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

NCT07792122 | Not Yet Recruiting Phase 3

• 3 other identifiers: RC31/23/04342025-523107-30-012025
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Post-Traumatic Stress Disorder, PTSD

Keywords

PTSD; women victims of violence; Propranolol; Memory reactivation

Outcome Measures

Primary Outcomes (1)

• 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).

  7 weeks (propranolol group) or 9 weeks (psychotherapy group)

Secondary Outcomes (10)

• Number of sessions

  7 weeks

• Stability of the treatment effect

  6 months

• Percentage of cases not remitted

  6 months

• Perceived intensity

  6 months

• Symptoms of depression

  6 months

Study Arms (2)

Propranolol group

EXPERIMENTAL

Drug: Propranolol

Psychotherapy group

ACTIVE COMPARATOR

Behavioral: Psychotherapy

Interventions

Propranolol DRUG

The 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.

Propranolol group

Psychotherapy BEHAVIORAL

After 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.

Psychotherapy group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (2)

Lapeyronie Hospital - Montpellier University Hospital

Montpellier, 34 295, France

Location

Toulouse University Hospital - Psychiatry Department

Toulouse, 31 059, France

Location

MeSH Terms

Conditions

Combat Disorders; Stress Disorders, Post-Traumatic

Interventions

Propranolol; Psychotherapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Behavioral Disciplines and Activities

Study Officials

• Philippe Birmes, PHD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe Birmes, PHD

CONTACT

05 34 55 75 00; birmes.p@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2030
• Last Updated: August 28, 2026

Record last verified: 2026-08

Locations

FR (2)