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临床试验/NCT03154151
NCT03154151已完成不适用

Internet-based Psychotherapies for PTSD Symptoms in World Trade Center (WTC) Responders and Survivors

Icahn School of Medicine at Mount Sinai7 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2017年8月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
105
试验地点
7
主要终点
PTSD symptom change on the PTSD Checklist for DSM-5

研究概览

简要总结

If you worked or volunteered as a WTC rescue, recovery or clean-up worker after the 9/11 attacks, or are a survivor of the WTC 9/11 attacks, and you are still experiencing Posttraumatic Stress Disorder (PTSD) symptoms related to your WTC experience, you might be eligible to participate in this clinical trial of therapist-assisted, Internet-based (online) writing therapy for WTC responders and survivors with persistent PTSD symptoms. This study is for WTC responders and survivors who are not currently receiving psychotherapy/counseling. In this study, the researchers aim to find out if Internet-based therapy can help WTC responders and survivors who are still experiencing PTSD symptoms.

详细描述

Some people who live through traumatic experiences, such as the 9/11 WTC attacks or their aftermath, suffer from mental and physical problems that occur as a result of the incident and can persist over time. These problems are known as post-traumatic stress reactions or symptoms, and may include sleep disturbances, feelings of guilt and shame, persistent nightmares or upsetting memories of the incident, avoidance of reminders that might trigger upsetting memories, loss of interest in activities, concentration difficulties, and feeling distant from other people.

People who experience persistent PTSD symptoms often receive treatment in person in an outpatient clinic. However, recent findings suggest that Internet-based treatment can also yield positive treatment effects. The Internet offers people the opportunity to receive psychological support from home. For some people, it is easier to communicate without direct visual contact with another person about their experiences. Despite the distance, people can reflect on their situation or concerns with the help of a personal therapist.

As mentioned above, this study is for WTC responders who are not currently receiving psychotherapy/ counseling. After completing the online consent form and an initial online questionnaire, participants complete a telephone assessment conducted by a member of the team at Mount Sinai Medical Center. If you are eligible and agree to participate, you will be randomly assigned (as by the flip of a coin) to receive one of two therapies: Internet-based cognitive-behavioral therapy or Internet-based supportive therapy. Each participant is assigned a personal therapist from the team at Mount Sinai to work with throughout the treatment. In this study, communication between participant and therapist is conducted exclusively across the Internet, in written form, through the secure Web platform housed at Mount Sinai. The treatment involves written exchanges between participant and therapist over the course of approximately six weeks. Through guided writing, online therapy aims to help WTC responders process their traumatic experiences or better manage current life problems. In this study, the researchers aim to find out if Internet-based therapy can help WTC responders who are still experiencing PTSD symptoms.

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
All
接受健康志愿者

入选标准

  • Men and women who have worked or volunteered as rescue, recovery or clean-up workers at the WTC site following the 9/11 attacks, or who were living as a resident or working as an employee within the NYC disaster area during the 9/11 attacks, and who:
  • are currently still experiencing significant posttraumatic stress symptoms related to what they witnessed or lived through during the 9/11 attacks or their WTC recovery work and:
  • are not currently receiving psychotherapy or counseling
  • do not have psychosis, a psychotic disorder, or bipolar disorder
  • have not had recent alcohol or drug use problems
  • are not experiencing suicidal thoughts,thoughts of harming others, or significant dissociative symptoms.

排除标准

  • are currently taking antipsychotic medication, lithium or valproic acid.
  • have a current uncontrolled medical illness, neurological disorder affecting the central nervous system, or history of head injury
  • currently taking daily benzodiazepines or daily opioid medication

结局指标

主要结局

PTSD symptom change on the PTSD Checklist for DSM-5

时间窗: Pre- to Post-treatment, average 9 weeks

WTC-related PTSD symptoms, assessed using total PTSD Checklist-5 (PCL-5) score. PCL-5 scores range from 0-80, with higher score indicating more severe PTSD symptoms.

次要结局

  • Durability of PTSD symptom change on the PCL-5(3 months post-treatment)
  • Change in PTSD symptom clusters on the PCL-5(Pre- to Post-treatment, average 9 weeks)
  • Beck Depression Inventory II (BDI-II)(3 months post-treatment)
  • Medical Outcomes Study Short Form 8 Health Survey(3 months post-treatment)
  • Durability of change in PTSD symptom clusters on the PCL-5(3 months post-treatment)
  • GAD-7(3 months post-treatment)
  • Posttraumatic Growth Inventory - 10 Item Short Form (PTGI-SF)(3 months post-treatment)

研究者

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

Adriana Feder

Associate Professor

Icahn School of Medicine at Mount Sinai

研究点 (7)

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