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Innovative Service Delivery for Secondary Prevention of PTSD

11 de setembro de 2015 atualizado por: Charleston Research Institute

Innovative Service Delivery for Secondary Prevention of PTSD in At-Risk OIF-OEF Service Men and Women

The purpose of this study is to determine whether therapy for Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) veterans with Post-traumatic Stress Disorder (PTSD) symptoms can be delivered effectively using videoconferencing technology ("telepsychology"), which allows a therapist and patient who are not in the same room as one another to communicate.

Visão geral do estudo

Status

Concluído

Condições

Descrição detalhada

OIF and OEF service men and women exposed to high levels of violence are at risk for developing mental health disorders including Post-traumatic Stress Disorder (PTSD) and Major Depressive Disorder (MDD). Even those with less severe symptoms who fail to meet diagnostic criteria for a mental health disorder may struggle to return to pre-deployment functioning. Studies suggest that a significant percentage of veterans may suffer from "subthreshold" PTSD; although their symptom presentation is less severe, these veterans experience emotional distress and reduced quality of life.

Given that Veterans Affairs (VA) mental-health service providers are faced with the important and challenging task of alleviating the emotional suffering of our service men and women while staying within budget confines, we need effective, practical, evidence-based treatments that can be delivered in an expedient and cost-effective manner. Thus, the current project has two primary objectives: 1) to develop, implement, and evaluate a treatment program (Behavioral Activation and Therapeutic Exposure, BATE) for OIF and OEF veterans with PTSD symptoms, and 2) to determine whether or not this program delivered via telepsychology will be as effective as in-person treatment. Secondary objectives include determining: 1) which treatment modality is more effective in terms of process variables (e.g., treatment satisfaction, session attendance), 2) which treatment modality is more cost-effective, and 3) whether treatment effects differ across race and gender. Study participants will be randomized to two treatment conditions, BATE delivered via telepsychology (BATE-T) and BATE delivered in-person (BATE-IP).

The current treatment protocol is based on two, research-supported therapeutic rationales, Behavioral Activation (BA) and Therapeutic Exposure (TE). Briefly, the treatment aims to increase the participant's engagement in healthy activities (i.e., activities that are naturally reinforcing and promote the participant's life values) and exposure activities (i.e., activities that target specific PTSD symptoms such as avoidance and hyperarousal). Treatment will be implemented in eight, one and half hour sessions. Although research supports the effectiveness of behavior- and exposure-based treatments for trauma-related mental health problems, a potential risk for any counseling program that targets avoidance symptoms is a temporary increase in emotional distress. Therapists will inform participants that this is a normal "side effect" of treatment. However, over the course of treatment should a participant's emotional distress rise to a level above what can be handled via outpatient counseling, the participant will be removed from the study and appropriate referrals will be made.

The anticipated duration of this study is four years. Based on results of the study, we will finalize the treatment manual. In terms of clinical applicability, we plan to present study findings at conferences and disseminate the treatment manual to VA mental health service providers in approximately four to five years. Study findings will address important gaps in the PTSD literature, yielding several contributions to the field. First, to the extent that BATE effectively reduces symptom severity, this investigational treatment may benefit individual OIF/OEF service men and women by alleviating emotional suffering and improving quality of life. Second, to the extent that BATE prevents the development of full-blown PTSD in subclinical military personnel, this investigational treatment may reduce attrition from the military due to untreated mental health problems. Third, only a small percentage of those who might benefit from counseling actually seek services due to barriers associated with traditional service delivery practices such as geographic distance from the VA hospital and stigma of psychological treatment. Thus, as telemedicine has been shown to circumvent these barriers to care, the current project has the potential to reach an otherwise underserved population: subclinical OIF and OEF service men and women who may be reluctant to seek care. Fourth, to the extent that BATE-T produces results comparable to BATE-IP, this study may potentially identify a cost-effective alternative to in-person treatment thereby reducing post-service treatment costs to VA's.

Tipo de estudo

Intervencional

Inscrição (Real)

280

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

    • South Carolina
      • Charleston, South Carolina, Estados Unidos, 29403
        • Medical University of South Carolina
      • Charleston, South Carolina, Estados Unidos, 29403
        • Ralph H. Johnson VAMC

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

21 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Participants will be OIF/OEF military personnel,
  • age 21 and above, and
  • with symptoms of posttraumatic stress disorder (PTSD) assigned on the basis of the Clinician Administered PTSD Scale (CAPS) and PTSD Checklist-Military (PCL-M).

