GamblingPhase 1NCT00158314
Cognitive Behavioral Therapy for Treatment of Pathological Gambling
A Phase 1 study testing Referral to Gamblers Anonymous, Cognitive behavioral therapy and Cognitive behavioral self-help manual in people with Gambling, run by UConn Health at 1 site in United States.
Trial summary
This study will determine the effectiveness and cost-effectiveness of three different treatment strategies in reducing gambling behaviors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gambling
- What is being tested?
- Referral to Gamblers Anonymous, Cognitive behavioral therapy and Cognitive behavioral self-help manual
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 231 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 1998to Nov 2003
- Phase
- Phase 1
- 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
- Diagnosis of pathological gambling
- 3 or more gambling episodes within 60 days prior to study entry
Who cannot join
- Inability to read English at the 5th grade level
- Uncontrolled psychiatric condition
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut Health Center
Farmington, Connecticut, 06030
About this study
Official title: Cognitive Behavioral Treatment for Pathological Gambling
This study will determine the effectiveness and cost-effectiveness of three different treatment strategies in reducing gambling behaviors.
Read the detailed description
The number of pathological gamblers in the United States is steadily growing, leading to significant financial, psychological, and public health consequences. However, studies examining the effectiveness of treatment interventions for pathological gamblers are limited. This study will compare the effectiveness of three different treatment strategies, including referral to Gambler's Anonymous (GA), a self-help manual, and cognitive behavioral therapy (CBT), in reducing gambling behaviors and other problems related to pathological gambling.
This study will last 8 weeks. Participants will be randomly assigned to one of three interventions. Group 1 participants will be referred to GA and 8 weeks of CBT, which focuses on teaching skills to help reduce gambling urges and develop alternative behaviors to gambling. Group 2 participants will be referred to GA and given an 8-week self-help manual. Group 3 participants will be referred to GA alone. Questionnaires will be used to assess participants' gambling behavior and any personal, legal, or health problems they may be experiencing. The questionnaires will be completed at study entry, study completion, and at 6- and 12-month follow-up visits.
Participants will be asked to identify at least one person who knows about their gambling problem and will have regular contact with them during the study and for at least 1 year This person will be interviewed at the beginning of the study, and at Months 2, 6 and 12. Researchers will ask contact persons about participants' gambling behaviors, personal relationships, legal problems, use of health care and mental health services, and how the participant can be contacted if he or she moves.
For information on related studies, please follow these links:
http://clinicaltrials.gov/show/NCT00118391
http://clinicaltrials.gov/show/NCT00618462
- Conditions
- Gambling
- Being tested
- Referral to Gamblers Anonymous, Cognitive behavioral therapy, Cognitive behavioral self-help manual
- Keywords
- Pathological gambling, Gambler's anonymous, Cognitive behavioral therapy, CBT
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Referral to Gamblers AnonymousBehavioural
Cognitive behavioral therapyBehavioural
Cognitive behavioral self-help manualBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Addiction Severity Index (ASI) gambling severity scores
time spent gambling
days of non-gambling
Secondary outcomes (2)
Psychiatric symptoms
psychosocial functioning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startMar 1998
- Primary completionNov 2003
- Study completionNov 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 231 participants
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Nancy M. Petry, PhD, Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00158314
- Sponsor's protocol ID
- R01MH060417-01
- Other IDs
- R01MH060417-01, DATR A2-AIR
- Status last verified
- Jun 2013
- First submitted
- 7 Sep 2005
- Last updated
- 1 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Treatment for Pathological Gambling
- ClinicalTrials.gov ID
- NCT00158314
- Acronym / sponsor ID
- R01MH060417-01
- Conditions
- Gambling
- Keywords
- Pathological gambling, Gambler's anonymous, Cognitive behavioral therapy, CBT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Mar 1998
- Primary completion
- Nov 2003 (actual)
- Study completion
- Nov 2003 (actual)
- First posted
- 12 Sep 2005 (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.
This study will determine the effectiveness and cost-effectiveness of three different treatment strategies in reducing gambling behaviors.
Detailed description
The number of pathological gamblers in the United States is steadily growing, leading to significant financial, psychological, and public health consequences. However, studies examining the effectiveness of treatment interventions for pathological gamblers are limited. This study will compare the effectiveness of three different treatment strategies, including referral to Gambler's Anonymous (GA), a self-help manual, and cognitive behavioral therapy (CBT), in reducing gambling behaviors and other problems related to pathological gambling.
This study will last 8 weeks. Participants will be randomly assigned to one of three interventions. Group 1 participants will be referred to GA and 8 weeks of CBT, which focuses on teaching skills to help reduce gambling urges and develop alternative behaviors to gambling. Group 2 participants will be referred to GA and given an 8-week self-help manual. Group 3 participants will be referred to GA alone. Questionnaires will be used to assess participants' gambling behavior and any personal, legal, or health problems they may be experiencing. The questionnaires will be completed at study entry, study completion, and at 6- and 12-month follow-up visits.
Participants will be asked to identify at least one person who knows about their gambling problem and will have regular contact with them during the study and for at least 1 year This person will be interviewed at the beginning of the study, and at Months 2, 6 and 12. Researchers will ask contact persons about participants' gambling behaviors, personal relationships, legal problems, use of health care and mental health services, and how the participant can be contacted if he or she moves.
For information on related studies, please follow these links:
http://clinicaltrials.gov/show/NCT00118391
http://clinicaltrials.gov/show/NCT00618462
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of pathological gambling
- 3 or more gambling episodes within 60 days prior to study entry
Key exclusion criteria (2 listed)
- Inability to read English at the 5th grade level
- Uncontrolled psychiatric condition
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 |
|---|---|---|
| Referral to Gamblers Anonymous | Behavioural | – |
| Cognitive behavioral therapy | Behavioural | – |
| Cognitive behavioral self-help manual | Behavioural | – |
Primary outcome
Addiction Severity Index (ASI) gambling severity scores
time spent gambling
days of non-gambling
2 secondary outcomes
Psychiatric symptoms
psychosocial functioning
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 1 Jul 2013.
- Click here for more information about the University of Connecticut Health Center Gambling Treatment and Research Center.Link provided by the sponsor.
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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, PhD 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 Phase 1 study testing Referral to Gamblers Anonymous, Cognitive behavioral therapy and Cognitive behavioral self-help manual in people with 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 2 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 1 Jul 2013. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Addiction Severity Index (ASI) gambling severity scores. The study lists 3 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 1 Jul 2013.