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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Trauma and Stressor Related Disorders; Post-traumatic Stress Disorders; Adjustment Disorders; Acute Stress Disorder
• Intervention / Treatment: Drug: Propranolol Hydrochloride; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Alain Brunet, PhD.; Phone Number: 4348 514-761-6131; Email: alain.brunet@mcgill.ca
• Study Contact Backup: Name: Daniel Saumier, PhD.; Phone Number: 4349 514-761-6131; Email: irsst.brunet@gmail.com

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H4H1R3
      • Recruiting
      • Douglas Mental Health University Institute
      • Sub-Investigator: Jacques Tremblay, MD., MSc.
      • Contact: Daniel Saumier; Phone Number: 4349 514-761-6131; Email: irsst.brunet@gmail.com
      • Principal Investigator: Alain Brunet, PhD.
      • Sub-Investigator: Isabelle Rouleau, PhD.
      • Sub-Investigator: Helen-Maria Vasiliadis, PhD.
      • Sub-Investigator: Alexandra Bisson-Desrochers, C. Phil.
      • Sub-Investigator: Daniel Saumier, PhD.
      • Sub-Investigator: Maxime Guérin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Propranolol Hydrochloride; 1mg / kg of propranolol hydrochloride administered as a capsule 60 minutes prior to memory reactivation	Drug: Propranolol Hydrochloride; 1mg / kg of propranolol hydrochloride, oral capsule; Other Names: Teva-propranolol
Placebo Comparator: Placebo; Placebo manufactured as a capsule to mimic 1mg/kg of propranolol hydrochloride administered 60 minutes prior to memory reactivation	Drug: Placebo; 1mg / kg of matched placebo, oral capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EuroQol five dimensions questionnaire with five-level scale	This questionnaire is a standardized instrument for measuring generic health status	The weighted average of the questionnaire responses will be calculated over a 12 month period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-traumatic Checklist for the Diagnostic and Statistical Manual for Mental Disorders - 5th edition (PCL-5)	Measure of trauma and stressor related symptoms	Change from baseline (week 0) to weeks 1, 2, 3, 4 , 5, 7, 26, and 52.
Hopkins Symptom Checklist - 25 (HSCL - 25).	Measure of depression and anxiety symptom severity	Change from baseline (week 0) to weeks 1, 2, 3, 4 , 5, 7, 26, and 52.
Operational Police Stress Questionnaire (PSQ-OP)	Measure of severity of occupational stress	Change from baseline (week 0) to weeks 7, 26, and 52.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social Functioning Questionnaire (SFQ)	Measure of psycho-social functional	Change from baseline (week 0) to weeks 7, 26, and 52.
Rey's 15-Item Memory test	Measure of verbal learning and memory	Change from baseline (week 0) to weeks 7 and 52.
The Logical Memory subtest of the Wechsler Memory Scale - III	Measure of verbal learning and memory	Change from baseline (week 0) to weeks 7 and 52.
Trail Making Test	Measure of mental flexibility	Change from baseline (week 0) to weeks 7 and 52.
Color-Word Interference Test of the Delis-Kaplan Executive Function System	Measure of selective attention	Change from baseline (week 0) to weeks 7 and 52.
Coding subtest of the Wechsler Adult Intelligence Scale-IV	Measure of working memory	Change from baseline (week 0) to weeks 7 and 52.
Attention subtest of the Paced Auditory Serial Addition Test (PASAT)	Measure of working memory, divided attention, and information processing speed	Change from baseline (week 0) to weeks 7 and 52.
D2 Test of attention	Measure of selective and sustained attention	Change from baseline (week 0) to weeks 7 and 52.
Verbal Fluency Test	Measure of verbal ability and executive control	Change from baseline (week 0) to weeks 7 and 52.
Subjective Units of Distress Scale	Measure of subjective distress from exposure to an event	Changes from week 1 to weeks 2, 3, 4 and 5.

Collaborators and Investigators

• Sponsor: Douglas Mental Health University Institute
• Collaborators: Institut de Recherche Robert-Sauvé en Santé et en Sécurité du Travail
• Investigators: Principal Investigator: Alain Brunet, PhD., Douglas Mental Health University Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2017
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: March 30, 2017
• First Submitted That Met QC Criteria: May 11, 2017
• First Posted (Actual): May 12, 2017

Study Record Updates

• Last Update Posted (Actual): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 16, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Efficacy; Cost-effectiveness; Propranolol; Memory Reconsolidation; Police officers; 911 operators
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Adjustment Disorders; Stress Disorders, Traumatic, Acute; Trauma and Stressor Related Disorders; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Propranolol
• Other Study ID Numbers: PRPL-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No