ClinicalTrials.gg
CompletedNCT03145792Updated Mar 30, 2025

Online Coping Skills Counseling for Problem Gambling and Trauma

An interventional study of Seeking Safety and CBT for Pathological Gambling in Gambling Disorder, Trauma, Psychological and Problem Gambling, sponsored by University of Windsor. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-03-30.

Sponsored by University of Windsor · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Oct 2016, registered Apr 2017).

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Phase
Not applicable
Study type
Interventional
Enrollment
65
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 38 studies in Gambling with a site in United States — 4 open to participants now, 4 under way, none of them phase 3. Gambling · United States.

Enrollment
18th of 33
65 · median 66
Started
2016
with 1 other
No phase
17 of 38
4 open now
Registered
30th of 38
by date

Among the 38 studies in Gambling with a site in United States, this one is the 18th largest by enrollment of the 33 interventional ones that give a count, is one of 2 that started in 2016, is one of 17 with no phase, and was the 30th registered.

Gambling

158 studies on the registry are indexed under Gambling; 42 are open to participants now.

Browse Gambling studies →

Open to participants now

4 of the 38 studies in Gambling with a site in United States are open now. Recruiting first, the newest first:

All 4 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 24 Gambling studies recruiting now, 14 (58%) set no upper age limit and 10 (42%) stop at 75 or younger; 1 takes children under 18; 5 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · no healthy volunteers.

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02

Study 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.

Read the 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:

  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.

03

Conditions studied

  • Gambling Disorder
  • Trauma, Psychological
  • Problem Gambling
  • Posttraumatic Stress Disorder
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 Diagnostic Interview of Gambling Severity

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
65 participants (actual)

Study arms

  • Experimental
    Seeking Safety

    Behavioral therapy for trauma and addiction.

    Behavioral: Seeking Safety

  • Active comparator
    CBT for Pathological Gambling

    Behavioral therapy for gambling problems.

    Behavioral: CBT for Pathological Gambling

Interventions

  • BehavioralSeeking 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.

  • BehavioralCBT 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.

06

What researchers measure

Primary outcomes

  1. Money spent gambling

    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

  2. Number of gambling sessions

    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 outcomes

  1. PTSD Checklist (PCL) scores

    Posttraumatic stress disorder (PTSD) symptoms

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

  2. Trauma Symptom Checklist 40

    Change in baseline in broad trauma-related symptoms

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

  3. Brief Symptom Inventory-18 scores

    Change from baseline in general psychiatric symptoms

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

  4. Brief Addiction Monitor scores

    Change from baseline in substance use and associated problems

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

07

Study locations

1 site
  • Treatment Innovations
    Newton Center, Massachusetts 02459, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2016 to primary completion in Jun 2021, 56 months.

Of 47 non-industry interventional studies with no phase under Gambling, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 51. This study's 56 months is above that.

Counting every sponsor, half of 47 studies reached it within 16 months; a quarter within 10 and three quarters within 51.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 25, 2017
First posted
May 9, 2017
StartActual
Oct 1, 2016
Primary completionActual
Jun 2021
CompletionActual
Jun 2021
Last update
Mar 30, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03145792
Lead sponsor
University of Windsor
Collaborators
Manitoba Gambling Research Program, Treatment Innovations, University of Manitoba
Responsible party
David Ledgerwood (Adjunct Assistant Professor, University of Windsor) — Principal investigator
First posted
May 9, 2017
Start date
Oct 1, 2016
Primary completion
Jun 2021
Completion
Jun 2021
Last update
Mar 30, 2025

Study contacts

David M Ledgerwood, PhD
principal investigator · University of Windsor
Lisa Najavits, PhD
study director · Treatment Innovations

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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