Post-traumatic stress disorder (PTSD) develops after life-threatening events, with domestic violence and sexual assault being major risk factors. An innovative approach using traumatic memory reactivation with propranolol has shown promise in reducing PTSD symptoms. This study aims to compare the efficacy of propranolol with trauma-focused psychotherapy in women suffering from severe PTSD after violence.
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.
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
Parallel
Propranolol
DrugThe first treatment session consists of preparing the traumatic script. Ninety minutes after taking propranolol, the preparation of the traumatic scenario will be conducted by a trained psychologist at the center. This standardized procedure (CHU de Toulouse, 2022) involves asking the patient to write a report on the most distressing aspects of the traumatic event, incorporating as many sensory modalities as possible (visual, olfactory, auditory elements, etc.) and episodic details (such as location, time, season, people present, etc.). This first session lasts approximately 30 minutes. The report will then be briefly discussed with the participant to ensure it contains sufficient detail. This "traumatic scenario" will be typed by the psychologist, resulting in a one-page script, which the subject will read during sessions 2 to 6 for memory reactivation. These five subsequent sessions last approximately 10 minutes each.
Psychotherapy
BehavioralAfter randomization, participants in the "psychotherapy group" will receive PE. The eight to ten PE sessions follow classical and operant conditioning principles, emphasizing habituation. They use imaginal exposure, applied with progressivity and repetition, ensuring prolonged and complete exposure. Each session lasts 45 minutes.
Effect of traumatic memory reactivation under propranolol in women who are victims of violence and suffer from PTSD
It will be assessed by the PTSD symptom score on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) administered 1 week after the last psychotherapy session (V7 for propranolol group or V9 for for psychotherapy group). The CAPS-5 scale is a 45 to 60-minutes structured interview that assesses the frequency and severity of each PTSD symptom related to a traumatic event. It provides a diagnosis of PTSD as well as a PTSD symptom severity score (0 to 80) and an intrusion symptom severity score (0 to 25).
Number of sessions
The PTSD symptom score on the Clinician-Administered PSTD Scale for DSM-5 (CAPS-5) will be used to evaluate the effect of 6 sessions PPNL in comparison with 6 sessions PE. It will be assessed 1 week after the 6th session, on V7.
Stability of the treatment effect
The PTSD symptom scores on the CAPS-5 at S1, M3, and M6 will be used to assess the stability of the treatment effect.
Percentage of cases not remitted
The percentage of female patients with a clinical diagnosis of PTSD 1 week, 3 months, and 6 months after the last treatment session, as recommended by the DSM-5 and assessed using the CAPS-5 will be used to evaluate the cases not remitted.
Perceived intensity
It will be assessed by the score measured by the PTSD Checklist-5 (PCL-5) self-report questionnaire administered at V7 (propranolol and PE group), V9 (PE group), M3, and M6 following the last PPNL session and the last PE sessions. The PCL-5 is a 20-item self-report questionnaire used to assess the presence and severity of post-traumatic stress disorder (PTSD) symptoms according to the DSM-5 criteria. Each item is scored on a scale of 0 to 4, for a total score ranging from 0 to 80 (where 0 indicates no symptoms and 80 indicates the presence of all symptoms).
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