NCT03145792

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 9, 2017

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

March 30, 2025

Status Verified

March 1, 2025

Enrollment Period

4.7 years

First QC Date

April 25, 2017

Last Update Submit

March 25, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • PTSD Checklist (PCL) scores

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

  • Trauma Symptom Checklist 40

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

  • Brief Symptom Inventory-18 scores

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

  • Brief Addiction Monitor scores

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

Study Arms (2)

Seeking Safety

EXPERIMENTAL

Behavioral therapy for trauma and addiction.

Behavioral: Seeking Safety

CBT for Pathological Gambling

ACTIVE COMPARATOR

Behavioral therapy for gambling problems.

Behavioral: CBT for Pathological Gambling

Interventions

Seeking SafetyBEHAVIORAL

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.

Seeking Safety

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.

CBT for Pathological Gambling

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Treatment Innovations

Newton Center, Massachusetts, 02459, United States

Location

MeSH Terms

Conditions

GamblingPsychological TraumaStress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Risk-TakingBehaviorDisruptive, Impulse Control, and Conduct DisordersMental DisordersStress Disorders, TraumaticTrauma and Stressor Related Disorders

Study Officials

  • David M Ledgerwood, PhD

    University of Windsor

    PRINCIPAL INVESTIGATOR
  • Lisa Najavits, PhD

    Treatment Innovations

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Assistant Professor

Study Record Dates

First Submitted

April 25, 2017

First Posted

May 9, 2017

Study Start

October 1, 2016

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

March 30, 2025

Record last verified: 2025-03

Locations