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

Primary Purpose

Hypermobility, Joint, Depression, Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Emotional Freedom Techniques (EFT)
Diaphragmatic Breathing (DB)
Sponsored by
Soul Medicine Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypermobility, Joint

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Integrative Medical Clinic of Santa Rosa (IMCSR)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

1

2

3

Arm Description

No Treatment

Outcomes

Primary Outcome Measures

Mental Health Symptoms

Secondary Outcome Measures

Range of Motion (ROM) of joints of the upper body

Full Information

First Posted
September 6, 2007
Last Updated
April 23, 2018
Sponsor
Soul Medicine Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00526266
Brief Title
Evaluating Physiological Markers of Emotional Trauma: A Randomized Controlled Comparison of Mind-Body Therapies
Official Title
Evaluating Physiological Markers of Emotional Trauma: A Randomized Controlled Comparison of Mind-Body Therapies
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Soul Medicine Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypermobility, Joint, Depression, Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Arm Title
3
Arm Type
No Intervention
Arm Description
No Treatment
Intervention Type
Behavioral
Intervention Name(s)
Emotional Freedom Techniques (EFT)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Diaphragmatic Breathing (DB)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mental Health Symptoms
Time Frame
One Treatment Session
Secondary Outcome Measure Information:
Title
Range of Motion (ROM) of joints of the upper body
Time Frame
Before and immediately after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawson Church, PhD
Organizational Affiliation
Soul Medicine Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Integrative Medical Clinic of Santa Rosa (IMCSR)
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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
Results Reference
result
Links:
URL
http://www.imcsr.com
Description
Integrative Medical Clinic of Santa Rosa
URL
http://www.soulmedicineinstitute.org
Description
Soul Medicine Institute, sponsoring organization

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

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