Online Coping Skills Counseling for Problem Gambling and Trauma

NCT ID: NCT03145792

Last Updated: 2025-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-01

Study Completion Date

2021-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gambling Disorder Trauma, Psychological Problem Gambling Posttraumatic Stress Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Seeking Safety

Behavioral therapy for trauma and addiction.

Group Type EXPERIMENTAL

Seeking Safety

Intervention Type 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 therapy for gambling problems.

Group Type ACTIVE_COMPARATOR

CBT for Pathological Gambling

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Manitoba Gambling Research Program

UNKNOWN

Sponsor Role collaborator

Treatment Innovations

INDUSTRY

Sponsor Role collaborator

University of Manitoba

OTHER

Sponsor Role collaborator

University of Windsor

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

David Ledgerwood

Adjunct Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David M Ledgerwood, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Windsor

Lisa Najavits, PhD

Role: STUDY_DIRECTOR

Treatment Innovations

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Treatment Innovations

Newton Center, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LG-15-13

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Groups for Regaining Our Wellbeing (GROW)
NCT01971541 WITHDRAWN PHASE2/PHASE3