- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00872118
Brief Intervention for Socially Anxious College Drinkers (BISAD)
Brief Intervention for Socially Anxious Alcohol Abusers
Visão geral do estudo
Status
Descrição detalhada
Episodic alcohol abuse is common among college students. Recently, brief interventions focusing on motivational strategies and behavior skills to reduce heavy drinking and alcohol-related problems have shown beneficial small to medium effects in college drinkers who reported heavy drinking and/or alcohol-related problems. Most interventions have not taken into account psychiatric comorbidity, in particular social anxiety, a frequent problem for college students that has been linked to excessive alcohol use. This project will extend knowledge on brief interventions by integrating cognitive-behavioral therapeutic strategies for social anxiety with an existing alcohol intervention designed for college students.
The efficacy of a new integrated treatment, the Brief Intervention for Socially Anxious Drinkers (BISAD) was developed and tested. All participants reported heavy alcohol use, alcohol-related problems and social anxiety based on standardized measures. Phase I of the study focused on the development of the treatment manuals and measures of therapy integrity for BISAD and an alcohol-focused intervention, a modified treatment-as-usual at the local university. During this phase therapists were trained to administer the manualized interventions to study participants (N=12). Phase II included further refinement of the therapy integrity measures and data collection for the pilot study (N=41). Participants were randomized to either BISAD (n=21) or a modified treatment-as-usual (n=20) condition. The pilot study provide preliminary data on the efficacy of the proposed intervention in reducing heavy drinking, social anxiety, and their negative consequences at 1-month and 4-month follow-ups after treatment termination. These data provide estimated effect sizes for future testing of BISAD in a full-scale clinical trial. Furthermore, the study results contribute to the conceptualization and methodological development of combined interventions for other substance use and psychiatric problems.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 1
Contactos e Locais
Locais de estudo
-
-
Ohio
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Cincinnati, Ohio, Estados Unidos, 45221-0376
- Psychology Department, University of Cincinnati
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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:
- at least one heavy drinking episode (4 or more drinks for women and 5 or more for men)
- occasional to frequent drinking related problems
- moderate social anxiety symptoms
Exclusion Criteria:
- history of schizophrenia, bipolar disorder, organic brain syndrome or mental retardation
- current illicit substance dependence, severe alcohol dependence, anxiety disorders (except simple phobia), unipolar depression, major medical illness, pregnancy, suicidality, or homicidality
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 1
Brief Intervention for Socially Anxious Drinkers
|
integrated alcohol and social anxiety individual intervention
|
|
Comparador Ativo: 2
Enhanced Alcohol Skills and Education Program
|
alcohol-focused group intervention
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
heavy drinking days
Prazo: pre-treatment, 1-month follow-up and 4-month follow-up
|
pre-treatment, 1-month follow-up and 4-month follow-up
|
|
total alcohol consumption
Prazo: pre-treatment, 1-month follow-up and 4-month follow-up
|
pre-treatment, 1-month follow-up and 4-month follow-up
|
|
drinking-related negative consequences
Prazo: pre-treatment, 1-month follow-up and 4-month follow-up
|
pre-treatment, 1-month follow-up and 4-month follow-up
|
|
social (interactional) anxiety
Prazo: pre-treatment, 1-month follow-up and 4-month follow-up
|
pre-treatment, 1-month follow-up and 4-month follow-up
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
alcohol expectancies of social evaluative situations
Prazo: pre-treatment, 1-month follow-up and 4-month follow-up
|
pre-treatment, 1-month follow-up and 4-month follow-up
|
|
drink refusal self-efficacy in social situations
Prazo: pre-treatment, 1-month follow-up and 4-month follow-up
|
pre-treatment, 1-month follow-up and 4-month follow-up
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Giao Q. Tran, Ph.D., University of Cincinnati
Publicações e links úteis
Publicações Gerais
- Tran, G.Q. (2008). Efficacy of a brief intervention for college hazardous drinkers with social anxiety: A randomized controlled pilot study. Alcoholism: Clinical and Experimental Research, 32 (Supplement), 190A.
- Tran, G.Q., Lanman, S.A., Perciful, M.S., Thompson, R.D., & Smith, J.P. (2006). Promising inexpensive methods for recruiting college-age heavy drinkers for brief alcohol and social anxiety interventions. Alcoholism: Clinical and Experimental Research, 30 (Supplement), 101A.
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 (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- NIAAA-Tran-AA014014
- R21AA017291 (Concessão/Contrato do NIH dos EUA)
- NIH Grant R21AA014014
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