Mind-Body Interventions in Coronary Artery Disease

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Change in Perceived Stress Scale (PSS) Score [Срок оценки: Baseline and 4 weeks]

Вторичные конечные точки (3)

• Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Score [Срок оценки: Baseline and 4 weeks]
• Change in Hospital Anxiety and Depression Scale (HADS) Depression Score [Срок оценки: Baseline and 4 weeks]
• Change in COPE Coping Strategies Scale Scores [Срок оценки: Baseline and 4 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Ufuk University Faculty of Medicine, Department of Cardiology — Ankara

Публикации

• Richards SH, Anderson L, Jenkinson CE, Whalley B, Rees K, Davies P, Bennett P, Liu Z, West R, Thompson DR, Taylor RS. Psychological interventions for coronary heart disease. Cochrane Database Syst Rev. 2017 Apr 28;4(4):CD002902. doi: 10.1002/14651858.CD002902.pub4. PMID 28452408

Идентификаторы

NCT: NCT07633132 · UFUK-SAGBIL-BADEK-2026/05

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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