Pathological GamblingSMARTNCT00685724
A Pilot SMART Design for Pathological Gamblers
A study testing Motivational Enhancement Therapy (MET) and Cognitive-Behavioral Therapy (CBT) in people with Pathological Gambling, run by UConn Health at 1 site in United States.
Trial summary
Pathological gambling is serious problem, with significant psychological, financial, and public health consequences. Nevertheless, controlled trials examining the efficacy of therapeutic interventions for pathological gamblers are sparse, and many pathological gamblers recover on their own, or with only minimal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pathological Gambling
- What is being tested?
- Motivational Enhancement Therapy (MET) and Cognitive-Behavioral Therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Mar 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 years old, DSM-IV criteria for pathological gambling
- >2 gambling episodes in past 60 days
- spent >$100 wagering in the past 60 days
- willingness to accept random assignment after the brief intervention.
Who cannot join
- Reading level below 5th grade
- uncontrolled psychiatric conditions (e.g., active suicidal intention, psychosis, bipolar disorder)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut Health Center
Farmington, Connecticut, 06030
About this study
Pathological gambling is serious problem, with significant psychological, financial, and public health consequences. Nevertheless, controlled trials examining the efficacy of therapeutic interventions for pathological gamblers are sparse, and many pathological gamblers recover on their own, or with only minimal interventions. In this initial study of a SMART design for pathological gamblers, we will offer a brief intervention to all (n = 100), and subsequently randomize individuals based upon their initial treatment response to varying intensities of additional care from none to 8 sessions of individual cognitive behavioral therapy (CBT) plus 14 weeks of Aftercare. Gambling outcomes will be assessed pre-treatment and at about weeks 10, 24, 36 and 52.
- Conditions
- Pathological Gambling
- Being tested
- Motivational Enhancement Therapy (MET), Cognitive-Behavioral Therapy (CBT)
- Keywords
- pathological gambling, cognitive-behavioral therapy, motivational enhancement therapy
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Enhancement Therapy (MET)Behavioural
MET is a client-centered, directive form of therapy designed to enhance clients' intrinsic motivation to change.
Cognitive-Behavioral Therapy (CBT)Behavioural
In CBT, clients learn to modify their thoughts as well as their behaviors by increasing awareness of the relationship between thoughts, emotions, and actions.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Following 2 sessions of MET intervention received by all patients, patients in Condition 1 receive no further intervention. Receives: Behavioral: Motivational Enhancement Therapy (MET) |
| 2 | Experimental | Patients in Condition 2 will receive 8 sessions of the CBT (Cognitive Behavioral Therapy) intervention. Receives: Behavioral: Motivational Enhancement Therapy (MET) |
| 3 | Experimental | Patients in Condition 3 will receive 8 sessions of CBT plus aftercare treatment. Receives: Behavioral: Motivational Enhancement Therapy (MET); Behavioral: Cognitive-Behavioral Therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
self and collateral indices of gambling and gambling related problems
Measured: baseline and each follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2008 (estimated)
- Study startJan 2008
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pathological GamblingStudies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Nancy M Petry, Ph.D., Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00685724
- Sponsor's protocol ID
- 07-259
- Other IDs
- P50DA009241
- Acronym
- SMART
- Status last verified
- Apr 2019
- First submitted
- 23 May 2008
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot SMART Design for Pathological Gamblers
- ClinicalTrials.gov ID
- NCT00685724
- Acronym / sponsor ID
- SMART / 07-259
- Conditions
- Pathological Gambling
- Keywords
- pathological gambling, cognitive-behavioral therapy, motivational enhancement therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jan 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 28 May 2008 (estimated)
- 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.
Pathological gambling is serious problem, with significant psychological, financial, and public health consequences. Nevertheless, controlled trials examining the efficacy of therapeutic interventions for pathological gamblers are sparse, and many pathological gamblers recover on their own, or with only minimal interventions. In this initial study of a SMART design for pathological gamblers, we will offer a brief intervention to all (n = 100), and subsequently randomize individuals based upon their initial treatment response to varying intensities of additional care from none to 8 sessions of individual cognitive behavioral therapy (CBT) plus 14 weeks of Aftercare. Gambling outcomes will be assessed pre-treatment and at about weeks 10, 24, 36 and 52.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Motivational Enhancement Therapy (MET)Following 2 sessions of MET intervention received by all patients, patients in Condition 1 receive no further intervention. |
| 2 | Experimental | Behavioral: Motivational Enhancement Therapy (MET)Patients in Condition 2 will receive 8 sessions of the CBT (Cognitive Behavioral Therapy) intervention. |
| 3 | Experimental | Behavioral: Motivational Enhancement Therapy (MET), Behavioral: Cognitive-Behavioral Therapy (CBT)Patients in Condition 3 will receive 8 sessions of CBT plus aftercare treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age > 18 years old, DSM-IV criteria for pathological gambling
- >2 gambling episodes in past 60 days
- spent >$100 wagering in the past 60 days
- willingness to accept random assignment after the brief intervention.
Key exclusion criteria (2 listed)
- Reading level below 5th grade
- uncontrolled psychiatric conditions (e.g., active suicidal intention, psychosis, bipolar disorder)
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 |
|---|---|---|
| Motivational Enhancement Therapy (MET)MET is a client-centered, directive form of therapy designed to enhance clients' intrinsic motivation to change. | Behavioural | 1, 2, 3 |
| Cognitive-Behavioral Therapy (CBT)In CBT, clients learn to modify their thoughts as well as their behaviors by increasing awareness of the relationship between thoughts, emotions, and actions. | Behavioural | 3 |
Primary outcome
self and collateral indices of gambling and gambling related problems
Time frame: baseline and each follow-up
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 9 Apr 2019.
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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.
Nancy M Petry, Ph.D. principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Enhancement Therapy (MET) and Cognitive-Behavioral Therapy (CBT) in people with Pathological Gambling, run by UConn Health 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 2 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 9 Apr 2019. 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?
self and collateral indices of gambling and gambling related problems (time frame: baseline and each follow-up). 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 9 Apr 2019.