跳至主要内容
临床试验/NCT05530642
NCT05530642进行中(未招募)不适用

An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel

University of Regina1 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2020年9月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
192
试验地点
1
主要终点
Change in Generalized Anxiety Disorder Symptoms from Time 1 (pre-training; week 1) to Time 2 (post-training; week 13)

研究概览

简要总结

Public safety personnel (PSP; e.g., border services personnel, correctional workers, firefighters, paramedics, police, public safety communicators) are frequently exposed to potentially psychologically traumatic events. Such events contribute to substantial and growing challenges from posttraumatic stress injuries (PTSIs), including but not limited to posttraumatic stress disorder. The PSP PTSI Study has been designed to evaluate an evidence-informed, proactive system of mental health assessment and training among Royal Canadian Mounted Police (www.rcmpstudy.ca) for delivery among diverse PSP (i.e., firefighters, municipal police, paramedics, public safety communicators). The training is based on the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders, adapted for PSP, and named Emotional Resilience Skills Training (ERST). The subsequent PSP PTSI Study results are expected to benefit the mental health of all participants and, ultimately, all PSP.

详细描述

Public safety personnel (PSP; e.g., border services personnel, correctional workers, firefighters, paramedics, police, public safety communicators) are frequently exposed to potentially psychologically traumatic events. Such events contribute to substantial and growing challenges from posttraumatic stress injuries (PTSIs), including but not limited to posttraumatic stress disorder. The PSP PTSI Study has been designed to evaluate an evidence-informed, proactive system of mental health assessment and training among Royal Canadian Mounted Police (www.rcmpstudy.ca) for delivery among diverse PSP (i.e., firefighters, municipal police, paramedics, public safety communicators). The training is based on the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders, adapted for PSP, and named Emotional Resilience Skills Training (ERST). Specifically, the PSP PTSI Study will: 1) adapt, implement, and assess the impact of a system for ongoing (i.e., annual, monthly, daily) evidence-based assessments; 2) evaluate associations between demographic variables and PTSI; 3) longitudinally assess individual differences associated with PTSI; and, 4) assess the impact of providing diverse PSP with a tailored version of the ERST originally developed for the Royal Canadian Mounted Police in mitigating PTSIs based on the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders. Participants are assessed at pre-training; week 1 (i.e., Time 1) and post-training; week 13 (i.e., Time 2), and then at a 1-year follow-up after training, during week 65 (Time 3). The assessments include clinical interviews, self-report surveys including brief daily and monthly assessments, and daily biometric data. The PSP PTSI Study hypotheses were pre-registered with aspredicted.org for the PSP PTSI Study and associated hypotheses occurred on March 7, 2022 with the name, "An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel" (#90136). Hypotheses specific to individual difference variables are publicly available; however, the overarching PSP PTSI Study hypotheses are: 1) participant mental health disorder prevalence at Time 1, based on Clinical Interviews or screening tools based on self-reported symptoms, will be higher than would be expected for the general population; 2) from Time 1 to Time 2, participants will evidence reductions in risk, increases in resiliency, and improvements in mental health, as a function of the ERST; 3) participants will evidence statistically significant predictive relationships between completing assessments and changes to individual differences over time (i.e., inversely with risk, positively with resilience, positively with mental health); 4) participants will evidence statistically significant sequential predictive relationships for environmental factors or individual differences reported during the Daily Assessments, Monthly Assessments, and Full Assessments; 5) all participants will evidence sustained reductions in risk, increases in resilience, and increases in mental health at Time 3 relative to Time 2; 6) participants will evidence a statistically significant relationship between changes in individual differences over time and engagement with ERST content; 7) participants will evidence a statistically significant relationship between changes in environmental factors or individual differences over time, frequency of exercise, and other self-reported indicators of physical health; 8) relative to men, women will report more difficulties with mental disorder symptoms and occupational stressors; 9) diastole will be reduced in PSP who report symptoms consistent with one or more PTSI; 10) the biometric data will be statistically significantly and substantively correlated with measures of PTSI; 11) there will be a statistically significant and substantive relationship between PTSI symptom severity and reduced diastolic function; and 12) changes in biological variables (i.e., autonomic nervous system reactivity, heart rate variability, cardiac mechanical changes) will be associated with environmental factors or individual differences. The subsequent PSP PTSI Study results are expected to benefit the mental health of all participants and, ultimately, all PSP.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
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
是

