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Evaluation of Propranolol‑Enhanced Traumatic Memory Reactivation for Post‑Traumatic Stress Disorder in Women Victims of Violence

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on women who have experienced violence and who suffer from Post‑traumatic stress disorder, a condition that can cause intense fear, flashbacks, and difficulty sleeping after a traumatic event. The treatment being tested uses a single dose of propranolol, a medication that can reduce the emotional strength of memories, taken before a short session in which the painful memory is briefly recalled (called traumatic memory reactivation). This approach is compared with the standard care of eight weekly sessions of prolonged exposure psychotherapy, a type of talk therapy that helps people confront and lessen the impact of their traumatic memories. The purpose of the study is to compare the effect of the medication‑assisted memory reactivation with the standard psychotherapy on the severity of PTSD symptoms.

Participants will be assigned to one of two groups. In the first group, a dose of propranolol is taken orally before each of six weekly memory‑reactivation sessions. In the second group, participants attend eight weekly psychotherapy sessions without any medication. After the final session, researchers will check the participants’ symptoms a week later and then again at three and six months to see how the treatment worked over time. Throughout the study, any side effects or changes in mood, depression, or daily functioning will be recorded to evaluate safety and overall benefit.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline assessment

    After you join the study, you will complete a set of questionnaires and a clinical interview that measure the severity of post‑traumatic stress disorder (ptsd) and related symptoms.

    The interview uses the clinician administered ptsd scale for dsm‑5 (caps‑5), which is a standard tool for evaluating ptsd symptoms.

  2. Step 2

    Treatment allocation

    You will be assigned to one of two groups:

    • the propranolol memory reactivation group, which includes six weekly sessions, or

    • the prolonged exposure psychotherapy group, which includes eight weekly sessions.

  3. Step 3

    Weekly session – propranolol memory reactivation

    If you are in the propranolol group, you will attend one session each week for six weeks.

    One hour before each session you will take a single oral tablet of propranolol 40 mg (the tablet is film‑coated and can be split if needed).

    The medication is taken to reduce the physical response to stress during the memory reactivation exercise.

    The session itself involves recalling the traumatic memory while the medication is active, under the supervision of the study staff.

  4. Step 4

    Weekly session – prolonged exposure psychotherapy

    If you are in the psychotherapy group, you will attend one session each week for eight weeks.

    No medication is taken in this arm.

    Each session focuses on gradually confronting trauma‑related memories and situations in a safe environment, which is called prolonged exposure (pe).

  5. Step 5

    Completion of treatment

    After the sixth propranolol session or the eighth psychotherapy session, the active phase of the trial ends for you.

    You will be reminded of the upcoming follow‑up assessments.

  6. Step 6

    Follow‑up assessment – 1 week after last session

    One week after the final treatment session, you will complete the same set of questionnaires as at baseline.

    The primary outcome is the ptsd symptom score measured with caps‑5.

    Additional questionnaires evaluate depression (bdi‑ii), dissociative symptoms (des), suicidal thoughts (c‑ssrs), functional improvement (cgi‑i), and quality of life (whoqol‑brief).

  7. Step 7

    Follow‑up assessment – 3 months after last session

    Three months after the final treatment session, you will again complete the same questionnaires.

    These results help determine whether the treatment effect remains stable over time.

  8. Step 8

    Follow‑up assessment – 6 months after last session

    Six months after the final treatment session, a final set of questionnaires is administered.

    The assessment includes the ptsd symptom score (caps‑5), depression score (bdi‑ii), dissociative symptoms (des), suicidal ideation (c‑ssrs), functional improvement (cgi‑i), and quality of life (whoqol‑brief).

    Any adverse events that occurred during the follow‑up period are also recorded.

Who can join the trial?

