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

Not Applicable

Active, not recruiting

• Conditions: Melanoma (Skin)
• Interventions: Behavioral: Emotional Freedom Techniques (EFT)

• Registration Number: NCT05421988
• Lead Sponsor: Soul Medicine Institute

Brief 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.

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:

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.

Study Timeline

• Study First Submitted: 2022-04-03
• Study First Submitted QC: 2022-06-14
• Study First Posted: 2022-06-16
• Study Start: 2022-10-20
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-16
• Primary Completion: 2027-07-20
• Study Completion: 2027-07-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 57

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Individual EFT Therapy	Emotional Freedom Techniques (EFT)	Personal EFT instruction and practice group
Group EFT Therapy	Emotional Freedom Techniques (EFT)	Group EFT instruction and practice group

Primary Outcome Measures

Name	Time	Method
Illness perception	Pre intervention, post 4 week intervention, and 3 month follow-up	Change in score on Revised Illness Perception Questionnaire (IPQ-R)
Perception of recurrence	Pre intervention, post 4 week intervention, and 3 month follow-up	Change of perceived recurrence risk on a Likert scale

Secondary Outcome Measures

Name	Time	Method
Other physical symptoms	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
Depression	Pre intervention, post 4 week intervention, and 3 month follow-up	Change in depressive symptoms on the Positive and Negative Affect Schedule (PANAS)
Patient's self-report of quality of life	Pre intervention, post 4 week intervention, and 3 month follow-up	Change in quality of life scores on the Quality of Life Scale (QOLS)
Anxiety	Pre intervention, post 4 week intervention, and 3 month follow-up	Change in anxiety symptoms on the Positive and Negative Affect Schedule (PANAS)
Wellbeing	Pre intervention, post 4 week intervention, and 3 month follow-up	Change in score on The Well-being Numerical Rating Scales (WB-NRSs).

Trial Locations

Locations (1)

The School Of Social Work Tel Aviv University; 🇮🇱 Tel Aviv, Israel