Coronary Artery Disease (CAD)MBSR-CADWOMENNCT07371806
EFFETCS OF MİNDFULNESS-BASED STRESS REDUCTION İN WOMEN WİTH CORONARY ARTERY DİSEASE
A study testing Mindfulness-Based Intervention Program in people with Coronary Artery Disease (CAD), run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
Coronary artery disease (CAD) is a common cardiovascular condition characterized by the narrowing or blockage of the coronary arteries that supply oxygen-rich blood to the heart muscle. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Coronary Artery Disease (CAD)
- What is being tested?
- Mindfulness-Based Intervention Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2026to 20 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with coronary artery disease (CAD) for at least 1 month.
- Score of 14 or higher on the Short Form of the State-Trait Anxiety Inventory (STAI-SF) at baseline.
- At least primary school education.
- Age between 18 and 50 years.
- Sexually active.
- Having an active social network.
Who cannot join
- Individuals with hearing or language impairments that would hinder communication.
- Women who have entered menopause.
- Women with psychiatric disorders.
- Discontinuation Criteria:
- Participants who choose to withdraw from the study.
- Participants who miss two intervention sessions.
- Participants with incomplete data on study forms.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kayseri Şehir Hastanesi
Kayseri, Türki̇ye, 38000
Hatice Penekli- Master, +9, peneklihatice@gmail.com
About this study
Official title: THE EFFECT OF A MINDFULNESS-BASED STRESS REDUCTION PROGRAM ON QUALITY OF LIFE , ANXIETY AND EMPOWERMENT LEVELS IN WOMEN WITH CORONARY ARTERY DISEASE
Coronary artery disease (CAD) is a common cardiovascular condition characterized by the narrowing or blockage of the coronary arteries that supply oxygen-rich blood to the heart muscle. CAD represents a significant cause of morbidity and mortality, particularly among individuals aged 40 and older, affecting millions of men and women worldwide. Patients with CAD experience not only physical symptoms but also psychological challenges, including stress and anxiety, which can negatively impact quality of life. In recent years, mindfulness-based interventions have emerged as scientifically supported approaches to help individuals with chronic diseases manage stress and enhance emotional regulation skills. While the existing literature includes studies evaluating the effects of mindfulness-based interventions in CAD and other cardiovascular conditions, most investigations address mixed patient populations and do not thoroughly examine sex-specific differences. Notably, women with CAD may experience symptoms and psychological effects differently than men. Therefore, there is a need for tailored, comprehensive intervention models that address the multidimensional needs of female patients, including stress management, anxiety reduction, and empowerment. This study aims to evaluate the effectiveness of mindfulness-based interventions in women with CAD, providing a targeted approach that addresses both clinical and psychosocial outcomes. The findings are expected to offer valuable insights into improving quality of life and enhancing coping strategies for women living with chronic cardiovascular disease.
Read the detailed description
Coronary artery disease (CAD) is a prevalent cardiovascular condition that develops as a result of narrowing or blockage of the coronary arteries supplying blood to the heart, significantly affecting the cardiovascular system. CAD is recognized as a major cause of morbidity and mortality, particularly among individuals aged 40 and older. According to 2024 data from the British Heart Foundation (BHF), approximately 110 million men and 80 million women worldwide are affected by CAD, with the disease accounting for one in every six deaths globally. Similarly, data from the Turkish Statistical Institute, indicate that circulatory system diseases represent 36% of total deaths in Turkey, with 42.9% of these deaths attributable to ischemic heart diseases. CAD not only adversely impacts individual health but also imposes a significant burden on public health and healthcare systems. Its high prevalence, associated morbidity and mortality, long-term and costly treatment requirements, and the resulting decline in quality of life position CAD as a critical public health priority. Affecting millions of men and women worldwide, CAD leads not only to physical symptoms but also to psychological challenges that reduce quality of life. Stress, anxiety, and depressive symptoms are common psychosocial issues among patients with CAD and can complicate the management of chronic disease. In managing chronic illnesses, it is essential to enhance individuals' stress-coping skills, improve emotional regulation, and strengthen psychological resilience. In recent years, mindfulness-based interventions have emerged as scientifically supported approaches to achieve these objectives. Mindfulness and other awareness-based programs have been shown to help individuals cope with stress, manage anxiety, and improve psychological resilience. Existing literature includes studies evaluating the effects of mindfulness-based interventions in CAD and other cardiovascular conditions. However, most of these studies examine mixed patient populations and do not thoroughly investigate sex-specific differences. Notably, women with CAD experience symptoms, psychological stress, and quality-of-life challenges differently than men. Therefore, there is a clear need for tailored, targeted intervention models specifically designed for female patients with CAD.
