Online Coping Skills Counseling for Problem Gambling and Trauma

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.

Study Overview

• Status: Completed
• Conditions: Posttraumatic Stress Disorder; Gambling Disorder; Trauma, Psychological; Problem Gambling
• Intervention / Treatment: Behavioral: Seeking Safety; Behavioral: CBT for Pathological Gambling

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.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Newton Center, Massachusetts, United States, 02459
      • Treatment Innovations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Seeking Safety; Behavioral therapy for trauma and addiction.	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.
Active Comparator: CBT for Pathological Gambling; Behavioral therapy for gambling problems.	Behavioral: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Windsor
• Collaborators: University of Manitoba; Treatment Innovations; Manitoba Gambling Research Program
• Investigators: Principal Investigator: David M Ledgerwood, PhD, University of Windsor; Study Director: Lisa Najavits, PhD, Treatment Innovations

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: April 25, 2017
• First Submitted That Met QC Criteria: May 4, 2017
• First Posted (Actual): May 9, 2017

Study Record Updates

• Last Update Posted (Actual): September 14, 2021
• Last Update Submitted That Met QC Criteria: September 11, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Trauma and Stressor Related Disorders; Disruptive, Impulse Control, and Conduct Disorders; Stress Disorders, Traumatic; Disease; Stress Disorders, Post-Traumatic; Wounds and Injuries; Psychological Trauma; Gambling
• Other Study ID Numbers: LG-15-13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No