Gene Expression Correlates of Post-Traumatic Stress Disorder (PTSD) Symptom Change After EFT (Emotional Freedom Techniques)

Sponsor

Soul Medicine Institute (Other)

Overall Status

Completed

CT.gov ID

NCT01250431

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to measure the change in psychological symptoms and gene expression in war veterans after a series of 10 EFT coaching sessions. Outcome studies have shown statistically significant reductions in depression, anxiety, and PTSD in veterans after EFT, and this study extends earlier research using biological sampling. EFT is a form of Energy Psychology (EP) that is sometimes referred to as "emotional acupuncture." It involves self-stimulation of 14 acupuncture points at the end of meridians with the fingertips, while recalling an emotional event such as a combat trauma. It is typically effective in 6 to 15 coaching sessions, making it an efficient clinical technique for reducing affect.

Condition or Disease	Intervention/Treatment	Phase
Stress Disorders, Post-Traumatic	Behavioral: EFT (Emotional Freedom Techniques)	Early Phase 1

Detailed Description

There is peer-reviewed published experimental evidence showing that (a) acupuncture reduces the fear response in the brain, especially the limbic system, and most particularly the amygdala; that (b) tapping or rubbing acupuncture points (acupressure) can be as effective as needling them; that (c) EFTs use of such acupressure is efficacious in reducing anxiety, PTSD and other mood disorders; that (d) EFT reliably reduces emotional intensity associated with traumatic memories, is safe and low-risk; that (e) all EP studies that included a long-term follow-up show that patient gains are maintained over time; that (f) the psychological questionnaires used in this study are validated and safe; and that for all these reasons (g) EP is a treatment of choice among therapists when dealing with the traumatic memories of clients. This study extends these findings by noting changes in gene expression associated with the remission of PTSD symptoms.

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

Gene Expression Correlates of PTSD Symptom Change After EFT (Emotional Freedom Techniques): A Randomized Controlled Trial

Actual Study Start Date :

Nov 1, 2010

Actual Primary Completion Date :

Nov 1, 2017

Actual Study Completion Date :

Nov 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EFT (Emotional Freedom Techniques) 10 sessions of EFT.	Behavioral: EFT (Emotional Freedom Techniques) 10 EFT sessions
No Intervention: Wait List 10 week wait period.

Arm

Intervention/Treatment

Experimental: EFT (Emotional Freedom Techniques)

10 sessions of EFT.

Behavioral: EFT (Emotional Freedom Techniques)

10 EFT sessions

No Intervention: Wait List

10 week wait period.

Outcome Measures

Primary Outcome Measures

QRT-PCR Assessment of Gene Expression Associated with Psychological Symptoms of Traumatic Stress [Pre-intervention and Post-intervention]
For the experimental group, the first data point is immediately before the first EFT (Emotional Freedom Techniques) session. The second data point is immediately after the last of 10 weekly sessions. The control group is assessed at intake, and after 10 weeks.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Military Service
The ability to follow instructions, complete written forms, understand English, and provide informed consent. Subjects are required to be literate and understand English.
Remaining under the care of a primary care provider such as a VA hospital throughout the entire period of the study
Between 18 and 80 years old. No children will be research subjects in this study.

Exclusion Criteria:

A current or past physical or psychiatric disorder that would preclude their being able to respond to the psychosocial measures adequately, or to give blood safely (i.e. cognitive dysfunction, psychosis, or any blood or bleeding disorder)
Regularly work a night or graveyard shift (to avoid effects of alterations in circadian rhythm)
Inability to come into the San Francisco laboratory for an afternoon for testing
Immunomodulatory disorders (e.g. AIDS, rheumatoid arthritis, multiple sclerosis, lupus) or cancer history
Aggressive chronic periodontitis
Antibiotics within the last 3 months prior to the recruitment date
A score of more than 4 on questions 34 and 35 of the SA-45:

Having urges to beat, injure, or harm someone Having urges to break or smash things

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Soul Medicine Institute	Santa Rosa	California	United States	95404

Sponsors and Collaborators

Soul Medicine Institute

Investigators

Principal Investigator: Dawson Church, PhD, Soul Medicine Institute
Principal Investigator: Garret Yount, PhD, Soul Medicine Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dawson Church, Principal Investigator, Soul Medicine Institute

ClinicalTrials.gov Identifier:

NCT01250431

Other Study ID Numbers:

SMI-YOUNT-11/24/10

First Posted:

Nov 30, 2010

Last Update Posted:

Apr 25, 2018

Last Verified:

Apr 1, 2018

Additional relevant MeSH terms:

Stress Disorders, Traumatic

Stress Disorders, Post-Traumatic

Study Results

No Results Posted as of Apr 25, 2018