Posttraumatic Stress Disorders in Police, Correctional Service Officers, and 911 Operators

Phase 2

• Conditions: Adjustment Disorders; Acute Stress Disorder; Trauma and Stressor Related Disorders; Post-traumatic Stress Disorders
• Interventions: Drug: Propranolol Hydrochloride; Drug: Placebo

• Registration Number: NCT03152175
• Lead Sponsor: Douglas Mental Health University Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-30
• Study First Submitted: 2017-03-30
• Study First Submitted QC: 2017-05-11
• Study First Posted: 2017-05-12
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-16
• Last Update Posted: 2021-06-18
• Primary Completion: 2022-03
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• 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.

Exclusion Criteria

• Systolic blood pressure < 100mm Hg (millimeter of mercury) at visit 0.
• Heart rate < 55 bpm (beats per minute) at visit 0.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propranolol Hydrochloride	Propranolol Hydrochloride	1mg / kg of propranolol hydrochloride administered as a capsule 60 minutes prior to memory reactivation
Placebo	Placebo	Placebo manufactured as a capsule to mimic 1mg/kg of propranolol hydrochloride administered 60 minutes prior to memory reactivation

Primary Outcome Measures

Name	Time	Method
EuroQol five dimensions questionnaire with five-level scale	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

Secondary Outcome Measures

Name	Time	Method
Hopkins Symptom Checklist - 25 (HSCL - 25).	Change from baseline (week 0) to weeks 1, 2, 3, 4 , 5, 7, 26, and 52.	Measure of depression and anxiety symptom severity
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.	Measure of trauma and stressor related symptoms
Operational Police Stress Questionnaire (PSQ-OP)	Change from baseline (week 0) to weeks 7, 26, and 52.	Measure of severity of occupational stress

Trial Locations

Locations (1)

Douglas Mental Health University Institute; 🇨🇦 Montreal, Quebec, Canada