A Pilot SMART Design for Pathological Gamblers (SMART)

April 5, 2019 updated by: UConn Health
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • University of Connecticut Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
self and collateral indices of gambling and gambling related problems
Time Frame: baseline and each follow-up
baseline and each follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UConn Health

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Nancy M Petry, Ph.D., UConn Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

May 23, 2008

First Submitted That Met QC Criteria

May 23, 2008

First Posted (Estimate)

May 28, 2008

Study Record Updates

Last Update Posted (Actual)

April 9, 2019

Last Update Submitted That Met QC Criteria

April 5, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-259
  • P50DA009241 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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