Stress Disorders, Post-TraumaticNCT01117545
Psychological Symptom Change in Veterans After Six Sessions of EFT (Emotional Freedom Techniques)
A study testing EFT (Emotional Freedom Techniques) in people with Stress Disorders, Post-Traumatic, run by Soul Medicine Institute at 1 site in United States.
Trial summary
EFT (Emotional Freedom Techniques) has been shown to significantly reduce post-traumatic stress disorder (PTSD) and other psychological symptoms such as anxiety and depression in a variety of clinical trials. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- EFT (Emotional Freedom Techniques)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Dec 2017
- Phase
- Interventional
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Military Service
- The ability to follow instructions, complete written forms, and provide informed consent.
- Remaining under the care of a primary care provider such as a VA hospital throughout the entire period of the study
- Between 18 and 90 years old
Who cannot join
- Participants with a score of more than 3 on questions 34 and 35 of the Symptom Assessment-45 Questionnaire (SA-45) will receive phone/skype sessions, not office visits
Trial locations and contacts
1 site in 1 country.
United States1 site
Soul Medicine Institute
Santa Rosa, California, 95404
About this study
Official title: Psychological Symptom Change in Veterans After Six Sessions of EFT (Emotional Freedom Techniques): A Randomized Controlled Trial
EFT (Emotional Freedom Techniques) has been shown to significantly reduce post-traumatic stress disorder (PTSD) and other psychological symptoms such as anxiety and depression in a variety of clinical trials. This study examines the effect of a six session EFT protocol on the symptoms of veterans with clinical scores on the PTSD Checklist-Military (PCL-M). Subjects in the experimental group receive EFT coaching supplemental to, and supportive of, the "usual care" treatment provided by their primary care provider. Subjects in the wait list control group receive usual care for a month, with pre and posttests, after which they also receive the EFT coaching protocol. Subjects are followed at three month intervals to determine if gains are maintained, and whether the symptom reductions are similar to those observed in other trials of EFT.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- EFT (Emotional Freedom Techniques)
- Keywords
- veterans,, PTSD,, EFT (Emotional Freedom Techniques),, depression,, anxiety
- 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.
EFT (Emotional Freedom Techniques)Behavioural
Six sessions of EFT
| Study group | Role | What they receive |
|---|---|---|
| EFT | Experimental | Six sessions of EFT (Emotional Freedom Techniques) Receives: Behavioral: EFT (Emotional Freedom Techniques) |
| Wait List | No intervention | One month wait period |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Scores on the PCL-M Assessment
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 posted5 May 2010 (estimated)
- Study startMay 2010
- Primary completionJul 2017
- Study completionDec 2017
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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soul Medicine Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dawson Church, Soul Medicine Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01117545
- Sponsor's protocol ID
- SMI-PTSD-5410
- Status last verified
- Apr 2018
- First submitted
- 4 May 2010
- Last updated
- 25 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Church D, Hawk C, Brooks AJ, Toukolehto O, Wren M, Dinter I, Stein P. Psychological trauma symptom improvement in veterans using emotional freedom techniques: a randomized controlled trial. J Nerv Ment Dis. 2013 Feb;201(2):153-60. doi: 10.1097/NMD.0b013e31827f6351.
PubMed 23364126
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
- Psychological Symptom Change in Veterans After Six Sessions of EFT (Emotional Freedom Techniques): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01117545
- Acronym / sponsor ID
- SMI-PTSD-5410
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- veterans,, PTSD,, EFT (Emotional Freedom Techniques),, depression,, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Soul Medicine InstituteUniversity, hospital or other
- Study start
- May 2010 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 5 May 2010 (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.
EFT (Emotional Freedom Techniques) has been shown to significantly reduce post-traumatic stress disorder (PTSD) and other psychological symptoms such as anxiety and depression in a variety of clinical trials. This study examines the effect of a six session EFT protocol on the symptoms of veterans with clinical scores on the PTSD Checklist-Military (PCL-M). Subjects in the experimental group receive EFT coaching supplemental to, and supportive of, the "usual care" treatment provided by their primary care provider. Subjects in the wait list control group receive usual care for a month, with pre and posttests, after which they also receive the EFT coaching protocol. Subjects are followed at three month intervals to determine if gains are maintained, and whether the symptom reductions are similar to those observed in other trials of EFT.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EFT | Experimental | Behavioral: EFT (Emotional Freedom Techniques)Six sessions of EFT (Emotional Freedom Techniques) |
| Wait List | No intervention | –One month wait period |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Military Service
- The ability to follow instructions, complete written forms, and provide informed consent.
- Remaining under the care of a primary care provider such as a VA hospital throughout the entire period of the study
- Between 18 and 90 years old
Key exclusion criteria (1 listed)
- Participants with a score of more than 3 on questions 34 and 35 of the Symptom Assessment-45 Questionnaire (SA-45) will receive phone/skype sessions, not office visits
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 |
|---|---|---|
| EFT (Emotional Freedom Techniques)Six sessions of EFT | Behavioural | EFT |
Primary outcome
PTSD Scores on the PCL-M Assessment
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.
- Results publication: PubMed 23364126Church D, Hawk C, Brooks AJ, Toukolehto O, Wren M, Dinter I, Stein P. Psychological trauma symptom improvement in veterans using emotional freedom techniques: a randomized controlled trial. J Nerv Ment Dis. 2013 Feb;201(2):153-60. doi: 10.1097/NMD.0b013e31827f6351.
- Veterans Stress Project. This site is a primary web site recruiting subjects.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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EFT (Emotional Freedom Techniques) 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.
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?
PTSD Scores on the PCL-M Assessment (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 NCT01117545, 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.