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| Name | Class |
|---|---|
| Institut de Recherche Robert-Sauvé en Santé et en Sécurité du Travail | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propranolol Hydrochloride | Experimental | 1mg / kg of propranolol hydrochloride administered as a capsule 60 minutes prior to memory reactivation |
|
| Placebo | Placebo Comparator | Placebo manufactured as a capsule to mimic 1mg/kg of propranolol hydrochloride administered 60 minutes prior to memory reactivation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propranolol Hydrochloride | Drug | 1mg / kg of propranolol hydrochloride, oral capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Hopkins Symptom Checklist - 25 (HSCL - 25). |
| Measure | Description | Time Frame |
|---|---|---|
| Social Functioning Questionnaire (SFQ) | Measure of psycho-social functional | Change from baseline (week 0) to weeks 7, 26, and 52. |
| Rey's 15-Item Memory test | Measure of verbal learning and memory |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alain Brunet, PhD. | Contact | 514-761-6131 | 4348 | alain.brunet@mcgill.ca |
| Daniel Saumier, PhD. | Contact | 514-761-6131 | 4349 | irsst.brunet@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Alain Brunet, PhD. | Douglas Mental Health University Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Douglas Mental Health University Institute | Recruiting | Montreal | Quebec | H4H1R3 | Canada |
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Repeated measures parallel design.
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| Placebo | Drug | 1mg / kg of matched placebo, oral capsule |
|
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) | Measure of severity of occupational stress | Change from baseline (week 0) to weeks 7, 26, and 52. |
| Change from baseline (week 0) to weeks 7 and 52. |
| 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. |
| Trail Making Test | 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 | Measure of selective attention | Change from baseline (week 0) to weeks 7 and 52. |
| Coding subtest of the Wechsler Adult Intelligence Scale-IV | Measure of working memory | Change from baseline (week 0) to weeks 7 and 52. |
| 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. |
| D2 Test of attention | Measure of selective and sustained attention | Change from baseline (week 0) to weeks 7 and 52. |
| Verbal Fluency Test | Measure of verbal ability and executive control | Change from baseline (week 0) to weeks 7 and 52. |
| 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. |
| ID | Term |
|---|---|
| D000068099 | Trauma and Stressor Related Disorders |
| D013313 | Stress Disorders, Post-Traumatic |
| D000275 | Adjustment Disorders |
| D040701 | Stress Disorders, Traumatic, Acute |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D040921 | Stress Disorders, Traumatic |
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| ID | Term |
|---|---|
| D011433 | Propranolol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
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