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The Effect of Psychotherapy on Stress Biochemistry: An RCT of Psychotherapy and Emotional Freedom Techniques (EFT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00641394
Recruitment Status : Completed
First Posted : March 24, 2008
Last Update Posted : April 25, 2018
Information provided by:
Soul Medicine Institute

Brief Summary:
The purpose of this study is to determine whether there is a change in levels of cortisol, a key stress hormone, during the course of a psychotherapy session. The two forms of psychotherapy compared are Cognitive Behavioral Therapy (CBT) and Emotional Freedom Techniques (EFT). A no treatment control group provides a baseline measure. The change in cortisol level is compared between the start and end of a one hour session.

Condition or disease Intervention/treatment Phase
Stress Depression Anxiety Behavioral: Psychotherapy: Emotional Freedom Techniques (EFT) Behavioral: Cognitive Behavioral Therapy (CBT) Not Applicable

Detailed Description:

Cortisol is a crucial physiological marker for stress. Stress produces elevated cortisol levels for as long as the body can supply the precursors. Elevated cortisol levels are associated with physical conditions such as impaired immune system function, cardiovascular disease, stroke, and accelerated aging. Elevated cortisol levels are also implicated in many psychological conditions. If the adrenal glands, which produce cortisol, are stimulated by the physical or psychological environment to produce stress hormones, they shunt production away from making DHEA, which is vital for cell regeneration.

The current pilot study examines the change in cortisol levels that result from a one hour psychotherapy session. It measures salivary cortisol, which indicates the levels of cortisol readily available to the body. This measure is relatively stable, and is not susceptible to large swings in the relatively brief period of a one hour psychotherapy session. Excluded are subjects with major depressive disorder, posttraumatic stress syndrome, and chronic diseases which have been shown to affect cortisol levels. Cortisol assessments will also take place in the afternoon or evening, to control for low waking cortisol which may be present in some normal subjects.

It is hypothesized that if psychotherapy is successful at treating trauma, cortisol levels will decline between the beginning of the hour and the end of the hour. The structure of the session is that the client discusses their emotional trauma in the first half of the session, and is treated with either cognitive behavioral therapy (CBT) or emotional freedom techniques (EFT) in the second half of the session. A no treatment control group provides baseline data. Half an hour is sufficient time for cortisol reuptake, and if therapy is successful at reducing physiological markers of stress, the client might demonstrate lower levels of cortisol at the conclusion of the psychotherapy session. Subjects who spontaneously have recall of a new significant trauma during the treatment portion of the session will also be excluded, since such recall can result in a cortisol spike. The study also evaluates a range of psychological conditions before and after the session using the SA-45. This brief questionnaire has subscales for anxiety, depression, phobias, hostility and other characteristics; these can be compared to cortisol levels to determine any correlations between psychological and physiological change.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Psychotherapy on Stress Biochemistry: A Randomized Blind Controlled Trial of Psychotherapy and Emotional Freedom Techniques (EFT)
Study Start Date : April 2008
Actual Primary Completion Date : August 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: 1
Psychotherapy: Emotional Freedom Techniques (EFT), a psychotherapy intervention with a somatic component
Behavioral: Psychotherapy: Emotional Freedom Techniques (EFT)
A form of therapy that includes cognitive reframing with somatic reinforcement through touch or tapping of specified points on the body

Active Comparator: 2
Psychotherapy: Cognitive Behavioral Therapy (CBT), a psychotherapy intervention
Behavioral: Cognitive Behavioral Therapy (CBT)
A form of therapy that focuses on negative cognitions of problems, and reframing them in positive terms, but without somatic reinforcement.

No Intervention: 3

Primary Outcome Measures :
  1. spot cortisol level [ Time Frame: 60 minutes ]

Secondary Outcome Measures :
  1. SA-45 symptom assessment questionnaire, with subscales for depression, anxiety, hostility, interpersonal sensitivity, phobias, and other psychological traits [ Time Frame: 60 minutes ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Good Health History

Exclusion Criteria:

  • MDD (Major Depressive Disorder)
  • PTSD (Post Traumatic Stress Disorder)
  • Psychotropic Prescription Drug Use
  • Currently Under Psychiatric Care
  • Major disease, cancer, cardiovascular disease
  • Autoimmune disease
  • CFS (Chronic Fatigue Syndrome)
  • Cushing's Syndrome
  • Addison's Disease
  • Spontaneous Trauma Recall in Final 20 minutes of Session
  • History of Psychological Illness
  • Pretest Cortisol level of .5 ng/ml or under, or 7 ng/ml or over

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 identifier (NCT number): NCT00641394

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United States, California
Soul Medicine Institute
Santa Rosa, California, United States, 95403
Sponsors and Collaborators
Soul Medicine Institute
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Principal Investigator: Dawson Church, PhD Soul Medicine Institute
Publications of Results:
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Responsible Party: Dawson Church, Executive Director, Soul Medicine Institute Identifier: NCT00641394    
Other Study ID Numbers: SMI-CORT-32008
First Posted: March 24, 2008    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018
Keywords provided by Soul Medicine Institute:
Emotional Freedom Techniques (EFT)
Cognitive Behavioral Therapy (CBT)
Additional relevant MeSH terms:
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Behavioral Symptoms