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

This study has been completed.

Sponsored by: Soul Medicine Institute
Information provided by: Soul Medicine Institute
ClinicalTrials.gov Identifier: NCT00641394
  Purpose

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 Intervention
Stress
Depression
Anxiety
Behavioral: Psychotherapy: Emotional Freedom Techniques (EFT)
Behavioral: Cognitive Behavioral Therapy (CBT)

MedlinePlus related topics:   Anxiety    Depression    Stress   

ChemIDplus related topics:   Hydrocortisone    Cortisol 21-phosphate    Cortisol succinate    Hydrocortamate    Hydrocortisone 21-sodium succinate    Hydrocortisone acetate    Hydrocortisone cypionate    Hydrocortisone hemisuccinate    Proctofoam-HC   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:   The Effect of Psychotherapy on Stress Biochemistry: A Randomized Blind Controlled Trial of Psychotherapy and Emotional Freedom Techniques (EFT)

Further study details as provided by Soul Medicine Institute:

Primary Outcome Measures:
  • spot cortisol level [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SA-45 symptom assessment questionnaire, with subscales for depression, anxiety, hostility, interpersonal sensitivity, phobias, and other psychological traits [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment:   30
Study Start Date:   April 2008
Study Completion Date:   July 2008
Primary Completion Date:   May 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
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
2: Active Comparator
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.
3: No Intervention

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.

  Eligibility
Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00641394

Locations
United States, California
Soul Medicine Institute    
      Santa Rosa, California, United States, 95403

Sponsors and Collaborators
Soul Medicine Institute

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


Publications:

Responsible Party:   Soul Medicine Institute ( Dawson Church, Executive Director )
Study ID Numbers:   SMI-CORT-32008
First Received:   March 18, 2008
Last Updated:   July 6, 2008
ClinicalTrials.gov Identifier:   NCT00641394
Health Authority:   United States: Institutional Review Board

Keywords provided by Soul Medicine Institute:
cortisol  
hydrocortisone  
psychotherapy  
Emotional Freedom Techniques (EFT)  
Cognitive Behavioral Therapy (CBT)
depression
anxiety

Study placed in the following topic categories:
Hydrocortisone
Depression
Cortisol succinate
Mental Disorders
Mood Disorders
Stress
Hydrocortisone acetate
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:
Pathologic Processes

ClinicalTrials.gov processed this record on October 17, 2008




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