Effect of Emotional Freedom Technique and Diaphragmatic B... | NCT00514956

Studies
Effect of Emotional Freedom Technique and Diaphragmatic Breathing on Post Traumatic Stress Disorder (PTSD)

NCT00514956

Sponsor

Soul Medicine Institute

Status

Completed

Last Update Posted

Sep 22, 2009Estimated

Enrollment

12Estimated

Phase

Phase 1

Conditions

Stress Disorders, Post-Traumatic

Interventions

Emotional Freedom Techniques (EFT)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Jan 2009Actual

Completion Date

Jan 2009Actual

First Submitted Date

Aug 8, 2007

First Submission Date that Met QC Criteria

Aug 9, 2007

First Posted Date

Aug 10, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 21, 2009

Last Update Posted Date

Sep 22, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Name	Type	Description	Arm Group Labels	Other Names
Emotional Freedom Techniques (EFT)	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in baseline cortisol and DHEA production		Six months

Secondary Outcomes

Measure	Description	Time Frame
Changes in scores on Trauma Assessment Inventory and other instruments normed for trauma		Six months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dawson Church, PhD	Soul Medicine Institute	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Marshall University Medical School		Charleston	West Virginia		United States
Marshall University, Joan Edwards School of Medicine

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Result	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.

ID	Term
D013313	Stress Disorders, Post-Traumatic
D003130	Combat Disorders

ID	Term
D040921	Stress Disorders, Traumatic
D000068099	Trauma and Stressor Related Disorders
D001523	Mental Disorders