Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Santa Rosa, California 95403


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.


Study summary:

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.


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


Study is Available At:


Original ID:

SMI-CORT-32008


NCT ID:

NCT00641394


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Soul Medicine Institute


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

83


Enrollment Type:

Actual


Overall Contact Information

Official Name:Dawson Church, PhD
Principal Investigator
Soul Medicine Institute

Study Dates

Start Date:April 2008
Completion Date:September 2010
Completion Type:Actual
Primary Completion Date:August 2010
Primary Completion Type:Actual
Verification Date:April 2018
Last Changed Date:April 23, 2018
First Received Date:March 18, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:SA-45 symptom assessment questionnaire, with subscales for depression, anxiety, hostility, interpersonal sensitivity, phobias, and other psychological traits
Time Frame:60 minutes
Safety Issues:False
Outcome Type:Primary Outcome
Measure:spot cortisol level
Time Frame:60 minutes
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Psychotherapy: Emotional Freedom Techniques (EFT)
Description:A form of therapy that includes cognitive reframing with somatic reinforcement through touch or tapping of specified points on the body
Arm Name:1
Intervention Type:Behavioral
Name:Cognitive Behavioral Therapy (CBT)
Description:A form of therapy that focuses on negative cognitions of problems, and reframing them in positive terms, but without somatic reinforcement.
Arm Name:2

Study Arms

Study Arm Type:No Intervention
Arm Name:3
Study Arm Type:Active Comparator
Arm Name:2
Description:Psychotherapy: Cognitive Behavioral Therapy (CBT), a psychotherapy intervention
Study Arm Type:Experimental
Arm Name:1
Description:Psychotherapy: Emotional Freedom Techniques (EFT), a psychotherapy intervention with a somatic component

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Soul Medicine Institute

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation: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.
PMID:22986277

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.