- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00122109
Telemedicine and Anger Management Groups With PTSD Veterans in the Hawaiian Islands
Telemedicine and Anger Management Groups for PTSD Veterans in the Hawaiian Islands
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Hawaii
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Honolulu, Hawaii, Estados Unidos, 96819-1522
- VA Pacific Islands Health Care System, Honolulu, HI
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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:
- male
- PTSD diagnosis
- anger level at Staxi Trait Score=22 or higher
- stable medication regime
Exclusion Criteria:
- current substance dependence
- current psychosis
- suicidal
- homicidal
- cognitive impairment
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: Videoteleconferencing AMT
The experimental arm is the group condition that received the AMT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality. Behavioral: 12 sessions Anger Management Therapy. Anger Management Treatment (AMT), a 12-session manual-driven cognitive-behavioral intervention developed and found efficacious for anger management treatment with substance abuse veterans and has been applied to the PTSD population. AMT is highly structured with both psychoeducational and psychotherapy components. AMT is aimed at reducing anger affect and aggression through increasing anger management skills. |
Anger Management Treatment (AMT), a 12-session manual-driven cognitive-behavioral intervention developed and found efficacious for anger management treatment with substance abuse veterans and has been applied to the PTSD population.
AMT is highly structured with both psychoeducational and psychotherapy components.
AMT is aimed at reducing anger affect and aggression through increasing anger management skills.
Outros nomes:
|
Comparador Ativo: Face to Face AMT
The control arm is the group condition that received the AMT treatment intervention via a traditional face-to-face modality as compared to the experimental condition which is the videoteleconferencing modality. Behavioral: 12 sessions Anger Management Therapy. Anger Management Treatment (AMT), a 12-session manual-driven cognitive-behavioral intervention developed and found efficacious for anger management treatment with substance abuse veterans and has been applied to the PTSD population. AMT is highly structured with both psychoeducational and psychotherapy components. AMT is aimed at reducing anger affect and aggression through increasing anger management skills. |
Anger Management Treatment (AMT), a 12-session manual-driven cognitive-behavioral intervention developed and found efficacious for anger management treatment with substance abuse veterans and has been applied to the PTSD population.
AMT is highly structured with both psychoeducational and psychotherapy components.
AMT is aimed at reducing anger affect and aggression through increasing anger management skills.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
State-Trait Anger Inventory (STAXI-2) Anger Expression Index
Prazo: Baseline
|
Anger expression was measured using the STAXI-2's 32-item Anger Expression Index (range 0 - 96).
The STAXI-2 subscale have robust psychometric properties including high internal consistency, external validity, and construct validity.
The Anger Expression Index provides a general measure of anger expression; assessing one's experience, expression and efforts to control anger.
Higher scores indicate more problematic levels of anger and its expression.
|
Baseline
|
State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale
Prazo: Post-treatment (2 weeks following last treatment session)
|
Anger expression was measured using the STAXI-2's 32-item Anger Expression Index (range 0 - 96).
The STAXI-2 subscale have robust psychometric properties including high internal consistency, external validity, and construct validity.
The Anger Expression Index provides a general measure of anger expression; assessing one's experience, expression and efforts to control anger.
Higher scores indicate more problematic levels of anger and its expression.
|
Post-treatment (2 weeks following last treatment session)
|
State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale
Prazo: 3-month Follow Up
|
Anger expression was measured using the STAXI-2's 32-item Anger Expression Index (range 0 - 96).
The STAXI-2 subscale have robust psychometric properties including high internal consistency, external validity, and construct validity.
The Anger Expression Index provides a general measure of anger expression; assessing one's experience, expression and efforts to control anger.
Higher scores indicate more problematic levels of anger and its expression.
|
3-month Follow Up
|
State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale
Prazo: 6-month Follow Up
|
Anger expression was measured using the STAXI-2's 32-item Anger Expression Index (range 0 - 96).
The STAXI-2 subscale have robust psychometric properties including high internal consistency, external validity, and construct validity.
The Anger Expression Index provides a general measure of anger expression; assessing one's experience, expression and efforts to control anger.
Higher scores indicate more problematic levels of anger and its expression.
|
6-month Follow Up
|
Novaco Anger Scale (NAS)
Prazo: Baseline
|
Anger disposition was assessed using the total scale score from the Novaco Anger Scale.
This 60-item measure (range = 60 - 180) is a well validated self-report instrument designed to measure cognitive, arousal, and behavioral aspects of anger in both clinical and non-patient populations.
Higher scores indicate more anger-related symptoms.
|
Baseline
|
Novaco Anger Scale (NAS)
Prazo: Post-treatment (2 weeks following last treatment session)
|
Anger disposition was assessed using the total scale score from the Novaco Anger Scale.
