The Effect of Psychotherapy on Stress Biochemistry: An RCT of Psychotherapy and Emotional Freedom Techniques (EFT)
|ClinicalTrials.gov Identifier: NCT00641394|
Recruitment Status : Completed
First Posted : March 24, 2008
Last Update Posted : April 11, 2012
|Condition or disease||Intervention/treatment||Phase|
|Stress Depression Anxiety||Behavioral: Psychotherapy: Emotional Freedom Techniques (EFT) Behavioral: Cognitive Behavioral Therapy (CBT)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||83 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|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|
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|
- spot cortisol level [ Time Frame: 60 minutes ]
- SA-45 symptom assessment questionnaire, with subscales for depression, anxiety, hostility, interpersonal sensitivity, phobias, and other psychological traits [ Time Frame: 60 minutes ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00641394
|United States, California|
|Soul Medicine Institute|
|Santa Rosa, California, United States, 95403|
|Principal Investigator:||Dawson Church, PhD||Soul Medicine Institute|