Study on the Effectiveness of Reconsolidation Therapy with Propranolol for Patients with Severe Post-Traumatic Stress Disorder

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What is this study about?

This clinical trial is focused on studying the effectiveness of a treatment for post-traumatic stress disorder (PTSD), a condition that can develop after experiencing or witnessing a traumatic event. The study will explore a therapy called reconsolidation therapy, which aims to help patients with severe and chronic PTSD who require hospital care. The trial will compare this therapy to another method known as prolonged exposure therapy, which is commonly recommended for treating PTSD. Additionally, the study will investigate whether the medication propranolol, taken in the form of film-coated tablets, can enhance the effectiveness of prolonged exposure therapy by helping to reduce fear responses.

Participants in the study will be divided into different groups. Some will receive prolonged exposure therapy combined with propranolol, while others will receive prolonged exposure therapy without propranolol. The goal is to determine if propranolol can help improve the outcomes of the therapy. The study will last for a period of up to six months, during which participants will take propranolol orally, in doses of either 10 mg or 40 mg, depending on the group they are in. The maximum daily dose will not exceed 80 mg.

The purpose of this study is to verify the effectiveness of these treatments in helping patients manage their PTSD symptoms. The trial will use various scales and measures to assess changes in symptoms, emotions, and overall well-being. By comparing the different treatment approaches, the study aims to provide valuable insights into how best to support individuals living with PTSD.

1 initial assessment

Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes verifying age, language proficiency, and diagnosis of post-traumatic stress disorder (PTSD).

Women of childbearing potential will undergo a high sensitivity pregnancy test. Contraception must be maintained throughout the clinical sessions.

2 group assignment

Participants will be randomly assigned to one of the therapeutic groups. One group will receive prolonged exposure therapy with propranolol, and the other group will receive prolonged exposure therapy without propranolol.

3 medication administration

If assigned to the group receiving propranolol, participants will take Inderal tablets. The dosage will be either 10 mg or 40 mg, taken orally as prescribed by the study protocol.

The frequency and duration of medication administration will be determined by the study team and communicated to participants.

4 therapy sessions

Participants will attend regular therapy sessions as part of the study. These sessions will focus on reconsolidation therapy and prolonged exposure therapy techniques.

The therapy aims to address symptoms of PTSD and improve emotional regulation.

5 progress evaluation

Throughout the study, progress will be evaluated using various scales, including the Posttraumatic Stress Disorder Checklist Scale (PCL-S) and the Positive and Negative Affect Schedule (PANAS).

Additional assessments may include the Hospital Anxiety and Depression Scale (HADs), Difficulties in Emotion Regulation Scale (DERS), and Heart Rate Variability (HRV) monitoring.

6 study completion

Upon completion of the study, participants will undergo a final assessment to evaluate the effectiveness of the therapy received.

Feedback on the overall experience and outcomes will be collected to contribute to the study’s findings.

Who Can Join the Study?

Age between 18 and 65 years old.
Currently staying in a psychiatric care unit.
Speaks French as their first language.
Has been diagnosed with post-traumatic stress disorder (PTSD), which may include symptoms like difficulty managing emotions, acting impulsively, having trouble with relationships, feeling empty or abandoned, and experiencing dissociative symptoms (feeling disconnected from reality).
Women who can become pregnant must use hormonal contraception (like birth control pills) or a non-hormonal intrauterine device (IUD). This must be continued throughout the study. Participation will only begin after a negative pregnancy test.

Who Cannot Join the Study?

Patients who are not diagnosed with post-traumatic stress disorder (PTSD) cannot participate.
Patients who are not in the age range of 18 to 65 years old cannot participate.
Patients who are part of a vulnerable population, such as those unable to give informed consent, cannot participate.
Patients who are not able to follow the study procedures or attend scheduled visits cannot participate.
Patients who have a medical condition that might interfere with the study or pose a risk to their health cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients who have a known allergy or adverse reaction to propranolol (a medication used in the study) cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have a history of severe heart problems cannot participate.
Patients who have uncontrolled high blood pressure cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	01.02.2023

Trial locations

Investigated drugs:

Propranolol Hydrochloride

Reconsolidation Therapy is a type of psychological treatment aimed at helping people with post-traumatic stress disorder (PTSD). This therapy works by helping patients revisit and process their traumatic memories in a safe environment, which can help reduce the emotional impact of these memories over time. The goal is to change the way the brain stores these memories, making them less distressing.

Prolonged Exposure Therapy is another psychological treatment used for PTSD. In this therapy, patients are gradually exposed to their trauma-related memories, feelings, and situations that they have been avoiding. This exposure is done in a controlled and safe way, helping patients face their fears and reduce their anxiety over time. The therapy aims to help patients process their trauma and reduce the symptoms of PTSD.

Propranolol is a medication that is sometimes used in combination with psychological therapies for PTSD. It is a type of drug known as a beta-blocker, which is commonly used to treat high blood pressure and heart problems. In the context of PTSD treatment, propranolol is thought to help reduce the physical symptoms of anxiety and may help make psychological therapies more effective by reducing the emotional response to traumatic memories.

Investigated diseases:

Post-traumatic stress disorder

Post-traumatic stress disorder – Post-traumatic stress disorder is a mental health condition triggered by experiencing or witnessing a traumatic event. It is characterized by symptoms such as intrusive memories, avoidance of reminders of the trauma, negative changes in mood and thoughts, and heightened reactions. The disorder can develop shortly after the traumatic event or may appear months or even years later. Symptoms can vary in intensity and may become more severe during periods of stress or when exposed to reminders of the trauma. Over time, individuals may experience difficulties in daily functioning, including challenges in relationships and work. The progression of the disorder can be influenced by factors such as the nature of the trauma, personal history, and available support systems.

Trial ID:

2022-500870-32-02

Protocol code:

ULB-PTSD-Propranolol

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness of Reconsolidation Therapy with Propranolol for Patients with Severe Post-Traumatic Stress Disorder

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?