- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01135264
Cognitive-Motivational Behavior Therapy for Pathological Gamblers
Gambling Addiction: Treatment Mediators and Moderators
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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New York
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New York, New York, Estados Unidos, 10032
- New York Psychiatric Institute
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: 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.
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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.
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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)
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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)
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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patient retention
Prazo: 60 weeks
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Retention will be measured by the number of treatment sessions attended
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60 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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gambling behavior
Prazo: 60 weeks
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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.
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60 weeks
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Carlos Blanco, M.D., New York Psychiatric Institute
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- #5946/6970R
- 1R01MH082773-01A1 (Concessão/Contrato do NIH dos EUA)
- 1R01MH082733-01A1 (Concessão/Contrato do NIH dos EUA)
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