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Enrolling by Invitation

NCT Number: NCT05570708

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

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).

Enrolling by Invitation

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Key information

Age range

27 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Basel

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

MDMA, LSD, psilocybin

Drug
  • 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

Primary outcomes

  1. TASC-2 scale

    Time frame: Three weeks after last PE

    The primary endpoint is changes on the TASC-2 scale of the Therapeutic attitude questionnaire (ThAT)

Secondary outcomes

  1. semi-structured interview

    Time frame: Five months after last PE

    A semi-structured interview will be used to explore the range of effects and systematically collect and record subjective effects of the personal experience

  2. TASC-2 scale

    Time frame: Three weeks after each PE and six months after last PE

    TASC-2 scale of the Therapeutic attitude questionnaire (ThAT)

  3. SOCS-S

    Time frame: Three weeks after each PE and six months after last PE

    Compassion with self

  4. SPCS-O

    Time frame: Three weeks after each PE and six months after last PE

    Compassion with others

  5. SPF/IRI

    Time frame: Three weeks after each PE and six months after last PE

    Empathy questionnaire

  6. 5D-ASC

    Time frame: Directly after each PE

    5 dimensions of altered states of consciousness questionnaire

  7. CEQ

    Time frame: Directly after each PE

    Challenging experience questionnaire

  8. APEQ

    Time frame: Directly after each PE

    Acceptance /avoidance-promoting experiences questionnaire

  9. PIQ

    Time frame: Directly after each PE

    Psychological insights questionnaire

  10. CSOWD

    Time frame: Directly after each PE

    Connectedness scale

  11. EBI

    Time frame: Directly after each PE

    Emotional breakthrough inventory

  12. BFW/E

    Time frame: Three weeks after each PE and six months after last PE

    Berner Subjective Well-Being questionnaire

  13. PEQ

    Time frame: Three weeks after each PE and six months after last PE

    Persisting effects questionnaire

Sponsors and collaborators

Lead sponsor

Felix Mueller

Other

Collaborators

  • Swiss Medical Society for Psycholytic Therapy

Registry information

Acronym: TherPsySE

Important dates

Study start
2022
Primary completion
2029
Study completion
2029
First posted
Oct 7, 2022
Registry last updated
Apr 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.