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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date September 2021
Source University of Windsor
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Intervention

Behavioral:
Seeking Safety
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.
CBT for Pathological Gambling
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.

Locations

Country Name City State
United States Treatment Innovations Newton Center Massachusetts

Sponsors (4)

Lead Sponsor Collaborator
University of Windsor Manitoba Gambling Research Program, Treatment Innovations, University of Manitoba

Country where clinical trial is conducted

United States, 

Outcome

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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