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

Depression Clinical Trial

Official title:

The Effect of Psychotherapy on Stress Biochemistry: A Randomized Blind Controlled Trial of Psychotherapy and Emotional Freedom Techniques (EFT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00641394
• Other study ID #: SMI-CORT-32008
• Status: Completed
• Phase: N/A
• First received: March 18, 2008
• Last updated: April 23, 2018
• Start date: April 2008
• Est. completion date: September 2010

Study information

• Verified date: April 2018
• Source: Soul Medicine Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: September 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Stress

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	Soul Medicine Institute	Santa Rosa	California

Sponsors (1)

Lead Sponsor	Collaborator
Soul Medicine Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

Church D, Yount G, Brooks AJ. The effect of emotional freedom techniques on stress biochemistry: a randomized controlled trial. J Nerv Ment Dis. 2012 Oct;200(10):891-6. doi: 10.1097/NMD.0b013e31826b9fc1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	spot cortisol level		60 minutes
Secondary	SA-45 symptom assessment questionnaire, with subscales for depression, anxiety, hostility, interpersonal sensitivity, phobias, and other psychological traits		60 minutes