Cognitive-Motivational Behavior Therapy for Pathological Gamblers

NCT ID: NCT01135264

Last Updated: 2017-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2016-06-30

Brief Summary

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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

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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.

Conditions

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Pathological Gambling

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

CBT

Intervention Type BEHAVIORAL

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.

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)

Group Type EXPERIMENTAL

CMBT

Intervention Type BEHAVIORAL

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)

Interventions

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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.

Intervention Type 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)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carlos Blanco, M.D.

Role: PRINCIPAL_INVESTIGATOR

New York Psychiatric Institute

Locations

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New York Psychiatric Institute

New York, New York, United States

Site Status

Countries

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United States

References

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Blanco C, Potenza MN, Kim SW, Ibanez A, Zaninelli R, Saiz-Ruiz J, Grant JE. A pilot study of impulsivity and compulsivity in pathological gambling. Psychiatry Res. 2009 May 15;167(1-2):161-8. doi: 10.1016/j.psychres.2008.04.023. Epub 2009 Apr 1.

Reference Type BACKGROUND
PMID: 19339053 (View on PubMed)

Blanco C, Hasin DS, Petry N, Stinson FS, Grant BF. Sex differences in subclinical and DSM-IV pathological gambling: results from the National Epidemiologic Survey on Alcohol and Related Conditions. Psychol Med. 2006 Jul;36(7):943-53. doi: 10.1017/S0033291706007410. Epub 2006 May 2.

Reference Type BACKGROUND
PMID: 16650342 (View on PubMed)

Okuda M, Balan I, Petry NM, Oquendo M, Blanco C. Cognitive-behavioral therapy for pathological gambling: cultural considerations. Am J Psychiatry. 2009 Dec;166(12):1325-30. doi: 10.1176/appi.ajp.2009.08081235.

Reference Type BACKGROUND
PMID: 19952084 (View on PubMed)

Wulfert E, Blanchard EB, Freidenberg BM, Martell RS. Retaining pathological gamblers in cognitive behavior therapy through motivational enhancement: A pilot study. Behav Modif. 2006 May;30(3):315-40. doi: 10.1177/0145445503262578.

Reference Type BACKGROUND
PMID: 16574817 (View on PubMed)

Wulfert E, Maxson J, Jardin B. Cue-specific reactivity in experienced gamblers. Psychol Addict Behav. 2009 Dec;23(4):731-5. doi: 10.1037/a0017134.

Reference Type BACKGROUND
PMID: 20025381 (View on PubMed)

Wulfert E, Franco C, Williams K, Roland B, Maxson JH. The role of money in the excitement of gambling. Psychol Addict Behav. 2008 Sep;22(3):380-390. doi: 10.1037/0893-164X.22.3.380.

Reference Type BACKGROUND
PMID: 18778131 (View on PubMed)

Other Identifiers

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1R01MH082773-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R01MH082733-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

#5946/6970R

Identifier Type: -

Identifier Source: org_study_id

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