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CompletedNCT00641394Updated Apr 25, 2018

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

An interventional study of Psychotherapy: Emotional Freedom Techniques (EFT) and Cognitive Behavioral Therapy (CBT) in Stress, Depression and Anxiety, sponsored by Soul Medicine Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-25.

Sponsored by Soul Medicine Institute · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
83
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Stress
  • Depression
  • Anxiety

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Keywords

  • cortisol
  • hydrocortisone
  • psychotherapy
  • Emotional Freedom Techniques (EFT)
  • Cognitive Behavioral Therapy (CBT)
  • depression
  • anxiety
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 83 is close to the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Soul Medicine Institute is the lead sponsor of 12 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Good Health History

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
83 participants (actual)

Study arms

  • Experimental
    1

    Psychotherapy: Emotional Freedom Techniques (EFT), a psychotherapy intervention with a somatic component

    Behavioral: Psychotherapy: Emotional Freedom Techniques (EFT)

  • Active comparator
    2

    Psychotherapy: Cognitive Behavioral Therapy (CBT), a psychotherapy intervention

    Behavioral: Cognitive Behavioral Therapy (CBT)

  • No intervention
    3

Interventions

  • BehavioralPsychotherapy: 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

  • BehavioralCognitive Behavioral Therapy (CBT)

    A form of therapy that focuses on negative cognitions of problems, and reframing them in positive terms, but without somatic reinforcement.

06

What researchers measure

Primary outcomes

  1. spot cortisol level

    Time frame: 60 minutes

Secondary outcomes

  1. SA-45 symptom assessment questionnaire, with subscales for depression, anxiety, hostility, interpersonal sensitivity, phobias, and other psychological traits

    Time frame: 60 minutes

07

Study locations

1 site
  • Soul Medicine Institute
    Santa Rosa, California 95403, United States
08

References and documents

Publications

  • 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. PubMed 22986277 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00641394
Lead sponsor
Soul Medicine Institute
First posted
Mar 24, 2008
Start date
Apr 2008
Primary completion
Aug 2010
Completion
Sep 2010
Last update
Apr 25, 2018

Study contacts

Dawson Church, PhD
principal investigator · Soul Medicine Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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