- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00105911
A Cognitive-Behavioral Intervention for Depression and Anxiety in COPD
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Background:
The literature and our preliminary studies found that in COPD patients, psychosocial factors affect quality of life (QOL) and functioning more than would be expected given the severity of their disease. To improve QOL and functioning in the approximately 50% of COPD patients with significant anxiety and/or depressive symptoms, interventions are needed. Much research documents the utility of cognitive behavioral therapy (CBT) in treating depression and anxiety, showing it to have promise as a self-management intervention to improve QOL in COPD patients.
Objectives:
Objectives were to compare CBT for anxiety and depression with COPD education for COPD patients with moderate-to-severe anxiety and/or depressive symptoms.
Methods:
Veterans were recruited from VAMC clinics and through press releases. Two hundred and thirty-eight COPD patients with comorbid anxiety and/or depressive symptoms were randomized to either 8 weeks of CBT/usual care or 8 weeks of COPD Education/usual care. We hypothesized that COPD patients receiving CBT/usual care would improve more than COPD patients receiving COPD Education/usual care. Improvement was defined as increased disease-specific QOL, generic QOL, and 6-minute walk distance; and decreased depression, anxiety, and health service use. Outcomes were examined pre-, mid- and post-treatment and at 4, 8 and 12 months.
Status:
The study was scheduled to officially end December 31, 2005, but was granted a no-cost extension by HSR&D to complete data analyses and prepare final papers. The extension was granted through June 30, 2006. As of the date of this final report, the study is complete.
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Texas
-
Houston, Texas, Estados Unidos, 77030
- Michael E. DeBakey VA Medical Center, Houston, TX
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
Moderate depression or anxiety, COPD
Exclusion Criteria:
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Outro: Braço 1
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mark E. Kunik, MD MPH, Michael E. DeBakey VA Medical Center, Houston, TX
Publicações e links úteis
Publicações Gerais
- Maurer J, Rebbapragada V, Borson S, Goldstein R, Kunik ME, Yohannes AM, Hanania NA; ACCP Workshop Panel on Anxiety and Depression in COPD. Anxiety and depression in COPD: current understanding, unanswered questions, and research needs. Chest. 2008 Oct;134(4 Suppl):43S-56S. doi: 10.1378/chest.08-0342.
- Kunik ME, Veazey C, Cully JA, Souchek J, Graham DP, Hopko D, Carter R, Sharafkhaneh A, Goepfert EJ, Wray N, Stanley MA. COPD education and cognitive behavioral therapy group treatment for clinically significant symptoms of depression and anxiety in COPD patients: a randomized controlled trial. Psychol Med. 2008 Mar;38(3):385-96. doi: 10.1017/S0033291707001687. Epub 2007 Oct 9.
- Kunik ME, Azzam PN, Souchek J, Cully JA, Wray NP, Krishnan LL, Nelson HA, Stanley MA. A practical screening tool for anxiety and depression in patients with chronic breathing disorders. Psychosomatics. 2007 Jan-Feb;48(1):16-21. doi: 10.1176/appi.psy.48.1.16.
- Cully JA, Graham DP, Stanley MA, Kunik ME. Depressed and Anxious COPD Patients: Predictors of Psychotherapy Engagement from a Clinical Trial. Journal of Clinical Psychology in Medical Settings. 2007 Jan 1; 14:160-164.
- Kraus CA, Kunik ME, Stanley MA. Use of cognitive behavioral therapy in late-life psychiatric disorders. Geriatrics. 2007 Jun;62(6):21-6.
- Burgess A, Kunik ME, Stanley MA. Chronic obstructive pulmonary disease: assessing and treating psychological issues in patients with COPD. Geriatrics. 2005 Dec;60(12):18-21. No abstract available.
- Roundy K, Cully JA, Stanley MA, Veazey C, Souchek J, Wray NP, Kunik ME. Are anxiety and depression addressed in primary care patients with chronic obstructive pulmonary disease? A chart review. Prim Care Companion J Clin Psychiatry. 2005;7(5):213-8. doi: 10.4088/pcc.v07n0501.
- Kunik ME, Roundy K, Veazey C, Souchek J, Richardson P, Wray NP, Stanley MA. Surprisingly high prevalence of anxiety and depression in chronic breathing disorders. Chest. 2005 Apr;127(4):1205-11. doi: 10.1378/chest.127.4.1205.
- Stanley MA, Veazey C, Hopko D, Diefenback G, Kunik ME. Anxiety and Depression in chronic obstructive pulmonary disease: a new intervention and case report. Cognitive and behavioral practice. 2005 Dec 1; 12(4):424-436.
- Cully JA, Graham DP, Stanley MA, Ferguson CJ, Sharafkhaneh A, Souchek J, Kunik ME. Quality of life in patients with chronic obstructive pulmonary disease and comorbid anxiety or depression. Psychosomatics. 2006 Jul-Aug;47(4):312-9. doi: 10.1176/appi.psy.47.4.312.
- Ferguson CJ, Stanley M, Souchek J, Kunik ME. The utility of somatic symptoms as indicators of depression and anxiety in military veterans with chronic obstructive pulmonary disease. Depress Anxiety. 2006;23(1):42-9. doi: 10.1002/da.20136.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
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
- IIR 00-097
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 .
Ensaios clínicos em Terapia cognitiva comportamental
-
Florida International UniversityAinda não está recrutandoTranstorno de Déficit de Atenção e HiperatividadeEstados Unidos
-
Pamukkale UniversityConcluído
-
University of PennsylvaniaRescindidoInfecção Recorrente por Clostridium DifficileEstados Unidos
-
Square2 Systems, Inc.National Institute on Drug Abuse (NIDA)RecrutamentoTranstornos Relacionados a Substâncias | Transtornos por Uso de SubstânciasEstados Unidos
-
Azienda Ospedaliera Universitaria Integrata VeronaConcluído
-
University of Roma La SapienzaConcluídoFalha no implante dentário | Mucosite OralItália
-
University of Applied Sciences and Arts of Southern...Vrije Universiteit Brussel; Universiteit Antwerpen; THIM - die internationale...Concluído
-
NeuroTronik Inc.DesconhecidoInsuficiência Cardíaca AgudaPanamá
-
CellMedX CorporationNutrasource Pharmaceutical and Nutraceutical Services, Inc.Concluído
-
Columbia UniversityRescindido