Effect of Emotional Freedom Technique and Diaphragmatic Breathing on Post Traumatic Stress Disorder (PTSD)
Primary Purpose
Stress Disorders, Post-Traumatic
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Emotional Freedom Techniques (EFT)
Sponsored by
About this trial
This is an interventional treatment trial for Stress Disorders, Post-Traumatic focused on measuring Post-Traumatic Stress Syndrome (PTSD)
Eligibility Criteria
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
Sites / Locations
- Marshall University Medical School
- Marshall University, Joan Edwards School of Medicine
Outcomes
Primary Outcome Measures
Change in baseline cortisol and DHEA production
Secondary Outcome Measures
Changes in scores on Trauma Assessment Inventory and other instruments normed for trauma
Full Information
NCT ID
NCT00514956
First Posted
August 8, 2007
Last Updated
September 21, 2009
Sponsor
Soul Medicine Institute
1. Study Identification
Unique Protocol Identification Number
NCT00514956
Brief Title
Effect of Emotional Freedom Technique and Diaphragmatic Breathing on Post Traumatic Stress Disorder (PTSD)
Official Title
Effect of Emotional Freedom Technique and Diaphragmatic Breathing on PTSD
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Soul Medicine Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic
Keywords
Post-Traumatic Stress Syndrome (PTSD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Emotional Freedom Techniques (EFT)
Primary Outcome Measure Information:
Title
Change in baseline cortisol and DHEA production
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Changes in scores on Trauma Assessment Inventory and other instruments normed for trauma
Time Frame
Six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawson Church, PhD
Organizational Affiliation
Soul Medicine Institute
Official's Role
Study Director
Facility Information:
Facility Name
Marshall University Medical School
City
Charleston
State/Province
West Virginia
Country
United States
Facility Name
Marshall University, Joan Edwards School of Medicine
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
12. IPD Sharing Statement
Citations:
Citation
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.
Results Reference
result
Links:
URL
http://www.StressProject.org
Description
Web site to connect veterans to assistance using study protocol, and enrollment option for larger followup study.
Learn more about this trial
Effect of Emotional Freedom Technique and Diaphragmatic Breathing on Post Traumatic Stress Disorder (PTSD)
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