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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Soul Medicine Institute
Sponsor:
Information provided by (Responsible Party):
Dawson Church, Soul Medicine Institute
ClinicalTrials.gov Identifier:
NCT01250431
First received: November 24, 2010
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Stress Disorders, Post-Traumatic
Behavioral: EFT (Emotional Freedom Techniques)
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Gene Expression Correlates of PTSD Symptom Change After EFT (Emotional Freedom Techniques): A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Soul Medicine Institute:

Primary Outcome Measures:
  • QRT-PCR Assessment of Gene Expression Associated with Psychological Symptoms of Traumatic Stress [ Time Frame: Pre-intervention and Post-intervention ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 24
Study Start Date: November 2010
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01250431

Locations
United States, California
Soul Medicine Institute Recruiting
Santa Rosa, California, United States, 95404
Contact: Deburah Tribbey    707-297-6951    deb@soulmedicine.net   
Sponsors and Collaborators
Soul Medicine Institute
Investigators
Principal Investigator: Dawson Church, PhD Soul Medicine Institute
Principal Investigator: Garret Yount, PhD Soul Medicine Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Dawson Church, Principal Investigator, Soul Medicine Institute
ClinicalTrials.gov Identifier: NCT01250431     History of Changes
Other Study ID Numbers: SMI-YOUNT-11/24/10
Study First Received: November 24, 2010
Last Updated: December 2, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 24, 2014