- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04040582
Psychedelics and Wellness Study (PAWS) (PAWS)
December 5, 2023 updated by: Saundra Jain, MA, PsyD, LPC, WILD 5 Wellness
Psychedelics and Wellness Study (PAWS): An Online Anonymous Survey Investigating the Interrelationship Between Past Psychedelic Use and Its Impact on Levels of Wellness
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
3234
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Austin, Texas, United States, 78745
- WILD 5 Wellness
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 96 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Adults ages 18 and older that have taken a psychedelic at least once.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Through study completion, an average of 1 year
|
|
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).
|
Through study completion, an average of 1 year
|
|
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).
|
Through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Saundra Jain, PsyD, LPC, WILD 5 Wellness
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 30, 2019
Primary Completion (Actual)
July 25, 2023
Study Completion (Actual)
July 25, 2023
Study Registration Dates
First Submitted
July 25, 2019
First Submitted That Met QC Criteria
July 30, 2019
First Posted (Actual)
July 31, 2019
Study Record Updates
Last Update Posted (Estimated)
December 7, 2023
Last Update Submitted That Met QC Criteria
December 5, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WILD 5 Wellness
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data that will be shared with other researchers will not be identified by participant; it will only be shared in aggregate form.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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