9 criteria

  • Be a woman between 18 and 75 years old.
  • Have experienced severe violence such as rape, sexual assault, or physical assault.
  • Currently have post‑traumatic stress disorder (PTSD) related to that event, diagnosed by a psychiatrist or psychologist using the DSM‑5 criteria (the standard manual for mental health diagnoses) and the CAPS‑5 interview (a detailed questionnaire that measures PTSD severity).
  • Have a heart rate of at least 55 beats per minute (the number of times the heart beats in one minute).
  • Have signed the informed consent form, agreeing to take part in the study.
  • Be enrolled in a social security program (a government health insurance system).
  • Be able to understand and read French.
  • Agree to follow the study’s contraception requirements (use of birth control methods as specified in the protocol).
  • Score 33 or higher on the CAPS‑5 total score (indicating a certain level of PTSD severity).

Who cannot join the trial?

21 criteria

  • Systolic blood pressure (the top number when blood pressure is measured) lower than 100 mm Hg.
  • A head injury that happened within the past year or lasting brain symptoms (known as neurological sequelae).
  • Wearing contact lenses.
  • Being hospitalized or receiving treatment for suicidal behavior in the past three months.
  • Having previously not tolerated a beta‑blocker medication (a drug that slows the heart).
  • Being a woman of child‑bearing age who is not using contraception (methods to prevent pregnancy).
  • Being pregnant or breastfeeding.
  • Currently taking any beta‑blocker medication, no matter the form.
  • Having known drug interactions with propranolol (the study medication) as listed in its safety information.
  • Receiving psychotherapy or psychiatric medicines such as antidepressants, neuroleptics (antipsychotic drugs), or mood stabilizers unless these medicines have been stopped for at least 2 weeks (6 weeks if taking fluoxetine).
  • Being under legal protection such as guardianship, curatorship, family authorization, or a future protection order.
  • Having severe psychiatric conditions, including very strong anxiety, severe Obsessive‑Compulsive Disorder (OCD), a history of or current psychotic disorder (loss of touch with reality), bipolar mood disorder, severe personality disorder, or alcohol or other substance use disorder (addiction).
  • Being a relative of anyone working on the study at the investigator’s site, the research organization, or the sponsor.
  • Having participated in another interventional research study or clinical trial within the past six months.
  • Answering “Yes” to questions indicating active suicidal thoughts with intent to act on them (as measured by the C‑SSRS questionnaire).
  • Any medical reason that makes taking propranolol unsafe (contraindications).
  • Having heart failure (whether stable or unstable), a condition where the heart cannot pump blood effectively.
  • Having severe liver disease (significant damage to the liver).
  • Having significant kidney problems (reduced kidney function).
  • Having myasthenia gravis, a disease that causes muscle weakness.
  • Having a personal or family history of psoriasis, a skin condition that causes red, scaly patches.
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Investigated drugs

Propranolol is a medication that blocks certain signals in the body that are part of the “fight‑or‑flight” response. In this study, participants take a single dose of the drug before a session where they recall a traumatic memory. The drug is expected to make the emotional reaction to that memory weaker, helping the brain store the memory with less distress.

Prolonged exposure psychotherapy (often called EP) is a type of counseling where participants meet with a therapist once a week for several weeks. During each session, they are guided to talk about and relive their traumatic experiences in a safe, controlled way. Repeatedly facing these memories is meant to reduce fear and anxiety over time, helping the symptoms of PTSD improve.

What is already known about the treatment

Propranolol - This medication is taken as an oral, film‑coated tablet that can be split if needed. It is a well‑known drug that has been used for many years and is described in many medical books and research papers. It is mainly prescribed for high blood pressure, heart rhythm problems, and anxiety, and is also studied for helping with PTSD symptoms. It works by blocking beta‑adrenergic receptors, which reduces the body’s response to adrenaline, and it belongs to the class of non‑selective beta‑blockers.

Investigated diseases

Post-traumatic stress disorder - Post‑traumatic stress disorder is a mental condition that can develop after a person experiences or witnesses a threatening or harmful event. It often begins with intense feelings of fear, helplessness, or horror that may recur as vivid memories or nightmares. Over time, the individual may avoid places, people, or activities that remind them of the event and may feel constantly on edge or have trouble concentrating. These symptoms can become more persistent and interfere with daily life as the disorder continues.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523107-30-01Protocol codeRC31/23/0434Estimated enrolment76 patientsSponsorCentre Hospitalier Universitaire De Toulouse

sourced from the EU Clinical Trials Register and site verification

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