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Pathological GamblingNCT01135264

Cognitive-Motivational Behavior Therapy for Pathological Gamblers

A study testing CBT and CMBT in people with Pathological Gambling, run by New York State Psychiatric Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pathological Gambling
What is being tested?
CBT and CMBT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
1 siteUnited States
Study dates
Aug 2009to Jun 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • New York Psychiatric Institute

    New York, New York, 10032

Other trials in United States

About this study

Official title: Gambling Addiction: Treatment Mediators and Moderators

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).

Read the 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.

Being tested
CBT, CMBT
Medical subject headings
Gambling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CBTBehavioural

    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.

  • CMBTBehavioural

    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)

Study groups in NCT01135264
Study groupRoleWhat they receive
CBTActive comparatorThe 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.
Receives: Behavioral: CBT
CMBTExperimentalWe 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)
Receives: Behavioral: CMBT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. patient retention

    Retention will be measured by the number of treatment sessions attended

    Measured: 60 weeks

Secondary outcomes (1)

  1. gambling behavior

    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.

    Measured: 60 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2010 (estimated)
  2. Study startAug 2009
  3. Primary completionJun 2016
  4. Study completionJun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01135264
Sponsor's protocol ID
#5946/6970R
Other IDs
1R01MH082773-01A1, 1R01MH082733-01A1
Status last verified
Jan 2017
First submitted
1 Jun 2010
Last updated
24 Mar 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19339053

  • 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.

    PubMed 16650342

  • 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.

    PubMed 19952084

  • 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.

    PubMed 16574817

  • 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.

    PubMed 20025381

  • 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.

    PubMed 18778131

Questions about this trial

What is this clinical trial studying?

A study testing CBT and CMBT in people with Pathological Gambling, run by New York State Psychiatric Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

patient retention (time frame: 60 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01135264, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2017.

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