Telemedicine for Improved Delivery of Psychosocial Treatments for Post Traumatic Stress Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 211
- 试验地点
- 2
- 主要终点
- Clinician-administered PTSD Scale (CAPS) diagnostic interview
研究概览
简要总结
The objective of the proposed study is to conduct a systematic comparison of post traumatic stress disorder (PTSD) outcomes for veterans receiving exposure therapy via telemedicine versus in-person care. The primary aim is to determine feasibility: whether telemedicine can be used as a tool to extend effective, specialized mental health services, such as Prolonged Exposure therapy (PE; a therapy designed to help clients face fears related to a traumatic event), to veterans with limited access to care. A secondary aim is to determine if therapy delivered by telemedicine affects the quality of care in terms of clinical outcomes and the quality of patient-therapist interaction. A tertiary aim is to examine whether results from neuropsychological testing predict treatment outcomes.
详细描述
The objective of the proposed study is to conduct a systematic comparison of post traumatic stress disorder (PTSD) outcomes for veterans receiving exposure therapy via telemedicine versus in-person care. Specifically, prolonged exposure therapy (PE) was conducted with veterans individually, either in person or via videoconferencing technology. PE is designed to help clients face fears related to a traumatic experience by guiding individuals through exposures to the memory of the event (called "imaginal exposure") and exposures to feared situations (called "in vivo" exposures).
The primary aim is to determine the feasibility of whether telemedicine can be used as a tool to extend effective, specialized mental health services, such as PE to veterans with limited access to care. This is measured in part through patient and therapist satisfaction ratings in each condition.
A secondary aim is to determine if therapy delivered by telemedicine affects the quality of care in terms of clinical outcomes and the quality of patient-therapist interaction. This is measured by relative changes in symptoms, primarily in PTSD, depressive symptoms, and anxiety symptoms.
A tertiary aim is to examine whether results from neuropsychological testing predict treatment outcomes across conditions. This includes seven measures of executive functioning. The hypothesis is that poorer performance on these measures may be associated with less improvement on measures of symptom severity.
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
- •Primary diagnosis of chronic PTSD due to combat; comorbid mood and anxiety disorders are expected, and will be permitted (to maximize generalizability) if PTSD symptoms are judged to be predominant based on primacy and severity of symptoms
- •Age 18 or older
- •English literacy
排除标准
- •Unmanaged psychosis or manic episodes in past year
- •Concurrent psychotherapies targeting PTSD or depression or that entail exposure therapy [veterans who are engaged in treatment for non-PTSD symptoms (e.g., 12-step programs for substance problems) will be eligible]
- •Severe cardiovascular or respiratory disease that would make it difficult to ensure regular attendance at psychotherapy sessions
- •Probable dementia; OR
- •Head trauma resulting in loss of consciousness longer than 20 minutes. Potential participants who have had changes in the type and dosage of psychotropic medications in the preceding two months will be asked to wait until their medication regimen has stabilized to minimize treatment confounds.
结局指标
主要结局
Clinician-administered PTSD Scale (CAPS) diagnostic interview
时间窗: Pre-treatment, post-treatment (14 weeks after pre-treatment assessment), follow-up six months after post-treatment assessment
Measure of PTSD diagnosis and severity
次要结局
- PTSD Checklist (PCL; self-reported PTSD symptoms)(Pre-treatment, weekly during 12 weeks of treatment, post-treatment (14 weeks after pre-treatment assessment), follow-up six months after post-treatment assessment)
- PHQ-9 (self-reported depression)(Pre-treatment, weekly during 12 weeks of treatment, post-treatment (14 weeks after pre-treatment assessment), follow-up six months after post-treatment assessment)
- Neuropsychological testing battery to assess cognitive functioning(Pre-treatment and post-treatment (14 weeks after pre-treatment assessment))