PARTING Trial
WHAT IS THIS STUDY ABOUT?
Grief is a normal reaction to loss. However, for some people, grief does not improve over time. Instead, the distress remains intense and overwhelming, and makes it hard to function at home, work, in relationships, and in other important areas of life. When this has been the case for more than 12 months, it is sometimes called prolonged grief, and people are recommended to seek help for grief-related distress and suffering.
In the general population 10% of people experience prolonged grief following bereavement of a loved one. However in cancer carers the prevalence is reported to be around 30%.
Psilocybin-assisted psychotherapy is an experimental intervention that could help those living with intense grief reduce their distress and find new ways of learning to live with their loss. The PARTING trial aims to determine whether this approach is safe and acceptable to participants and to establish an initial impression of whether it might help people with prolonged grief.
WHO IS RUNNING THIS STUDY?
The PARTING trial has been funded by QIMR Berghofer Medical Research Institute and Woke Pharmaceuticals. The Coordinating Principal Investigator is Associate Professor Vanessa Beesley, a behavioural scientist who has spent two decades researching ways to improve supportive care for people affected by cancer. The Site Principal Investigator is Associate Professor Stephen Parker, a psychiatrist committed to improving the experiences and outcomes of people affected by mental illness.
WHO CAN PARTICIPATE?
Eligibility for this trial is very strict and involves a lot of screening measures for safety.
You may be eligible to participate if you:
• Are a relative or friend of a person who died from cancer more than 12 months ago
• Are experiencing intense overwhelming grief that makes it hard to function in important areas of life.
• Are over 18 years of age
• Weigh over 40kg
• Are not currently pregnant or trying to get pregnant
• Have a good command of English
• Are able to swallow pills
• Live in Brisbane, Queensland or are able to travel and stay in Brisbane for one week at your own expense
• Are willing to complete 8 therapy sessions over 5 weeks
WHAT WILL I HAVE TO DO TO TAKE PART?
We will give you detailed information and answer any questions you have before you decide to take part in the study. Some brief information is below.
BEFORE STARTING THERAPY
Before starting the therapy, we will ask you to sign some consent forms and complete some screening measures to assess your eligibility. If you are eligible, your will be enrolled in the therapy by the study staff. If you are not enrolled, an explanation will be provided to you as to why.
DURING THE STUDY
This trial will take place at QIMR Berghofer Medical Research Institute (QIMR Berghofer) in Herston, Brisbane. Some appointments will be in person and some can be by video-link. In total, the duration of your participation is estimated to be about 15 weeks. It will consist of:
(1) Screening to assess your eligibility
(2) Three sessions of psychotherapy (talk therapy) before you receive psilocybin
(3) A psilocybin dosing day
(4) Four sessions of psychotherapy after the dosing day
(5) Follow-up interviews and surveys
DATA COLLECTION
If you are enrolled in the therapy we will ask you to complete four online surveys over three months. These will include a number of questions about your grief, psychological symptoms, and quality of life. We will also conduct four clinical interviews with you over approximately three months to assess your grief symptoms.
After you have completed all of your therapy sessions we will ask you to take part in an evaluation interview to ask about your experience of the trial treatment and any effects it has had on your grief and other aspects of your life.
Our trial nurse will also take a blood samples and perform a physical exam and electrocardiogram before and after your psilocybin dose.
All of your screening, therapy and interview sessions will be recorded on video and audio as part of our data collection. These recordings will not be used outside the context of this clinical trial without your written approval.
WHAT HAPPENS NEXT?
If you are interested, please provide your contact details and declaration through the button below. We will contact you with some more information and answer any question you have before you decide to take part.