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Clinical Trials/NCT05421988
NCT05421988CompletedNot Applicable

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

Soul Medicine Institute2 sites in 1 country56 target enrollmentStarted: October 20, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
56
Locations
2
Primary Endpoint
Illness perception

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential
Primary Purpose
Supportive Care
Masking
Double (Participant, Outcomes Assessor)

Masking Description

Participants in the two treatment arms, and data analysts, will be blind to group assignment.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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
  • other malignant disease

Arms & Interventions

Individual EFT Therapy

Experimental

Personal EFT instruction and practice group

Intervention: Emotional Freedom Techniques (EFT) (Behavioral)

Group EFT Therapy

Experimental

Group EFT instruction and practice group

Intervention: Emotional Freedom Techniques (EFT) (Behavioral)

Wait List

No Intervention

Wait list control group

Outcomes

Primary Outcomes

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)

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

Secondary Outcomes

  • Other physical symptoms(Pre intervention, post 4 week intervention, and 3 month follow-up)
  • Depression(Pre intervention, post 4 week intervention, and 3 month follow-up)
  • Patient's self-report of quality of life(Pre intervention, post 4 week intervention, and 3 month follow-up)
  • Anxiety(Pre intervention, post 4 week intervention, and 3 month follow-up)
  • Wellbeing(Pre intervention, post 4 week intervention, and 3 month follow-up)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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