Anxiety and Depression Levels in Cancer Patients After Self-Application of EFT (Emotional Freedom Techniques)

This study is currently recruiting participants.
Verified December 2013 by Soul Medicine Institute
Sponsor:
Information provided by (Responsible Party):
Dawson Church, Soul Medicine Institute
ClinicalTrials.gov Identifier:
NCT00737399
First received: August 18, 2008
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

Anxiety and depression have been found to be significant co-occurring conditions in cancer patients. This study examines these and other psychological conditions in patients diagnosed with cholangiocarcinoma, a rare cancer of the bile duct, with an average survival time of three to six months post-diagnosis. Participants are taught EFT in a telephone and internet group coaching session, prior to which they complete the SA-45, a 45 item questionnaire, and the ISI or Insomnia Severity Index. The SA-45 has nine subscales for such conditions as anxiety, depression, hostility and psychoticism, as well as two primary scales to determine the breadth and severity of psychological distress. Self-assessed pain severity will also be measured on a Likert-type scale. The study is expected to enroll 10 to 15 cholangiocarcinoma patients, and use a within-subjects, time series, repeated measures design. Symptoms are assessed prior to coaching, after four, and again after eight weekly coaching sessions. It is hypothesized that a drop in the severity of co-occurring psychological symptoms, pain and insomnia may occur after EFT coaching.


Condition Intervention Phase
Depression
Behavioral: Lifestyle Counseling with Emotional Freedom Techniques (EFT)
Phase 0

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Anxiety and Depression Levels in Cancer Patients After Self-Application of EFT (Emotional Freedom Techniques)

Resource links provided by NLM:


Further study details as provided by Soul Medicine Institute:

Primary Outcome Measures:
  • depression [ Time Frame: duration of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • anxiety [ Time Frame: duration of study ] [ Designated as safety issue: No ]
  • pain [ Time Frame: duration of study ] [ Designated as safety issue: No ]
  • insomnia [ Time Frame: duration of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 14
Study Start Date: September 2008
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Lifestyle Counseling with Emotional Freedom Techniques (EFT)
Behavioral: Lifestyle Counseling with Emotional Freedom Techniques (EFT)
Two series of four sessions of phone support group coaching instruction in the use of EFT

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of cholangiocarcinoma
  • Ability to complete forms and attend phone coaching sessions

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00737399

Contacts
Contact: Dawson Church, PhD 707 237 6951 dawson@soulmedicine.net
Contact: Deburah Tribbey 707 237 6951 deb@soulmedicine.net

Locations
United States, California
Soul Medicine Institute Recruiting
Santa Rosa, California, United States, 95403
Contact: Dawson Church, PhD    707-237-6951    dawson@soulmedicine.net   
Contact: Deb Tribbey    707 237 6951    deb@soulmedicine.net   
Principal Investigator: Dawson Church, PhD         
Sponsors and Collaborators
Soul Medicine Institute
Investigators
Principal Investigator: Dawson Church, PhD Soul Medicine Institute
  More Information

Additional Information:
Publications:
Responsible Party: Dawson Church, Principal Investigator, Soul Medicine Institute
ClinicalTrials.gov Identifier: NCT00737399     History of Changes
Other Study ID Numbers: SMI-CHOL-82008
Study First Received: August 18, 2008
Last Updated: December 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Soul Medicine Institute:
depression
anxiety
pain
insomnia
cancer
cholangiocarcinoma
EFT (Emotional Freedom Techniques)

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Mental Disorders
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on April 17, 2014