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

Primary Purpose

Trauma and Stressor Related Disorders, Post-traumatic Stress Disorders, Adjustment Disorders

Status

Unknown status

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Propranolol Hydrochloride

Placebo

About this trial

This is an interventional treatment trial for Trauma and Stressor Related Disorders focused on measuring Memory Reconsolidation, Propranolol, Police officers, 911 operators, Efficacy, Cost-effectiveness

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Douglas Mental Health University InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Propranolol Hydrochloride

Placebo

Arm Description

1mg / kg of propranolol hydrochloride administered as a capsule 60 minutes prior to memory reactivation

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

Outcomes

Primary Outcome Measures

EuroQol five dimensions questionnaire with five-level scale

This questionnaire is a standardized instrument for measuring generic health status

Secondary Outcome Measures

Post-traumatic Checklist for the Diagnostic and Statistical Manual for Mental Disorders - 5th edition (PCL-5)

Measure of trauma and stressor related symptoms

Hopkins Symptom Checklist - 25 (HSCL - 25).

Measure of depression and anxiety symptom severity

Operational Police Stress Questionnaire (PSQ-OP)

Measure of severity of occupational stress

Full Information

NCT ID

NCT03152175

First Posted

March 30, 2017

Last Updated

June 16, 2021

Sponsor

Douglas Mental Health University Institute

Collaborators

Institut de Recherche Robert-Sauvé en Santé et en Sécurité du Travail

1. Study Identification

Unique Protocol Identification Number

NCT03152175

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Unknown status

Study Start Date

March 30, 2017 (Actual)

Primary Completion Date

March 2022 (Anticipated)

Study Completion Date

March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Douglas Mental Health University Institute

Collaborators

Institut de Recherche Robert-Sauvé en Santé et en Sécurité du Travail

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Trauma and Stressor Related Disorders, Post-traumatic Stress Disorders, Adjustment Disorders, Acute Stress Disorder

Keywords

Memory Reconsolidation, Propranolol, Police officers, 911 operators, Efficacy, Cost-effectiveness

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Repeated measures parallel design.

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Propranolol Hydrochloride

Arm Type

Experimental

Arm Description

1mg / kg of propranolol hydrochloride administered as a capsule 60 minutes prior to memory reactivation

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Propranolol Hydrochloride

Other Intervention Name(s)

Teva-propranolol

Intervention Description

1mg / kg of propranolol hydrochloride, oral capsule

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

1mg / kg of matched placebo, oral capsule

Primary Outcome Measure Information:

Title

EuroQol five dimensions questionnaire with five-level scale

Description

This questionnaire is a standardized instrument for measuring generic health status

Time Frame

The weighted average of the questionnaire responses will be calculated over a 12 month period

Secondary Outcome Measure Information:

Title

Post-traumatic Checklist for the Diagnostic and Statistical Manual for Mental Disorders - 5th edition (PCL-5)

Description

Measure of trauma and stressor related symptoms

Time Frame

Change from baseline (week 0) to weeks 1, 2, 3, 4 , 5, 7, 26, and 52.

Title

Hopkins Symptom Checklist - 25 (HSCL - 25).

Description

Measure of depression and anxiety symptom severity

Time Frame

Change from baseline (week 0) to weeks 1, 2, 3, 4 , 5, 7, 26, and 52.

Title

Operational Police Stress Questionnaire (PSQ-OP)

Description

Measure of severity of occupational stress

Time Frame

Change from baseline (week 0) to weeks 7, 26, and 52.

Other Pre-specified Outcome Measures:

Title

Social Functioning Questionnaire (SFQ)

Description

Measure of psycho-social functional

Time Frame

Change from baseline (week 0) to weeks 7, 26, and 52.

Title

Rey's 15-Item Memory test

Description

Measure of verbal learning and memory

Time Frame

Change from baseline (week 0) to weeks 7 and 52.

Title

The Logical Memory subtest of the Wechsler Memory Scale - III

Description

Measure of verbal learning and memory

Time Frame

Change from baseline (week 0) to weeks 7 and 52.

Title

Trail Making Test

Description

Measure of mental flexibility

Time Frame

Change from baseline (week 0) to weeks 7 and 52.

Title

Color-Word Interference Test of the Delis-Kaplan Executive Function System

Description

Measure of selective attention

Time Frame

Change from baseline (week 0) to weeks 7 and 52.

Title

Coding subtest of the Wechsler Adult Intelligence Scale-IV

Description

Measure of working memory

Time Frame

Change from baseline (week 0) to weeks 7 and 52.

Title

Attention subtest of the Paced Auditory Serial Addition Test (PASAT)

Description

Measure of working memory, divided attention, and information processing speed

Time Frame

Change from baseline (week 0) to weeks 7 and 52.

Title

D2 Test of attention

Description

Measure of selective and sustained attention

Time Frame

Change from baseline (week 0) to weeks 7 and 52.

Title

Verbal Fluency Test

Description

Measure of verbal ability and executive control

Time Frame

Change from baseline (week 0) to weeks 7 and 52.

Title

Subjective Units of Distress Scale

Description

Measure of subjective distress from exposure to an event

Time Frame

Changes from week 1 to weeks 2, 3, 4 and 5.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alain Brunet, PhD.

Phone

514-761-6131

Ext

4348

alain.brunet@mcgill.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Daniel Saumier, PhD.

Phone

514-761-6131

Ext

4349

irsst.brunet@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alain Brunet, PhD.

Organizational Affiliation

Douglas Mental Health University Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Douglas Mental Health University Institute

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H4H1R3

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Daniel Saumier

Phone

514-761-6131

Ext

4349

irsst.brunet@gmail.com

First Name & Middle Initial & Last Name & Degree

Alain Brunet, PhD.

First Name & Middle Initial & Last Name & Degree

Isabelle Rouleau, PhD.

First Name & Middle Initial & Last Name & Degree

Helen-Maria Vasiliadis, PhD.

First Name & Middle Initial & Last Name & Degree

Alexandra Bisson-Desrochers, C. Phil.

First Name & Middle Initial & Last Name & Degree

Daniel Saumier, PhD.

First Name & Middle Initial & Last Name & Degree

Jacques Tremblay, MD., MSc.

First Name & Middle Initial & Last Name & Degree

Maxime Guérin

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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