This 60-item measure (range = 60 - 180) is a well validated self-report instrument designed to measure cognitive, arousal, and behavioral aspects of anger in both clinical and non-patient populations.
Higher scores indicate more anger-related symptoms.
|
Post-treatment (2 weeks following last treatment session)
|
Novaco Anger Scale (NAS)
Prazo: 3-Month Follow Up
|
Anger disposition was assessed using the total scale score from the Novaco Anger Scale.
This 60-item measure (range = 60 - 180) is a well validated self-report instrument designed to measure cognitive, arousal, and behavioral aspects of anger in both clinical and non-patient populations.
Higher scores indicate more anger-related symptoms.
|
3-Month Follow Up
|
Novaco Anger Scale (NAS)
Prazo: 6-Month Follow Up
|
Anger disposition was assessed using the total scale score from the Novaco Anger Scale.
This 60-item measure (range = 60 - 180) is a well validated self-report instrument designed to measure cognitive, arousal, and behavioral aspects of anger in both clinical and non-patient populations.
Higher scores indicate more anger-related symptoms.
|
6-Month Follow Up
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
PTSD Checklist-military Version (PCL-M)
Prazo: Baseline
|
Self report that measures severity of PTSD symptoms.
The PCL-M measures the 17 cardinal symptoms of PTSD as described in the DSM-IV-TR.
The scale ranges from 0 - 85 with higher scores indicating worse PTSD symptoms.
PTSD symptoms were measured at baseline and post-treatment only.
|
Baseline
|
PTSD Checklist-military Version (PCL-M)
Prazo: Post-treatment (2 weeks following last treatment session)
|
Self report that measures severity of PTSD symptoms.
The PCL-M measures the 17 cardinal symptoms of PTSD as described in the DSM-IV-TR.
The scale ranges from 0 - 85 with higher scores indicating worse PTSD symptoms.
PTSD symptoms were measured at baseline and post-treatment only.
|
Post-treatment (2 weeks following last treatment session)
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- Greene CJ, Morland LA, Durkalski VL, Frueh BC. Noninferiority and equivalence designs: issues and implications for mental health research. J Trauma Stress. 2008 Oct;21(5):433-9. doi: 10.1002/jts.20367.
- Greene CJ, Morland LA, Macdonald A, Frueh BC, Grubbs KM, Rosen CS. How does tele-mental health affect group therapy process? Secondary analysis of a noninferiority trial. J Consult Clin Psychol. 2010 Oct;78(5):746-50. doi: 10.1037/a0020158.
- Morland LA, Greene CJ, Rosen CS, Foy D, Reilly P, Shore J, He Q, Frueh BC. Telemedicine for anger management therapy in a rural population of combat veterans with posttraumatic stress disorder: a randomized noninferiority trial. J Clin Psychiatry. 2010 Jul;71(7):855-63. doi: 10.4088/JCP.09m05604blu. Epub 2010 Jan 26.
- Gros DF, Gros K, Acierno R, Frueh BC, Moreland L. Relation between treatment satisfaction and treatment outcome in veterans with posttraumatic stress disorder. Journal of psychopathology and behavioral assessment. 2013 Jun 28; 35(4):522-30.
- Macdonald A, Greene CJ, Torres JG, Frueh BC, Morland LA. Concordance between clinician-assessed and self-report ratings of posttraumatic stress disorder across three ethnoracial groups. Psychological trauma : theory, research, practice and policy. 2012 Jan 1; 24:doi: 10.1037/a0027313.
- Morland LA, Greene CJ, Grubbs K, Kloezeman K, Mackintosh MA, Rosen C, Frueh BC. Therapist adherence to manualized cognitive-behavioral therapy for anger management delivered to veterans with PTSD via videoconferencing. J Clin Psychol. 2011 Jun;67(6):629-38. doi: 10.1002/jclp.20779. Epub 2011 Feb 25.
- Mackintosh MA, Morland LA, Kloezeman K, Greene CJ, Rosen CS, Elhai JD, Frueh BC. Predictors of anger treatment outcomes. J Clin Psychol. 2014 Oct;70(10):905-13. doi: 10.1002/jclp.22095. Epub 2014 Apr 17.
- Morland LA, Raab M, Mackintosh MA, Rosen CS, Dismuke CE, Greene CJ, Frueh BC. Telemedicine: a cost-reducing means of delivering psychotherapy to rural combat veterans with PTSD. Telemed J E Health. 2013 Oct;19(10):754-9. doi: 10.1089/tmj.2012.0298. Epub 2013 Aug 9.
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- TEL 03-080
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Ensaios clínicos em 12 sessions Anger Management Therapy.
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naomi goldsteinNational Institute of Mental Health (NIMH)Concluído