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

This study has been completed.
Sponsor:
Information provided by:
Soul Medicine Institute
ClinicalTrials.gov Identifier:
NCT00641394
First received: March 18, 2008
Last updated: April 9, 2012
Last verified: April 2012
  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)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


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 ]

Enrollment: 83
Study Start Date: April 2008
Study Completion Date: September 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  • Pretest Cortisol level of .5 ng/ml or under, or 7 ng/ml or over
  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: Dawson Church, Executive Director, Soul Medicine Institute
ClinicalTrials.gov Identifier: NCT00641394     History of Changes
Other Study ID Numbers: SMI-CORT-32008
Study First Received: March 18, 2008
Last Updated: April 9, 2012
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

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Mental Disorders
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on April 16, 2014