- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04969562
The Effect of Emotional Freedom Technique on Depression, Anxiety and Distress of Individuals With Multiple Sclerosis
The Effect of Emotional Freedom Technique on Depressive Symptom, Anxiety and Psychological Distress of Individuals With New Diagnosis Multiple Sclerosis: A Randomized Controlled Study
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Multiple sclerosis (MS); It is an autoimmune central nervous system (CNS) disease characterized by inflammation, demyelination and axon damage, progressing with attacks and remissions. It ranks first among the diseases that cause neurological disability in adults, regardless of trauma. Being diagnosed with MS usually creates a state of shock in patients and it takes time to get used to the disease. Individuals with MS have to struggle daily with various physical, cognitive and psychological symptoms such as walking and movement limitations, pain, fatigue, depression, memory and concentration difficulties. This type of chronic disease, which occurs in adulthood (between the ages of 20-40), increases the size of the problems because it is seen in a period when life is most active and functional, and family, social and professional goals and activities are at the highest level. Individuals with MS may be prone to depression and anxiety due to various psychosocial risk factors such as inadequate coping or inadequate social support, as well as biological processes associated with MS (such as changes in brain structure or immunological and inflammatory pathways). Psychiatric symptoms may occur before the diagnosis, when the first neurological symptoms appear, or after diagnosis as indicated in retrospective studies.
Because depression and anxiety can worsen over time in individuals with MS, it is important to improve early recognition and management of these symptoms. Individuals with MS experience intense anxiety and stress in the process from the first symptoms to the diagnosis process. Depression affects 15 to 47% of individuals with MS, and this rate is much higher than other chronic neurological diseases and is three times higher than in the general population. Anxiety disorders are present in 36-54% of the MS population, and approximately 30% of individuals with MS have symptoms consistent with generalized anxiety disorder. It is important to create short and cost-effective interventions to reduce depressive symptoms, psychological distress, and improve the quality of life of individuals with MS. Emotional Freedom Technique (EFT) is a psychophysiological intervention that combines elements of cognitive behavioral therapy (CBT), exposure therapy, and somatic stimulation using acupuncture points. EFT is an intervention in which one's physical or psychological awareness focuses on a specific issue and simultaneously stimulates selected acupuncture points along the body meridians, especially on the head and upper body, by touching them with the fingertips. Since it is a simple applicable, evidence-based self-help technique like EFT, it is a suitable first-line option for treating psychiatric symptoms. As a safe and reliable self-help method, EFT is highly effective in reducing symptoms of depression in a wide range of settings and demographic groups and shows clinical benefit as a low-cost drug-free treatment. It is also suggested that EFT improves symptoms occurring in more than one physiological system simultaneously.
Determining and intervening the depression or anxiety levels of individuals with MS is especially important in the treatment of newly diagnosed individuals. For these symptoms, EFT is a short, easy, reliable, cost-effective and self-administered method, while being a self-administered method allows the individual to manage the disease. The aim of this study is to examine the effect of EFT on depressive symptoms, anxiety, psychological distress levels, SDMT scores, resting heart rate and blood pressure in individuals with newly diagnosed multiple sclerosis.
The study will consist of volunteers over the age of 18 who have been diagnosed with multiple sclerosis in the last three months, one month has passed since the treatment was started, followed in the Neurology Outpatient Clinic of Dokuz Eylul University Medical Faculty Hospital or treated in the MS Day Treatment Unit. 50 participants, including 2 groups (with EFT and no EFT), will be included in the study. EDSS will be applied to individuals by a specialist physician. They will be referred to the MS day treatment unit. Since it is a randomized controlled experimental study, the sample and follow-up measurements will be carried out by a psychologist in the unit where the research is conducted, who does not carry out the EFT application. Scales will be applied in the daily unit. The study will be randomized and divided into two groups at the beginning. The psychologist who made the sampling selection will not know which group the participants will belong to, and the EFT practitioner will not know the anxiety, depression and psychological distress levels of the individuals participating in the study.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Izmir, Pavo
- Dokuz Eylul University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 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
Exclusion Criteria:
- Being in the flare of psychiatric illness
- Using psychiatric medication for less than three months
- Having an MS attack
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: experiment
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.
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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.
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Sin intervención: control
They will continue their routine treatment.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change from baseline anxiety levels at 6 weeks assessed by anxiety subscale of Hospital Anxiety Depression Scale (HADS)
Periodo de tiempo: Change from Baseline Anxiety at 6 weeks
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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
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Change from baseline depressive symptoms levels at 6 weeks assessed by depressive symptoms subscale of Hospital Anxiety Depression Scale (HADS)
Periodo de tiempo: Change from Baseline depressive symptoms at 6 weeks
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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
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Change from baseline psychological distress symptoms levels at 6 weeks assessed by Subjective Units of Distress Scale (SUDS).
Periodo de tiempo: Change from Baseline distress at 6 weeks
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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.
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Change from Baseline distress at 6 weeks
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Síntomas de comportamiento
- Desordenes mentales
- Procesos Patológicos
- Enfermedades del Sistema Nervioso
- Enfermedades del sistema inmunológico
- Enfermedades Autoinmunes Desmielinizantes, SNC
- Enfermedades Autoinmunes del Sistema Nervioso
- Enfermedades desmielinizantes
- Enfermedades autoinmunes
- Depresión
- Esclerosis múltiple
- Esclerosis
- Desórdenes de ansiedad
Otros números de identificación del estudio
- 6198-GOA
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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