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

Stress Disorders, Post-Traumatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01250431
• Other study ID #: SMI-YOUNT-11/24/10
• Status: Completed
• Phase: Early Phase 1
• First received: November 24, 2010
• Last updated: April 23, 2018
• Start date: November 2010
• Est. completion date: November 2017

Study information

• Verified date: April 2018
• Source: Soul Medicine Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• EFT (Emotional Freedom Techniques)
10 EFT sessions

Locations

Country	Name	City	State
United States	Soul Medicine Institute	Santa Rosa	California

Sponsors (1)

Lead Sponsor	Collaborator
Soul Medicine Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

Church D, Yount G, Rachlin K, Fox L, Nelms J. Epigenetic Effects of PTSD Remediation in Veterans Using Clinical Emotional Freedom Techniques: A Randomized Controlled Pilot Study. Am J Health Promot. 2018 Jan;32(1):112-122. doi: 10.1177/0890117116661154. E — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QRT-PCR Assessment of Gene Expression Associated with Psychological Symptoms of Traumatic Stress	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.	Pre-intervention and Post-intervention