Online Coping Skills Counseling for Problem Gambling and Trauma

Study Overview
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Brief Summary
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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
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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: To conduct an RCT of SS versus CBT-PG in a sample of 84 people with current PG and PTSD (full or subthreshold). 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.

Official Title
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Online Coping Skills Counseling for Problem Gambling and Trauma

Conditions
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Gambling Disorder, Trauma, Psychological, Problem Gambling, Posttraumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Seeking Safety
* Behavioral: CBT for Pathological Gambling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Seeking Safety<br>Behavioral therapy for trauma and addiction. | Behavioral: Seeking Safety<br>* 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.<br>|
| Active Comparator: CBT for Pathological Gambling<br>Behavioral therapy for gambling problems. | Behavioral: CBT for Pathological Gambling<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD Checklist (PCL) scores | Posttraumatic stress disorder (PTSD) symptoms | 6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months | 
| Trauma Symptom Checklist 40 | Change in baseline in broad trauma-related symptoms | 6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months | 
| Brief Symptom Inventory-18 scores | Change from baseline in general psychiatric symptoms | 6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months | 
| 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 |