Mind-Body Interventions in Coronary Artery Disease (MBI-CAD)
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Ankara
-
Ankara, Ankara, Turquia (Türkiye), 06000
- Ufuk University Faculty of Medicine, Department of Cardiology
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
|
A structured mind-body intervention consisting of progressive muscle relaxation and guided imagery techniques delivered in eight individualized sessions over four weeks.
|
|
Sem intervenção: Control Group
Participants in this arm will receive standard medical care only without any additional psychological or behavioral intervention.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Perceived Stress Scale (PSS) Score
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Score
Prazo: 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
Prazo: 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
Prazo: 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
Patrocinador
Investigadores
- Diretor de estudo: Şeyda Candeniz, PhD, Ankara University
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças Vasculares
- Doenças cardiovasculares
- Transtornos Mentais, Desordem Mental
- Doenças cardíacas
- Sintomas Comportamentais
- Arteriosclerose
- Doenças Arteriais Oclusivas
- Doença cardíaca
- Isquemia do miocárdio
- Comportamento
- Transtornos de ansiedade
- Depressão
- Doença arterial coronária
- Terapêutica
- Terapias mente-corpo
- Terapias complementares
- Psicoterapia
- Disciplinas e atividades comportamentais
- Hipnose
- Imagens, psicoterapia
- Treinamento autogênico
Outros números de identificação do estudo
- UFUK-SAGBIL-BADEK-2026/05
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .