Gambling DisorderNCT03145792
Online Coping Skills Counseling for Problem Gambling and Trauma
A study testing Seeking Safety and CBT for Pathological Gambling in people with Gambling Disorder and Trauma, Psychological, run by University of Windsor at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gambling Disorder, Trauma, Psychological, Problem Gambling
- What is being tested?
- Seeking Safety and CBT for Pathological Gambling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2016to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Treatment Innovations
Newton Center, Massachusetts, 02459
About this study
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:
- 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.
- Being tested
- Seeking Safety, CBT for Pathological Gambling
- Medical subject headings
- Gambling, Psychological Trauma, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seeking SafetyBehavioural
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 GamblingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Seeking Safety | Experimental | Behavioral therapy for trauma and addiction. Receives: Behavioral: Seeking Safety |
| CBT for Pathological Gambling | Active comparator | Behavioral therapy for gambling problems. Receives: Behavioral: CBT for Pathological Gambling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Money spent gambling
Change from baseline in amount of money spent gambling in the past month
Measured: 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
Measured: 6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months
Secondary outcomes (4)
PTSD Checklist (PCL) scores
Posttraumatic stress disorder (PTSD) symptoms
Measured: 6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months
Trauma Symptom Checklist 40
Change in baseline in broad trauma-related symptoms
Measured: 6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months
Brief Symptom Inventory-18 scores
Change from baseline in general psychiatric symptoms
Measured: 6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months
Brief Addiction Monitor scores
Change from baseline in substance use and associated problems
Measured: 6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start1 Oct 2016
- Primary completionJun 2021
- Study completionJun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gambling DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Windsor
- Sponsor type
- University, hospital or other
- Collaborators
- Manitoba Gambling Research Program, Treatment Innovations, University of Manitoba
- Responsible party
- Principal investigator, David Ledgerwood, University of Windsor
- Investigators
- David M Ledgerwood, PhD, Principal investigator, University of WindsorLisa Najavits, PhD, Study director, Treatment Innovations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03145792
- Sponsor's protocol ID
- LG-15-13
- Status last verified
- Mar 2025
- First submitted
- 25 Apr 2017
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Coping Skills Counseling for Problem Gambling and Trauma
- ClinicalTrials.gov ID
- NCT03145792
- Acronym / sponsor ID
- LG-15-13
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of WindsorUniversity, hospital or other
- Collaborators
- Manitoba Gambling Research Program, Treatment Innovations, University of Manitoba
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- Jun 2021 (actual)
- Study completion
- Jun 2021 (actual)
- First posted
- 9 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Seeking Safety | Experimental | Behavioral: Seeking SafetyBehavioral therapy for trauma and addiction. |
| CBT for Pathological Gambling | Active comparator | Behavioral: CBT for Pathological GamblingBehavioral therapy for gambling problems. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Seeking SafetySeeking 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. | Behavioural | Seeking Safety |
| CBT for Pathological GamblingCognitive 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. | Behavioural | CBT for Pathological Gambling |
Primary outcome
Money spent gambling
Time frame: 6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months
Change from baseline in amount of money spent gambling in the past month
Number of gambling sessions
Time frame: 6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months
Change from baseline in number of days in the past month during which gambling occurred
4 secondary outcomes
PTSD Checklist (PCL) scores
Time frame: 6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months
Trauma Symptom Checklist 40
Time frame: 6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months
Brief Symptom Inventory-18 scores
Time frame: 6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months
Brief Addiction Monitor scores
Time frame: 6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David M Ledgerwood, PhD principal investigator
University of Windsor
Lisa Najavits, PhD study director
Treatment Innovations
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Seeking Safety and CBT for Pathological Gambling in people with Gambling Disorder and Trauma, Psychological, run by University of Windsor at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Money spent gambling (time frame: 6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.