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NCT Number: NCT07633132

Mind-Body Interventions in 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.

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Key information

Conditions

Coronary Artery Disease (CAD) Anxiety Disorders Arterial Occlusive Diseases Arteriosclerosis Behavior Behavioral Symptoms Cardiovascular Diseases Coronary Artery Disease Coronary Disease Depression Heart Diseases Mental Disorders Myocardial Ischemia Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ufuk University Faculty of Medicine, Department of Cardiology

Ankara, 06000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Progressive Muscle Relaxation and Guided Imagery

Behavioral

A structured mind-body intervention consisting of progressive muscle relaxation and guided imagery techniques delivered in eight individualized sessions over four weeks.

Primary outcomes

  1. Change in Perceived Stress Scale (PSS) Score

    Time frame: 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.

Secondary outcomes

  1. Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Score

    Time frame: 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.

  2. Change in Hospital Anxiety and Depression Scale (HADS) Depression Score

    Time frame: 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.

  3. Change in COPE Coping Strategies Scale Scores

    Time frame: 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.

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Sponsors and collaborators

Lead sponsor

şeyda candeniz

Other

Registry information

Official study title

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

Acronym: MBI-CAD

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 8, 2026
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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