Online Coping Skills Counseling for Problem Gambling and Trauma

Posttraumatic Stress Disorder Clinical Trial

Official title:

Online Coping Skills Counseling for Problem Gambling and Trauma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03145792
• Other study ID #: LG-15-13
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Disease
• Gambling
• Gambling Disorder
• Posttraumatic Stress Disorder
• Problem Gambling
• Psychological Trauma
• Stress Disorders, Post-Traumatic
• Trauma, Psychological
• Wounds and Injuries

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