Anxiety and Depression Levels in Cancer Patients After Self-Application of EFT (Emotional Freedom Techniques)
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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) |
- depression [ Time Frame: duration of study ] [ Designated as safety issue: No ]
- 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 2014 |
| Estimated Primary Completion Date: | April 2014 (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 |
Inclusion Criteria:
- Diagnosis of cholangiocarcinoma
- Ability to complete forms and attend phone coaching sessions
Exclusion Criteria:
- None
Contacts and Locations| Contact: Dawson Church, PhD | 707 237 6951 | dawson@soulmedicine.net |
| Contact: Deburah Tribbey | 707 237 6951 | deb@soulmedicine.net |
| 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 | |
| Principal Investigator: | Dawson Church, PhD | Soul Medicine Institute |
More Information
Additional Information:
Publications:
| Responsible Party: | Dawson Church, Executive Director, 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: | August 20, 2012 |
| 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 May 23, 2013