Exclusion Criteria:

  • Actively psychotic or demented persons,
  • individuals with both suicidal ideation and clear intent, and
  • individuals meeting criteria for substance dependence will be excluded from participation.

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

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: BATE-T
Behavioral Activation Therapeutic Exposure done while the patient is at home via videoconferencing technology
This intervention combines Behavior Activation Therapy and Exposure Therapy to treat PTSD symptoms.
Comparador Ativo: BATE-IP
Behavioral Activation Therapeutic Exposure done in the therapist's office
This intervention combines Behavior Activation Therapy and Exposure Therapy to treat PTSD symptoms.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
The major objective of this study is to determine if Behavioral Activation with Therapeutic Exposure (BATE) delivered via Telemedicine is as effective as BATE In Person.
Prazo: 1 year
This is measured in terms of (1) clinical (PTSD and Depression); (2) process (Treatment Satisfaction and Attrition); and (3) economic (Cost) outcomes.
1 year

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Inventário de Depressão de Beck-II (BDI-II)
Prazo: Linha de base
Linha de base
Inventário de Depressão de Beck-II (BDI-II)
Prazo: 3 meses
3 meses
Escala de TEPT administrado pelo médico (CAPS)
Prazo: 8 semanas
8 semanas
Clinician Administered PTSD Scale (CAPS)
Prazo: Baseline
Baseline
Clinician Administered PTSD Scale (CAPS)
Prazo: 3 months
3 months
Clinician Administered PTSD Scale (CAPS)
Prazo: 1 year
1 year
The Deployment Risk and Resiliency Inventory (DRRI)
Prazo: Baseline
Baseline
PTSD Checklist-Military (PCL-M)
Prazo: Baseline
Baseline
PTSD Checklist-Military (PCL-M)
Prazo: 4 weeks
4 weeks
PTSD Checklist-Military (PCL-M)
Prazo: 8 weeks
8 weeks
PTSD Checklist-Military (PCL-M)
Prazo: 3 months
3 months
PTSD Checklist-Military (PCL-M)
Prazo: 1 year
1 year
Beck Depression Inventory-II (BDI-II)
Prazo: 4 weeks
4 weeks
Beck Depression Inventory-II (BDI-II)
Prazo: 8 weeks
8 weeks
Beck Depression Inventory-II (BDI-II)
Prazo: 1 year
1 year
Health Related Functioning: Medical Outcome Study Short Study Forms-36 Health Survey (SF 36)
Prazo: Baseline
Baseline
Health Related Functioning: Medical Outcome Study Short Study Forms-36 Health Survey (SF 36)
Prazo: 4 weeks
4 weeks
Health Related Functioning: Medical Outcome Study Short Study Forms-36 Health Survey (SF 36)
Prazo: 8 weeks
8 weeks
Health Related Functioning: Medical Outcome Study Short Study Forms-36 Health Survey (SF 36)
Prazo: 3 months
3 months
Health Related Functioning: Medical Outcome Study Short Study Forms-36 Health Survey (SF 36)
Prazo: 1 year
1 year
Charleston Psychiatric Outpatient Satisfaction Scale (CPOSS-VA)
Prazo: 8 weeks
8 weeks
Service Delivery Perceptions Questionnaire
Prazo: 8 weeks
8 weeks
Prior Experience with Computer and Audiovisual Technology
Prazo: Baseline
Short measure to learn more about participants' prior experience and comfort level with computers and audiovisual technology
Baseline

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Ronald Acierno, PhD, VA Office of Research and Development

Publicações e links úteis

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Publicações Gerais

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 2008

Conclusão Primária (Real)

1 de agosto de 2014

Conclusão do estudo (Real)

1 de fevereiro de 2015

Datas de inscrição no estudo

Enviado pela primeira vez

12 de abril de 2010

Enviado pela primeira vez que atendeu aos critérios de CQ

5 de agosto de 2010

Primeira postagem (Estimativa)

9 de agosto de 2010

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

14 de setembro de 2015

Última atualização enviada que atendeu aos critérios de controle de qualidade

11 de setembro de 2015

Última verificação

1 de setembro de 2015

Mais Informações

Termos relacionados a este estudo

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