The Effect of EFT on Psychological States in a Veterans Population

April 23, 2018 updated by: Soul Medicine Institute

The Effect of EFT (Emotional Freedom Techniques) on Psychological States in a Veterans Population: A Randomized Controlled Trial

A need exists to find fast yet effective treatment protocols for the large number of US military service personnel coming back from Iraq with post traumatic stress disorder (PTSD), and a variety of co-occurring psychological problems. EFT (Emotional Freedom Techniques) has demonstrated promise as a PTSD treatment in pilot studies. This study examines the effects of six sessions of EFT coaching on veterans who score at or above the military cutoff point for PSTD. Subjects are also assessed for conditions that often accompany PTSD, such as depression and anxiety. Changes pain, cravings, and physical symptoms are also measured. Assessments are made after six sessions are complete, and again after three and six months.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A need exists to find fast yet effective treatment protocols for the large number of US military service personnel coming back from Iraq with post traumatic stress disorder (PTSD), and a variety of co-occurring psychological problems. This study examines the effects of six sessions of EFT coaching on a veterans population. The sample will recruited from clients of practitioners who are coaching veterans. Participants will be assessed for PTSD and other psychological conditions such as anxiety and depression. Evaluations will be made using well-validated instruments, the SA-45 (Symptom Assessment 45) and the PCL-M (Posttraumatic Stress Disorder Checklist - Military). Those meeting the military's criterion for a PTSD-positive assessment on the PCL-M will be randomized into two groups. A wait list control group continues to receive Standard of Care (SOC) from their current healthcare provider. The experimental group receives SOC plus EFT coaching. A baseline measurement is obtained approximately thirty days in advance of coaching, when subjects apply to participate in the study, and again immediately before coaching begins. Participants are assessed after three sessions and six sessions, to determine symptom changes at these milestones. Followup assessments occur three months and six months post-coaching. Pain levels, alcohol use, recreational drug use, and prescription drug dosages are also tracked, in order to determine any correlation between participant characteristics and psychological symptom change. Data will also be analyzed to determine if there are outcome differences between participants receiving EFT from life coaches, and those whose EFT coaching is delivered by licensed psychologists or social workers.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • California
      • Santa Rosa, California, United States, 95403
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Military Service
  • Score of 50 or more on the PCL-M (PTSD Checklist-Military)
  • The ability to follow instructions and complete written forms
  • Under the care of a primary care provider

Exclusion Criteria:

  • A score of 3 or more on questions 34 and 35 of the SA-45

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: 2
Standard of Care (SOC)
Experimental: 1
Standard of Care plus EFT (Emotional Freedom Techniques)
Behavioral: Emotional Freedom Techniques (EFT)
EFT is an exposure therapy with a cognitive component, consisting of recall of a trauma along with a statement of self-acceptance, in combination with touching or tapping on a series of stress reduction points on the body
Other Names:
  • EFT Emotional Freedom Technique

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Scores on the PCL-M (PTSD Symptom Checklist-Military)
Time Frame: One Month Before, At Start, After 3 and 6 Sessions, After 3 and 6 Months
One Month Before, At Start, After 3 and 6 Sessions, After 3 and 6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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.

General Publications

  • Geronilla, L., Minewiser, L., Mollon, P., McWilliams, M., & Clond, M. (2016). EFT (Emotional Freedom Techniques) remediates PTSD and psychological symptoms in veterans: A randomized controlled replication trial. Energy Psychology: Theory, Research, and Treatment, 8(2), 29-41. doi:10.9769/EPJ.2016.8.2.LG

Helpful Links

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2008

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SMI-PTSD-82508

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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