GamblingPhase 1CBT/CMNCT00118391
Cognitive-Behavioral Treatment of Gambling
A Phase 1 study testing Cognitive behavior therapy and Contingency management in people with Gambling and Mental Health, run by UConn Health at 1 site in United States.
Trial summary
This study will determine the effectiveness of cognitive behavior therapy (CBT) and contingency management (CM) in reducing gambling behaviors and other related problems in pathological gambling. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gambling, Mental Health
- What is being tested?
- Cognitive behavior therapy and Contingency management
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2002to Oct 2005
- 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
- At least 1 gambling episode within 30 days prior to study entry
- Able to read English at a 5th grade level
- Willing and able to comply with all study requirements
Who cannot join
- Uncontrolled psychiatric conditions
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: Enhanced Cognitive Behavior Therapy for the Treatment of Pathological Gambling
This study will determine the effectiveness of cognitive behavior therapy (CBT) and contingency management (CM) in reducing gambling behaviors and other related problems in pathological gambling.
Study hypothesis: Participants who receive CBT and CM will attend more treatment sessions and show better outcomes than those who receive CBT alone.
Read the detailed description
Pathological gambling has become an increasingly problematic condition in the United States, often causing serious financial, psychological, and public health consequences. In an effort to treat this growing problem, researchers have evaluated numerous therapies; one such therapy is CBT. CBT has been shown to improve pathological gambling outcomes. However, evidence suggests that adding CM to CBT could result in even more improved outcomes. This study will compare the effectiveness of CBT and CM with that of CBT alone in reducing pathological gambling.
This study will last 12 months. Participants will be randomly assigned to receive either CBT and CM or CBT alone for 8 weeks. CBT will focus on reducing gambling urges and helping patients develop alternative behaviors to gambling. CM will focus on encouraging patients to avoid gambling. Participants in the CBT and CM group will receive voucher incentives for completing homework assignments and engaging in non-gambling social activities. The vouchers will allow participants to take part in non-gambling activities of their choice. Changes in gambling activities and problems will be assessed with self-report scales and interviews at study start and at Weeks 10, 24, and 52.
Participants will be asked to identify at least one person who knows about their gambling and will have regular contact with them over the 12 months of the study. This person will be interviewed at study start and at Months 2, 6, and 12. Contact persons will be asked 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/NCT00158314
http://clinicaltrials.gov/show/NCT00618462
- Conditions
- Gambling, Mental Health
- Being tested
- Cognitive behavior therapy, Contingency management
- Keywords
- Pathological Gambling, CBT, CM
- Medical subject headings
- Gambling, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavior therapyBehavioural
Receive 8 50-minute sessions of one-on-one cognitive behavioral therapy
Contingency managementBehavioural
Receive vouchers that can be spent on rewards for completing activities that support abstinence from gambling
What is being measured
The primary outcome is the main question the study is designed to answer.
Addiction Severity Index (ASI) gambling severity scores
amount spent gambling per gambling episode
longest period of non-gambling
days until first gambling episode
percent of days gambling
proportion meeting diagnostic criteria
number of treatment sessions attended
Secondary outcomes (1)
Psychosocial functioning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2005 (estimated)
- Study startNov 2002
- Primary completionOct 2005
- Study completionOct 2005
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
- 120 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
- NCT00118391
- Sponsor's protocol ID
- R01MH060417-02
- Other IDs
- R01MH060417-02
- Acronym
- CBT/CM
- Status last verified
- Jun 2013
- First submitted
- 6 Jul 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
- Enhanced Cognitive Behavior Therapy for the Treatment of Pathological Gambling
- ClinicalTrials.gov ID
- NCT00118391
- Acronym / sponsor ID
- CBT/CM / R01MH060417-02
- Conditions
- Gambling, Mental Health
- Keywords
- Pathological Gambling, CBT, CM
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Nov 2002
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 11 Jul 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 of cognitive behavior therapy (CBT) and contingency management (CM) in reducing gambling behaviors and other related problems in pathological gambling.
Study hypothesis: Participants who receive CBT and CM will attend more treatment sessions and show better outcomes than those who receive CBT alone.
Detailed description
Pathological gambling has become an increasingly problematic condition in the United States, often causing serious financial, psychological, and public health consequences. In an effort to treat this growing problem, researchers have evaluated numerous therapies; one such therapy is CBT. CBT has been shown to improve pathological gambling outcomes. However, evidence suggests that adding CM to CBT could result in even more improved outcomes. This study will compare the effectiveness of CBT and CM with that of CBT alone in reducing pathological gambling.
This study will last 12 months. Participants will be randomly assigned to receive either CBT and CM or CBT alone for 8 weeks. CBT will focus on reducing gambling urges and helping patients develop alternative behaviors to gambling. CM will focus on encouraging patients to avoid gambling. Participants in the CBT and CM group will receive voucher incentives for completing homework assignments and engaging in non-gambling social activities. The vouchers will allow participants to take part in non-gambling activities of their choice. Changes in gambling activities and problems will be assessed with self-report scales and interviews at study start and at Weeks 10, 24, and 52.
Participants will be asked to identify at least one person who knows about their gambling and will have regular contact with them over the 12 months of the study. This person will be interviewed at study start and at Months 2, 6, and 12. Contact persons will be asked 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/NCT00158314
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 (4 listed)
- Diagnosis of pathological gambling
- At least 1 gambling episode within 30 days prior to study entry
- Able to read English at a 5th grade level
- Willing and able to comply with all study requirements
Key exclusion criteria (1 listed)
- Uncontrolled psychiatric conditions
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 behavior therapyReceive 8 50-minute sessions of one-on-one cognitive behavioral therapy | Behavioural | – |
| Contingency managementReceive vouchers that can be spent on rewards for completing activities that support abstinence from gambling | Behavioural | – |
Primary outcome
Addiction Severity Index (ASI) gambling severity scores
amount spent gambling per gambling episode
longest period of non-gambling
days until first gambling episode
percent of days gambling
proportion meeting diagnostic criteria
number of treatment sessions attended
1 secondary outcome
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 Cognitive behavior therapy and Contingency management in people with Gambling and Mental Health, 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 1 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 7 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.