- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00743041
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
100
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, 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
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 |
Intervention / Treatment |
|---|---|
|
No Intervention: 2
Standard of Care (SOC)
|
|
|
Experimental: 1
Standard of Care plus EFT (Emotional Freedom Techniques)
|
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:
|
What is the study measuring?
Primary Outcome Measures
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
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
December 1, 2008
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
August 27, 2008
First Submitted That Met QC Criteria
August 27, 2008
First Posted (Estimate)
August 28, 2008
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-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.