Effectiveness of Group and Individual Training in EFT for Patients in Remission From Melanoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effectiveness of Group and Individual Training in Emotional Freedom Techniques for Patients in Remission From Melanoma

Conditions
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Melanoma (Skin)

Intervention / Treatment
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* Behavioral: Emotional Freedom Techniques (EFT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Individual EFT Therapy<br>Personal EFT instruction and practice group | Behavioral: Emotional Freedom Techniques (EFT)<br>* 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.<br>|
| Experimental: Group EFT Therapy<br>Group EFT instruction and practice group | Behavioral: Emotional Freedom Techniques (EFT)<br>* 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.<br>|
| No Intervention: Wait List<br>Wait list control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Illness perception | Change in score on Revised Illness Perception Questionnaire (IPQ-R) | Pre intervention, post 4 week intervention, and 3 month follow-up | 
| Perception of recurrence | 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 | 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 | Change in depressive symptoms on the Positive and Negative Affect Schedule (PANAS) | Pre intervention, post 4 week intervention, and 3 month follow-up | 
| Anxiety | 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 | 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 | Change in score on The Well-being Numerical Rating Scales (WB-NRSs). | Pre intervention, post 4 week intervention, and 3 month follow-up |