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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014