Stress Disorders, Post-TraumaticPhase 1NCT00514956
Effect of Emotional Freedom Technique and Diaphragmatic Breathing on Post Traumatic Stress Disorder (PTSD)
A Phase 1 study testing Emotional Freedom Techniques (EFT) in people with Stress Disorders, Post-Traumatic, run by Soul Medicine Institute at 2 sites in United States.
Trial summary
A great many soldiers are returning from Iraq and Afghanistan with symptoms of Post Traumatic Stress Disorder (PTSD). Clinical experience with many people has shown the effectiveness of the techniques of Energy Psychology for rapidly alleviating PTSD symptoms. Read more about this study
- Who is it for?
- Ages 18 to 70 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
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2007to Jan 2009
- Phase
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PTSD
- Recent Service in Afghanistan or Iraq
- Good Health History
Who cannot join
- Illegal Drug Use
- Recent Physical Trauma
- Head injuries, concussions, amputees
- Mental health issues prior to entering military service
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Marshall University Medical School
Charleston, West Virginia
Marshall University, Joan Edwards School of Medicine
Huntington, West Virginia, 25701
About this study
Official title: Effect of Emotional Freedom Technique and Diaphragmatic Breathing on PTSD
A great many soldiers are returning from Iraq and Afghanistan with symptoms of Post Traumatic Stress Disorder (PTSD). Clinical experience with many people has shown the effectiveness of the techniques of Energy Psychology for rapidly alleviating PTSD symptoms. The study proposes to determine whether a very brief course of treatment (3 sessions) with a common form of Energy Psychology called Emotional Freedom Techniques (EFT) has an effect on the stress biochemistry of subjects, by measuring their levels of stress hormones (cortisol, DHEA) before and after treatment.
Read the detailed description
The Purpose of the Research: The purpose of this study is to test the effectiveness of Emotional Freedom Technique (EFT) versus Diaphragmatic Breathing in Reducing Post Traumatic Stress Disorders.
The Scientific or Scholarly Rationale: Clinical experience and anecdotal reports have demonstrated EFT to be effective for a wide range of behavioral disorders, including PTSD. However with the exception of several studies demonstrating the efficacy of EFT for the treatment of simple phobias, there have been no formal research studies in this area. It is the intention of this study to extend the phobia studies to the area of PTSD, and to determine what other conditions EFT might be effective in treating. Another intention of this study is to see whether, and to what degree, changes in psychological functioning (as measure by the PAI and TSI) are reflected in physiological markers such as HRV (Heart Rate Variability) and levels of cortisol and DHEA.
The Procedures to be Performed: Approximately 8 to 10 subjects would be randomly designated to either the experimental or Diaphragmatic Breathing control groups. There will be 4-5 subjects in the EFT experimental group and 4-5 subjects in the control Diaphragmatic Breathing group.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- Emotional Freedom Techniques (EFT)
- Keywords
- Post-Traumatic Stress Syndrome (PTSD)
- Medical subject headings
- Stress Disorders, Post-Traumatic, Combat 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline cortisol and DHEA production
Measured: Six months
Secondary outcomes (1)
Changes in scores on Trauma Assessment Inventory and other instruments normed for trauma
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2007 (estimated)
- Study startSep 2007
- Primary completionJan 2009
- Study completionJan 2009
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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soul Medicine Institute
- Sponsor type
- University, hospital or other
- Investigators
- Dawson Church, PhD, Study director, Soul Medicine Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00514956
- Sponsor's protocol ID
- PTSD-ACEP-SMI-MU-1
- Status last verified
- Sep 2009
- First submitted
- 8 Aug 2007
- Last updated
- 22 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Church, D., Geronilla, L., & Dinter, I. (2009) Psychological symptom change in veterans after six sessions of Emotional Freedom Techniques (EFT). International Journal of Healing and Caring, January, 9:1.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Emotional Freedom Technique and Diaphragmatic Breathing on PTSD
- ClinicalTrials.gov ID
- NCT00514956
- Acronym / sponsor ID
- PTSD-ACEP-SMI-MU-1
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- Post-Traumatic Stress Syndrome (PTSD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Soul Medicine InstituteUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 10 Aug 2007 (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 great many soldiers are returning from Iraq and Afghanistan with symptoms of Post Traumatic Stress Disorder (PTSD). Clinical experience with many people has shown the effectiveness of the techniques of Energy Psychology for rapidly alleviating PTSD symptoms. The study proposes to determine whether a very brief course of treatment (3 sessions) with a common form of Energy Psychology called Emotional Freedom Techniques (EFT) has an effect on the stress biochemistry of subjects, by measuring their levels of stress hormones (cortisol, DHEA) before and after treatment.
Detailed description
The Purpose of the Research: The purpose of this study is to test the effectiveness of Emotional Freedom Technique (EFT) versus Diaphragmatic Breathing in Reducing Post Traumatic Stress Disorders.
The Scientific or Scholarly Rationale: Clinical experience and anecdotal reports have demonstrated EFT to be effective for a wide range of behavioral disorders, including PTSD. However with the exception of several studies demonstrating the efficacy of EFT for the treatment of simple phobias, there have been no formal research studies in this area. It is the intention of this study to extend the phobia studies to the area of PTSD, and to determine what other conditions EFT might be effective in treating. Another intention of this study is to see whether, and to what degree, changes in psychological functioning (as measure by the PAI and TSI) are reflected in physiological markers such as HRV (Heart Rate Variability) and levels of cortisol and DHEA.
The Procedures to be Performed: Approximately 8 to 10 subjects would be randomly designated to either the experimental or Diaphragmatic Breathing control groups. There will be 4-5 subjects in the EFT experimental group and 4-5 subjects in the control Diaphragmatic Breathing group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- PTSD
- Recent Service in Afghanistan or Iraq
- Good Health History
Key exclusion criteria (4 listed)
- Illegal Drug Use
- Recent Physical Trauma
- Head injuries, concussions, amputees
- Mental health issues prior to entering military service
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) | Behavioural | – |
Primary outcome
Change in baseline cortisol and DHEA production
Time frame: Six months
1 secondary outcome
Changes in scores on Trauma Assessment Inventory and other instruments normed for trauma
Time frame: Six 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 22 Sep 2009.
- Results publicationChurch, D., Geronilla, L., & Dinter, I. (2009) Psychological symptom change in veterans after six sessions of Emotional Freedom Techniques (EFT). International Journal of Healing and Caring, January, 9:1.
- Web site to connect veterans to assistance using study protocol, and enrollment option for larger followup study.Link 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 study director
Soul Medicine Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Emotional Freedom Techniques (EFT) in people with Stress Disorders, Post-Traumatic, run by Soul Medicine Institute at 2 sites 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 3 inclusion and 4 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 22 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Change in baseline cortisol and DHEA production (time frame: Six 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 NCT00514956, 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 22 Sep 2009.