- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01135264
Cognitive-Motivational Behavior Therapy for Pathological Gamblers
Gambling Addiction: Treatment Mediators and Moderators
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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New York
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New York, New York, États-Unis, 10032
- New York Psychiatric Institute
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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.
|
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.
|
|
Expérimental: 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)
|
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)
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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patient retention
Délai: 60 weeks
|
Retention will be measured by the number of treatment sessions attended
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60 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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gambling behavior
Délai: 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.
|
60 weeks
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Carlos Blanco, M.D., New York Psychiatric Institute
Publications et liens utiles
Publications générales
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- #5946/6970R
- 1R01MH082773-01A1 (Subvention/contrat des NIH des États-Unis)
- 1R01MH082733-01A1 (Subvention/contrat des NIH des États-Unis)
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