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OMTP: OM and Trauma Study

Sponsor
Institute of OM Foundation (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05577377
Collaborator
(none)
40
Enrollment
1
Arm
5
Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Orgasmic Meditation
 Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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.
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: OM intervention

Behavioral: Orgasmic Meditation
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.

Outcome Measures

Primary Outcome Measures

  1. Correlation between OM and PTSD symptoms [4 weeks]

    Change in PCL-5 Score

  2. Number of participants who withdraw from the study [4 weeks]

    Safety will be measured by completion rate

  3. 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

  1. Correlation between Eudaimonia and OM [4 weeks]

    Changes in Eudaimonia Assessment

  2. Correlation between depression and OM [4 weeks]

    Changes in The Patient Health Questionnaire: Depression Scale (PHQ-9)

  3. Correlation between anxiety and OM [4 weeks]

    Changes in the Generalized Anxiety Disorder 7-Item Scale (GAD-7)

  4. Correlation between psychosocial functioning and OM [4 weeks]

    Changes in The Brief Inventory for Psychosocial Functioning (B-IPF)

Other Outcome Measures

  1. Correlation between OM and tumescence [4 weeks]

    Changes in the Tumescence Assessment. Tumescence is the measure of internal energy available in a person to be used for creativity and purpose

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Institute of OM Foundation

Investigators

  • Principal Investigator: Dan Kriegman, PhD, Institute of OM Foundation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institute of OM Foundation
ClinicalTrials.gov Identifier:
NCT05577377
Other Study ID Numbers:
  • Pro00061665
First Posted:
Oct 13, 2022
Last Update Posted:
Oct 13, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 13, 2022