跳至主要内容
临床试验/NCT02362477
NCT02362477已完成3 期

Telemental Health and Cognitive Processing Therapy for Female Veterans With Military-related PTSD

VA Pacific Islands Health Care System2 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2010年9月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
126
试验地点
2
主要终点
Clinician Administered PTSD Scale (CAPS-IV)

研究概览

简要总结

The immediate objective of this project is to evaluate the clinical effectiveness of a telemental health modality (video-teleconferencing) for providing an evidence-based group intervention to female rural veterans, Reservists, National Guardsmen, and civilians suffering with PTSD. This study is an expansion, seeking to add a treatment arm of women, to an already CDMRP-funded study that completed in July 2014 treating male combat veterans with military-related PTSD. The long-term objective of this project is to disseminate an empirically sound TMH PTSD protocol for male and female veterans, Reserve and Guard that will extend the use of CPT to remote rural sites. It is hypothesized that using VTC, will be as effective as the in-person mode of service delivery for providing CPT.

详细描述

This expansion is a 4-year RCT, plus a 1 year no-cost extension, which provides a direct comparison of the VTC and in-person modalities using rigorous methodology and a sophisticated analysis of treatment equivalency in clinical and process outcome domains. Outcome domains include clinical and process outcomes. Approximately 154 female veterans, Reservists, National Guardsmen, or civilians with PTSD have been recruited from multiple VA clinical sites and community health centers (for N=110 completers). Consistent with the male combat veterans CPT study, prospective participants received a comprehensive assessment battery at baseline to determine eligibility. The exclusion criteria selected are consistent with large PTSD randomized clinical trials as well as research using the CPT protocol with military populations with PTSD. The treatment is delivered up to twice a week for up to 12 weeks by a doctoral level psychologist. Quality control procedures have been incorporated into the study's design to ensure integrity, fidelity and standard administration of the CPT intervention across both conditions. It is expected that the results from this project can be applied to other VA and military locations, where similar specialized PTSD clinical services are needed but unavailable due to geographic barriers.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • diagnosis of current PTSD established by the Clinician-Administered PTSD Scale (CAPS) and
  • a stable psychotropic medication regimen for a minimum of 45 days prior to study entry for those taking such medications.

排除标准

  • significant cognitive impairment or history of organic mental disorder,
  • active psychotic symptoms/disorder,
  • active homicidal or suicidal ideation,
  • current substance dependence, and
  • unwillingness to refrain from substance abuse during treatment.

结局指标

主要结局

Clinician Administered PTSD Scale (CAPS-IV)

时间窗: 6 months post-treatment

次要结局

未报告次要终点

研究者

发起方
VA Pacific Islands Health Care System
申办方类型
Fed
责任方
Sponsor

研究点 (2)

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