Post-Traumatic Stress Disorder, PTSDPhase 3VIOFEMNCT07792122
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
A Phase 3 study testing Propranolol and Psychotherapy in people with Post-Traumatic Stress Disorder, PTSD, run by University Hospital, Toulouse at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Post-Traumatic Stress Disorder, PTSD
- What is being tested?
- Propranolol and Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesFrance
- Study dates
- Dec 2026to Mar 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
Lapeyronie Hospital - Montpellier University Hospital
Montpellier, 34 295
Matthieu Fraigneau, MD, 04 67 33 85 99 ext. +33, m-fraigneau@chu-montpellier.fr
Matthieu Fraigneau, MD
Toulouse University Hospital - Psychiatry Department
Toulouse, 31 059
Philippe Birmes, PHD, 05 34 55 75 00 ext. +33, birmes.p@chu-toulouse.fr
Philippe Birmes, PHD
About this study
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.
Read the detailed description
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.
- Conditions
- Post-Traumatic Stress Disorder, PTSD
- Being tested
- Propranolol, Psychotherapy
- Keywords
- PTSD, women victims of violence, Propranolol, Memory reactivation
- Medical subject headings
- Combat Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropranololDrug
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.
PsychotherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Propranolol group | Experimental | Not described Receives: Drug: Propranolol |
| Psychotherapy group | Active comparator | Not described Receives: Behavioral: Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 7 weeks (propranolol group) or 9 weeks (psychotherapy group)
Secondary outcomes (10)
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.
Measured: 7 weeks
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.
Measured: 6 months
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.
Measured: 6 months
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).
Measured: 6 months
Symptoms of depression
They will be assessed by the depression symptom scores on the 21-item Beck Depression Inventory, Version II (BDI-II) at S7, M3, and M6.
The BDI-II is a 21-item self-report questionnaire used to assess the severity of depressive symptoms in adolescents and adults, yielding a total score ranging from 0 to 63 (0 = no or very few depressive symptoms, 63 = maximum level of symptoms).
Measured: 6 months
Symptoms of dissociation
They will be assessed by the dissociative symptom scores on the Dissociative Experiences Scale (DES) at S7, M3, and M6.
The DES is a 28-item self-report questionnaire that assesses the frequency of dissociative experiences. Each item is rated on a scale from 0 to 100 percent, depending on how often the described experience occurs. The total score is the average of the 28 items and therefore also ranges from 0 to 100 (<20 = low level of dissociation, 20-30 = moderate level, and >30 = high level).
Measured: 6 months
Suicidal ideation
It will be assessed by the scores on the suicidal ideation subscale of the Columbia Suicide Severity Rating Scale (C-SSRS) at S7, M3, and M6.
The C-SSRS is a clinical scale used to assess suicidal thoughts and behaviors. In particular, it assesses: the presence of suicidal thoughts, their intensity and frequency, the existence of a suicide plan or intent, suicide attempts and other suicidal behaviors, and certain preparatory behaviors. It uses a scale ranging from 1 to 5; the higher the level, the more concerning the risk of suicide.
Measured: 6 months
Adverse events
The adverse events (AEs) and serious AEs occurring during the 6-month follow-up period will be collected.
Measured: 6 months
Functionnal improvement
It will be assessed by the Clinical Global Impression Improvement Scale (CGI-I) score at M3 and M6.
The CGI is a clinical assessment used to provide an overall evaluation of a patient's condition and/or progress during treatment. It consists of two dimensions: severity and improvement, each rated on a scale of 7 (where 1 corresponds to normal/significantly improved and 7 to extremely ill/significantly worsened).
Measured: 6 months
Perceived quality of life
It will be assessed by the World Health Organization Quality of Life Brief (WHO-QOL) score, translated into French, at S7, M3, and M6.
The WHO-QOL is a questionnaire consisting of 26 items that assess physical and psychological health, social relationships, and the environment. It evaluates the overall impact of health status on daily life.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study startDec 2026 (estimated)
- Primary completionMar 2030 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress Disorder, PTSDStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Birmes, PHD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07792122
- Sponsor's protocol ID
- RC31/23/0434
- Other IDs
- 2025-523107-30-01, 2025
- Acronym
- VIOFEM
- Status last verified
- Nov 2026
- First submitted
- 24 Aug 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
- ClinicalTrials.gov ID
- NCT07792122
- Acronym / sponsor ID
- VIOFEM / RC31/23/0434
- Conditions
- Post-Traumatic Stress Disorder, PTSD
- Keywords
- PTSD, women victims of violence, Propranolol, Memory reactivation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propranolol group | Experimental | Drug: Propranolol |
| Psychotherapy group | Active comparator | Behavioral: Psychotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropranololThe 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. | Drug | Propranolol group |
| PsychotherapyAfter 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. | Behavioural | Psychotherapy group |
Primary outcome
Effect of traumatic memory reactivation under propranolol in women who are victims of violence and suffer from PTSD
Time frame: 7 weeks (propranolol group) or 9 weeks (psychotherapy group)
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).
10 secondary outcomes
Number of sessions
Time frame: 7 weeks
Stability of the treatment effect
Time frame: 6 months
Percentage of cases not remitted
Time frame: 6 months
Perceived intensity
Time frame: 6 months
Symptoms of depression
Time frame: 6 months
Symptoms of dissociation
Time frame: 6 months
Suicidal ideation
Time frame: 6 months
Adverse events
Time frame: 6 months
Functionnal improvement
Time frame: 6 months
Perceived quality of life
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Philippe Birmes, PHD principal investigator
University Hospital, Toulouse
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Propranolol and Psychotherapy in people with Post-Traumatic Stress Disorder, PTSD, run by University Hospital, Toulouse at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philippe Birmes, PHD (05 34 55 75 00 ext. +33, birmes.p@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of traumatic memory reactivation under propranolol in women who are victims of violence and suffer from PTSD (time frame: 7 weeks (propranolol group) or 9 weeks (psychotherapy group)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.