Not yet recruitingPHASE2INTERVENTIONAL

Psilocybin-assisted Therapy for Post-Traumatic Stress Disorder in Survivors of Intimate Partner Violence

This research trial is open to adults aged 18-65 who are survivors of domestic abuse and have Post-Traumatic Stress Disorder (PTSD). The study wants to find out if a treatment combining a substance called psilocybin with a talking therapy called Acceptance and Commitment Therapy (ACT) can help reduce PTSD symptoms. Some participants will receive a higher dose of psilocybin, while others will receive a very low dose, along with the therapy. Researchers will compare these groups to see if the higher dose is more effective. They will also look at how this treatment might affect quality of life, mood, and anxiety, both immediately after treatment and in the months that follow.

At a glance

Status

Not yet recruiting

Phase

PHASE2

Sponsor

University of Calgary

Enrolment target

Start

01 Aug 2026

Estimated completion

01 Aug 2029

Post Traumatic Stress Disorder PTSD Intimate Partner Violence (IPV)

What is this study about?

This study is investigating a new approach to help adults who have experienced domestic abuse and are now living with Post-Traumatic Stress Disorder (often called PTSD). PTSD can cause a lot of distress, affecting daily life long after a difficult event. The main goal of this research is to see if a special kind of treatment can make a real difference in reducing these symptoms.

The treatment being tested combines a substance called psilocybin with a type of talking therapy known as Acceptance and Commitment Therapy (ACT). Psilocybin is a naturally occurring compound. In this study, it's given under very controlled conditions. ACT is a therapy that helps people accept difficult thoughts and feelings, while committing to changes that improve their lives. By bringing these two together, researchers hope to find a more effective way to help people recover from PTSD.

The study will compare two groups: one receiving a higher, active dose of psilocybin and the other receiving a very low dose (which acts as a comparison). Both groups will also have ACT sessions. Researchers will then carefully check if the higher dose of psilocybin, alongside therapy, is better at easing PTSD symptoms. They will also look at other important aspects like overall quality of life, how people's mood changes, and if it helps with worry and anxiety in the months following the treatment.

Key takeaways

Looks at a new treatment for PTSD in domestic abuse survivors.
Combines psilocybin with Acceptance and Commitment Therapy (ACT).
Compares a higher dose to a very low dose of psilocybin.
Aims to reduce PTSD symptoms and improve quality of life.
Includes talking therapy sessions and follow-up checks over six months.

Who may be eligible?

This study is looking for adults between 18 and 65 years old. You should have experienced domestic abuse at least six months ago and have a diagnosis of chronic PTSD. It's important that you can read and write in English to take part.

There are also some reasons why you might not be able to join. For example, if you've recently used certain substances, have a history of serious mental health conditions like schizophrenia or bipolar disorder, or if you've had recent thoughts of harming yourself. If you are pregnant, breastfeeding, or trying to become pregnant, you won't be able to participate.

The hospital will do a thorough health check to make sure the study is safe for you. This includes checking your heart and blood tests. You also shouldn't have certain medical conditions like uncontrolled diabetes or a history of seizures (epilepsy).

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 65 years old?
Have you experienced domestic abuse at least 6 months ago?
Do you have a diagnosis of lasting PTSD (chronic PTSD)?
Can you read and write in English?
Do you have a clear medical history, without conditions like schizophrenia or heart problems?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a two-step screening process to make sure the study is right for you. If you qualify, you'll come in for an initial health check and assessment.

Before receiving any treatment, you'll have one or more sessions to prepare you and explain everything clearly. Then, you'll have one main session where you'll receive either a full dose (25mg) or a very small dose (1mg) of psilocybin. Following this, you'll attend 5-6 weekly talking therapy sessions called ACT.

To check how well the treatment is working, you'll complete questionnaires and assessments at different times: one week, four weeks, three months, and six months after your psilocybin session. The assessments at three months might only be online. The total length of your participation will be around six months.

Potential risks and benefits

Taking part in this study could potentially offer a new way to understand and reduce your PTSD symptoms, and it might also improve your overall quality of life and mood. However, any medical study carries potential risks. Psilocybin can have psychological effects, and although it will be given under careful medical supervision, individual reactions can vary. There may also be side effects during or after the psilocybin session or from the therapy itself. You will be fully informed of all potential risks before you decide to join. Remember, participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

University of Calgary
Verified postcode
Calgary, Canada
The University of British Columbia - Okanagan Campus
Verified postcode
Kelowna, Canada

Common questions

What is psilocybin?

Psilocybin is a natural compound that can affect your thoughts, feelings, and senses. In this study, it's used under strict medical supervision as part of a potential treatment.

What is ACT therapy?

ACT, or Acceptance and Commitment Therapy, is a type of talking therapy that helps people accept difficult thoughts and feelings rather than fighting them, and then commit to actions that align with their personal values.

Will I know if I'm getting the full psilocybin dose?

No, you won't know if you're receiving the higher dose or the very low comparison dose. This is a common practice in studies to make sure the results are fair and unbiased.

What happens after the main treatment session?

After the main psilocybin session, you'll continue with weekly talking therapy sessions (ACT) for 5-6 weeks. You'll also have follow-up assessments over the next six months to see how you're doing.

What if I feel uncomfortable during the study?

Your safety and well-being are the top priority. There will always be medical staff and therapists available to support you. You can also leave the study at any point if you wish.

How to find out more

Chantel T Debert, MD MSc FRCPC

cdebert@ucalgary.ca 403) 944-4500 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.