Anxiety and Depression Levels in Cancer Patients After Self-Application of EFT (Emotional Freedom Techniques)
Primary Purpose
Depression
Status
Active
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lifestyle Counseling with Emotional Freedom Techniques (EFT)
Sponsored by

About this trial
This is an interventional supportive care trial for Depression focused on measuring depression, anxiety, pain, insomnia, cancer, cholangiocarcinoma, EFT (Emotional Freedom Techniques)
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of cholangiocarcinoma
- Ability to complete forms and attend phone coaching sessions
Exclusion Criteria:
- None
Sites / Locations
- Soul Medicine Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Lifestyle Counseling with Emotional Freedom Techniques (EFT)
Outcomes
Primary Outcome Measures
depression
Secondary Outcome Measures
anxiety
pain
insomnia
Full Information
NCT ID
NCT00737399
First Posted
August 18, 2008
Last Updated
April 11, 2023
Sponsor
Soul Medicine Institute
1. Study Identification
Unique Protocol Identification Number
NCT00737399
Brief Title
Anxiety and Depression Levels in Cancer Patients After Self-Application of EFT (Emotional Freedom Techniques)
Official Title
Anxiety and Depression Levels in Cancer Patients After Self-Application of EFT (Emotional Freedom Techniques)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2008 (undefined)
Primary Completion Date
April 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Soul Medicine Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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 telephone and internet group coaching sessions, and have access to an online support forum. They complete the Mini-Mental Adjustment to Cancer Scale (Mini-MAC), EORTC Quality of Life scale, the PTSD checklist, the Patient Health Questionnaire, and a brief health checklist. Participants also provide medical records confirming their diagnosis, and markers, both before and after the study. The study is expected to enroll 20-15 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. Follow-ups will occur in one month, three months, and one year. It is hypothesized that a drop in the severity of co-occurring psychological symptoms, pain and insomnia may occur after EFT coaching.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
depression, anxiety, pain, insomnia, cancer, cholangiocarcinoma, EFT (Emotional Freedom Techniques)
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Lifestyle Counseling with Emotional Freedom Techniques (EFT)
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Counseling with Emotional Freedom Techniques (EFT)
Intervention Description
Two series of four sessions of phone support group coaching instruction in the use of EFT
Primary Outcome Measure Information:
Title
depression
Time Frame
duration of study
Secondary Outcome Measure Information:
Title
anxiety
Time Frame
duration of study
Title
pain
Time Frame
duration of study
Title
insomnia
Time Frame
duration of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of cholangiocarcinoma
Ability to complete forms and attend phone coaching sessions
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawson Church, PhD
Organizational Affiliation
Soul Medicine Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soul Medicine Institute
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18580211
Citation
Endo I, Gonen M, Yopp AC, Dalal KM, Zhou Q, Klimstra D, D'Angelica M, DeMatteo RP, Fong Y, Schwartz L, Kemeny N, O'Reilly E, Abou-Alfa GK, Shimada H, Blumgart LH, Jarnagin WR. Intrahepatic cholangiocarcinoma: rising frequency, improved survival, and determinants of outcome after resection. Ann Surg. 2008 Jul;248(1):84-96. doi: 10.1097/SLA.0b013e318176c4d3.
Results Reference
background
Links:
URL
http://cholangiocarcinoma.org
Description
Cholangiocarcinoma Foundation
Learn more about this trial
Anxiety and Depression Levels in Cancer Patients After Self-Application of EFT (Emotional Freedom Techniques)
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