Stress Disorders, Post-TraumaticEarly Phase 1NCT01250431
Gene Expression Correlates of Post-Traumatic Stress Disorder (PTSD) Symptom Change After EFT (Emotional Freedom Techniques)
A Early Phase 1 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
The purpose of the study is to measure the change in psychological symptoms and gene expression in war veterans after a series of 10 EFT coaching sessions. Outcome studies have shown statistically significant reductions in depression, anxiety, and PTSD in veterans after EFT, and this study extends earlier research… Read more about this study
- Who is it for?
- Ages 18 to 80 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
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Nov 2017
- 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 80 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, understand English, and provide informed consent. Subjects are required to be literate and understand English.
- Remaining under the care of a primary care provider such as a VA hospital throughout the entire period of the study
- Between 18 and 80 years old. No children will be research subjects in this study.
Who cannot join
- A current or past physical or psychiatric disorder that would preclude their being able to respond to the psychosocial measures adequately, or to give blood safely (i.e. cognitive dysfunction, psychosis, or any blood or bleeding disorder)
- Regularly work a night or graveyard shift (to avoid effects of alterations in circadian rhythm)
- Inability to come into the San Francisco laboratory for an afternoon for testing
- Immunomodulatory disorders (e.g. AIDS, rheumatoid arthritis, multiple sclerosis, lupus) or cancer history
- Aggressive chronic periodontitis
- Antibiotics within the last 3 months prior to the recruitment date
- A score of more than 4 on questions 34 and 35 of the SA-45:
- Having urges to beat, injure, or harm someone Having urges to break or smash things
Trial locations and contacts
1 site in 1 country.
United States1 site
Soul Medicine Institute
Santa Rosa, California, 95404
About this study
Official title: Gene Expression Correlates of PTSD Symptom Change After EFT (Emotional Freedom Techniques): A Randomized Controlled Trial
The purpose of the study is to measure the change in psychological symptoms and gene expression in war veterans after a series of 10 EFT coaching sessions. Outcome studies have shown statistically significant reductions in depression, anxiety, and PTSD in veterans after EFT, and this study extends earlier research using biological sampling. EFT is a form of Energy Psychology (EP) that is sometimes referred to as "emotional acupuncture." It involves self-stimulation of 14 acupuncture points at the end of meridians with the fingertips, while recalling an emotional event such as a combat trauma. It is typically effective in 6 to 15 coaching sessions, making it an efficient clinical technique for reducing affect.
Read the detailed description
There is peer-reviewed published experimental evidence showing that (a) acupuncture reduces the fear response in the brain, especially the limbic system, and most particularly the amygdala; that (b) tapping or rubbing acupuncture points (acupressure) can be as effective as needling them; that (c) EFTs use of such acupressure is efficacious in reducing anxiety, PTSD and other mood disorders; that (d) EFT reliably reduces emotional intensity associated with traumatic memories, is safe and low-risk; that (e) all EP studies that included a long-term follow-up show that patient gains are maintained over time; that (f) the psychological questionnaires used in this study are validated and safe; and that for all these reasons (g) EP is a treatment of choice among therapists when dealing with the traumatic memories of clients. This study extends these findings by noting changes in gene expression associated with the remission of PTSD symptoms.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- EFT (Emotional Freedom Techniques)
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EFT (Emotional Freedom Techniques)Behavioural
10 EFT sessions
| Study group | Role | What they receive |
|---|---|---|
| EFT (Emotional Freedom Techniques) | Experimental | 10 sessions of EFT. Receives: Behavioral: EFT (Emotional Freedom Techniques) |
| Wait List | No intervention | 10 week wait period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
QRT-PCR Assessment of Gene Expression Associated with Psychological Symptoms of Traumatic Stress
For the experimental group, the first data point is immediately before the first EFT (Emotional Freedom Techniques) session. The second data point is immediately after the last of 10 weekly sessions. The control group is assessed at intake, and after 10 weeks.
