Back to resultsOnline Coping Skills Counseling for Problem Gambling and Trauma
Primary Purpose
Gambling Disorder, Trauma, Psychological, Problem Gambling
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Seeking Safety
CBT for Pathological Gambling
Sponsored by
About this trial
This is an interventional treatment trial for Gambling Disorder
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
Sites / Locations
- Treatment Innovations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Seeking Safety
CBT for Pathological Gambling
Arm Description
Behavioral therapy for trauma and addiction.
Behavioral therapy for gambling problems.
Outcomes
Primary Outcome Measures
Money spent gambling
Change from baseline in amount of money spent gambling in the past month
Number of gambling sessions
Change from baseline in number of days in the past month during which gambling occurred
Secondary Outcome Measures
PTSD Checklist (PCL) scores
Posttraumatic stress disorder (PTSD) symptoms
Trauma Symptom Checklist 40
Change in baseline in broad trauma-related symptoms
Brief Symptom Inventory-18 scores
Change from baseline in general psychiatric symptoms
Brief Addiction Monitor scores
Change from baseline in substance use and associated problems
Full Information
NCT ID
NCT03145792
First Posted
April 25, 2017
Last Updated
September 11, 2021
Sponsor
University of Windsor
Collaborators
Manitoba Gambling Research Program, Treatment Innovations, University of Manitoba
1. Study Identification
Unique Protocol Identification Number
NCT03145792
Brief Title
Online Coping Skills Counseling for Problem Gambling and Trauma
Official Title
Online Coping Skills Counseling for Problem Gambling and Trauma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
June 2021 (Actual)
Study Completion Date
June 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Windsor
Collaborators
Manitoba Gambling Research Program, Treatment Innovations, University of Manitoba
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gambling Disorder, Trauma, Psychological, Problem Gambling, Posttraumatic Stress Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Seeking Safety
Arm Type
Experimental
Arm Description
Behavioral therapy for trauma and addiction.
Arm Title
CBT for Pathological Gambling
Arm Type
Active Comparator
Arm Description
Behavioral therapy for gambling problems.
Intervention Type
Behavioral
Intervention Name(s)
Seeking Safety
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CBT for Pathological Gambling
Intervention Description
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 Outcome Measure Information:
Title
Money spent gambling
Description
Change from baseline in amount of money spent gambling in the past month
Time Frame
6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months
Title
Number of gambling sessions
Description
Change from baseline in number of days in the past month during which gambling occurred
Time Frame
6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months
Secondary Outcome Measure Information:
Title
PTSD Checklist (PCL) scores
Description
Posttraumatic stress disorder (PTSD) symptoms
Time Frame
6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months
Title
Trauma Symptom Checklist 40
Description
Change in baseline in broad trauma-related symptoms
Time Frame
6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months
Title
Brief Symptom Inventory-18 scores
Description
Change from baseline in general psychiatric symptoms
Time Frame
6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months
Title
Brief Addiction Monitor scores
Description
Change from baseline in substance use and associated problems
Time Frame
6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M Ledgerwood, PhD
Organizational Affiliation
University of Windsor
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lisa Najavits, PhD
Organizational Affiliation
Treatment Innovations
Official's Role
Study Director
Facility Information:
Facility Name
Treatment Innovations
City
Newton Center
State/Province
Massachusetts
ZIP/Postal Code
02459
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Online Coping Skills Counseling for Problem Gambling and Trauma
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