Back to results

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

Primary Purpose

Stress Disorders, Post-Traumatic

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

EFT (Emotional Freedom Techniques)

About this trial

This is an interventional screening trial for Stress Disorders, Post-Traumatic

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Soul Medicine Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

EFT (Emotional Freedom Techniques)

Wait List

Arm Description

10 sessions of EFT.

10 week wait period.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01250431

First Posted

November 24, 2010

Last Updated

April 23, 2018

Sponsor

Soul Medicine Institute

1. Study Identification

Unique Protocol Identification Number

NCT01250431

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

November 2010 (Actual)

Primary Completion Date

November 2017 (Actual)

Study Completion Date

November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Soul Medicine Institute

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stress Disorders, Post-Traumatic

7. Study Design

Primary Purpose

Screening

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EFT (Emotional Freedom Techniques)

Arm Type

Experimental

Arm Description

10 sessions of EFT.

Arm Title

Wait List

Arm Type

No Intervention

Arm Description

10 week wait period.

Intervention Type

Behavioral

Intervention Name(s)

EFT (Emotional Freedom Techniques)

Intervention Description

10 EFT sessions

Primary Outcome Measure Information:

Title

QRT-PCR Assessment of Gene Expression Associated with Psychological Symptoms of Traumatic Stress

Description

Time Frame

Pre-intervention and Post-intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dawson Church, PhD

Organizational Affiliation

Soul Medicine Institute

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Garret Yount, PhD

Organizational Affiliation

Soul Medicine Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Soul Medicine Institute

City

Santa Rosa

State/Province

California

ZIP/Postal Code

95404

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

27520015

Citation

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. Epub 2016 Aug 12.

Results Reference

result

Learn more about this trial

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

We'll reach out to this number within 24 hrs