NCT00641394

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2008

Completed
8 days until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

April 25, 2018

Status Verified

April 1, 2018

Enrollment Period

2.3 years

First QC Date

March 18, 2008

Last Update Submit

April 23, 2018

Conditions

Keywords

cortisolhydrocortisonepsychotherapyEmotional Freedom Techniques (EFT)Cognitive Behavioral Therapy (CBT)depressionanxiety

Outcome Measures

Primary Outcomes (1)

  • spot cortisol level

    60 minutes

Secondary Outcomes (1)

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

    60 minutes

Study Arms (3)

1

EXPERIMENTAL

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

Behavioral: Psychotherapy: Emotional Freedom Techniques (EFT)

2

ACTIVE COMPARATOR

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

Behavioral: Cognitive Behavioral Therapy (CBT)

3

NO INTERVENTION

Interventions

A form of therapy that includes cognitive reframing with somatic reinforcement through touch or tapping of specified points on the body

1

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

2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Good Health History

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soul Medicine Institute

Santa Rosa, California, 95403, United States

Location

Related 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.

MeSH Terms

Conditions

DepressionAnxiety Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Dawson Church, PhD

    Soul Medicine Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 18, 2008

First Posted

March 24, 2008

Study Start

April 1, 2008

Primary Completion

August 1, 2010

Study Completion

September 1, 2010

Last Updated

April 25, 2018

Record last verified: 2018-04

Locations