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Psychedelics and Wellness Study (PAWS) (PAWS)

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ClinicalTrials.gov Identifier: NCT04040582
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : September 11, 2020
Sponsor:
Information provided by (Responsible Party):
Saundra Jain, MA, PsyD, LPC, WILD 5 Wellness

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
Depression, Anxiety, PTSD

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.

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Study Type : Observational
Estimated 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 : September 30, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety




Primary Outcome Measures :
  1. Change in Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adults ages 18 and older that have taken a psychedelic at least once.
Criteria

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.

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): NCT04040582


Contacts
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Contact: Saundra Jain, PsyD, LPC 979-417-3402 drjain@wild5wellness.com
Contact: Rakesh Jain, MD, MPH 979-480-9886 jaintexas@gmail.com

Locations
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United States, Texas
WILD 5 Wellness Recruiting
Austin, Texas, United States, 78745
Contact: Saundra Jain, MA, PsyD, LPC    5126604650    saundrajain@gmail.com   
Sponsors and Collaborators
WILD 5 Wellness
Investigators
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Principal Investigator: Saundra Jain, PsyD, LPC WILD 5 Wellness
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Responsible Party: Saundra Jain, MA, PsyD, LPC, Psychotherapist, WILD 5 Wellness
ClinicalTrials.gov Identifier: NCT04040582    
Other Study ID Numbers: WILD 5 Wellness
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: September 11, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data that will be shared with other researchers will not be identified by participant; it will only be shared in aggregate form.

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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, WILD 5 Wellness:
Psychedelics, Wellness
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms