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

June 18, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06000
        • Recruiting
        • Ufuk University Faculty of Medicine, Department of Cardiology
        • Contact:
        • Contact:
        • Principal Investigator:
          • Berkay Ekici, MD
        • Sub-Investigator:
          • Şeyda Candeniz, PhD
        • Sub-Investigator:
          • Gamze Ekici, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: 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.
No Intervention: Control Group
Participants in this arm will receive standard medical care only without any additional psychological or behavioral intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 4 weeks
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.
Baseline and 4 weeks
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.
Baseline and 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

şeyda candeniz

Investigators

  • Study Director: Şeyda Candeniz, PhD, Ankara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

June 3, 2026

First Submitted That Met QC Criteria

June 3, 2026

First Posted (Actual)

June 8, 2026

Study Record Updates

Last Update Posted (Actual)

June 22, 2026

Last Update Submitted That Met QC Criteria

June 18, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UFUK-SAGBIL-BADEK-2026/05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

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

IPD Sharing Access Criteria

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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