A Pilot Randomized Controlled Trial in Patients Within One Week of Acute Physical Trauma to Test the Feasibility and Effectiveness of AEPET Plus RBT Versus RBT Alone for the Prevention of PTSD and Depression
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- PTSD Presence and Severity at 1 month follow-up
研究概览
简要总结
The objective of this study is to assess the feasibility and effectiveness of AEPET plus Resilience Based Therapy (RBT) versus RBT alone for the prevention of PTSD and depression in trauma patients. The intervention group who have AEPET plus RBT will have reduced level of post traumatic stress symptoms and depression post sessions as well as reduced symptoms of PTSD and depression at 4- 6 weeks as compared to the control group who have -"Resilience Based" less specific supportive therapy.
详细描述
Background:
The Sunnybrook Health Sciences Centre contains one of the largest trauma centers in Canada, treating approximately 1,100 patients annually. Many of these cases typically include unexpected events that can cause severe or life-threatening injuries and at the time patients often experience horror and helplessness and even threat of death. Many of these traumatic injuries are not only physically damaging but psychologically as well. Lower psychological well-being has been reported in trauma survivors, specifically symptoms related to Depression and Post Traumatic Stress Disorder (PTSD).
Methods:
Patients in trauma units admitted within the previous week will be approached by a trauma team member to see if they are willing to be approached by a Research Assistant (RA). If they agree, an RA will seek permission to screen for eligibility and complete recruitment and the informed consent process. Patients will be recruited if they have a premorbid risk factor for PTSD or if their current trauma resulted in clear memories of it being life threatening and horrifying to them or resulted in dissociation. Participants will be excluded if they were intoxicated at the time of the trauma, they seem cognitively impaired or if they suffered a severe head injury.
After stratified 1:1 randomization to either AEPET plus RBT (n=10-15) or RBT alone (n=10-15) , consenting participants will complete baseline measures and 3 therapy sessions, starting within 1 week post-trauma. Participants will be scheduled for their first 30-60 minute therapy session at consent . Participants will receive two more face-to-face / telephone sessions as close together as possible, followed by completing three questionnaires after the second session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 17 Years 至 75 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Experienced an acute physical trauma in the past 4 days where the patient believed it was potentially life-threatening in their mind at the time of the trauma
- •Have some clear memories of the trauma
- •Contain any risk factors for PTSD
- •An abbreviated Injury Severity (AIS) score of 1-3 (Minor, Moderate and Severe; not life threatening)
排除标准
- •Inability to communicate sufficiently in English to be able to complete questionnaires and provide informed consent
- •A diagnosis of psychosis, mental retardation or autism
- •Blood alcohol level of >0.08mmol/L (25 mg/dl) at time of admission
- •Cognitive impairment apparent on interview/collateral from trauma team
- •Severe head injury
- •Withdrawal Criteria
- •If the patient is thought to be at risk to self or others, or be in need of immediate psychiatric assessment, in which case the patient will be referred urgently for assessment with psychosocial oncology or department of psychiatry
- •If the patient wishes to discontinue the study
- •If the patient is noted to be cognitively impaired during the course of the study such that he/she cannot complete a questionnaire reliably or physically impaired such that it is too burdensome for the patient to complete the questionnaire package.
研究组 & 干预措施
Treatment As Usual + Resilience-Based Supportive Therapy
Routine psychosocial management of trauma patients, including Manualized Resilience-Based Therapy.
Abbreviated Early Prolonged Exposure Therapy
AEPET, including Manualized Resilience-Based supportive Therapy.
干预措施: Abbreviated Early Prolonged Exposure Therapy (Behavioral)
结局指标
主要结局
PTSD Presence and Severity at 1 month follow-up
时间窗: 1 - 2 Months
Scale used to assess presence and measure severity: The Post-Traumatic Stress Disorder (PTSD) Symptom Scale -Interview (PSS-I)
次要结局
- Psychological Well-being at 1 month follow-up(1 - 2 Months)
- Change from Baseline Depresssive Symptoms at Therapy Time-Point 2 and 1 month follow-up(1 - 2 Months)
- Change from Baseline Trauma-related Thoughts and Beliefs at Therapy Time-Point 2 and 1 month follow-up(1 - 2 Months)
- PTSD Presence and Severity and Diagnosis at 1 month follow-up(1 - 2 Months)
