Acute Stress Disorder, Adjustment Disorders, Post-traumatic Stress Disorders, Trauma and Stressor Related Disorders
Conditions
Keywords
Memory Reconsolidation, Propranolol, Police officers, 911 operators, Efficacy, Cost-effectiveness
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.
Interventions
DRUGPropranolol Hydrochloride
1mg / kg of propranolol hydrochloride, oral capsule
DRUGPlacebo
1mg / kg of matched placebo, oral capsule
Sponsors
Institut de Recherche Robert-Sauvé en Santé et en Sécurité du Travail
Douglas Mental Health University Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Repeated measures parallel design.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EuroQol five dimensions questionnaire with five-level scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Post-traumatic Checklist for the Diagnostic and Statistical Manual for Mental Disorders - 5th edition (PCL-5) | Change from baseline (week 0) to weeks 1, 2, 3, 4 , 5, 7, 26, and 52. | Measure of trauma and stressor related symptoms |
| Hopkins Symptom Checklist - 25 (HSCL - 25). | Change from baseline (week 0) to weeks 1, 2, 3, 4 , 5, 7, 26, and 52. | Measure of depression and anxiety symptom severity |
| Operational Police Stress Questionnaire (PSQ-OP) | Change from baseline (week 0) to weeks 7, 26, and 52. | Measure of severity of occupational stress |
Other
| Measure | Time frame | Description |
|---|---|---|
| Color-Word Interference Test of the Delis-Kaplan Executive Function System | Change from baseline (week 0) to weeks 7 and 52. | Measure of selective attention |
| Coding subtest of the Wechsler Adult Intelligence Scale-IV | Change from baseline (week 0) to weeks 7 and 52. | Measure of working memory |
| Attention subtest of the Paced Auditory Serial Addition Test (PASAT) | Change from baseline (week 0) to weeks 7 and 52. | Measure of working memory, divided attention, and information processing speed |
| Social Functioning Questionnaire (SFQ) | Change from baseline (week 0) to weeks 7, 26, and 52. | Measure of psycho-social functional |
| Verbal Fluency Test | Change from baseline (week 0) to weeks 7 and 52. | Measure of verbal ability and executive control |
| Subjective Units of Distress Scale | Changes from week 1 to weeks 2, 3, 4 and 5. | Measure of subjective distress from exposure to an event |
| D2 Test of attention | Change from baseline (week 0) to weeks 7 and 52. | Measure of selective and sustained attention |
| Rey's 15-Item Memory test | Change from baseline (week 0) to weeks 7 and 52. | Measure of verbal learning and memory |
| The Logical Memory subtest of the Wechsler Memory Scale - III | Change from baseline (week 0) to weeks 7 and 52. | Measure of verbal learning and memory |
| Trail Making Test | Change from baseline (week 0) to weeks 7 and 52. | Measure of mental flexibility |
Countries
Canada
Contacts
Primary ContactAlain Brunet, PhD.
Backup ContactDaniel Saumier, PhD.
Outcome results
None listed