Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol

Post-traumatic stress disorder (PTSD) develops following exposure to a life-threatening event. Being a victim of domestic physical violence and/or sexual assaults is among the highest risk factors for developing PTSD (Darves-Bornoz et al., 2008). The World Health Organization (WHO) recommends trauma-focused psychotherapy (such as PE) as the most effective treatment for PTSD. However, these treatments can be costly and difficult to access. Recently, PTSD treatment involving traumatic memory reactivation procedure combined with Propranolol - a widely used beta-blocker - has demonstrated both safety and efficacy. Given that PTSD is characterized by emotional hypermnesia of the traumatic memory, this approach aims to reduce PTSD symptoms severity by attenuating the emotional charge associated with the traumatic memory. The primary objective of our study is to compare the efficacy of Propranolol with Prolonged Exposure/PE in women who have experienced violence and suffer from severe PTSD.

In the propranolol group, for the first session, ninety minutes after propranolol ingestion, participants write a one-page trauma narrative script focusing on the event's most disturbing moments. The five following sessions consist of lecture of the traumatic script after ingestion of propranolol.

In the psychotherapy group, PE is standardly realized during eight to ten sessions.

A follow-up session is scheduled three months after the treatment for both groups.

Inclusion criteria

• Women aged from 18 to 75 years
• Having been victim of severe violence (rape, sexual assault, physical assault) Currently suffering from PTSD related to the traumatic event. The diagnosis of PTSD is made according to the DSM-5 criteria by a psychiatrist/psychologist using the CAPS-5, regardless of the traumatic event meeting criterion A of the DSM-5, with or without dissociative symptoms as described in the "With dissociative symptoms" section of the DSM-5, Immediate or delayed PTSD CAPS-5 total score ≥ 33 heart rate ≥ 55 bpm
• The subject must have signed the consent form.
• The subject must be enrolled in a social security program.
• The participant must be able to understand and read French.
• The participant agrees to comply with the contraception requirements outlined in the protocol.

Exclusion criteria

• Systolic blood pressure below 100 mm Hg.
• Contraindications to the administration of propranolol: Asthma, Chronic obstructive pulmonary disease, Decompensated heart failure, Cardiogenic shock, Unpaced second-degree atrioventricular block, Unpaced third-degree atrioventricular block, Spasmodic angina, Uncompensated sinus node dysfunction, bradycardia, Raynaud's syndrome, severe peripheral circulatory disorder, untreated pheochromocytoma, arterial hypotension, hypersensitivity to beta-blockers, history of anaphylactic allergic reaction.
• Heart failure (compensated or decompensated)
• Severe liver disease
• Significant renal impairment
• Myasthenia gravis
• Personal or family history of psoriasis
• Patients who have suffered a head injury within the past year or who have clinical symptoms and residual neurological sequelae
• Wearing contact lenses
• Severe psychiatric disorders: Severe symptoms of other anxiety disorders, severe symptoms of Obsessive-Compulsive Disorder, history of or current psychotic disorder, bipolar mood disorder, severe personality disorder, alcohol or other substance use disorder
• "Yes" response to item 4 of the C-SSRS: active suicidal ideation with intent to act, without a specific plan, and/or "Yes" response to item 5 of the C-SSRS: active suicidal ideation with a specific plan and intent to act
• Hospitalized or treated for suicidal behavior within the past 3 months
• Previous intolerance to a beta-blocker.
• Women of childbearing age not using contraception.
• Pregnancy, breastfeeding.
• Current use of a beta-blocker, regardless of the formulation.
• Known interactions with Propranolol (combination use not recommended and combinations to be used with caution) as indicated in the summary of product characteristics.
• Undergoing psychotherapy or pharmacological treatment with psychotropic agents such as antidepressants, neuroleptics, and/or mood stabilizers. However, these subjects may be included after a 2-week therapeutic abstinence period (6 weeks for treatment with fluoxetine).
• Patients under judicial protection, under guardianship or curatorship, individuals under family authorization, or under a future protection order with representation regarding the person
• Participants who are related to a person involved in the study at the investigator's center, within the clinical research organization (CRO), or at the sponsor
• Participation in another interventional research study, clinical trial, or clinical investigation within the 6 months preceding selection