- Conditions
- Coronary Artery Disease (CAD)
- Being tested
- Mindfulness-Based Intervention Program
- Keywords
- Coronary artery disease, Mindfulness-based intervention, Quality of life
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Intervention ProgramBehavioural
This intervention is an 8-week structured mindfulness-based program designed to cultivate awareness related to anxiety, psychological resilience, and quality of life in women with coronary artery disease. The program includes meditation, breathing, and mindfulness exercises, distinguishing it from the standard care received by the control group.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Intervention Group | Experimental | Participants in the intervention group will take part in an 8-week mindfulness-based program designed to cultivate awareness related to anxiety, psychological resilience, and quality of life in women with coronary artery disease. Receives: Behavioral: Mindfulness-Based Intervention Program |
| Standard Care in Women with Coronary Artery Disease | No intervention | Participants in the control group will receive standard care, including routine medical follow-up and discharge education, without any structured intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Quality of Life Scale
The Heart Quality of Life Scale (HeartQoL) is a reliable instrument developed to assess quality of life in individuals with ischemic heart disease (Oldridge, 2014). The scale consists of 14 items, with 10 assessing physical aspects and 4 assessing emotional aspects. Each item is scored from 0 to 3, with higher scores indicating better quality of life. It can be applied to individuals aged 18 and above. Turkish validity and reliability were established by Duğan (2018).
Measured: Baseline and at the end of the 8-week program
Secondary outcomes (1)
State-Trait Anxiety Inventory - Short Form (STAI-SF)
The State-Trait Anxiety Inventory - Short Form (STAI-SF) is a reliable tool developed to assess general anxiety levels in individuals (Spielberger et al., 1970). Its Turkish adaptation was made by Öner and Le Compte (1985). The short form was later developed by Zsido et al. (2020) and consists of 5 items using a 4-point Likert scale. Scores of 14 or higher indicate clinically significant anxiety. The internal consistency ranges between 0.83-0.86, and its Turkish validity and reliability have been established (Döner et al., 2021). The scale can be applied to individuals aged 18 and above.
Measured: Baseline and at the end of the 8-week program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 Sep 2026
- Primary completion20 Jan 2027 (estimated)
- Study completion20 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease (CAD)Studies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study includes one intervention group and one control group.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Collaborators
- Kayseri City Hospital
- Responsible party
- Principal investigator, HATİCE PENEKLİ, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07371806
- Sponsor's protocol ID
- ErciyesU-SBF-HP-01
- Acronym
- MBSR-CADWOMEN
- Status last verified
- Sep 2026
- First submitted
- 20 Jan 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant information will not be shared at this time, as the study has not yet started and confidentiality must be maintained.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF A MINDFULNESS-BASED STRESS REDUCTION PROGRAM ON QUALITY OF LIFE , ANXIETY AND EMPOWERMENT LEVELS IN WOMEN WITH CORONARY ARTERY DISEASE
- ClinicalTrials.gov ID
- NCT07371806
- Acronym / sponsor ID
- MBSR-CADWOMEN / ErciyesU-SBF-HP-01
- Conditions
- Coronary Artery Disease (CAD)
- Keywords
- Coronary artery disease, Mindfulness-based intervention, Quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Collaborators
- Kayseri City Hospital
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 20 Jan 2027 (estimated)
- Study completion
- 20 May 2027 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Coronary artery disease (CAD) is a common cardiovascular condition characterized by the narrowing or blockage of the coronary arteries that supply oxygen-rich blood to the heart muscle. CAD represents a significant cause of morbidity and mortality, particularly among individuals aged 40 and older, affecting millions of men and women worldwide. Patients with CAD experience not only physical symptoms but also psychological challenges, including stress and anxiety, which can negatively impact quality of life. In recent years, mindfulness-based interventions have emerged as scientifically supported approaches to help individuals with chronic diseases manage stress and enhance emotional regulation skills. While the existing literature includes studies evaluating the effects of mindfulness-based interventions in CAD and other cardiovascular conditions, most investigations address mixed patient populations and do not thoroughly examine sex-specific differences. Notably, women with CAD may experience symptoms and psychological effects differently than men. Therefore, there is a need for tailored, comprehensive intervention models that address the multidimensional needs of female patients, including stress management, anxiety reduction, and empowerment. This study aims to evaluate the effectiveness of mindfulness-based interventions in women with CAD, providing a targeted approach that addresses both clinical and psychosocial outcomes. The findings are expected to offer valuable insights into improving quality of life and enhancing coping strategies for women living with chronic cardiovascular disease.
