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Psychedelics and Wellness Study (PAWS)

Sponsor
WILD 5 Wellness (Other)
Overall Status
Recruiting
CT.gov ID
NCT04040582
Collaborator
(none)
5,000
Enrollment
1
Location
33
Anticipated Duration (Months)
151.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The Psychedelics and Wellness Study (PAWS), is an anonymous online survey investigating the interrelationship between psychedelics and wellness. The study population is adults ages 18 and older that have taken a psychedelic at least once. The maximum sample size is 5,000 survey respondents. It is expected that this anonymous online survey will support the hypothesis that there is a robust interrelationship between past psychedelic use and its impact on wellness.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Following a four-decade moratorium, the therapeutic use of psychedelics has once more captured the collective attention of the medical community and the public at large. Now, at the forefront of a renaissance in psychedelic research, this study is investigating the interrelationship of psychedelics and mental wellness - a state of well-being in which the individual realizes his or her own abilities, can cope with the normal stresses of life, can work productively and fruitfully, and is able to make a contribution to his or her community. This work will be unique in that it will collect both objective and subjective data to assess the interrelationship between psychedelic and wellness. It will lend support to the growing body of research in the use of psychedelics for both mental health conditions and the pursuit of overall mental wellness.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    5000 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Psychedelics and Wellness Study (PAWS): An Online Anonymous Survey Investigating the Interrelationship Between Past Psychedelic Use and Its Impact on Levels of Wellness
    Actual Study Start Date :
    Sep 30, 2019
    Anticipated Primary Completion Date :
    Jun 30, 2022
    Anticipated Study Completion Date :
    Jun 30, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Change in Patient Health Questionnaire-9 (PHQ-9) [Through study completion, an average of 1 year]

      The PHQ-9 is a nine-item depression self-report questionnaire for screening and measurement of severity of major depression. Scores range from 0-27 (Lower scores = Less depression).

    2. Change in Generalized Anxiety Disorder-7 (GAD-7) [Through study completion, an average of 1 year]

      The GAD-7 is a seven-item self-report questionnaire for screening and measurement of severity of generalized anxiety disorder. Scores range from 0-21 (Lower scores = Less anxiety).

    3. Change in HERO Wellness Scale [Through study completion, an average of 1 year]

      The HERO Wellness Scale is a brief 5-item scale designed to measure four wellness traits plus perceived mental wellness. Scores range from 0-50 (Lower scores = Lower levels of mental wellness).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Adults ages 18 and older that have taken a psychedelic at least once.
    Exclusion Criteria:
    • Individuals less than 18 years old and have previously never taken a psychedelic substance.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 WILD 5 Wellness Austin Texas United States 78745

    Sponsors and Collaborators

    • WILD 5 Wellness

    Investigators

    • Principal Investigator: Saundra Jain, PsyD, LPC, WILD 5 Wellness

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Saundra Jain, MA, PsyD, LPC, Psychotherapist, WILD 5 Wellness
    ClinicalTrials.gov Identifier:
    NCT04040582
    Other Study ID Numbers:
    • WILD 5 Wellness
    First Posted:
    Jul 31, 2019
    Last Update Posted:
    Apr 27, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Saundra Jain, MA, PsyD, LPC, Psychotherapist, WILD 5 Wellness
    Psychedelics, Wellness
    Additional relevant MeSH terms:
    Depression

    Study Results

    No Results Posted as of Apr 27, 2022