- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01250431
Gene Expression Correlates of Post-Traumatic Stress Disorder (PTSD) Symptom Change After EFT (Emotional Freedom Techniques)
April 23, 2018 updated by: Dawson Church, Soul Medicine Institute
Gene Expression Correlates of PTSD Symptom Change After EFT (Emotional Freedom Techniques): A Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
18
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Santa Rosa, California, United States, 95404
- Soul Medicine Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: EFT (Emotional Freedom Techniques)
10 sessions of EFT.
|
10 EFT sessions
|
|
No Intervention: Wait List
10 week wait period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
QRT-PCR Assessment of Gene Expression Associated with Psychological Symptoms of Traumatic Stress
Time Frame: 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.
|
Pre-intervention and Post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Garret Yount, PhD, Soul Medicine Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2010
Primary Completion (Actual)
November 1, 2017
Study Completion (Actual)
November 1, 2017
Study Registration Dates
First Submitted
November 24, 2010
First Submitted That Met QC Criteria
November 29, 2010
First Posted (Estimate)
November 30, 2010
Study Record Updates
Last Update Posted (Actual)
April 25, 2018
Last Update Submitted That Met QC Criteria
April 23, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMI-YOUNT-11/24/10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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