None listed
Conditions
Brief summary
It has been shown that different psychological factors may influence a person’s response to treatment. For example, studies have shown that people with certain character traits, beliefs, thought processes etc may be more likely to respond to certain therapy or treatment more than others. Psilocybin has been shown to result in temporary changes in these mental processes that may create a change in the way a person receives and processes new information – such as psychological therapy. In this study, all participants will receive psilocybin within two to four weeks after completion of therapy, and then changes in mood and cognition will be followed-up.
Interventions
1. This study is an open label fixed sequence study design of participants with mood disturbances (mild – moderate depression/anxiety symptoms) who have had limited improvements from brief psychological intervention. Participants will be recruited after brief intervention with psychological services such as Student Health, Community Mental Health Teams, or private clinics.
2. Screening session will consist of one two-hour session by team psychologist and psychology researcher that will occur wit
1. This study is an open label fixed sequence study design of participants with mood disturbances (mild – moderate depression/anxiety symptoms) who have had limited improvements from brief psychological intervention. Participants will be recruited after brief intervention with psychological services such as Student Health, Community Mental Health Teams, or private clinics. 2. Screening session will consist of one two-hour session by team psychologist and psychology researcher that will occur within a month after end of brief psychological intervention which includes psychoeducation about the dosing and baseline measures. 3. Single dose of psilocybin administration (25mg) orally in the morning at the start of 8-hour long monitoring while reviewing content from participants' previous brief psychological input that they have learnt from their previous individual therapy sessions. The specific content is not controlled for aside from ensuring that they contain elements of Acceptance Commitment Therapy components - the range of content will be part of the descriptive analysis. 4. Acute measures will be taken approximately 4hrs after capsule administration, subacute measures taken 24hrs after, and outcome measures taken at 6- and 12-week follow-up.
Sponsors
University of Otago
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
25 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Capable of understanding and signing an informed consent form. 2. Aged 25 - 60 years on the day of consent. 3. Psychiatric history: Clinical interviews and assessments by referral agent – psychologists at student health/community mental health teams/private clinics 4. Participants with anxiety: Baseline scores of moderate to severe anxiety according to DASS-21 criteria and clinical assessment from referral agent (psychologist) 5. Participants with depression: Baseline scores of moderate to severe depression according to DASS-21 criteria and clinical assessment from referral agent (psychologist)
Exclusion criteria
To be included in the study, participants must meet none of the following exclusion criteria: 1. Female Participants who are or intend to become pregnant, or are lactating. 2. Participants who, in the opinion of the investigator, do not understand the information and procedures of the study, or would not be compliant with them (in particular the study restrictions and risks involved). 3. Any participant for whom the investigator believes, for any reason, that participation would not be an acceptable risk. 4. Participants with cardiovascular conditions 5. Current use of antidepressants, anxiolytics, MAOIs, thyroxine or stimulants (amphetamine/methylphenidate). 6. Participants with severe, acute or chronic medical illnesses. 7. Participants with a history of schizophrenia, psychosis, bipolar disorder, borderline personality disorder, or seizure disorders. 8. Participants with a family history of schizophrenia, psychosis, or bipolar disorder. 9. Participants with current active suicidal ideation. 10. Substance abuse disorder, current or within the last 6 months.
Outcome results
None listed