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Clinical Trials/NCT01135264
NCT01135264CompletedNot Applicable

Gambling Addiction: Treatment Mediators and Moderators

New York State Psychiatric Institute1 site in 1 country170 target enrollmentStarted: August 2009Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
170
Locations
1
Primary Endpoint
patient retention

Study Overview

Brief Summary

In the proposed two-arm randomized controlled trial, 200 patients meeting DSM-IV criteria for PG will be randomized to 12 sessions of Cognitive-Motivational Behavior Therapy (CMBT) or to Cognitive Behavior Therapy (CBT).

Detailed Description

CMBT has been developed by our team over the last five years, and has shown very promising results in a small, NIMH-funded randomized pilot trial (R21 MH 064568). We will assess patients biweekly during the active treatment phase and follow them for 12 months after the end of treatment to obtain data on long-term treatment outcome. We hypothesize that CMBT will show higher efficacy and retention than CBT in the treatment phase, and that gains will be maintained at a higher rate during follow-up.

A second major purpose of the proposed study is to elucidate the presumed mechanisms of change by examining potential mediators (readiness to change, irrational beliefs about gambling, coping skills, therapeutic alliance) and moderators (psychiatric comorbidity with Axis I and II disorders, family history of PG, impulsivity, and baseline motivation to change) of treatment response. A better understanding of how the proposed interventions work will help advance the science and treatment of PG and will be helpful in the future refinement and adaptation of CMBT. Identifying patient subgroups for which the intervention is particularly effective is essential for rational treatment selection. Thus, the immediate goal of the project is to compare CBMT versus CBT for the treatment of PG. A long-term goal of the proposed research is to establish effective treatment procedures that reduce the considerable individual and social costs of PG.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • pathological gambling
  • be able to read, understand and sign an informed consent form prior to any procedure and must be willing to comply with all study procedures and timelines

Exclusion Criteria

  • to meet DSM-IV criteria for comorbid substance use disorders in the last six months
  • current comorbid psychiatric conditions which require treatment and are not clearly secondary to pathological gambling
  • psychotropic medication

Outcomes

Primary Outcomes

patient retention

Time Frame: 60 weeks

Retention will be measured by the number of treatment sessions attended

Secondary Outcomes

  • gambling behavior(60 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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