Cognitive Behavioral Treatment for Post-Traumatic Stress Disorder in People With Additional Serious Mental Illnesses
Cognitive Behavioral Treatment of Post-Traumatic Stress Disorder in Clients With Severe Mental Illness (in New Jersey)
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Post-traumatic stress disorder (PTSD) is an anxiety disorder that can develop after experiencing a terrifying event or ordeal in which grave physical harm occurred or was threatened. People with PTSD have persistent frightening thoughts and memories about the traumatic event and may experience sleep problems, feel detached or numb, or be easily startled. Studies have shown that PTSD occurs at high rates among people with serious mental illnesses (SMI), such as bipolar disorder, schizophrenia, and major depression. Research has also proven that cognitive behavioral therapy (CBT) is an effective PTSD treatment for caucasians living in rural areas when it is administered by a PhD-level clinician. It is not clear, however, how successful this treatment will be when it is delivered to a minority population by frontline mental health clinicians in an urban setting. This study will evaluate the effectiveness of tailored CBT in treating PTSD in people with additional mental illnesses who live in urban areas of New Jersey.
Participants in this 4- to 5-month open-label study will be randomly assigned to receive either brief PTSD treatment or CBT. Participants assigned to brief PTSD treatment will have three meetings with a therapist per week. Participants will learn about PTSD, how symptoms may be affecting their lives, and a technique for reducing anxiety associated with PTSD. Participants assigned to CBT will attend 12 to 16 counseling sessions per week or every other week. Participants will learn about PTSD and ways to decrease anxiety associated with PTSD by completing homework assignments and practicing skills learned in counseling sessions. Outcomes will be assessed for all participants through interviews that will occur immediately post-treatment, 6 months post-treatment, and 1 year post-treatment.
For information on a related study, please follow this link:
http://clinicaltrials.gov/show/NCT00053690
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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New Jersey
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Monmouth Junction, New Jersey, Estados Unidos, 08852
- United Behavioral HealthCare (UBHC): Partial Hospital Program
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New Brunswick, New Jersey, Estados Unidos, 08901
- University Behavioral HealthCare (UBHC) Adult Outpatient Psychiatric Services
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New Brunswick, New Jersey, Estados Unidos, 08901
- University Behavioral HealthCare (UBHC) Extended Treatment
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Newark, New Jersey, Estados Unidos, 07101
- University Behavioral HealthCare (UBHC) Extended Treatment Division - Adult Outpatient Psychiatric Services
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Newark, New Jersey, Estados Unidos, 07101
- University Behavioral HealthCare (UBHC) Extended Treatment Division - Partial Hospital Program
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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:
- Meets New Jersey definition of severe mental illness (SMI), which includes a DSM-IV diagnosis of an SMI; within the 3 to 6 months prior to study entry, functional limitations in major life activities that would be appropriate for the client's developmental stage; and within 2 years prior to study entry, two or more treatment episodes of greater intensity than outpatient services (such as inpatient, emergency, or partial hospitalization care, or a single episode lasting 3 months or more) OR a normal living situation disrupted to the point that supportive services were required to maintain the patient in their home or residence, or law enforcement officials were required to intervene
- DSM-IV Axis I diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depression (as determined by Structured Clinical Interview)
- Diagnosis of current severe PTSD at baseline assessment (as determined by a score greater than 65 on a Clinician Administered PTSD Scale)
- Speaks English
Exclusion Criteria:
- Current diagnosis of alcohol or drug dependence
- Hospitalization or suicide attempt in the past 2 months
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 |
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Experimental: 1
Participants will receive cognitive behavioral therapy.
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CBT will include 12 to 16 counseling sessions, occurring weekly or every other week.
Participants will learn about PTSD and ways to decrease anxiety associated with PTSD by completing homework assignments and practicing skills learned in counseling sessions.
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Comparador Ativo: 2
Participants will receive brief PTSD treatment.
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Brief PTSD treatment will include three weekly meetings with a therapist.
Participants will learn about PTSD, how symptoms may be affecting their lives, and a technique for reducing anxiety associated with PTSD.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Knowledge of PTSD and effectiveness in correcting faulty, trauma-related beliefs
Prazo: Measured post-treatment and at 6- and 12-month follow-ups
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Measured post-treatment and at 6- and 12-month follow-ups
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Depression, anxiety, and other psychiatric symptoms
Prazo: Measured post-treatment and at 6- and 12-month follow-ups
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Measured post-treatment and at 6- and 12-month follow-ups
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PTSD diagnoses and symptom severity
Prazo: Measured post-treatment and at 6- and 12-month follow-ups
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Measured post-treatment and at 6- and 12-month follow-ups
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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Total cost for mental health and substance abuse treatment services utilization within the University Behavioral Health Care system
Prazo: Measured post-treatment and at 6- and 12-month follow-ups
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Measured post-treatment and at 6- and 12-month follow-ups
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Quality of life and community functioning
Prazo: Measured post-treatment and at 6- and 12-month follow-ups
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Measured post-treatment and at 6- and 12-month follow-ups
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Kim T. Mueser, PhD, Dartmouth-Hitchcock Medical Center
Publicações e links úteis
Publicações Gerais
- Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
- Mueser KT, Gottlieb JD, Xie H, Lu W, Yanos PT, Rosenberg SD, Silverstein SM, Duva SM, Minsky S, Wolfe RS, McHugo GJ. Evaluation of cognitive restructuring for post-traumatic stress disorder in people with severe mental illness. Br J Psychiatry. 2015 Jun;206(6):501-8. doi: 10.1192/bjp.bp.114.147926. Epub 2015 Apr 9.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (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
- R01MH064662-02 (Concessão/Contrato do NIH dos EUA)
- DSIR 83-ATIT
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Ensaios clínicos em Cognitive behavioral therapy (CBT)
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The University of Hong KongChinese University of Hong Kong; University of Oxford; Flinders UniversityRecrutamentoInsônia | Fase de sono atrasadaHong Kong