The Effect of EFT on Psychological States in a Veterans Population
Primary Purpose
Stress Disorders, Post-Traumatic
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Emotional Freedom Techniques (EFT)
Sponsored by
About this trial
This is an interventional supportive care trial for Stress Disorders, Post-Traumatic focused on measuring PTSD, EFT, depression, anxiety, telephone
Eligibility Criteria
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
Sites / Locations
- Soul Medicine Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
Standard of Care plus EFT (Emotional Freedom Techniques)
Standard of Care (SOC)
Outcomes
Primary Outcome Measures
Scores on the PCL-M (PTSD Symptom Checklist-Military)
Secondary Outcome Measures
Full Information
NCT ID
NCT00743041
First Posted
August 27, 2008
Last Updated
April 23, 2018
Sponsor
Soul Medicine Institute
1. Study Identification
Unique Protocol Identification Number
NCT00743041
Brief Title
The Effect of EFT on Psychological States in a Veterans Population
Official Title
The Effect of EFT (Emotional Freedom Techniques) on Psychological States in a Veterans Population: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Soul Medicine Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic
Keywords
PTSD, EFT, depression, anxiety, telephone
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Standard of Care plus EFT (Emotional Freedom Techniques)
Arm Title
2
Arm Type
No Intervention
Arm Description
Standard of Care (SOC)
Intervention Type
Behavioral
Intervention Name(s)
Emotional Freedom Techniques (EFT)
Other Intervention Name(s)
EFT Emotional Freedom Technique
Intervention Description
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
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawson Church, 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
95403
Country
United States
12. IPD Sharing Statement
Citations:
Citation
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
Results Reference
background
Links:
URL
http://www.NIIH.org
Description
National Institute for Integrative Healthcare
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The Effect of EFT on Psychological States in a Veterans Population
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