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Mind-Body Interventions in Coronary Artery Disease (MBI-CAD)

13 de septiembre de 2026 actualizado por: şeyda candeniz

Effects of Combined Mind-Body Interventions in Patients With Coronary Artery Disease

This randomized controlled study aims to evaluate the effects of a combined mind-body intervention consisting of progressive muscle relaxation and guided imagery on psychological outcomes in patients with stable coronary artery disease.

A total of 40 participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive eight individualized sessions over four weeks in addition to standard medical care, while the control group will continue with standard care only.

Primary and secondary outcomes will be assessed using validated self-report instruments, including the Perceived Stress Scale (PSS), Hospital Anxiety and Depression Scale (HADS), and COPE Inventory, administered at baseline and after the intervention period.

The main objective of the study is to determine whether structured mind-body techniques can reduce perceived stress, anxiety, and depressive symptoms and improve coping strategies in patients with coronary artery disease.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

This study is a prospective, randomized controlled clinical trial designed to evaluate the effects of a structured mind-body intervention on psychological outcomes in patients with stable coronary artery disease.

Eligible participants will be recruited from Ufuk University Department of Cardiology and randomly assigned to either an intervention group or a control group using a simple randomization method. The intervention group will receive eight individualized sessions of progressive muscle relaxation and guided imagery over a four-week period in addition to standard medical care. Each session will last approximately 45-60 minutes and will be conducted in a controlled clinical environment by trained researchers. The control group will continue receiving standard medical care without any additional psychological or behavioral intervention.

Outcomes will be assessed at baseline and post-intervention using validated self-report instruments, including the Perceived Stress Scale (PSS), Hospital Anxiety and Depression Scale (HADS), and COPE Inventory. The primary outcome is change in perceived stress levels. Secondary outcomes include changes in anxiety, depression, and coping strategies.

Data will be analyzed using repeated measures ANOVA to examine the interaction effects between group (intervention vs control) and time (baseline vs post-intervention). Effect sizes will be reported, and statistical significance will be set at p < 0.05.

The study does not involve any investigational drugs, biologics, or medical devices, and poses minimal risk to participants.

Tipo de estudio

Intervencionista

Inscripción (Actual)

40

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

  • Turquía (Türkiye)
    • Ankara
      • Ankara, Ankara, Turquía (Türkiye), 06000
        • Ufuk University Faculty of Medicine, Department of Cardiology

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

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Diagnosed with stable coronary artery disease
  • Aged between 18 and 65 years
  • Able to read and understand Turkish
  • Able to complete study questionnaires and assessments
  • Willing to provide written informed consent

Exclusion Criteria:

  • History of acute coronary syndrome within the last 3 months
  • Presence of a diagnosed severe psychiatric disorder
  • Cognitive impairment or communication difficulties that may interfere with study participation
  • Previous regular participation in mind-body interventions such as progressive muscle relaxation, guided imagery, meditation, or similar programs

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: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Intervention Group
Participants in this arm will receive an eight-session individualized mind-body intervention consisting of progressive muscle relaxation and guided imagery in addition to standard medical care. Sessions will be delivered twice weekly over four weeks in a clinical setting by trained researchers.
Conductual: Progressive Muscle Relaxation and Guided Imagery
A structured mind-body intervention consisting of progressive muscle relaxation and guided imagery techniques delivered in eight individualized sessions over four weeks.
Sin intervención: Control Group
Participants in this arm will receive standard medical care only without any additional psychological or behavioral intervention.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Perceived Stress Scale (PSS) Score
Periodo de tiempo: Baseline and 4 weeks
The primary outcome is the change in perceived stress levels measured by the Perceived Stress Scale (PSS) between baseline and the end of the 4-week intervention period.Scores range from 0 to 16, with higher scores indicating greater perceived stress.
Baseline and 4 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Score
Periodo de tiempo: Baseline and 4 weeks
Change in anxiety measured by the Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS). Scores range from 0 to 21, with higher scores indicating greater anxiety symptoms. Outcome will be assessed at baseline and 4 weeks.
Baseline and 4 weeks
Change in Hospital Anxiety and Depression Scale (HADS) Depression Score
Periodo de tiempo: Baseline and 4 weeks
Change in depression measured by the Hospital Anxiety and Depression Scale - Depression Subscale (HADS). Scores range from 0 to 21, with higher scores indicating greater depressive symptoms. Outcome will be assessed at baseline and 4 weeks.
Baseline and 4 weeks
Change in COPE Coping Strategies Scale Scores
Periodo de tiempo: Baseline and 4 weeks
Change in coping strategies measured by the COPE Inventory. The instrument contains 15 coping subscales, each scored from 4 to 16, with higher scores indicating greater use of the respective coping strategy. Outcomes will be assessed at baseline and 4 weeks.
Baseline and 4 weeks

Colaboradores e Investigadores

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

Patrocinador

şeyda candeniz

Investigadores

  • Director de estudio: Şeyda Candeniz, PhD, Ankara 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)

9 de junio de 2026

Finalización primaria (Actual)

4 de septiembre de 2026

Finalización del estudio (Actual)

4 de septiembre de 2026

Fechas de registro del estudio

Enviado por primera vez

3 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

3 de junio de 2026

Publicado por primera vez (Actual)

8 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

16 de septiembre de 2026

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

13 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • UFUK-SAGBIL-BADEK-2026/05

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

De-identified individual participant data underlying the results reported in publications, including demographic characteristics, baseline assessments, outcome measures (PSS, HADS, and COPE scores), and relevant study variables, will be made available upon reasonable request to qualified researchers. All shared data will be stripped of personal identifiers to protect participant confidentiality.

Marco de tiempo para compartir IPD

De-identified individual participant data and supporting documents will be available beginning 6 months after publication of the primary study results and will remain available for 5 years thereafter

Criterios de acceso compartido de IPD

De-identified individual participant data, study protocol, statistical analysis plan, and informed consent form will be available to qualified researchers upon reasonable request. Requests must include a scientifically sound research proposal and will be subject to approval by the study investigators. Data will be provided in a secure manner to protect participant confidentiality.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF

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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