OM and Trauma Study

Early Phase 1

Not yet recruiting

• Conditions: PTSD
• Interventions: Behavioral: Orgasmic Meditation

• Registration Number: NCT05577377
• Lead Sponsor: Institute of OM Foundation

Brief 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. 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-29
• Status Verified: 2022-10
• Study Start: 2022-10
• Study First Submitted QC: 2022-10-10
• Last Update Submitted: 2022-10-10
• Study First Posted: 2022-10-13
• Last Update Posted: 2022-10-13
• Primary Completion: 2023-03
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OM intervention	Orgasmic Meditation	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institute of OM Foundation; 🇺🇸 Santa Rosa, California, United States