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Evaluating Physiological Markers of Emotional Trauma: A Randomized Controlled Comparison of Mind-Body Therapies

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ClinicalTrials.gov Identifier: NCT00526266
Recruitment Status : Recruiting
First Posted : September 10, 2007
Last Update Posted : December 29, 2015
Information provided by (Responsible Party):
Dawson Church, Soul Medicine Institute

Brief Summary:
The purpose of the study is to determine if a physiological marker, joint rotation of the upper body, can be affected by the release of emotional trauma during a brief psychotherapeutic encounter, and whether acupressure is an active ingredient in EFT.

Condition or disease Intervention/treatment
Hypermobility, Joint Depression Anxiety Behavioral: Emotional Freedom Techniques (EFT) Behavioral: Diaphragmatic Breathing (DB)

Detailed Description:

The effect of emotional trauma on physiological functioning has been documented in a number of studies. The largest of these is the ACE study, (ACE=Adverse Childhood Experiences), which examined the health outcomes of over 17,000 patients at Kaiser Permanente Hospitals. It was performed by Kaiser in collaboration with the Centers for Disease Control, on a population with a median age of 56. The ACE study found that those patients with a high incidence of Adverse Childhood Experiences or ACEs had higher rates of bone fractures, cancer, heart disease, hypertension, depression, smoking, suicide, diabetes, and other physical and psychological ailments. The authors of the study compared the health care system's focus on treating disease in adults to a fire brigade directing their water at the smoke, rather than at the originating fire. They recommended that health care providers focus on the emotional trauma which they believe contributes to many illnesses.

The current study seeks to determine if the treatment of emotional trauma has an effect on physiological function. As a marker of physiological function, the authors of this study have chosen the range of motion of the joints of the upper body. Shoulder joint stiffness and syndromes such as frozen shoulder typically take months or even years to heal, and rapid resolution is unusual, though most such injuries do indeed heal over time. Range of motion is a convenient marker of physiological change because it can be measured accurately in degrees using a goniometer, a protractor-like device routinely used in occupational therapy and physical therapy. Changes after treatment can be immediately noted.

The emotional trauma treatment modalities being investigated are Emotional Freedom Techniques or EFT, and Diaphragmatic Breathing or DB, with the DB group receiving an identical protocol but with DB substituted for the acupressure component of EFT. They are being compared with a no treatment control group. Studies of EFT have shown this therapy to be effective in removing or reducing emotional traumas, such as phobias, in a single brief treatment session, as well as in reducing anxiety. The effects hold over time. Most prior studies using EFT as a treatment modality study the effects of only one session, and have found that EFT can be effective even with a very brief course of treatment. For the current study, one 30 minute EFT treatment is undertaken. The range of motion of the shoulder joint is recorded before and after treatment by a licensed occupational therapist using a goniometer. The Diaphragmatic Breathing protocol used by the second group has a verbal content identical to the EFT group, but substitutes DB for acupressure. A follow up assessment of subjects is done after 30 days. Range of motion usually does not relapse, but instead becomes greater, following conventional treatments, and this measure has the advantage of requiring a relatively short follow up period, rather than the longer period required for other physiological markers.

The purpose of the study is to discover if a significant change in the range of motion occurs after treatment, and to dismantle the acupressure from the verbal component of EFT by substituting DB for this portion of the protocol.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating Physiological Markers of Emotional Trauma: A Randomized Controlled Comparison of Mind-Body Therapies
Study Start Date : September 2007
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Behavioral: Emotional Freedom Techniques (EFT)
A half hour treatment with EFT following a standardized protocol. Both Range of Motion (ROM) physical issues are treated with EFT, as well as any possible emotional issues underlying limited ROM.
Placebo Comparator: 2 Behavioral: Diaphragmatic Breathing (DB)
Diaphragmatic Breathing (DB) instead of EFT tapping, but with all the "Setup Statements" and components of the Experimental Group, with the exception of tapping. DB is substituted for tapping.
No Intervention: 3
No Treatment

Primary Outcome Measures :
  1. Mental Health Symptoms [ Time Frame: One Treatment Session ]

Secondary Outcome Measures :
  1. Range of Motion (ROM) of joints of the upper body [ Time Frame: Before and immediately after treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Limited Range of Motion (ROM) of a joint in the upper body

Exclusion Criteria:

  • Post-operative recovery
  • Receiving rehabilitation treatment
  • Under psychiatric care
  • Currently using prescription psychotropic medication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00526266

Contact: Michaela McGivern, BS 707 217 7732 mcgivern@sonic.net

United States, California
Integrative Medical Clinic of Santa Rosa (IMCSR) Recruiting
Santa Rosa, California, United States, 95403
Contact: Robert Dozor, MD    707-237-6951    bob@imcsr.com   
Sponsors and Collaborators
Soul Medicine Institute
Principal Investigator: Dawson Church, PhD Soul Medicine Institute

Additional Information:
Responsible Party: Dawson Church, Executive Director, Soul Medicine Institute
ClinicalTrials.gov Identifier: NCT00526266     History of Changes
Other Study ID Numbers: ROM-ACEP-SMI-IMCSR-1
First Posted: September 10, 2007    Key Record Dates
Last Update Posted: December 29, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Joint Instability
Joint Diseases
Musculoskeletal Diseases