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

April 23, 2018 updated by: Dawson Church, Soul Medicine Institute
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.

Study Overview

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

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Santa Rosa, California, United States, 95403
        • Integrative Medical Clinic of Santa Rosa (IMCSR)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mental Health Symptoms
Time Frame: One Treatment Session
One Treatment Session

Secondary Outcome Measures

Outcome Measure
Time Frame
Range of Motion (ROM) of joints of the upper body
Time Frame: Before and immediately after treatment
Before and immediately after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Church, D., & Nelms, J. (2016). Pain, range of motion, and psychological symptoms in a population with frozen shoulder: A randomized controlled dismantling study of Clinical EFT (emotional freedom techniques). Archives of Scientific Psychology, 15(1), 38-48. doi:10.1037/arc0000028

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

September 6, 2007

First Submitted That Met QC Criteria

September 6, 2007

First Posted (Estimate)

September 10, 2007

Study Record Updates

Last Update Posted (Actual)

April 25, 2018

Last Update Submitted That Met QC Criteria

April 23, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • ROM-ACEP-SMI-IMCSR-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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