NCT01250431

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Nov 2010

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 30, 2010

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

April 25, 2018

Status Verified

April 1, 2018

Enrollment Period

7 years

First QC Date

November 24, 2010

Last Update Submit

April 23, 2018

Conditions

Stress Disorders, Post-Traumatic

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

EFT (Emotional Freedom Techniques)

EXPERIMENTAL

10 sessions of EFT.

Behavioral: EFT (Emotional Freedom Techniques)

Wait List

NO INTERVENTION

10 week wait period.

Interventions

EFT (Emotional Freedom Techniques)BEHAVIORAL

10 EFT sessions

EFT (Emotional Freedom Techniques)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soul Medicine Institute

Santa Rosa, California, 95404, United States

Location

Related 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. Epub 2016 Aug 12.

    PMID: 27520015RESULT

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Dawson Church, PhD

    Soul Medicine Institute

    PRINCIPAL INVESTIGATOR

  • Garret Yount, PhD

    Soul Medicine Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 24, 2010

First Posted

November 30, 2010

Study Start

November 1, 2010

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

April 25, 2018

Record last verified: 2018-04

Locations

US(1)