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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00514956
Other study ID # PTSD-ACEP-SMI-MU-1
Secondary ID
Status Completed
Phase Phase 1
First received August 8, 2007
Last updated September 21, 2009
Start date September 2007
Est. completion date January 2009

Study information

Verified date September 2009
Source Soul Medicine Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

A great many soldiers are returning from Iraq and Afghanistan with symptoms of Post Traumatic Stress Disorder (PTSD). Clinical experience with many people has shown the effectiveness of the techniques of Energy Psychology for rapidly alleviating PTSD symptoms. The study proposes to determine whether a very brief course of treatment (3 sessions) with a common form of Energy Psychology called Emotional Freedom Techniques (EFT) has an effect on the stress biochemistry of subjects, by measuring their levels of stress hormones (cortisol, DHEA) before and after treatment.


Description:

The Purpose of the Research: The purpose of this study is to test the effectiveness of Emotional Freedom Technique (EFT) versus Diaphragmatic Breathing in Reducing Post Traumatic Stress Disorders.

The Scientific or Scholarly Rationale: Clinical experience and anecdotal reports have demonstrated EFT to be effective for a wide range of behavioral disorders, including PTSD. However with the exception of several studies demonstrating the efficacy of EFT for the treatment of simple phobias, there have been no formal research studies in this area. It is the intention of this study to extend the phobia studies to the area of PTSD, and to determine what other conditions EFT might be effective in treating. Another intention of this study is to see whether, and to what degree, changes in psychological functioning (as measure by the PAI and TSI) are reflected in physiological markers such as HRV (Heart Rate Variability) and levels of cortisol and DHEA.

The Procedures to be Performed: Approximately 8 to 10 subjects would be randomly designated to either the experimental or Diaphragmatic Breathing control groups. There will be 4-5 subjects in the EFT experimental group and 4-5 subjects in the control Diaphragmatic Breathing group.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date January 2009
Est. primary completion date January 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- PTSD

- Recent Service in Afghanistan or Iraq

- Good Health History

Exclusion Criteria:

- Illegal Drug Use

- Recent Physical Trauma

- Head injuries, concussions, amputees

- Mental health issues prior to entering military service

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Behavioral:
Emotional Freedom Techniques (EFT)


Locations

Country Name City State
United States Marshall University Medical School Charleston West Virginia
United States Marshall University, Joan Edwards School of Medicine Huntington West Virginia

Sponsors (1)

Lead Sponsor Collaborator
Soul Medicine Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

Church, D., Geronilla, L., & Dinter, I. (2009) Psychological symptom change in veterans after six sessions of Emotional Freedom Techniques (EFT). International Journal of Healing and Caring, January, 9:1.

Outcome

Type Measure Description Time frame Safety issue
Primary Change in baseline cortisol and DHEA production Six months No
Secondary Changes in scores on Trauma Assessment Inventory and other instruments normed for trauma Six months No
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