OM and Trauma Study

Study Overview
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Brief Summary
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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).

Official Title
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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.

Conditions
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PTSD

Intervention / Treatment
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* Behavioral: Orgasmic Meditation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OM intervention<br> | Behavioral: Orgasmic Meditation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between OM and PTSD symptoms | Change in PCL-5 Score | 4 weeks | 
| Number of participants who withdraw from the study | Safety will be measured by completion rate | 4 weeks | 
| Number of participants who score a 39 or higher using the OM perceived value survey | feasibility measured by OM perceived value survey | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between Eudaimonia and OM | Changes in Eudaimonia Assessment | 4 weeks | 
| Correlation between depression and OM | Changes in The Patient Health Questionnaire: Depression Scale (PHQ-9) | 4 weeks | 
| Correlation between anxiety and OM | Changes in the Generalized Anxiety Disorder 7-Item Scale (GAD-7) | 4 weeks | 
| Correlation between psychosocial functioning and OM | Changes in The Brief Inventory for Psychosocial Functioning (B-IPF) | 4 weeks |