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

Melanoma (Skin) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05421988
• Other study ID #: NIIH20220324
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 20, 2022
• Est. completion date: July 20, 2027

Study information

• Verified date: April 2024
• Source: Soul Medicine Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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:

1. To assess the effect of instruction and practice of EFT on illness perception, fear of cancer recurrence, and wellbeing.

2. 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.

3. To describe the emotions related to life events reported by patients in connection with the appearance and location of melanoma.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 57
• Est. completion date: July 20, 2027
• Est. primary completion date: July 20, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Behavioral:
• Emotional Freedom Techniques (EFT)
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.

Locations

Country	Name	City	State
Israel	The School Of Social Work Tel Aviv University	Tel Aviv

Sponsors (2)

Lead Sponsor	Collaborator
Soul Medicine Institute	Tel Aviv University

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Illness perception	Change in score on Revised Illness Perception Questionnaire (IPQ-R)	Pre intervention, post 4 week intervention, and 3 month follow-up
Primary	Perception of recurrence	Change of perceived recurrence risk on a Likert scale	Pre intervention, post 4 week intervention, and 3 month follow-up
Secondary	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
Secondary	Depression	Change in depressive symptoms on the Positive and Negative Affect Schedule (PANAS)	Pre intervention, post 4 week intervention, and 3 month follow-up
Secondary	Anxiety	Change in anxiety symptoms on the Positive and Negative Affect Schedule (PANAS)	Pre intervention, post 4 week intervention, and 3 month follow-up
Secondary	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
Secondary	Wellbeing	Change in score on The Well-being Numerical Rating Scales (WB-NRSs).	Pre intervention, post 4 week intervention, and 3 month follow-up