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El efecto del programa de reducción del estrés basado en la atención plena (Mindfulness)

5 de octubre de 2026 actualizado por: Munevver Bogahan, Mersin University

El efecto del programa de reducción del estrés basado en Mindfulness sobre el estado mental y la carga de atención de las familias de pacientes psicóticos

This randomized controlled study evaluate the effect of the Mindfulness-Based Stress Reduction Program on the state-trait anxiety, hopelessness, self-compassion and care burden of the families of psychotic patients. The hypothesis of this study is that the Mindfulness-Based Stress Reduction Program improves the state-trait anxiety, hopelessness, self-compassion and care burden of the families of psychotic patients.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

Introduction: One of the chronic mental diseases, psychosis causes social and economic losses by negatively affecting the patient's feelings, thoughts and behaviors, interpersonal relations, work and social harmony, and the patient and family may experience different difficulties. With the transition to the community-based model in the provision of mental health services, the relatives of the patients have become the primary caregivers in the care of the patient and their responsibilities have increased even more.When the family is considered as a system, there is a constant interaction between the parts of the system and the change in the patient in case of illness can affect the whole family.When the disease occurs, one of the family members has to take care of the sick individual and caregivers experience emotional (decreased self-esteem, restlessness, depression, insomnia, social isolation, etc.), social (restriction of entertaining, relaxing and leisure time activities, reduction in the role of self-care, etc.). ) and economically (expenses not covered by social security creating an additional burden, reducing working hours, etc.). It is emphasized that psychosocial interventions for families increase the perception of social support, self-efficacy and satisfaction with treatment among caregivers, and reduce the perceived burden and recurrence of the disease.However, the high level of emotional expression and perceived stress of the families may trigger the recurrence of the disease. For this reason, family is naturally emphasized as an important factor in the recovery of the individual with a psychotic illness. Therefore, rehabilitation processes should be aimed not only at patients, but also towards caregivers. One of the interventions used for this purpose today is the Mindfulness-Based Stress Reduction (MBSR) program, which is an evidence-based intervention that teaches skills to reduce stress and manage challenging emotions in a group setting. Although the MBSR intervention is usually aimed at people with chronic physical and mental illnesses, the purpose of the intervention is not to replace medical treatment, but can be used as a supplement, supportive, preventive, complementary or simply a stand-alone method to heal patients. In this respect, it is thought that it is important for psychiatric nurses to use the MBSR program, which is a complementary, supportive, preventive and protective program, in the protection and strengthening of mental health in family members who care for psychosis patients. When the literature is examined, it is emphasized that the MBSR program has positive effects on caregiver family members. In this context, this study is planned to determine the effect of the Mindfulness-Based Stress Reduction Program on the state-trait anxiety, hopelessness, self-compassion and care burden of the families of psychotic patients.

Methods: In the study, 60 family members caring for an individual with psychotic illness were randomly assigned to the study and control groups. 11-week MBSR program will be apply to study group (n = 28). No intervention will be made to the control group (n = 28). The primary outcome of the study is the effect of MBSR on the state-trait anxiety, hopelessness, and self-compassion levels of caregiver family members. The secondary outcome of the study is the effect of MBSR on the caregiving burden of family members. Data will be collected pre-intervention, post-intervention, 3 and 6 months after the intervention.

Tipo de estudio

Intervencionista

Inscripción (Actual)

50

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Above 18 years old
  • Able to read and understand Turkish
  • Taking care of the sick individual at home
  • Living in the same house with the sick individual
  • No psychiatric illness
  • No problems with movement, sight, hearing or understanding
  • Volunteer to participate in the study
  • Able to access the internet with their phone or computer
  • Those who did not receive any other psychological therapy during their working dates
  • No previous meditation experience
  • Having no practice in daily mind-body practices

Exclusion Criteria:

  • Under 18 years old
  • Can't read and understand Turkish
  • Any psychiatric illness receiving another psychological therapy on working dates
  • Meditation experience before the study; having practice in daily mind-body practices
  • Having problems with movement, vision, hearing, understanding
  • Not willing to participate in the study
  • Participants who participated in more than 50% of a mindfulness-based intervention prior to the study

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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
Experimental: MBSR Intervention

The intervention group will take part in mindfulness-based stress reduction (MBSR) program led by a certified MBSR instructor via Zoom. The MBSR program was structured as 11 weeks, taking into account the characteristics of the participants.

The intervention was structured as 11 weeks, taking into account the group. The program takes 2-2.5 hours per week. The program includes raisin exercise, body scanning meditation, breath awareness meditation, sitting meditation, mindfull movement, walking meditation, vision meditation, compassion meditation,mindfulness communication and day of silence.

Otros nombres:
  • MBSR
Sin intervención: Control

No intervention was applied to the control group. Data will be collected from the control group simultaneously with the study group.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Anxiety will be evaluated using the State-Trait Anxiety Scale
Periodo de tiempo: Change from preintervention, on average 1 week upon completion of the intervention, 3 months and 6 months after the intervention.

The total score obtained from both scales varies between 20 and 80. It states that 0-19 points mean no anxiety, 20-39 points mean mild, 40-59 points mean moderate, 60-79 points mean severe anxiety, and individuals with a score of 60 and above need professional help.

Change from preintervention, on average 1 week upon completion of the intervention, 3 months and 6 months after the intervention.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Care burden will be assessed using the Caregiver Burden Scale.
Periodo de tiempo: Change from preintervention, on average 1 week upon completion of the intervention, 3 months and 6 months after the intervention.

A score between 22 and 110 is taken from the scale. Obtained points; It is evaluated by grading as "light load" between 22-46, "medium load" between 47-55, "severe load" between 56-110.

Change from preintervention, on average 1 week upon completion of the intervention, 3 months and 6 months after the intervention.
Hopelessness will be measured using the Beck Hopelessness Scale.
Periodo de tiempo: Change from preintervention, on average 1 week upon completion of the intervention, 3 months and 6 months after the intervention.

The score range of the scale is 0-20. When the scores obtained are high, hopelessness in the individual is considered high

Change from preintervention, on average 1 week upon completion of the intervention, 3 months and 6 months after the intervention.
Self-compassion will be assessed using the Self-Compassion Scale.
Periodo de tiempo: Change from preintervention, on average 1 week upon completion of the intervention, 3 months and 6 months after the intervention.

To calculate the total self-compassion score, the "self-judgmental", "social isolation" and "over-identification" subscale items are reverse coded.

Then, the self-compassion level is calculated by taking the average of all the items.

The higher the score for each sub-dimension, the higher the level of self-compassion.

Change from preintervention, on average 1 week upon completion of the intervention, 3 months and 6 months after the intervention.
Focus Group Interview Questionnaire I
Periodo de tiempo: Within 1 week postintervention

Focus Group Interview Questionnaire I was created by the researcher in order to evaluate the experiences of the individuals in the study group regarding the MBSR program. There are five questions in the form.

Within 1 week postintervention

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Münevver Boğahan, Assistant, Mersin University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de mayo de 2022

Finalización primaria (Actual)

15 de mayo de 2022

Finalización del estudio (Actual)

28 de febrero de 2023

Fechas de registro del estudio

Enviado por primera vez

24 de enero de 2022

Primero enviado que cumplió con los criterios de control de calidad

8 de febrero de 2022

Publicado por primera vez (Actual)

17 de febrero de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

5 de octubre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • munevverbghn
  • Münevver Boğahan (Identificador de registro: Münevver Boğahan)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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