Mindfulness-assisted Psychedelic Therapy (MAPT)

This randomised, open-label, parallel arm trial (n=40) will examine the potential synergy between psilocybin (25mg) and mindfulness training in improving mental health.

Participants will be randomised into two groups: one receiving one 25mg dose of psilocybin combined with 8 weeks of mindfulness training, and the other receiving only psilocybin. The study aims to assess changes in depression symptoms, stress, and anxiety, as well as neurocognitive measures and blood inflammatory markers.

The primary outcome measure will be the change in self-reported depression symptoms on the CES-D scale from baseline to the 8-week follow-up. This study is conducted by the University of Southern California and is set to start in July 2024, with an estimated completion date in July 2026.

Topic Depression Anxiety
Compound Psilocybin
Country United States of America
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 July 2024
End date 31 July 2026
Phase Phase II
Design Open
Type Interventional
Generation First
Participants 40
Sex All
Age 25- 99
Therapy Yes

Trial Details

The goal of this clinical trial is to test psilocybin in combination with mindfulness training in healthy adults. The main question it aims to answer is "Does mindfulness training enhance the effects of psychedelic therapy (psilocybin) on mental health?" Interested individuals will complete an initial eligibility session and eligible participants will then be randomized into one of two groups: one dose of psilocybin (administered under the supervision of study therapists) combined with 8 weeks of weekly mindfulness training classes (Arm 1) or psilocybin alone (Arm 2). Both groups will complete baseline and post-treatment assessment sessions where they will complete questionnaires and have an EEG (a measure of electrical activity in the brain). Both groups will also complete 2 follow-up surveys (at 8 weeks and 1 year after the post-treatment assessment) either online through REDCap or by phone or video call with a research assistant.

Trial Number NCT06233344

Data attribution

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