The Role of Personal Experience for the Therapeutic Attitude in the Context of Substance-assisted Therapy Training (TherPsySE)

The study investigates two groups of participants of the SÄPT therapist's training starting in October 2022. The overall objective is to investigate the risks and benefits of personal experience (PE) with substance-induced altered states of consciousness for physicians or psychotherapists in the context of a training course for substance-assisted therapy. Specifically, the study aims to assess changes in therapeutic attitude and other factors important in interactions between patients and therapists (such as empathy and cognitive flexibility).

Study Overview

• Status: Enrolling by invitation
• Conditions: Personal Experience of Substance-assisted Therapy Using Psilocybin, MDMA, and LSD
• Intervention / Treatment: Drug: MDMA, LSD, psilocybin

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Helena Aicher, MSc; Phone Number: +41 61 265 25 25; Email: helena.aicher@usb.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 27 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participation in the SÄPT therapist training (medical doctors and psychologists)
• Age 27 years or older
• Sufficient understanding of the German language
• Understanding of procedures and risks associated with the study
• Willing to adhere to the protocol and signing of the consent form
• Willing not to operate heavy machinery (including driving cars) within 24 hours after substance administration
• Woman of childbearing potential are required to use effective, established contraception, such as oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device (IUD) or intrauterine system (IUS), barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository at least one month before and after each study substance intervention, and are willing to take a urine pregnancy test at the medical screening and before every study substance intervention.
• Men are required to use contraceptive methods in the month after each study substance intervention and are required to inform their partner(s) about their study participation.

Exclusion Criteria:

• Previous significant adverse response to a hallucinogenic drug
• Significant medical condition rendering volunteers unsuitable for participation (such as impaired kidney or liver function, or heart disease incl. uncontrolled hypertension or hypotension)
• Strong underweight (<45kg)
• Current major psychiatric disorder (including personality disorder, including suicidality) and / or previous psychotic or bipolar disorder.
• Psychotic disorder or bipolar disorder in first-degree relatives
• Use of medication that may interfere with the effects of the study medication. Patients must be willing to discontinue medications in cases where drug-related interactions are possible (the washout phase will be at least 5 times the particular drug's half-life [typically 3-7 days] prior to the respective study session). Discontinuation of medication must be judged to be acceptable by the responsible investigator.
• Women are excluded from substance intervention during pregnancy or breastfeeding.
• nParticipation in another clinical trial (currently or within the last 30 days)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Personal experience of substance-assisted therapy using psilocybin, MDMA, and LSD	Drug: MDMA, LSD, psilocybin; MDMA per os (2 x 100mg) in a group setting; LSD per os (75 and 150 mcg) in a 1:1 setting; Psilocybin per os (15 mg and 25 mg) in a group setting; Three study days are without drug administration: Participants experience the role of the therapist in a 1:1 setting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TASC-2 scale	The primary endpoint is changes on the TASC-2 scale of the Therapeutic attitude questionnaire (ThAT)	Three weeks after last PE

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
semi-structured interview	A semi-structured interview will be used to explore the range of effects and systematically collect and record subjective effects of the personal experience	Five months after last PE
TASC-2 scale	TASC-2 scale of the Therapeutic attitude questionnaire (ThAT)	Three weeks after each PE and six months after last PE
SOCS-S	Compassion with self	Three weeks after each PE and six months after last PE
SPCS-O	Compassion with others	Three weeks after each PE and six months after last PE
SPF/IRI	Empathy questionnaire	Three weeks after each PE and six months after last PE
5D-ASC	5 dimensions of altered states of consciousness questionnaire	Directly after each PE
CEQ	Challenging experience questionnaire	Directly after each PE
APEQ	Acceptance /avoidance-promoting experiences questionnaire	Directly after each PE
PIQ	Psychological insights questionnaire	Directly after each PE
CSOWD	Connectedness scale	Directly after each PE
EBI	Emotional breakthrough inventory	Directly after each PE
BFW/E	Berner Subjective Well-Being questionnaire	Three weeks after each PE and six months after last PE
PEQ	Persisting effects questionnaire	Three weeks after each PE and six months after last PE

Collaborators and Investigators

• Sponsor: Felix Mueller
• Collaborators: Swiss Society for Psycholytic Therapy (SÄPT)
• Investigators: Principal Investigator: Felix Müller, MD, University of Basel

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2022
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: September 21, 2022
• First Submitted That Met QC Criteria: October 5, 2022
• First Posted (Actual): October 7, 2022

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Psychotropic Drugs; Hallucinogens; Psilocybin
• Other Study ID Numbers: 2022-01173

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No