Posttraumatic Stress Disorder Clinical Trial
Official title:
Online Coping Skills Counseling for Problem Gambling and Trauma
NCT number | NCT03145792 |
Other study ID # | LG-15-13 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 1, 2016 |
Est. completion date | June 2021 |
Verified date | September 2021 |
Source | University of Windsor |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 65 |
Est. completion date | June 2021 |
Est. primary completion date | June 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Age 18 and over - Recruited from the province of Manitoba, Canada - Meets criteria for PTSD (full or subthreshold) on the Clinician-Administered PTSD Scale (CAPS) - Meets gambling disorder criteria per the DSM-5 Diagnostic Interview of Gambling Severity Exclusion Criteria: - Current uncontrolled psychotic or bipolar I disorder - Suicidal or homicidal ideation with intent and/or plan - Currently engaging in or planning to engage in any manualized, formal, evidence-based PTSD therapy |
Country | Name | City | State |
---|---|---|---|
United States | Treatment Innovations | Newton Center | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
University of Windsor | Manitoba Gambling Research Program, Treatment Innovations, University of Manitoba |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Money spent gambling | Change from baseline in amount of money spent gambling in the past month | 6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months | |
Primary | Number of gambling sessions | Change from baseline in number of days in the past month during which gambling occurred | 6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months | |
Secondary | PTSD Checklist (PCL) scores | Posttraumatic stress disorder (PTSD) symptoms | 6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months | |
Secondary | Trauma Symptom Checklist 40 | Change in baseline in broad trauma-related symptoms | 6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months | |
Secondary | Brief Symptom Inventory-18 scores | Change from baseline in general psychiatric symptoms | 6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months | |
Secondary | Brief Addiction Monitor scores | Change from baseline in substance use and associated problems | 6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months |
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