Stress Disorders, Post-TraumaticEarly Phase 1NCT00743041
The Effect of EFT on Psychological States in a Veterans Population
A Early Phase 1 study testing Emotional Freedom Techniques (EFT) in people with Stress Disorders, Post-Traumatic, run by Soul Medicine Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Emotional Freedom Techniques (EFT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to May 2010
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- A score of 3 or more on questions 34 and 35 of the SA-45
Trial locations and contacts
1 site in 1 country.
United States1 site
Soul Medicine Institute
Santa Rosa, California, 95403
About this study
Official title: 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.
Read the 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.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- Emotional Freedom Techniques (EFT)
- Keywords
- PTSD, EFT, depression, anxiety, telephone
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional Freedom Techniques (EFT)Behavioural
Also called EFT Emotional Freedom Technique
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Standard of Care plus EFT (Emotional Freedom Techniques) Receives: Behavioral: Emotional Freedom Techniques (EFT) |
| 2 | No intervention | Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores on the PCL-M (PTSD Symptom Checklist-Military)
Measured: One Month Before, At Start, After 3 and 6 Sessions, After 3 and 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2008 (estimated)
- Study startDec 2008
- Primary completionDec 2009
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soul Medicine Institute
- Sponsor type
- University, hospital or other
- Investigators
- Dawson Church, PhD, Principal investigator, Soul Medicine Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00743041
- Sponsor's protocol ID
- SMI-PTSD-82508
- Status last verified
- Apr 2018
- First submitted
- 27 Aug 2008
- Last updated
- 25 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of EFT (Emotional Freedom Techniques) on Psychological States in a Veterans Population: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00743041
- Acronym / sponsor ID
- SMI-PTSD-82508
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- PTSD, EFT, depression, anxiety, telephone
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Soul Medicine InstituteUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 28 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Emotional Freedom Techniques (EFT)Standard of Care plus EFT (Emotional Freedom Techniques) |
| 2 | No intervention | –Standard of Care (SOC) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- A score of 3 or more on questions 34 and 35 of the SA-45
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotional Freedom Techniques (EFT)Also: EFT Emotional Freedom TechniqueEFT 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 | Behavioural | 1 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2018.
- BackgroundGeronilla, 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
- National Institute for Integrative HealthcareLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawson Church, PhD principal investigator
Soul Medicine Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Emotional Freedom Techniques (EFT) in people with Stress Disorders, Post-Traumatic, run by Soul Medicine Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00743041, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2018.