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

June 16, 2021 updated by: Alain Brunet, Ph.D., Douglas Mental Health University Institute

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4H1R3
        • Recruiting
        • Douglas Mental Health University Institute
        • Sub-Investigator:
          • Jacques Tremblay, MD., MSc.
        • Contact:
        • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
EuroQol five dimensions questionnaire with five-level scale
Time Frame: 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
The weighted average of the questionnaire responses will be calculated over a 12 month period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Post-traumatic Checklist for the Diagnostic and Statistical Manual for Mental Disorders - 5th edition (PCL-5)
Time Frame: Change from baseline (week 0) to weeks 1, 2, 3, 4 , 5, 7, 26, and 52.
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).
Time Frame: Change from baseline (week 0) to weeks 1, 2, 3, 4 , 5, 7, 26, and 52.
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)
Time Frame: Change from baseline (week 0) to weeks 7, 26, and 52.
Measure of severity of occupational stress
Change from baseline (week 0) to weeks 7, 26, and 52.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Social Functioning Questionnaire (SFQ)
Time Frame: Change from baseline (week 0) to weeks 7, 26, and 52.
Measure of psycho-social functional
Change from baseline (week 0) to weeks 7, 26, and 52.
Rey's 15-Item Memory test
Time Frame: Change from baseline (week 0) to weeks 7 and 52.
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
Time Frame: Change from baseline (week 0) to weeks 7 and 52.
Measure of verbal learning and memory
Change from baseline (week 0) to weeks 7 and 52.
Trail Making Test
Time Frame: Change from baseline (week 0) to weeks 7 and 52.
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
Time Frame: Change from baseline (week 0) to weeks 7 and 52.
Measure of selective attention
Change from baseline (week 0) to weeks 7 and 52.
Coding subtest of the Wechsler Adult Intelligence Scale-IV
Time Frame: Change from baseline (week 0) to weeks 7 and 52.
Measure of working memory
Change from baseline (week 0) to weeks 7 and 52.
Attention subtest of the Paced Auditory Serial Addition Test (PASAT)
Time Frame: Change from baseline (week 0) to weeks 7 and 52.
Measure of working memory, divided attention, and information processing speed
Change from baseline (week 0) to weeks 7 and 52.
D2 Test of attention
Time Frame: Change from baseline (week 0) to weeks 7 and 52.
Measure of selective and sustained attention
Change from baseline (week 0) to weeks 7 and 52.
Verbal Fluency Test
Time Frame: Change from baseline (week 0) to weeks 7 and 52.
Measure of verbal ability and executive control
Change from baseline (week 0) to weeks 7 and 52.
Subjective Units of Distress Scale
Time Frame: Changes from week 1 to weeks 2, 3, 4 and 5.
Measure of subjective distress from exposure to an event
Changes from week 1 to weeks 2, 3, 4 and 5.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Douglas Mental Health University Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institut de Recherche Robert-Sauvé en Santé et en Sécurité du Travail

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alain Brunet, PhD., Douglas Mental Health University Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 30, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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