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

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ClinicalTrials.gov Identifier: NCT03152175
Recruitment Status : Recruiting
First Posted : May 12, 2017
Last Update Posted : March 12, 2019
Sponsor:
Collaborator:
Institut de Recherche Robert-Sauvé en Santé et en Sécurité du Travail
Information provided by (Responsible Party):
Alain Brunet, Ph.D., 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.

Condition or disease Intervention/treatment Phase
Trauma and Stressor Related Disorders Post-traumatic Stress Disorders Adjustment Disorders Acute Stress Disorder Drug: Propranolol Hydrochloride Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Repeated measures parallel design.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : March 30, 2017
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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


Other Outcome Measures:
  1. Social Functioning Questionnaire (SFQ) [ Time Frame: Change from baseline (week 0) to weeks 7, 26, and 52. ]
    Measure of psycho-social functional

  2. Rey's 15-Item Memory test [ Time Frame: Change from baseline (week 0) to weeks 7 and 52. ]
    Measure of verbal learning and memory

  3. 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

  4. Trail Making Test [ Time Frame: Change from baseline (week 0) to weeks 7 and 52. ]
    Measure of mental flexibility

  5. 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

  6. 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

  7. 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

  8. D2 Test of attention [ Time Frame: Change from baseline (week 0) to weeks 7 and 52. ]
    Measure of selective and sustained attention

  9. Verbal Fluency Test [ Time Frame: Change from baseline (week 0) to weeks 7 and 52. ]
    Measure of verbal ability and executive control

  10. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03152175


Contacts
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Contact: Alain Brunet, PhD. 514-761-6131 ext 4348 alain.brunet@mcgill.ca
Contact: Daniel Saumier, PhD. 514-761-6131 ext 4349 irsst.brunet@gmail.com

Locations
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Canada, Quebec
Douglas Mental Health University Institute Recruiting
Montreal, Quebec, Canada, H4H1R3
Contact: Daniel Saumier    514-761-6131 ext 4349    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: Jacques Tremblay, MD., MSc.         
Sub-Investigator: Maxime Guérin         
Sponsors and Collaborators
Douglas Mental Health University Institute
Institut de Recherche Robert-Sauvé en Santé et en Sécurité du Travail
Investigators
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Principal Investigator: Alain Brunet, PhD. Douglas Mental Health University Institute

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Responsible Party: Alain Brunet, Ph.D., Primary Investigator and Full Professor, Department of Psychiatry, McGill University., Douglas Mental Health University Institute
ClinicalTrials.gov Identifier: NCT03152175     History of Changes
Other Study ID Numbers: PRPL-007
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Alain Brunet, Ph.D., Douglas Mental Health University Institute:
Memory Reconsolidation
Propranolol
Police officers
911 operators
Efficacy
Cost-effectiveness
Additional relevant MeSH terms:
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Propranolol
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Adjustment Disorders
Stress Disorders, Traumatic, Acute
Trauma and Stressor Related Disorders
Pathologic Processes
Mental Disorders
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents