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Clinical Trials/NCT03145792
NCT03145792
Completed
Not Applicable

Online Coping Skills Counseling for Problem Gambling and Trauma

University of Windsor1 site in 1 country65 target enrollmentOctober 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gambling Disorder
Sponsor
University of Windsor
Enrollment
65
Locations
1
Primary Endpoint
Money spent gambling
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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. Our aims are: 1. To conduct an RCT of SS versus CBT-PG in a sample of 84 people with current PG and PTSD (full or subthreshold). 2. 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. Our 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.

Registry
clinicaltrials.gov
Start Date
October 1, 2016
End Date
June 2021
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

David Ledgerwood

Adjunct Assistant Professor

University of Windsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Money spent gambling

Time Frame: 6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months

Change from baseline in amount of money spent gambling in the past month

Number of gambling sessions

Time Frame: 6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months

Change from baseline in number of days in the past month during which gambling occurred

Secondary Outcomes

  • PTSD Checklist (PCL) scores(6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months)
  • Trauma Symptom Checklist 40(6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months)
  • Brief Symptom Inventory-18 scores(6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months)
  • Brief Addiction Monitor scores(6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months)

Study Sites (1)

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