Cognitive-Motivational Behavior Therapy for Pathological Gamblers

Sponsor
New York State Psychiatric Institute (Other)
Overall Status
Completed
CT.gov ID
NCT01135264
Collaborator
National Institute of Mental Health (NIMH) (NIH)
170
1
2
82
2.1

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: CBT
  • Behavioral: CMBT
N/A

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
Actual Enrollment :
170 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Gambling Addiction: Treatment Mediators and Moderators
Study Start Date :
Aug 1, 2009
Actual Primary Completion Date :
Jun 1, 2016
Actual Study Completion Date :
Jun 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: CBT

The CBT treatment developed by Ladouceur (Consultant) will serve as control condition (outline of published treatment manual by Ladouceur & Lachance, 2006. This treatment served as a model for the cognitive-behavioral component in CMBT and has received empirical support in two studies from Ladouceur's lab (Sylvain et al., 1997; Ladouceur et al., 2004). It places strong emphasis on cognitive correction of erroneous beliefs about gambling and also focuses on coping skills training and relapse prevention. CBT also lasts 12 weekly sessions.

Behavioral: CBT
The CBT treatment developed by Ladouceur (Consultant) will serve as control condition (outline of published treatment manual by Ladouceur & Lachance, 2006. This treatment served as a model for the cognitive-behavioral component in CMBT and has received empirical support in two studies from Ladouceur's lab (Sylvain et al., 1997; Ladouceur et al., 2004). It places strong emphasis on cognitive correction of erroneous beliefs about gambling and also focuses on coping skills training and relapse prevention. CBT also lasts 12 weekly sessions.

Experimental: CMBT

We used the NIMH-funded R21 mechanism to develop and test the CMBT intervention (Wulfert et al., 2003, 2005; 2006). Treatment will be implemented in 12 weekly sessions (3 motivational enhancement sessions, 8 sessions of cognitive-behavioral treatment, 1 session of relapse prevention)

Behavioral: CMBT
We used the NIMH-funded R21 mechanism to develop and test the CMBT intervention (Wulfert et al., 2003, 2005; 2006). Treatment will be implemented in 12 weekly sessions (3 motivational enhancement sessions, 8 sessions of cognitive-behavioral treatment, 1 session of relapse prevention)

Outcome Measures

Primary Outcome Measures

  1. patient retention [60 weeks]

    Retention will be measured by the number of treatment sessions attended

Secondary Outcome Measures

  1. gambling behavior [60 weeks]

    Our primary measure will be money lost gambling. Secondary measures will include days gambled; scores on the PG-YBOCS, proportion of patients meeting diagnosis of PG and of those having achieved abstinence.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 New York Psychiatric Institute New York New York United States 10032

Sponsors and Collaborators

  • New York State Psychiatric Institute
  • National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Carlos Blanco, M.D., New York Psychiatric Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01135264
Other Study ID Numbers:
  • #5946/6970R
  • 1R01MH082773-01A1
  • 1R01MH082733-01A1
First Posted:
Jun 2, 2010
Last Update Posted:
Mar 24, 2017
Last Verified:
Jan 1, 2017
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 24, 2017