Pathological GamblingPhase 2NCT00337753
Cognitive Behavioral Therapy for Pathological Gambling
A Phase 2 study testing Cognitive Behavioral Therapy and Wait-list in people with Pathological Gambling, run by University of Minnesota at 1 site in United States.
Trial summary
The purpose of the study is to evaluate a new form of counseling for pathological gambling and to see if the counseling is more effective than attending Gamblers Anonymous. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pathological Gambling
- What is being tested?
- Cognitive Behavioral Therapy and Wait-list
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Jun 2009
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatient men and women age 18 to 75
- Presence of current DSM-IV pathological gambling for at least 6 months duration
- PG is the most problematic psychiatric disorder (in the patient's and clinician's opinion) and the primary reason for seeking treatment
- Minimum score of >5 on the South Oaks Gambling Screen which reflects gambling severity consistent with pathological gambling
Who cannot join
- Current clinically significant suicidality, severe depression (a score of ≥ 19 on the Hamilton Rating Scale for Depression, 17-item version)(30) or any other disorder requiring immediate intervention
- Presence of any clinical features requiring a higher level of care than outpatient treatment
- Cognitive impairment that interferes with the capacity to engage in CBT or to provide informed consent
- DSM-IV substance abuse or dependence within the past 3 months (see Screening Visit)
- Current Axis I diagnosis of bipolar disorder or psychotic disorder
- Previous treatment of CBT for PG (duration of at least 6 sessions); because CBT is not widely used for PG, a minimum of 6 treatments will be rare.
- Current use of psychotropic medications or within 2 months prior to study entry.
- Current participation in Gambler's Anonymous (GA).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Medical Center
Minneapolis, Minnesota, 55454
About this study
The purpose of the study is to evaluate a new form of counseling for pathological gambling and to see if the counseling is more effective than attending Gamblers Anonymous.
Read the detailed description
Subjects will be assigned to counseling or be given a referral list of available Gamblers Anonymous meetings at the first visit based on answers to questions. Assignment to counseling or Gamblers Anonymous will be randomly selected (i.e. chance) with an equal chance of receiving either one. For those assigned to counseling, you will meet with the therapist for 60 minutes weekly. You will receive 5 sessions of counseling.
All subjects will be assessed with gambling questionnaires twice during the 5-week period and again at 3 and 6 months following the 5-week period.
For those assigned to Gamblers Anonymous, they will be offered 5 weeks of counseling at the end of the 6-month follow-up.
- Conditions
- Pathological Gambling
- Being tested
- Cognitive Behavioral Therapy, Wait-list
- Keywords
- Gambling
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
Also called CBT
5-weeks of Cognitive Behavioral Therapy
Wait-listBehavioural
subjects assigned to wait-list condition for six-weeks
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy | Active comparator | Weekly Cognitive Behavior therapy Receives: Behavioral: Cognitive Behavioral Therapy |
| Wait-list | Other | Subjects in wait-list for six-weeks Receives: Behavioral: Wait-list |
What is being measured
The primary outcome is the main question the study is designed to answer.
PG-YBOCS
Measured: At each visit prior to and after therapy has been completed
Secondary outcomes (1)
Time spent gambling
Measured: At each visit prior to and after therapy has been completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2006 (estimated)
- Study startJun 2006
- Primary completionJun 2009
- Study completionJun 2009
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Jon E Grant, MD, JD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00337753
- Sponsor's protocol ID
- 0503M68191
- Other IDs
- K23MH069754-01A1
- Status last verified
- Jan 2010
- First submitted
- 14 Jun 2006
- Last updated
- 5 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Therapy for Pathological Gambling
- ClinicalTrials.gov ID
- NCT00337753
- Acronym / sponsor ID
- 0503M68191
- Conditions
- Pathological Gambling
- Keywords
- Gambling
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jun 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 16 Jun 2006 (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.
The purpose of the study is to evaluate a new form of counseling for pathological gambling and to see if the counseling is more effective than attending Gamblers Anonymous.
Detailed description
Subjects will be assigned to counseling or be given a referral list of available Gamblers Anonymous meetings at the first visit based on answers to questions. Assignment to counseling or Gamblers Anonymous will be randomly selected (i.e. chance) with an equal chance of receiving either one. For those assigned to counseling, you will meet with the therapist for 60 minutes weekly. You will receive 5 sessions of counseling.
All subjects will be assessed with gambling questionnaires twice during the 5-week period and again at 3 and 6 months following the 5-week period.
For those assigned to Gamblers Anonymous, they will be offered 5 weeks of counseling at the end of the 6-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy | Active comparator | Behavioral: Cognitive Behavioral TherapyWeekly Cognitive Behavior therapy |
| Wait-list | Other | Behavioral: Wait-listSubjects in wait-list for six-weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Outpatient men and women age 18 to 75
- Presence of current DSM-IV pathological gambling for at least 6 months duration
- PG is the most problematic psychiatric disorder (in the patient's and clinician's opinion) and the primary reason for seeking treatment
- Minimum score of >5 on the South Oaks Gambling Screen which reflects gambling severity consistent with pathological gambling
Key exclusion criteria (8 listed)
- Current clinically significant suicidality, severe depression (a score of ≥ 19 on the Hamilton Rating Scale for Depression, 17-item version)(30) or any other disorder requiring immediate intervention
- Presence of any clinical features requiring a higher level of care than outpatient treatment
- Cognitive impairment that interferes with the capacity to engage in CBT or to provide informed consent
- DSM-IV substance abuse or dependence within the past 3 months (see Screening Visit)
- Current Axis I diagnosis of bipolar disorder or psychotic 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 |
|---|---|---|
| Cognitive Behavioral TherapyAlso: CBT5-weeks of Cognitive Behavioral Therapy | Behavioural | Cognitive Behavioral Therapy |
| Wait-listsubjects assigned to wait-list condition for six-weeks | Behavioural | Wait-list |
Primary outcome
PG-YBOCS
Time frame: At each visit prior to and after therapy has been completed
1 secondary outcome
Time spent gambling
Time frame: At each visit prior to and after therapy has been completed
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 5 Jan 2010.
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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.
Jon E Grant, MD, JD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cognitive Behavioral Therapy and Wait-list in people with Pathological Gambling, run by University of Minnesota 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 8 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 5 Jan 2010. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
PG-YBOCS (time frame: At each visit prior to and after therapy has been completed). 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 5 Jan 2010.