Mind-Body Interventions in Coronary Artery Disease
MBI-CAD
Effects of Combined Mind-Body Interventions in Patients With Coronary Artery Disease
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 3, 2026
CompletedFirst Posted
Study publicly available on registry
June 8, 2026
CompletedStudy Start
First participant enrolled
June 9, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
ExpectedJune 22, 2026
June 1, 2026
2 months
June 3, 2026
June 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Perceived Stress Scale (PSS) Score
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 Outcomes (3)
Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Score
Baseline and 4 weeks
Change in Hospital Anxiety and Depression Scale (HADS) Depression Score
Baseline and 4 weeks
Change in COPE Coping Strategies Scale Scores
Baseline and 4 weeks
Study Arms (2)
Intervention Group
EXPERIMENTALParticipants 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.
Control Group
NO INTERVENTIONParticipants in this arm will receive standard medical care only without any additional psychological or behavioral intervention.
Interventions
A structured mind-body intervention consisting of progressive muscle relaxation and guided imagery techniques delivered in eight individualized sessions over four weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- şeyda candenizlead
Study Sites (1)
Ufuk University Faculty of Medicine, Department of Cardiology
Ankara, 06000, Turkey (Türkiye)
Related Publications (1)
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: 28452408BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Şeyda Candeniz, PhD
Ankara University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- No additional masking is applied. This is an open-label study.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor (Dr.)
Study Record Dates
First Submitted
June 3, 2026
First Posted
June 8, 2026
Study Start
June 9, 2026
Primary Completion
August 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
June 22, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- 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
- 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.
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.