A Pilot SMART Design for Pathological Gamblers
This study has been completed.
Sponsor:
University of Connecticut Health Center
Collaborator:
Information provided by (Responsible Party):
University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT00685724
First received: May 23, 2008
Last updated: November 17, 2011
Last verified: November 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pathological Gambling |
Behavioral: Motivational Enhancement Therapy (MET) Behavioral: Cognitive-Behavioral Therapy (CBT) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot SMART Design for Pathological Gamblers |
Resource links provided by NLM:
Further study details as provided by University of Connecticut Health Center:
Primary Outcome Measures:
- self and collateral indices of gambling and gambling related problems [ Time Frame: baseline and each follow-up ] [ Designated as safety issue: No ]
| Enrollment: | 66 |
| Study Start Date: | January 2008 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Following 2 sessions of MET intervention received by all patients, patients in Condition 1 receive no further intervention.
|
Behavioral: Motivational Enhancement Therapy (MET)
MET is a client-centered, directive form of therapy designed to enhance clients' intrinsic motivation to change.
|
|
Experimental: 2
Patients in Condition 2 will receive 8 sessions of the CBT (Cognitive Behavioral Therapy) intervention.
|
Behavioral: Motivational Enhancement Therapy (MET)
MET is a client-centered, directive form of therapy designed to enhance clients' intrinsic motivation to change.
|
|
Experimental: 3
Patients in Condition 3 will receive 8 sessions of CBT plus aftercare treatment.
|
Behavioral: Motivational Enhancement Therapy (MET)
MET is a client-centered, directive form of therapy designed to enhance clients' intrinsic motivation to change.
Behavioral: 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Reading level below 5th grade
- uncontrolled psychiatric conditions (e.g., active suicidal intention, psychosis, bipolar disorder)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00685724
Locations
| United States, Connecticut | |
| University of Connecticut Health Center | |
| Farmington, Connecticut, United States, 06030 | |
Sponsors and Collaborators
University of Connecticut Health Center
Investigators
| Principal Investigator: | Nancy M Petry, Ph.D. | University of Connecticut Health Center |
More Information
No publications provided
| Responsible Party: | University of Connecticut Health Center |
| ClinicalTrials.gov Identifier: | NCT00685724 History of Changes |
| Other Study ID Numbers: | 07-259, P50DA009241 |
| Study First Received: | May 23, 2008 |
| Last Updated: | November 17, 2011 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by University of Connecticut Health Center:
|
pathological gambling cognitive-behavioral therapy motivational enhancement therapy |
Additional relevant MeSH terms:
|
Gambling Impulse Control Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013