Depression, Anxiety, PTSDPAWSNCT04040582
Psychedelics and Wellness Study (PAWS)
An observational study of Depression, Anxiety, PTSD, run by WILD 5 Wellness at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety, PTSD
- How many people
- 3,234 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2019to 25 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults ages 18 and older that have taken a psychedelic at least once.
Who may be able to join
- Adults ages 18 and older that have taken a psychedelic at least once.
Who cannot join
- Individuals less than 18 years old and have previously never taken a psychedelic substance.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Depression, Anxiety, PTSD
- Keywords
- Psychedelics, Wellness
- Medical subject headings
- Depression, Anxiety Disorders, Stress Disorders, Post-Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Health Questionnaire-9 (PHQ-9)
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).
Measured: Through study completion, an average of 1 year
Change in Generalized Anxiety Disorder-7 (GAD-7)
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).
Measured: Through study completion, an average of 1 year
Change in HERO Wellness Scale
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).
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start30 Sep 2019
- Primary completion25 Jul 2023
- Study completion25 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depression, Anxiety, PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 3,234 participants (actual)
Sponsor and investigators
- Lead sponsor
- WILD 5 Wellness
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saundra Jain, MA, PsyD, LPC, WILD 5 Wellness
- Investigators
- Saundra Jain, PsyD, LPC, Principal investigator, WILD 5 Wellness
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04040582
- Sponsor's protocol ID
- WILD 5 Wellness
- Acronym
- PAWS
- Status last verified
- Dec 2023
- First submitted
- 25 Jul 2019
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data that will be shared with other researchers will not be identified by participant; it will only be shared in aggregate form.
Publications
Herrmann Z, Levin AW, Cole SP, Slabaugh S, Barnett B, Penn A, Jain R, Raison C, Rajanna B, Jain S. Psychedelic Use Among Psychiatric Medication Prescribers: Effects on Well-Being, Depression, Anxiety, and Associations with Patterns of Use, Reported Harms, and Transformative Mental States. Psychedelic Med (New Rochelle). 2023 Sep 13;1(3):139-149. doi: 10.1089/psymed.2023.0030. eCollection 2023 Sep.
PubMed 40046570
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04040582
- Acronym / sponsor ID
- PAWS / WILD 5 Wellness
- Conditions
- Depression, Anxiety, PTSD
- Keywords
- Psychedelics, Wellness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,234 participants (actual)
- Lead sponsor
- WILD 5 WellnessUniversity, hospital or other
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 25 Jul 2023 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 31 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults ages 18 and older that have taken a psychedelic at least once.
Key inclusion criteria (1 listed)
- Adults ages 18 and older that have taken a psychedelic at least once.
Key exclusion criteria (1 listed)
- Individuals less than 18 years old and have previously never taken a psychedelic substance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Derived from this study: PubMed 40046570Herrmann Z, Levin AW, Cole SP, Slabaugh S, Barnett B, Penn A, Jain R, Raison C, Rajanna B, Jain S. Psychedelic Use Among Psychiatric Medication Prescribers: Effects on Well-Being, Depression, Anxiety, and Associations with Patterns of Use, Reported Harms, and Transformative Mental States. Psychedelic Med (New Rochelle). 2023 Sep 13;1(3):139-149. doi: 10.1089/psymed.2023.0030. eCollection 2023 Sep.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saundra Jain, PsyD, LPC principal investigator
WILD 5 Wellness
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, Anxiety, PTSD, run by WILD 5 Wellness at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Health Questionnaire-9 (PHQ-9) (time frame: Through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04040582, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.