008-01-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gambling urges', 'timeFrame': 'Baseline, post and 3 month fup'}, {'measure': 'Gambling-related expenditures', 'timeFrame': 'Baseline, post and 3 month fup'}], 'secondaryOutcomes': [{'measure': 'treatment adherence', 'timeFrame': 'Baseline, post and 3 month fup'}, {'measure': 'gambling cognitions', 'timeFrame': 'Baseline, post and 3 month fup'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Gambling', 'Mindfulness', 'Cognitive Behavioural Therapy'], 'conditions': ['Gambling']}, 'descriptionModule': {'briefSummary': 'In recent years, mindfulness meditation has been shown to be a promising approach for alleviating emotional distress associated with chronic medical and psychiatric conditions and in reducing relapse following treatment for depression. The applicability of mindfulness meditation to problem gambling has not yet been explored. Mindfulness meditation may be particularly suitable for this clinical disorder as it stresses a process-oriented, metacognitive, approach to cognitive pathology in contrast to a content-focused approach, characteristic of traditional approaches to treating cognitive psychopathology. Gambling-related cognitive psychopathology is a well-known characteristic of problem gambling and frequently the target of therapy. Although there is growing evidence that cognitive-behavioral treatments are effective for gambling, outcomes may be improved by teaching gamblers additional ways to cope with cognitive distortions that emphasize metacognitive processes.', 'detailedDescription': 'Hypothesis The mindfulness-enhanced CBT (MCBT) will report significant reductions in the frequency of gambling, gambling urges, gambling cognitions and gambling-related expenditures compared to the relaxation-enhanced CBT (RCBT) at end-of-treatment and at the 3-month follow-up.\n\nSignificance\n\n1. feasibility of mindfulness interventions for problem gamblers\n2. tentative data for the effectiveness of the intervention\n3. an additional clinical tool to treat problem gamblers\n4. basis of a larger, grant-funded study obtain more definitive data'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* current diagnosis of pathological gambling\n* willingness to practice mindfulness or relaxation\n\nExclusion Criteria:\n\n* substance abuse/dependence (except nicotine)\n* concurrent attendance at any treatment in which their gambling is addressed (including Gamblers Anonymous)'}, 'identificationModule': {'nctId': 'NCT00495261', 'briefTitle': 'Development and Validation of a Mindfulness Intervention for Problem Gambling: An Exploratory Study', 'organization': {'class': 'OTHER', 'fullName': 'Centre for Addiction and Mental Health'}, 'officialTitle': 'Development and Validation of a Mindfulness Intervention for Problem Gambling: An Exploratory Study', 'orgStudyIdInfo': {'id': '311/2006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Behavioral: Mindfulness-enhanced cognitive behavioural therapy (MCBT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Behavioral: relaxation-enhanced cognitive behavioural therapy (RCBT)']}], 'interventions': [{'name': 'Mindfulness-enhanced cognitive behavioural therapy (MCBT)', 'type': 'BEHAVIORAL', 'description': 'a variation of cognitive behavioural therapy (CBT)', 'armGroupLabels': ['1']}, {'name': 'relaxation-enhanced cognitive behavioural therapy (RCBT)', 'type': 'BEHAVIORAL', 'description': 'a variation of cognitive behavioural therapy (CBT)', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5S 2S1', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Centre for Addiction and Mental Health', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Tony Toneatto, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Addiction and Mental Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre for Addiction and Mental Health', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Tony Toneatto', 'oldOrganization': 'Centre for Addiction and Mental Health'}}}}