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

Adjustment Disorders Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03152175
• Other study ID #: PRPL-007
• Status: Recruiting
• Phase: Phase 2
• Start date: March 30, 2017
• Est. completion date: March 2023

Study information

• Verified date: June 2021
• Source: Douglas Mental Health University Institute
• Contact: Alain Brunet, PhD.
• Phone: 514-761-6131
• Email: alain.brunet[@]mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: March 2023
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Propranolol Hydrochloride
1mg / kg of propranolol hydrochloride, oral capsule
• Placebo
1mg / kg of matched placebo, oral capsule

Locations

Country	Name	City	State
Canada	Douglas Mental Health University Institute	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Douglas Mental Health University Institute	Institut de Recherche Robert-Sauvé en Santé et en Sécurité du Travail

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Social Functioning Questionnaire (SFQ)	Measure of psycho-social functional	Change from baseline (week 0) to weeks 7, 26, and 52.
Other	Rey's 15-Item Memory test	Measure of verbal learning and memory	Change from baseline (week 0) to weeks 7 and 52.
Other	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.
Other	Trail Making Test	Measure of mental flexibility	Change from baseline (week 0) to weeks 7 and 52.
Other	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.
Other	Coding subtest of the Wechsler Adult Intelligence Scale-IV	Measure of working memory	Change from baseline (week 0) to weeks 7 and 52.
Other	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.
Other	D2 Test of attention	Measure of selective and sustained attention	Change from baseline (week 0) to weeks 7 and 52.
Other	Verbal Fluency Test	Measure of verbal ability and executive control	Change from baseline (week 0) to weeks 7 and 52.
Other	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.
Primary	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	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.
Secondary	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.
Secondary	Operational Police Stress Questionnaire (PSQ-OP)	Measure of severity of occupational stress	Change from baseline (week 0) to weeks 7, 26, and 52.