None listed
Conditions
Brief summary
This study aims to evaluate whether a six-week program of psilocybin-assisted psychotherapy can more effectively reduce symptoms of major depressive disorder (MDD) compared to standard psychological care (represented by a waitlist control). Adults with MDD will be randomly assigned to either begin the treatment program immediately or after a 10-week delay. The treatment involves one supervised psilocybin dosing session and six psychotherapy sessions, delivered in a standard clinic setting using a fly-in-fly-out model, where specialist staff attend only for the intervention phase. Participants will also be randomly assigned to use either a virtual reality tool or journaling as an adjunct to support their therapy. Mental health outcomes will be tracked for up to 46 weeks. The study aims to test whether this innovative model can safely and effectively improve depression in real-world care settings.
Interventions
This trial investigates a new treatment program for Major Depressive Disorder (MDD), using Psilocybin-Assisted Therapy (PAT). The treatment involves psychotherapy sessions, a single 25 mg oral dose of the psychedelic substance psilocybin, and a reflective integration tool (a VR headset or journal) for home use. The intervention spans approximately ten weeks.
Participants will continue working with their regular psychotherapist, who will be paired with a specialist psychedelic therapist. The tre
This trial investigates a new treatment program for Major Depressive Disorder (MDD), using Psilocybin-Assisted Therapy (PAT). The treatment involves psychotherapy sessions, a single 25 mg oral dose of the psychedelic substance psilocybin, and a reflective integration tool (a VR headset or journal) for home use. The intervention spans approximately ten weeks. Participants will continue working with their regular psychotherapist, who will be paired with a specialist psychedelic therapist. The treatment will be delivered at a clinical partner organisation, and not a research centre. This model of care is referred to as ‘fly-in-fly-out psychedelic-assisted therapy’ (FIFO-PAT). All psychotherapists working on the study have undergone PAT specific training, delivered by qualified PAT supervisors. There will be ongoing supervision and support provided to therapists throughout the trial. Following a multi-stage screening procedure, the treatment for enrolled participants will typically include: -Three 90-minute preparatory psychotherapy sessions over three weeks. These sessions are designed to build rapport between the participant and therapists and prepare the participant for the psilocybin experience by providing education on the effects of psilocybin and discussing the participants intentions. -One dosing session (25 mg psilocybin capsule administered alongside therapeutic support). The dosing session will occur the week after the third preparatory session. -Three 90-minute integration psychotherapy sessions over the following three weeks. The first integration session will occur the day after the dosing session. These sessions will help the participant make sense of their psilocybin experience and apply insights to their daily lives. These sessions will be supported by the use of journaling or VR. -Ongoing use of a reflective home journal or VR headset to support integration. - Completion of online surveys at regular intervals throughout the trial. Participants will be randomised to one of the three initial conditions: PAT with journaling, PAT with VR, or Waitlist (treatment as usual). Those in the Waitlist group will be randomised 10 weeks later into either into PAT with journaling, or PAT with VR. The VR headset or journal assignment will be random and is not based on participant preference. The VR environment is a natural landscape that you can walk around in and it provides a method for expressing and recording insights from dosing and therapy sessions. Participants are advised to use the VR headset for about 15 minutes, 3-4 times a week but the exact duration and frequency is up to them. The journaling group will be provided with a journal and will be encouraged to record, revisit and reflect on the contents of their psychedelic experience and therapy session. The duration and frequency of journaling is up to the participant. Adherence to the intervention will be assessed by session attendance, completion of surveys and engagement with the VR or journaling tool.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
- Be aged 18 to 75 years. - Meet DSM-5 criteria for Major Depressive Disorder - Score at least 20 on the MADRS at screening - Be engaged in psychological services at the trial partner clinic, have completed at least four sessions, and attend at least monthly on average.
Exclusion criteria
- Have a current or lifetime history of meeting DSM-5 criteria for Schizophrenia, other Psychotic Disorder, Dissociative Identity Disorder, or Bipolar I or II Disorder or other mood disorder with psychotic features. - Have a current or past year history of meeting DSM-5 criteria for alcohol or drug dependence (excluding caffeine and nicotine), if determined by the PI or Study Physician to be incompatible with safe exposure to psilocybin. - Have current serious suicide risk, as determined through psychiatric interview, responses to Columbia Suicide Severity Rating Scale (C-SSRS), and clinical judgment of the AP or treating team - Require ongoing concomitant therapy with an excluded medication.
Outcome results
None listed