跳至主要内容
临床试验/NCT00941629
NCT00941629已完成3 期

Randomized Controlled Equivalence Trial Comparing Videoconference and Face-to-Face Delivery of Cognitive Processing Therapy for PTSD

University of Wisconsin, Madison2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2009年12月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
90
试验地点
2
主要终点
The Clinician Administered PTSD Scale(CAPS) score.

研究概览

简要总结

The purpose of this study is to evaluate the equivalence of CPT treatment delivered remotely via telemental health (TMH) over videoconferencing or via traditional face-to face (FTF) treatment to veterans who have Post-traumatic Stress Disorder (PTSD) from a military-related stressor (i.e., combat, sexual assault, non-combat physical assault). The secondary objective is to determine if patients' ratings of PTSD symptoms, affect, social adjustment, therapy alliance, treatment satisfaction and therapist satisfaction, are equivalent between service-delivery conditions (TMH vs. FTF). A final objective is to develop web-based practice assignments to assist participants in the TMH condition with treatment adherence (completion of the between- session practice assignments).

详细描述

PTSD is the most common mental health diagnosis affecting service men and women who have served in Iraq and Afghanistan (OEF/OIF). Despite unprecedented efforts by the Dept. of Defense (DoD) and Dept. of Veterans Affairs (VA) to treat these service personnel with mental disorders, significant gaps in the continuum of care for psychological health remain, specifically related to which services are offered, where services are offered, and who receives services. The DoD and VA have also attempted to address problems with accessibility through the development of a video teleconference (VTC) network to ensure that service members have access to top-quality specialized medical care regardless of their geographical location. Provision of medical treatment over VTC is often referred to as telemedicine; telemental health (TMH) refers to the provision of mental health treatment over the same system. A handful of studies have shown that psychiatry (primarily medication management) delivered over TMH systems can be as effective as face-to-face (FTF) treatment as long as the equipment and band-width are capable of delivering the communication in near real time.TMH is an increasingly common method of providing psychological treatment to service members with PTSD and other mental health problems, and yet there are no randomized trials of TMH provision of an empirically validated treatment for PTSD compared with FTF treatment. Therefore, this study aims to evaluate the treatment outcomes of patients with PTSD treated with CPT either remotely via TMH or traditionally in FTF treatment.

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • •18 years of age or older
  • •Literate in written English
  • •Fluent in spoken English
  • •Verified status as an OEF/OIF veteran
  • •Current PTSD diagnosis
  • •Index traumatic event related to military services
  • •If taking psychotropic medication, remains stable

排除标准

  • •Under 18 years of age
  • •Not literate in written English
  • •Not fluent in spoke English
  • •Current uncontrolled psychotic or bipolar disorder
  • •Substance dependence
  • •Current uncontrolled suicidal or homicidal ideation
  • •Significant cognitive impairment that would interfere with completion of therapy tasks

研究组 & 干预措施

Cognitive Processing Therapy FTF

Active Comparator

Cognitive Processing Therapy delivered in traditional face-to-face sessions (FTF)

干预措施: Cognitive Processing Therapy (CPT) (Behavioral)

Cognitive Processing Therapy TMH

Experimental

Cognitive Processing Therapy delivered over videoconferencing equipment to a distant location (or telemental health; TMH)

干预措施: Cognitive Processing Therapy (CPT) (Behavioral)

结局指标

主要结局

The Clinician Administered PTSD Scale(CAPS) score.

时间窗: At baseline, post-treatment( after 6 weeks) and the 3-month follow-up period

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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