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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05570708
Recruitment Status : Enrolling by invitation
First Posted : October 7, 2022
Last Update Posted : February 8, 2023
Sponsor:
Collaborator:
Swiss Society for Psycholytic Therapy (SÄPT)
Information provided by (Responsible Party):
Felix Mueller, University Hospital, Basel, Switzerland

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Personal Experience of Substance-assisted Therapy Using Psilocybin, MDMA, and LSD Drug: MDMA, LSD, psilocybin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Role of Personal Experience for the Therapeutic Attitude in the Context of Substance-assisted Therapy Training
Actual Study Start Date : October 25, 2022
Estimated Primary Completion Date : June 1, 2029
Estimated Study Completion Date : June 1, 2029

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   27 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05570708


Locations
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Switzerland
University Hospital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
Felix Mueller
Swiss Society for Psycholytic Therapy (SÄPT)
Investigators
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Principal Investigator: Felix Müller, MD University of Basel
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Responsible Party: Felix Mueller, Sponsor-Investigator PD Dr. med. Felix Müller MD, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT05570708    
Other Study ID Numbers: 2022-01173
First Posted: October 7, 2022    Key Record Dates
Last Update Posted: February 8, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psilocybin
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs