PTSDEarly Phase 1OMTPNCT05577377
OM and Trauma Study
A Early Phase 1 study testing Orgasmic Meditation in people with PTSD, run by Institute of OM Foundation at 1 site in United States.
Trial summary
The primary purpose of this study is to use an unblinded, uncontrolled, 1-month interventional single group pilot study, to assess the possibility of Orgasmic Meditation practice being used as a possible intervention for PTSD. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- PTSD
- What is being tested?
- Orgasmic Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2022to 25 Aug 2024
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults ≥18 years old
- One or more participants of the pair having a diagnosis of PTSD for > 6 months
- Relationship for > 6 months
- Self or partner of female sex
- Massachusetts residents
- Access and ability to use internet and a video platform called Zoom
- No history of doing the practice of OM
Who cannot join
- Ongoing or active use of illicit drugs at the time of the study
- Self-identify as pregnant
- Inability to speak English
- Recent hospitalization < 12 months
- Suicidal ideation < 12 months
- Self-harm < 12 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute of OM Foundation
Santa Rosa, California, 95404
About this study
Official title: An Unblinded, Uncontrolled, 1-month Interventional Single Group Pilot Study, to Assess the Possibility of Orgasmic Meditation Practice Being Used as a Possible Intervention for PTSD.
The primary purpose of this study is to use an unblinded, uncontrolled, 1-month interventional single group pilot study, to assess the possibility of Orgasmic Meditation practice being used as a possible intervention for PTSD. The secondary purpose of this study is to examine if OM is associated with a decrease in the symptoms and self-assessed experiences associated with trauma.
The OM Trauma Protocol (OMTP) is designed to systematize the application of Orgasmic Meditation (OM) for individuals seeking relief from a wide variety of problems and/or help them in their pursuit of eudaimonia. The study protocol will evaluate whether OMing (the act of practicing OM) shows potential for being an effective intervention for people suffering from Post-Traumatic Stress Disorder (PTSD).
- Conditions
- PTSD
- Being tested
- Orgasmic Meditation
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orgasmic MeditationBehavioural
Orgasmic Meditation (OM) is a structured attention training practice that you do with another person by following a predefined set of detailed instructions. One of the two people participating in the OM must have a clitoris. In this partnered practice, one person strokes the clitoris of another person with the tip of their left index finger for 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| OM intervention | Experimental | Not described Receives: Behavioral: Orgasmic Meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between OM and PTSD symptoms
Change in PCL-5 Score
Measured: 4 weeks
Number of participants who withdraw from the study
Safety will be measured by completion rate
Measured: 4 weeks
Number of participants who score a 39 or higher using the OM perceived value survey
feasibility measured by OM perceived value survey
Measured: 4 weeks
Secondary outcomes (4)
Correlation between Eudaimonia and OM
Changes in Eudaimonia Assessment
Measured: 4 weeks
Correlation between depression and OM
Changes in The Patient Health Questionnaire: Depression Scale (PHQ-9)
Measured: 4 weeks
Correlation between anxiety and OM
Changes in the Generalized Anxiety Disorder 7-Item Scale (GAD-7)
Measured: 4 weeks
Correlation between psychosocial functioning and OM
Changes in The Brief Inventory for Psychosocial Functioning (B-IPF)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start23 Mar 2022
- Primary completion18 Apr 2024
- Study completion25 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre and Post Intervention Study with Orgasmic Meditation - a meditation practice
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of OM Foundation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dan Kriegman, PhD, Principal investigator, Institute of OM Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577377
- Sponsor's protocol ID
- Pro00061665
- Acronym
- OMTP
- Status last verified
- Oct 2022
- First submitted
- 29 Sep 2022
- Last updated
- 20 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Unblinded, Uncontrolled, 1-month Interventional Single Group Pilot Study, to Assess the Possibility of Orgasmic Meditation Practice Being Used as a Possible Intervention for PTSD.
- ClinicalTrials.gov ID
- NCT05577377
- Acronym / sponsor ID
- OMTP / Pro00061665
- Conditions
- PTSD
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Institute of OM FoundationIndustry (pharma, biotech, devices)
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 18 Apr 2024 (actual)
- Study completion
- 25 Aug 2024 (actual)
- First posted
- 13 Oct 2022 (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 primary purpose of this study is to use an unblinded, uncontrolled, 1-month interventional single group pilot study, to assess the possibility of Orgasmic Meditation practice being used as a possible intervention for PTSD. The secondary purpose of this study is to examine if OM is associated with a decrease in the symptoms and self-assessed experiences associated with trauma.
The OM Trauma Protocol (OMTP) is designed to systematize the application of Orgasmic Meditation (OM) for individuals seeking relief from a wide variety of problems and/or help them in their pursuit of eudaimonia. The study protocol will evaluate whether OMing (the act of practicing OM) shows potential for being an effective intervention for people suffering from Post-Traumatic Stress Disorder (PTSD).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre and Post Intervention Study with Orgasmic Meditation - a meditation practice
| Arm | Type | Receives |
|---|---|---|
| OM intervention | Experimental | Behavioral: Orgasmic Meditation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults ≥18 years old
- One or more participants of the pair having a diagnosis of PTSD for > 6 months
- Relationship for > 6 months
- Self or partner of female sex
- Massachusetts residents
Key exclusion criteria (6 listed)
- Ongoing or active use of illicit drugs at the time of the study
- Self-identify as pregnant
- Inability to speak English
- Recent hospitalization < 12 months
- Suicidal ideation < 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orgasmic MeditationOrgasmic Meditation (OM) is a structured attention training practice that you do with another person by following a predefined set of detailed instructions. One of the two people participating in the OM must have a clitoris. In this partnered practice, one person strokes the clitoris of another person with the tip of their left index finger for 15 minutes. | Behavioural | OM intervention |
Primary outcome
Correlation between OM and PTSD symptoms
Time frame: 4 weeks
Change in PCL-5 Score
Number of participants who withdraw from the study
Time frame: 4 weeks
Safety will be measured by completion rate
Number of participants who score a 39 or higher using the OM perceived value survey
Time frame: 4 weeks
feasibility measured by OM perceived value survey
4 secondary outcomes
Correlation between Eudaimonia and OM
Time frame: 4 weeks
Correlation between depression and OM
Time frame: 4 weeks
Correlation between anxiety and OM
Time frame: 4 weeks
Correlation between psychosocial functioning and OM
Time frame: 4 weeks
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 20 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Dan Kriegman, PhD principal investigator
Institute of OM Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Orgasmic Meditation in people with PTSD, run by Institute of OM Foundation 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 7 inclusion and 6 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 20 Sep 2024. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Correlation between OM and PTSD symptoms (time frame: 4 weeks). 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?
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 20 Sep 2024.