Ignite Creation Date:
2025-12-24 @ 3:19 PM
Ignite Modification Date:
2026-01-29 @ 5:43 AM
Study NCT ID:
NCT03145792
Status:
COMPLETED
Last Update Posted:
2025-03-30
First Post:
2017-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Online Coping Skills Counseling for Problem Gambling and Trauma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005715', 'term': 'Gambling'}, {'id': 'D000067073', 'term': 'Psychological Trauma'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D012309', 'term': 'Risk-Taking'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D007174', 'term': 'Disruptive, Impulse Control, and Conduct Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2021-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2017-04-25', 'studyFirstSubmitQcDate': '2017-05-04', 'lastUpdatePostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Money spent gambling', 'timeFrame': '6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months', 'description': 'Change from baseline in amount of money spent gambling in the past month'}, {'measure': 'Number of gambling sessions', 'timeFrame': '6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months', 'description': 'Change from baseline in number of days in the past month during which gambling occurred'}], 'secondaryOutcomes': [{'measure': 'PTSD Checklist (PCL) scores', 'timeFrame': '6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months', 'description': 'Posttraumatic stress disorder (PTSD) symptoms'}, {'measure': 'Trauma Symptom Checklist 40', 'timeFrame': '6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months', 'description': 'Change in baseline in broad trauma-related symptoms'}, {'measure': 'Brief Symptom Inventory-18 scores', 'timeFrame': '6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months', 'description': 'Change from baseline in general psychiatric symptoms'}, {'measure': 'Brief Addiction Monitor scores', 'timeFrame': '6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months', 'description': 'Change from baseline in substance use and associated problems'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gambling Disorder', 'Trauma, Psychological', 'Problem Gambling', 'Posttraumatic Stress Disorder']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial examines the efficacy of two behavioral therapies. Seeking Safety, which addresses co-occurring problem gambling (PG) and posttraumatic stress disorder (PTSD), is being compared to Cognitive-Behavioral Therapy for PG, which addresses only PG. Both models are delivered via telehealth.', 'detailedDescription': 'Our key study question is whether an integrated focus on PG and PTSD (Seeking Safety; SS) offers a useful new option for clinical care compared to a purely problem gambling approach (Cognitive-Behavioral Therapy for PG; CBT-PG). This question-the impact of integrated versus non-integrated treatment for co-occurring disorders-is one of the key issues in the field currently and has never been studied in relation to PG and PTSD.\n\nOur aims are:\n\n1. To conduct an RCT of SS versus CBT-PG in a sample of 84 people with current PG and PTSD (full or subthreshold).\n2. To evaluate outcomes from baseline to end of treatment and 12 month followup on two primary variables (money lost gambling and number of gambling sessions) and several secondary variables.\n\nOur hypotheses are: (a) SS will do no worse than CBT-PG on the primary PG outcomes as both treatments are designed to address addiction; i.e., both will show improvement from baseline to end of treatment and maintenance of gains through the followup. (b) SS will show superior results on trauma symptoms as SS is designed to address those, whereas CBT-PG is not.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 and over\n* Recruited from the province of Manitoba, Canada\n* Meets criteria for PTSD (full or subthreshold) on the Clinician-Administered PTSD Scale (CAPS)\n* Meets gambling disorder criteria per the DSM-5 Diagnostic Interview of Gambling Severity\n\nExclusion Criteria:\n\n* Current uncontrolled psychotic or bipolar I disorder\n* Suicidal or homicidal ideation with intent and/or plan\n* Currently engaging in or planning to engage in any manualized, formal, evidence-based PTSD therapy'}, 'identificationModule': {'nctId': 'NCT03145792', 'briefTitle': 'Online Coping Skills Counseling for Problem Gambling and Trauma', 'organization': {'class': 'OTHER', 'fullName': 'University of Windsor'}, 'officialTitle': 'Online Coping Skills Counseling for Problem Gambling and Trauma', 'orgStudyIdInfo': {'id': 'LG-15-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Seeking Safety', 'description': 'Behavioral therapy for trauma and addiction.', 'interventionNames': ['Behavioral: Seeking Safety']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CBT for Pathological Gambling', 'description': 'Behavioral therapy for gambling problems.', 'interventionNames': ['Behavioral: CBT for Pathological Gambling']}], 'interventions': [{'name': 'Seeking Safety', 'type': 'BEHAVIORAL', 'description': 'Seeking Safety (SS) is a present-focused, evidence-based cognitive-behavioral therapy for trauma and/or addiction. It offers safe coping skills and education relevant to both problem areas.', 'armGroupLabels': ['Seeking Safety']}, {'name': 'CBT for Pathological Gambling', 'type': 'BEHAVIORAL', 'description': 'Cognitive Behavior Therapy for Pathological Gambling (CBT-PG) is an evidence-based therapy for gambling problems. It focuses on cognitive correction, problem solving, social skills and relapse prevention.', 'armGroupLabels': ['CBT for Pathological Gambling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02459', 'city': 'Newton Center', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Treatment Innovations', 'geoPoint': {'lat': 42.33065, 'lon': -71.1995}}], 'overallOfficials': [{'name': 'David M Ledgerwood, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Windsor'}, {'name': 'Lisa Najavits, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Treatment Innovations'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Windsor', 'class': 'OTHER'}, 'collaborators': [{'name': 'Manitoba Gambling Research Program', 'class': 'UNKNOWN'}, {'name': 'Treatment Innovations', 'class': 'INDUSTRY'}, {'name': 'University of Manitoba', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Adjunct Assistant Professor', 'investigatorFullName': 'David Ledgerwood', 'investigatorAffiliation': 'University of Windsor'}}}}