Measured: Pre-intervention and Post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionNov 2017
- Study completionNov 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
- Early Phase 1
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 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
- Investigators
- Dawson Church, PhD, Principal investigator, Soul Medicine InstituteGarret Yount, PhD, Principal investigator, Soul Medicine Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01250431
- Sponsor's protocol ID
- SMI-YOUNT-11/24/10
- Status last verified
- Apr 2018
- First submitted
- 24 Nov 2010
- Last updated
- 25 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Church D, Yount G, Rachlin K, Fox L, Nelms J. Epigenetic Effects of PTSD Remediation in Veterans Using Clinical Emotional Freedom Techniques: A Randomized Controlled Pilot Study. Am J Health Promot. 2018 Jan;32(1):112-122. doi: 10.1177/0890117116661154. Epub 2016 Aug 12.
PubMed 27520015
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
- Gene Expression Correlates of PTSD Symptom Change After EFT (Emotional Freedom Techniques): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01250431
- Acronym / sponsor ID
- SMI-YOUNT-11/24/10
- Conditions
- Stress Disorders, Post-Traumatic
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Soul Medicine InstituteUniversity, hospital or other
- Study start
- Nov 2010 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 30 Nov 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.
The purpose of the study is to measure the change in psychological symptoms and gene expression in war veterans after a series of 10 EFT coaching sessions. Outcome studies have shown statistically significant reductions in depression, anxiety, and PTSD in veterans after EFT, and this study extends earlier research using biological sampling. EFT is a form of Energy Psychology (EP) that is sometimes referred to as "emotional acupuncture." It involves self-stimulation of 14 acupuncture points at the end of meridians with the fingertips, while recalling an emotional event such as a combat trauma. It is typically effective in 6 to 15 coaching sessions, making it an efficient clinical technique for reducing affect.
Detailed description
There is peer-reviewed published experimental evidence showing that (a) acupuncture reduces the fear response in the brain, especially the limbic system, and most particularly the amygdala; that (b) tapping or rubbing acupuncture points (acupressure) can be as effective as needling them; that (c) EFTs use of such acupressure is efficacious in reducing anxiety, PTSD and other mood disorders; that (d) EFT reliably reduces emotional intensity associated with traumatic memories, is safe and low-risk; that (e) all EP studies that included a long-term follow-up show that patient gains are maintained over time; that (f) the psychological questionnaires used in this study are validated and safe; and that for all these reasons (g) EP is a treatment of choice among therapists when dealing with the traumatic memories of clients. This study extends these findings by noting changes in gene expression associated with the remission of PTSD symptoms.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EFT (Emotional Freedom Techniques) | Experimental | Behavioral: EFT (Emotional Freedom Techniques)10 sessions of EFT. |
| Wait List | No intervention | –10 week wait period. |
Who may qualify
- Ages
- 18 to 80 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, understand English, and provide informed consent. Subjects are required to be literate and understand English.
- Remaining under the care of a primary care provider such as a VA hospital throughout the entire period of the study
- Between 18 and 80 years old. No children will be research subjects in this study.
Key exclusion criteria (8 listed)
- A current or past physical or psychiatric disorder that would preclude their being able to respond to the psychosocial measures adequately, or to give blood safely (i.e. cognitive dysfunction, psychosis, or any blood or bleeding disorder)
- Regularly work a night or graveyard shift (to avoid effects of alterations in circadian rhythm)
- Inability to come into the San Francisco laboratory for an afternoon for testing
- Immunomodulatory disorders (e.g. AIDS, rheumatoid arthritis, multiple sclerosis, lupus) or cancer history
- Aggressive chronic periodontitis
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)10 EFT sessions | Behavioural | EFT (Emotional Freedom Techniques) |
Primary outcome
QRT-PCR Assessment of Gene Expression Associated with Psychological Symptoms of Traumatic Stress
Time frame: Pre-intervention and Post-intervention
For the experimental group, the first data point is immediately before the first EFT (Emotional Freedom Techniques) session. The second data point is immediately after the last of 10 weekly sessions. The control group is assessed at intake, and after 10 weeks.
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 27520015Church D, Yount G, Rachlin K, Fox L, Nelms J. Epigenetic Effects of PTSD Remediation in Veterans Using Clinical Emotional Freedom Techniques: A Randomized Controlled Pilot Study. Am J Health Promot. 2018 Jan;32(1):112-122. doi: 10.1177/0890117116661154. Epub 2016 Aug 12.
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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
Garret Yount, 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 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 8 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?
QRT-PCR Assessment of Gene Expression Associated with Psychological Symptoms of Traumatic Stress (time frame: Pre-intervention and Post-intervention). 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 NCT01250431, 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.