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

Sponsor
Soul Medicine Institute (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05421988
Collaborator
Tel Aviv University (Other)
45
3
42.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Emotional Freedom Techniques (EFT)
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Participants in the two treatment arms, and data analysts, will be blind to group assignment.
Primary Purpose:
Supportive Care
Official Title:
Effectiveness of Group and Individual Training in Emotional Freedom Techniques for Patients in Remission From Melanoma
Anticipated Study Start Date :
Jul 20, 2022
Anticipated Primary Completion Date :
Jul 20, 2025
Anticipated Study Completion Date :
Jan 30, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Individual EFT Therapy

Personal EFT instruction and practice group

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.

Experimental: Group EFT Therapy

Group EFT instruction and practice group

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.

No Intervention: Wait List

Wait list control group

Outcome Measures

Primary Outcome Measures

  1. Illness perception [Pre intervention, post 4 week intervention, and 3 month follow-up]

    Change in score on Revised Illness Perception Questionnaire (IPQ-R)

  2. 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

  1. 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

  2. Depression [Pre intervention, post 4 week intervention, and 3 month follow-up]

    Change in depressive symptoms on the Positive and Negative Affect Schedule (PANAS)

  3. Anxiety [Pre intervention, post 4 week intervention, and 3 month follow-up]

    Change in anxiety symptoms on the Positive and Negative Affect Schedule (PANAS)

  4. 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)

  5. Wellbeing [Pre intervention, post 4 week intervention, and 3 month follow-up]

    Change in score on The Well-being Numerical Rating Scales (WB-NRSs).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Soul Medicine Institute
  • Tel Aviv University

Investigators

  • Study Director: Yael Benyamini, PhD, Tel Aviv University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Soul Medicine Institute
ClinicalTrials.gov Identifier:
NCT05421988
Other Study ID Numbers:
  • NIIH20220324
First Posted:
Jun 16, 2022
Last Update Posted:
Jun 16, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 16, 2022