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临床试验/NCT02982538
NCT02982538已完成不适用

Implementation of Prolonged Exposure in the Army: Is Consultation Necessary for Effective Dissemination?

University of Pennsylvania3 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2012年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
128
试验地点
3
主要终点
Provider Use of PE Components

研究概览

简要总结

This randomized study examines how prolonged exposure (PE) therapy, an evidence-based treatment for posttraumatic stress disorder (PTSD), can be successfully disseminated and implemented in the Army. The study compares two PE training models: Standard PE training, comprised of a 4-day workshop only, and Extended PE training, comprised of a 4-day workshop plus expert case consultation. In addition, patients with posttraumatic stress symptoms receiving psychotherapy from participating providers will be invited to participate. After completing PE training, use of PE components with patients reporting PTS symptoms and clinical outcomes of these participating patients will be monitored for up to 18 months.

详细描述

This study will examine how evidence-based therapies (EBTs) such as Prolonged Exposure (PE) for posttraumatic stress disorder (PTSD) can be successfully disseminated and implemented in the Army by comparing two PE training models: Standard PE training (workshop only) and Extended PE training (workshop plus consultation). Up to 180 mental health providers at three medium-to large Army installations will be randomly assigned to either Standard PE training or Extended PE training. All providers will complete a 4-day PE workshop, along with the distribution of training materials and treatment manuals, conducted at the military site by the Overall Study PI, Dr. Edna Foa, and her team. Following the 4-day workshop, participants randomized to the Extended PE training will receive weekly phone consultation with a PE expert on two PE therapy cases. Participants randomized to the Standard PE training group will not receive any additional consultation following the workshop. Providers will not be required to use PE therapy with their patients with PTS symptoms; using PE will be optional. A major outcome of this study is the proportion of the providers PTSD patients that are offered PE or PE components. The mental health outcomes of providers' PTS patients will also be monitored as a second major outcome. Patients seeking treatment from participating providers will be recruited, consented, and assessed by independent evaluators at two time points to prospectively assess their response to treatment.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •FOR PROVIDERS: 1) Male and female behavioral health providers whose job duties include providing psychotherapy to adult patients, age ≥ 18,seeking treatment with symptoms of PTS. Behavioral health providers can include psychologists, social workers, psychiatric clinical nurse specialists, psychiatrists, and similarly trained professional providers.2) Twenty percent (or more) of expected caseload comprised of patients with PTS symptoms according to provider self-report.
  • •FOR PATIENTS: 1) Male and female patients age ≥
  • •Receiving treatment from one of the behavioral health providers participating in this study. 3) Significant PTS symptoms as determined by a score of 25 or higher on The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5).

排除标准

  • •FOR PROVIDERS: 1) Definite plans to terminate their position or relocate from the Army base at some point during the first year following training. 2) Extensive previous training in Prolonged Exposure (PE), defined as participation in a 4-day PE training workshop at any point prior to the start of the study, and self-reported use of PE (including both imaginal and in vivo exposure techniques) to treat 4 or more patients with PTS symptoms in the past year.
  • •FOR PATIENTS: 1) Current bipolar disorder I or psychotic disorder (as determined by the MINI). 2) Evidence of a moderate or severe traumatic brain injury (as determined by the inability to comprehend the baseline screening questionnaires). 3) Current suicidal ideation severe enough to warrant immediate attention (as determined by the MINI and the Beck Scale for Suicidal Ideation).

研究组 & 干预措施

Standard PE Training Condition

Other

Providers in this condition will complete a 4-day training workshop in PE.

干预措施: Standard Training in Prolonged Exposure Therapy for PTSD (Behavioral)

Extended PE Training Condition

Other

Providers in this condition will complete a 4-day training workshop in PE and will receive expert PE case consultation on two PE training cases via weekly phone consultation.

干预措施: Extended Training in Prolonged Exposure Therapy for PTSD (Behavioral)

结局指标

主要结局

Provider Use of PE Components

时间窗: Through study completion, an average of 2 years

Provider use of PE components will be assessed using a brief checklist of treatment procedures completed by providers directly following therapy sessions with participating patients.

次要结局

  • Provider Attitudes(Through study completion, an average of 2 years)
  • Patient Posttraumatic Stress Outcomes(8-15 sessions of therapy or after 5 months since initial assessment, whichever comes first)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Edna Foa

Principal Investigator

University of Pennsylvania

研究点 (3)

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