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StressNCT00641394

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

A study testing Psychotherapy: Emotional Freedom Techniques (EFT) and Cognitive Behavioral Therapy (CBT) in people with Stress and Depression, run by Soul Medicine Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Stress, Depression, Anxiety
What is being tested?
Psychotherapy: Emotional Freedom Techniques (EFT) and Cognitive Behavioral Therapy (CBT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
83 participants
Where
1 siteUnited States
Study dates
Apr 2008to Sep 2010
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Good Health History

Who cannot join

  • MDD (Major Depressive Disorder)
  • PTSD (Post Traumatic Stress Disorder)
  • Psychotropic Prescription Drug Use
  • Currently Under Psychiatric Care
  • Major disease, cancer, cardiovascular disease
  • Autoimmune disease
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Soul Medicine Institute

    Santa Rosa, California, 95403

Other trials in United States

About this study

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

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.

Being tested
Psychotherapy: Emotional Freedom Techniques (EFT), Cognitive Behavioral Therapy (CBT)
Keywords
cortisol, hydrocortisone, psychotherapy, Emotional Freedom Techniques (EFT), Cognitive Behavioral Therapy (CBT), depression, anxiety
Medical subject headings
Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Psychotherapy: Emotional Freedom Techniques (EFT)Behavioural

    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)Behavioural

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

Study groups in NCT00641394
Study groupRoleWhat they receive
1ExperimentalPsychotherapy: Emotional Freedom Techniques (EFT), a psychotherapy intervention with a somatic component
Receives: Behavioral: Psychotherapy: Emotional Freedom Techniques (EFT)
2Active comparatorPsychotherapy: Cognitive Behavioral Therapy (CBT), a psychotherapy intervention
Receives: Behavioral: Cognitive Behavioral Therapy (CBT)
3No interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. spot cortisol level

    Measured: 60 minutes

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

    Measured: 60 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionAug 2010
  4. Study completionSep 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00641394
Sponsor's protocol ID
SMI-CORT-32008
Status last verified
Apr 2018
First submitted
18 Mar 2008
Last updated
25 Apr 2018
Results posted
No
Data monitoring committee
Yes

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

Questions about this trial

What is this clinical trial studying?

A study testing Psychotherapy: Emotional Freedom Techniques (EFT) and Cognitive Behavioral Therapy (CBT) in people with Stress and Depression, run by Soul Medicine Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

spot cortisol level (time frame: 60 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00641394, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2018.

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