Detailed description
Coronary artery disease (CAD) is a prevalent cardiovascular condition that develops as a result of narrowing or blockage of the coronary arteries supplying blood to the heart, significantly affecting the cardiovascular system. CAD is recognized as a major cause of morbidity and mortality, particularly among individuals aged 40 and older. According to 2024 data from the British Heart Foundation (BHF), approximately 110 million men and 80 million women worldwide are affected by CAD, with the disease accounting for one in every six deaths globally. Similarly, data from the Turkish Statistical Institute, indicate that circulatory system diseases represent 36% of total deaths in Turkey, with 42.9% of these deaths attributable to ischemic heart diseases. CAD not only adversely impacts individual health but also imposes a significant burden on public health and healthcare systems. Its high prevalence, associated morbidity and mortality, long-term and costly treatment requirements, and the resulting decline in quality of life position CAD as a critical public health priority. Affecting millions of men and women worldwide, CAD leads not only to physical symptoms but also to psychological challenges that reduce quality of life. Stress, anxiety, and depressive symptoms are common psychosocial issues among patients with CAD and can complicate the management of chronic disease. In managing chronic illnesses, it is essential to enhance individuals' stress-coping skills, improve emotional regulation, and strengthen psychological resilience. In recent years, mindfulness-based interventions have emerged as scientifically supported approaches to achieve these objectives. Mindfulness and other awareness-based programs have been shown to help individuals cope with stress, manage anxiety, and improve psychological resilience. Existing literature includes studies evaluating the effects of mindfulness-based interventions in CAD and other cardiovascular conditions. However, most of these studies examine mixed patient populations and do not thoroughly investigate sex-specific differences. Notably, women with CAD experience symptoms, psychological stress, and quality-of-life challenges differently than men. Therefore, there is a clear need for tailored, targeted intervention models specifically designed for female patients with CAD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study includes one intervention group and one control group.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Intervention Group | Experimental | Behavioral: Mindfulness-Based Intervention ProgramParticipants in the intervention group will take part in an 8-week mindfulness-based program designed to cultivate awareness related to anxiety, psychological resilience, and quality of life in women with coronary artery disease. |
| Standard Care in Women with Coronary Artery Disease | No intervention | –Participants in the control group will receive standard care, including routine medical follow-up and discharge education, without any structured intervention. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Diagnosed with coronary artery disease (CAD) for at least 1 month.
- Score of 14 or higher on the Short Form of the State-Trait Anxiety Inventory (STAI-SF) at baseline.
- At least primary school education.
- Age between 18 and 50 years.
- Sexually active.
Key exclusion criteria (7 listed)
- Individuals with hearing or language impairments that would hinder communication.
- Women who have entered menopause.
- Women with psychiatric disorders.
- Participants who choose to withdraw from the study.
- Participants who miss two intervention sessions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Intervention ProgramThis intervention is an 8-week structured mindfulness-based program designed to cultivate awareness related to anxiety, psychological resilience, and quality of life in women with coronary artery disease. The program includes meditation, breathing, and mindfulness exercises, distinguishing it from the standard care received by the control group. | Behavioural | Mindfulness-Based Intervention Group |
Primary outcome
Cardiac Quality of Life Scale
Time frame: Baseline and at the end of the 8-week program
The Heart Quality of Life Scale (HeartQoL) is a reliable instrument developed to assess quality of life in individuals with ischemic heart disease (Oldridge, 2014). The scale consists of 14 items, with 10 assessing physical aspects and 4 assessing emotional aspects. Each item is scored from 0 to 3, with higher scores indicating better quality of life. It can be applied to individuals aged 18 and above. Turkish validity and reliability were established by Duğan (2018).
1 secondary outcome
State-Trait Anxiety Inventory - Short Form (STAI-SF)
Time frame: Baseline and at the end of the 8-week program
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant information will not be shared at this time, as the study has not yet started and confidentiality must be maintained.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Intervention Program in people with Coronary Artery Disease (CAD), run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hatice Penekli, Master (+9, peneklihatice@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Quality of Life Scale (time frame: Baseline and at the end of the 8-week program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.