- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05421988
Effectiveness of Group and Individual Training in EFT for Patients in Remission From Melanoma
Effectiveness of Group and Individual Training in Emotional Freedom Techniques for Patients in Remission From Melanoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Serious medical diagnosis frequently induce fear focused on specific anticipations or generalized anxiety, along with uncertainty, insecurity, and disorientation. Other emotions such as anger, depression, hopelessness, shame, or grief may also become involved following a serious diagnosis. The adverse impact of stress on health and immune function is well-established, as well as its link to depression and anxiety. Emotional Freedom Techniques (EFT) has demonstrated efficacy in treating anxiety, depression, and PTSD. This study tests its effectiveness in reducing negative emotional symptoms in general, and fear of recurrence in particular, among individuals previously diagnosed with melanoma and currently in remission.
Specifically, the study aims:
- To assess the effect of instruction and practice of EFT on illness perception, fear of cancer recurrence, and wellbeing.
- To assess whether the social support provided by EFT instruction in a group setting makes this efficient mode of implementation non-inferior or even beneficial in comparison to personal instruction.
- To describe the emotions related to life events reported by patients in connection with the appearance and location of melanoma.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Tel Aviv, Israel, 69978
- The School Of Social Work Tel Aviv University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Melanoma diagnosis over six months prior to the study; confirmed by clinical, dermoscopic examination and pathology results
Exclusion Criteria:
- In active treatment for melanoma
- schizophrenia
- epilepsy
- other malignant disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Individual EFT Therapy
Personal EFT instruction and practice group
|
EFT is an efficacious method demonstrated in over 100 clinical trials.
It combines cognitive and exposure techniques with acupressure, in the form of fingertip percussion on acupuncture meridian points.
|
|
Experimental: Group EFT Therapy
Group EFT instruction and practice group
|
EFT is an efficacious method demonstrated in over 100 clinical trials.
It combines cognitive and exposure techniques with acupressure, in the form of fingertip percussion on acupuncture meridian points.
|
|
No Intervention: Wait List
Wait list control group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Illness perception
Time Frame: Pre intervention, post 4 week intervention, and 3 month follow-up
|
Change in score on Revised Illness Perception Questionnaire (IPQ-R)
|
Pre intervention, post 4 week intervention, and 3 month follow-up
|
|
Perception of recurrence
Time Frame: Pre intervention, post 4 week intervention, and 3 month follow-up
|
Change of perceived recurrence risk on a Likert scale
|
Pre intervention, post 4 week intervention, and 3 month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Other physical symptoms
Time Frame: Pre intervention, post 4 week intervention, and 3 month follow-up
|
Change in patient's self-report of somatization, pain, and other symptoms on a Likert scale
|
Pre intervention, post 4 week intervention, and 3 month follow-up
|
|
Depression
Time Frame: Pre intervention, post 4 week intervention, and 3 month follow-up
|
Change in depressive symptoms on the Positive and Negative Affect Schedule (PANAS)
|
Pre intervention, post 4 week intervention, and 3 month follow-up
|
|
Anxiety
Time Frame: Pre intervention, post 4 week intervention, and 3 month follow-up
|
Change in anxiety symptoms on the Positive and Negative Affect Schedule (PANAS)
|
Pre intervention, post 4 week intervention, and 3 month follow-up
|
|
Patient's self-report of quality of life
Time Frame: Pre intervention, post 4 week intervention, and 3 month follow-up
|
Change in quality of life scores on the Quality of Life Scale (QOLS)
|
Pre intervention, post 4 week intervention, and 3 month follow-up
|
|
Wellbeing
Time Frame: Pre intervention, post 4 week intervention, and 3 month follow-up
|
Change in score on The Well-being Numerical Rating Scales (WB-NRSs).
|
Pre intervention, post 4 week intervention, and 3 month follow-up
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Yael Benyamini, PhD, Tel Aviv University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIIH20220324
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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