Post Traumatic Stress Disorder Clinical Trial
Official title:
Comparing Standard vs. Modified Reconsolidation Blockade for the Treatment of Psychological Trauma: A Randomized Controlled Trial
The investigators propose to examine a mismatch-based method of reconsolidation blockade for the treatment of psychological trauma in military personnel and Federal police officers. The standard reconsolidation blockade treatment (aka Reconsolidation Therapy) involves reactivating the trauma memory while under the influence of propranolol. The mismatch method of Reconsolidation Therapy will involve varying the contexts in which the weekly trauma memory retrieval will occur. This study will involve 10 visits (eligibility assessment, treatments, and follow-up visits) over a 6-month period for each participant. Treatments will be conducted once a week for a six-week period where the participant will take a dose of propranolol (or a placebo pill) 60 minutes prior to memory reactivation. The investigators hypothesize that reconsolidation blockade treatment will be as effective in treating PTSD among military personnel and Federal police officers, with the mismatch condition showing greater symptom improvement.
Status | Not yet recruiting |
Enrollment | 150 |
Est. completion date | December 2024 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: (i) Male or female 18-65 years old; (ii) Individuals who are either: - Employed full-time as part of the Canadian or US military forces or the RCMP; - On leave of absence from Canadian or US military forces, or the RCMP; - Veterans of the Canadian or US military forces or the RCMP; (iii) Evidence of a personally signed and dated informed consent form; (iv) Individuals suffering from occupationally related PTSD, as defined by the DSM-5, for 6 consecutive months or more. (v) Females of childbearing potential willing to use contraception for the duration of the treatment period of the study. Exclusion Criteria: (i) Basal systolic blood pressure < 100 mm Hg; (ii) Basal heart rate < 50 BPM; (iii) Medical conditions contraindicating the administration of propranolol or beta blockers (iv) A known hypersensitivity to propranolol or any of the study product or placebo ingredients; (v) Clinically significant lactose intolerance; (vi) Use of medication that involves unwanted interactions with propranolol including but not limited to other beta-blockers, anti-arrhythmic medications, and calcium channel blockers; (vii) Current use of propranolol; (viii) Pregnant or breast-feeding women; (ix) Individuals with borderline personality, bipolar disorder, psychosis; (x) Current DSM-5 substance dependence; (xi) Active suicidal ideations, as demonstrated by a response of 2 or 3 on item 7 of the Beck Depression Inventory - Short Form; (xii) A score below 'moderately ill' on the severity scale of the Clinical Global Impression scale; (xiii) Participating in active litigation related to the traumatic event (Veterans Affairs Canada claims are permitted, excluding judicial claims); (xiv) Strong dissociative tendencies, as evidenced by the Dissociative Experience Scale (8-item version, DES-T); (xv) Suspected or confirmed traumatic brain injury during the last 24 months; (xvi) Understanding neither English nor French; (xvii) Participants who receive exposure-based cognitive-behavioral therapy during the treatment phase of the study; (xviii) Presence of any medical condition that in the opinion of the investigator may compromise patient safety or study objectives. |
Country | Name | City | State |
---|---|---|---|
Canada | Douglas Mental Health University Institute | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Douglas Mental Health University Institute | Canadian Institutes of Health Research (CIHR) |
Canada,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Post-traumatic Checklist for the Diagnostic and Statistical Manual for Mental Disorders - 5th edition (PCL-5) scores | Change from baseline (week 0) to week 7 in PCL-5 scores | Questionnaire administered at weeks 0 and 7 | |
Secondary | Post-traumatic Checklist for the Diagnostic and Statistical Manual for Mental Disorders - 5th edition (PCL-5) scores | Changes from baseline in PCL-5 scores during treatment and at weeks 13 and 26 | Questionnaire administered at weeks 0, 1, 2, 3, 4, 5, 6, 13 and 26 | |
Secondary | Beck Depression Inventory (BDI) scores | Changes from baseline in BDI scores during treatment and at week 26 | Questionnaire administered at weeks 0, 1, 2, 3, 4 , 5, 6, 7, 13 and 26 | |
Secondary | Clinical Global Impression-Improvement (CGI-I) scores | Absolute CGI-I scores | Questionnaire administered at weeks 0, 7 and 26 | |
Secondary | Mini Psychiatric Interview, version 7 (MINI-7) | Proportion of participants who no longer meet PTSD diagnostic criteria at Weeks 7 and 26. | Questionnaire administered at weeks 0, 7 and 26 | |
Secondary | Social Functioning Questionnaire (QFS) | Changes from baseline in QFS scores | Questionnaire administered at weeks 0, 7, and 26 | |
Secondary | World Health Organization - Quality of Life BREF | Changes from baseline in World Health Organization - Quality of Life BREF scores | Questionnaire administered at weeks 0, 7, and 26 | |
Secondary | Dissociative Experiences Scale (DES-T) | Changes from baseline in DES-T scores | Questionnaire administered at week 0. | |
Secondary | International Trauma Questionnaire (ITQ) | Changes from baseline in ITQ scores | Questionnaire administered at baseline and weeks 0, 7, and 26 |
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