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Mood and Smoking: A Comparison of Smoking Cessation Treatments

25 de junho de 2015 atualizado por: US Department of Veterans Affairs

CSP #725 - Mood and Smoking: A Comparison of Smoking Cessation Treatments

Objectives:

The long term objectives of this research program are:

  1. To advance the mission of the VHA Boston Healthcare System to deliver comprehensive quality healthcare that meets the needs of patients (in this case, who have been unresponsive to standard smoking cessation treatment) through research and clinical care.
  2. To expand upon our knowledge of the feasibility and effectiveness of commonly-used treatments for nicotine dependence.
  3. To further explore variables related to mood and coping that may contribute to or prevent successful reduction and cessation of smoking behavior among veterans.

The short-term objectives of this project are:

  1. To evaluate the feasibility and effectiveness of two adjunctive treatments (a mood-focused exposure-based treatment, Mood Tolerance, with Nicotine Replacement Therapy [MTNRT] and mood-focused affect-management treatment, Mood Management, with Nicotine Replacement Therapy [MMNRT]) aimed at reduction and cessation of smoking behavior among veterans who were previously non-responders to smoking cessation treatment in the VA.
  2. To inform equivocal findings in the literature regarding the role of mood as trigger for smoking behavior.
  3. To explore selected mood, coping, and individual difference variable that may be predictive of successful abstinence from cigarettes among veterans.

Visão geral do estudo

Descrição detalhada

Objectives:

The short-term objectives of this project are:

  1. To evaluate the effectiveness of two adjunctive treatments (mood-focused exposure-based treatment, Mood Tolerance, with Nicotine Replacement Therapy [MT-NRT] and mood-focused affect-management treatment, Mood Management, with NRT [MM-NRT] aimed at reduction and cessation of smoking behavior among veterans who were previously non-responders to smoking cessation treatment.
  2. To examine specific variables that may serve as mechanisms of action for successful treatment (i.e., mood and coping variables).

The long-term objectives of this research program are:

  1. To advance the mission of the VA to deliver comprehensive quality healthcare that meets the needs of patients who have been unresponsive to standard smoking cessation treatment, through research and clinical care.
  2. To reduce the exorbitant healthcare costs of nicotine dependence (ND) to the VA, and to improve veterans' physical and psychological well-being, healthcare utilization, and mortality rates.
  3. To evaluate effectiveness of common treatments for ND.
  4. To explore mechanisms of action related to efficacy of treatment for ND among veterans (i.e., changes in mood and coping.)

Research Design:

This is a two-cell, single-blind, randomized, treatment outcome study.

Methodology:

One hundred and twenty-eight smoking outpatients who have previously participated in standard group smoking cessation treatment (treatment non-responders, with NRT) will be recruited through the VA Boston Outpatient Health Psychology Clinic. Advertising flyers posted throughout the Boston VA Medical Center and Outpatient Clinic will be used to supplement this recruitment.

Baseline Assessment:

Interested and eligible patients will sign an informed consent form, which will be thoroughly reviewed with each participant and co-signed by the investigators. Baseline evaluation of the participants will take approximately 90 minutes. This evaluation will include assessment of smoking-related variables, moods, and affect-regulation and coping strategies, as well as carbon monoxide (CO) levels in expired breath.

Treatment:

Participants will be randomly assigned to one of the two treatments. This will involve meeting with a pharmacist, primary care physician, psychiatrist, or nurse practitioner to be screened for use of nicotine replacement therapy (NRT; transdermal patch) and to initiate NRT use. A member of the research team will continue to monitor the participant's physical health during the course of the treatment. In addition, the participant will attend treatment groups once a week for 15 weeks. These treatment groups will be conducted by a member of the research team or clinical students supervised by the PI. Each of these groups will last 90 minutes.

Follow-Up:

The first follow-up appointment will take place in the week after completion of the treatment. Additional follow-up assessments will take place at 3-, 6-, 9-, and 12-months subsequent to the first follow-up appointment. These assessments will be almost identical to the baseline assessment, and will last approximately 90 minutes.

Findings:

Thirty-four participants have been enrolled in this study; 12 of whom are currently actively involved in the protocol. No data have been analyzed or presented yet.

Tipo de estudo

Intervencional

Inscrição

128

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02103
        • Boston VA Healthcare System

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Outpatient veteran smokers who have previously failed a smoking cessation treatment program with nicotine replacement therapy

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Solteiro

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de março de 2003

Conclusão do estudo

1 de março de 2006

Datas de inscrição no estudo

Enviado pela primeira vez

12 de janeiro de 2004

Enviado pela primeira vez que atendeu aos critérios de CQ

13 de janeiro de 2004

Primeira postagem (Estimativa)

14 de janeiro de 2004

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

26 de junho de 2015

Última atualização enviada que atendeu aos critérios de controle de qualidade

25 de junho de 2015

Última verificação

1 de junho de 2015

Mais Informações

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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