The Effect of Emotional Freedom Technique on Depression, Anxiety and Distress of Individuals With Multiple Sclerosis

NCT04969562 | Completed

• 1 other identifier: 6198-GOA
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Volunteers over the age of 18 who applied to the Neurology Outpatient Clinic of Dokuz Eylül University Hospital, who were diagnosed with multiple sclerosis in the last three months, one month after the initiation of treatment and accepted the study, will be included in the study after their eligibility to the sampling criteria is evaluated. EDSS will be applied to the individuals by the specialist physician and they will be directed to the MS daycare unit. Since it is a randomized controlled experimental study, the sampling and follow-up measurements will be carried out by a psychologist in the unit where the study is applied, who does not carry out EFT. Scales will be applied in the daily unit and will be randomly divided into two groups at the beginning of the study. The psychologist who chooses the sampling will not know which group the participants will fall into, and the EFT practitioner will not know the anxiety, depression and psychological distress levels of the individuals participating in the study. EFT will be applied to one of the groups, and the other group will continue their routine treatment. Individuals with multiple sclerosis in the experimental group seven days at intervals, six sessions in which one session lasts 30-45 minutes will be included in the EFT application. SUDS will be applied before and after each EFT session. At the same time, resting heart rate and blood pressure will be measured in the EFT group before and after each session. Depression, anxiety and psychological distress levels of individuals with MS will be evaluated with HAD and SUDS at the beginning of the study, at the end of six sessions and in the first month.

Conditions

Multiple Sclerosis; Anxiety; Depressive Symptoms; Psychiatric Nursing

Keywords

Multiple Sclerosis, anxiety, depression, pschological distress, emotional freedom technique

Outcome Measures

Primary Outcomes (3)

• Change from baseline anxiety levels at 6 weeks assessed by anxiety subscale of Hospital Anxiety Depression Scale (HADS)

  In this study, Hospital Anxiety Depression Scale is used to determine the anxiety levels of individuals with MS. Consisting of 14 questions in total, the seven items measure the anxiety. The cut-off point is 10 for the anxiety.The minimum score that can be obtained from the anxiety sub-dimension of the scale is 0 and the maximum score is 21. The higher the score, the higher the anxiety level. Higher score mean a worse outcome.

  Change from Baseline Anxiety at 6 weeks

• Change from baseline depressive symptoms levels at 6 weeks assessed by depressive symptoms subscale of Hospital Anxiety Depression Scale (HADS)

  In this study, Hospital Anxiety Depression Scale is used to measure depressive symptoms of individuals with MS. Consisting of 14 questions in total, the seven measure the depressive symptoms. For subscale, 0-7 points were predicted to be the normal range, 8-10 points were predicted to be considered, and 11 points were predicted to be over-estimated mood.The minimum score that can be obtained from the depression sub-dimension of the scale is 0 and the maximum score is 21. The higher the score, the higher the depressive symptoms level.Higher score mean a worse outcome.

  Change from Baseline depressive symptoms at 6 weeks

• Change from baseline psychological distress symptoms levels at 6 weeks assessed by Subjective Units of Distress Scale (SUDS).

  In this study, the Subjective Units of Distress Scale (SUDS) is used to assess the level of psychological distress. SUDS scores provide concrete and basic data about the individual's condition at the beginning and at the end of therapy, thus reflecting changes that may occur in the process. SUDS is frequently used by studies in the literature for the evaluation of EFT results. Participants typically identify a concern or problem they want to address and rate their level of distress on a Likert-type scale out of 10 (10 is the maximum amount of distress and 0 represents the minimum or neutral situation). By means of this scoring, the severity of the discomfort felt by the individual at that moment is determined. This figure serves as a concrete and basic starting point regarding the state of the individual at the time of implementation. Thus, at the end of the application, it gives the opportunity to obtain an indicator reflecting the change provided by the application.

  Change from Baseline distress at 6 weeks

Study Arms (2)

experiment

EXPERIMENTAL

Individuals with multiple sclerosis in the experimental group will be included in six sessions of EFT at seven-day intervals, in which one session lasts 30-45 minutes. SUDS will be applied before and after each EFT session. At the same time, resting heart rate and blood pressure will be measured in the EFT group before and after each session.

Behavioral: Emotional Freedom Technique

control

NO INTERVENTION

They will continue their routine treatment.

Interventions

Emotional Freedom Technique BEHAVIORAL

Emotional Freedom Technique (EFT, Emotional Freedom Technique) is a psychophysiological interpretation that combines elements of cognitive behavioral therapy (CBT), exposure therapy, and somatic stimulation using acupuncture points.

experiment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being over 18 years old
• Being cooperative and oriented enough to follow the given instructions
• Having been diagnosed with MS in the last three months
• Having been on MS treatment for at least a month
• Getting a score of 3 and above on the SUDS scale

You may not qualify if:

• Being in the flare of psychiatric illness
• Using psychiatric medication for less than three months
• Having an MS attack

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylul University

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. Prof.

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 20, 2021
• Study Start: August 1, 2020
• Primary Completion: October 30, 2021
• Study Completion: October 30, 2021
• Last Updated: March 23, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)