入选标准

  • •Currently serving PSP firefighters, municipal police officers, paramedics, and public safety communicators
  • •Potential participants were Canadian citizens or permanent residents
  • •18 years or older
  • •Fluently read, write, and speak either English or French
  • •Employed in their PSP sector for a minimum of three years
  • •Access to a computer with internet service

排除标准

  • •High risk of suicide or previous suicide attempt/hospitalization within the prior year
  • •Currently experiencing psychosis, mania
  • •Currently experiencing impairing drug or alcohol addictions
  • •Current or ongoing performance management concerns
  • •Any history of advocating against mental health care

研究组 & 干预措施

Emotional Resilience Skills Training (ERST)

Experimental

The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) is an evidence-based cognitive-behavioral intervention designed to cultivate constructive approach-oriented emotional engagement. The 13-week Emotional Resilience Training (ERST) is an adaptation of the UP designed for use as a proactive training course. The ERST frames emotional experiences as natural responses to threat, rather than pathological occurrences to avoid; as such, the ERST is well-suited for mitigating health challenges and the skills may also help PSP to support persons in distress, including other PSP and the community members they all serve. The ERST training materials include an instructor guide, didactic PowerPoints, and a trainee workbook.

干预措施: Emotional Resilience Skills Training (ERST) (Behavioral)

结局指标

主要结局

Change in Generalized Anxiety Disorder Symptoms from Time 1 (pre-training; week 1) to Time 2 (post-training; week 13)

时间窗: Time 1 (pre-training; week 1), Time 2 (post-training; week 13)

Generalized Anxiety Disorder Scale - 7 (GAD-7); Total scores range from 0 to 28; Higher scores indicate more severe symptoms.

Change in Posttraumatic Stress Disorder Symptoms from Time 1 (pre-training; week 1) to Time 2 (post-training; week 13)

时间窗: Time 1 (pre-training; week 1), Time 2 (post-training; week 13)

Posttraumatic Stress Disorder Checklist Version 5; Total scores range from 0 to 80; Higher scores indicate more severe symptoms.

Sustained Panic Disorder Symptoms from Time 2 (post-training; week 13) to Time 3 (1-year follow-up; week 65)

时间窗: Time 2 (post-training; week 13), Time 3 (1-year follow-up; week 65)

Panic Disorder Severity Scale (PDSS); Total scores range from 0 to 28; Higher scores indicate more severe symptoms.

Sustained Posttraumatic Stress Disorder Symptoms from Time 2 (post-training; week 13) to Time 3 (1-year follow-up; week 65)

时间窗: Time 2 (post-training; week 13), Time 3 (1-year follow-up; week 65)

Posttraumatic Stress Disorder Checklist Version 5; Total scores range from 0 to 80; Higher scores indicate more severe symptoms.

Change in Major Depressive Disorder Symptoms from Time 1 (pre-training; week 1) to Time 2 (post-training; week 13)

时间窗: Time 1 (pre-training; week 1), Time 2 (post-training; week 13)

Patient Health Questionnaire - 9 (PHQ-9); Total scores range from 0 to 36; Higher scores indicate more severe symptoms.

Sustained Major Depressive Disorder Symptoms from Time 2 (post-training; week 13) to Time 3 (1-year follow-up; week 65)

时间窗: Time 2 (post-training; week 13), Time 3 (1-year follow-up; week 65)

Patient Health Questionnaire - 9 (PHQ-9); Total scores range from 0 to 36; Higher scores indicate more severe symptoms.

Sustained Generalized Anxiety Disorder Symptoms from Time 2 (post-training; week 13) to Time 3 (1-year follow-up; week 65)

时间窗: Time 2 (post-training; week 13), Time 3 (1-year follow-up; week 65)

Generalized Anxiety Disorder Scale - 7 (GAD-7); Total scores range from 0 to 28; Higher scores indicate more severe symptoms.

Change in Panic Disorder Symptoms from Time 1 (pre-training; week 1) to Time 2 (post-training; week 13)

时间窗: Time 1 (pre-training; week 1), Time 2 (post-training; week 13)

Panic Disorder Severity Scale (PDSS); Total scores range from 0 to 28; Higher scores indicate more severe symptoms.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验