Post-traumatic Stress Disorders in Police, Correctional Service Officers, and 911 Operators: A Cost-effectiveness and Efficacy Comparison of Treatment as Usual and a Novel Intervention
试验速览
- 阶段
- 2 期
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- EuroQol five dimensions questionnaire with five-level scale
研究概览
简要总结
Police officers, correctional service officers, and 911-operators are at increased risk for suffering from trauma-related disorders due to their direct and indirect exposure to life-threatening events, such as shootings, violent assaults, or car accidents, among others. Typical treatments for post-traumatic stress disorders include psychotherapy and pharmacological therapies (i.e., antidepressants). Although these interventions are effective for many sufferers, they all have limitations. Thus, the investigators propose to explore the usefulness of a new therapeutic technique, reconsolidation blockade, which involves reactivating the trauma memory while under the influence of propranolol. Objectives and hypotheses: To explore the efficacy and cost-effectiveness of reconsolidation blockade therapy as an adjunct treatment for trauma- and stressor-related disorders as defined in the Diagnostic and Statistical Manual Mental Disorders-5. The investigators hypothesize that, compared to the control group, 5 weekly trauma-memory reactivations under propranolol treatment will confer a significant reduction in trauma-related symptoms and significantly more health-related economic benefits. Stress symptoms and health-related costs will be assessed at 7, 26 and 52 weeks after study inclusion. In this study, the investigators will also explore the effects of reconsolidation blockade with propranolol on various neuropsychological functions.
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
- Double (Participant, Investigator)
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
- 否
入选标准
- •Understands and reads French
- •Currently or previously worked for the Quebec City Police Department, or the 911 dispatch for Quebec City, or another police department or 911 dispatch in the province of Quebec, or for the Quebec Ministry of Public Security as a correctional service officer
- •Meets criteria for a trauma-and stressor-related disorder, such as: Acute Stress Disorder, Posttraumatic Stress Disorder, Adjustment Disorder, Other Trauma- and Stressor-Related Disorder, as defined by the Diagnostic and Statistical Manual for Mental Disorders, 5th edition.
- •The trauma-and stressor-related disorder must be due to a work-related event.
- •A score of at least 4 (moderately ill) on the Clinical Global Impressions-Severity Scale.
- •Participants who are currently taking a Selective Serotonin Reuptake Inhibitors or Selective Norepinephrine Reuptake Inhibitors (antidepressants) must accept to skip their morning dose on the days that they receive the study's intervention.
排除标准
- •Systolic blood pressure < 100mm Hg (millimeter of mercury) at visit
- •Heart rate < 55 bpm (beats per minute) at visit
- •Medical conditions that contraindicate propranolol administration, as determined by the treating physician.
- •Previous diagnosis of a traumatic brain injury (TBI).
- •Previous adverse reaction or non-compliance with a beta-blocker.
- •Medications that can have an dangerous interaction with propranolol.
- •Fertile women who are not using an adequate contraceptive methods.
- •Pregnant women.
- •Nursing women.
- •The following psychiatric conditions: past or present bipolar disorder, past or present psychotic disorder, present substance abuse or dependence, actively suicidal, past or present neurological disorder, complex posttraumatic stress disorder.
研究组 & 干预措施
Propranolol Hydrochloride
1mg / kg of propranolol hydrochloride administered as a capsule 60 minutes prior to memory reactivation
干预措施: Propranolol Hydrochloride (Drug)
Placebo
Placebo manufactured as a capsule to mimic 1mg/kg of propranolol hydrochloride administered 60 minutes prior to memory reactivation
干预措施: Placebo (Drug)
结局指标
主要结局
EuroQol five dimensions questionnaire with five-level scale
时间窗: The weighted average of the questionnaire responses will be calculated over a 12 month period
This questionnaire is a standardized instrument for measuring generic health status
次要结局
- Hopkins Symptom Checklist - 25 (HSCL - 25).(Change from baseline (week 0) to weeks 1, 2, 3, 4 , 5, 7, 26, and 52.)
- Post-traumatic Checklist for the Diagnostic and Statistical Manual for Mental Disorders - 5th edition (PCL-5)(Change from baseline (week 0) to weeks 1, 2, 3, 4 , 5, 7, 26, and 52.)
- Operational Police Stress Questionnaire (PSQ-OP)(Change from baseline (week 0) to weeks 7, 26, and 52.)
研究者
Alain Brunet, Ph.D.
Primary Investigator and Full Professor, Department of Psychiatry, McGill University.
Douglas Mental Health University Institute