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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Soul Medicine Institute
Sponsor:
Information provided by (Responsible Party):
Dawson Church, Soul Medicine Institute
ClinicalTrials.gov Identifier:
NCT00526266
First received: September 6, 2007
Last updated: May 13, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Joint Range of Motion
Behavioral: Emotional Freedom Techniques (EFT)
Behavioral: Diaphragmatic Breathing (DB)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating Physiological Markers of Emotional Trauma: A Randomized Controlled Comparison of Mind-Body Therapies

Resource links provided by NLM:


Further study details as provided by Soul Medicine Institute:

Primary Outcome Measures:
  • Range of Motion (ROM) of joints of the upper body [ Time Frame: One Treatment Session ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Score on a standardized psychological test, the SA-45 [ Time Frame: Before and immediately after treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: September 2007
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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. 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 experimental group, but omits the physical touch aspects of EFT. 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. Such a finding would reinforce the ACE study's conclusion of a link between physiological functioning and emotional trauma, by determining if the mediation of psychological trauma produces a measurable physiological effect.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00526266

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

Locations
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
Investigators
Principal Investigator: Dawson Church, PhD Soul Medicine Institute
  More Information

Additional Information:
No publications provided

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
Study First Received: September 6, 2007
Last Updated: May 13, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 21, 2014