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OpenTrials
Completed

NCT Number: NCT03145792

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.

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Key information

Conditions

Gambling Disorder Behavior Disruptive, Impulse Control, and Conduct Disorders Gambling Mental Disorders Posttraumatic Stress Disorder Problem Gambling Psychological Trauma Risk-Taking Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Trauma, Psychological

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Treatment Innovations

Newton Center, Massachusetts, 02459, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Seeking Safety

Behavioral

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

Behavioral

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.

Primary outcomes

  1. 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

  2. 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

  1. PTSD Checklist (PCL) scores

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

    Posttraumatic stress disorder (PTSD) symptoms

  2. Trauma Symptom Checklist 40

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

    Change in baseline in broad trauma-related symptoms

  3. Brief Symptom Inventory-18 scores

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

    Change from baseline in general psychiatric symptoms

  4. Brief Addiction Monitor scores

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

    Change from baseline in substance use and associated problems

Sponsors and collaborators

Lead sponsor

University of Windsor

Other

Collaborators

  • Manitoba Gambling Research Program
  • Treatment Innovations
  • University of Manitoba

Registry information

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
May 9, 2017
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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