Coronary Artery Disease (CAD)MBI-CADNCT07633132
Mind-Body Interventions in Coronary Artery Disease
A study testing Progressive Muscle Relaxation and Guided Imagery in people with Coronary Artery Disease (CAD), run by şeyda candeniz at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Coronary Artery Disease (CAD)
- What is being tested?
- Progressive Muscle Relaxation and Guided Imagery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Jun 2026to 4 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ufuk University Faculty of Medicine, Department of Cardiology
Ankara, Ankara, 06000
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Coronary Artery Disease (CAD)
- Being tested
- Progressive Muscle Relaxation and Guided Imagery
- Keywords
- Anxiety, Depression, Stress, Cardiac Rehabilitation
- Medical subject headings
- Coronary Artery Disease, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Muscle Relaxation and Guided ImageryBehavioural
A structured mind-body intervention consisting of progressive muscle relaxation and guided imagery techniques delivered in eight individualized sessions over four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Behavioral: Progressive Muscle Relaxation and Guided Imagery |
| Control Group | No intervention | Participants in this arm will receive standard medical care only without any additional psychological or behavioral intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 4 weeks
Secondary outcomes (3)
Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Score
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.
Measured: Baseline and 4 weeks
Change in Hospital Anxiety and Depression Scale (HADS) Depression Score
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.
Measured: Baseline and 4 weeks
Change in COPE Coping Strategies Scale Scores
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.
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start9 Jun 2026
- Primary completion4 Sep 2026
- Study completion4 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Disease (CAD)Studies of the same condition, open and under way.
- 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
- Participants will be randomly assigned to either an intervention group or a control group in a parallel design. The intervention group will receive an eight-session individualized mind-body program consisting of progressive muscle relaxation and guided imagery, while the control group will receive standard medical care only. Outcomes will be assessed at baseline and post-intervention to evaluate between-group and within-group changes over time.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- şeyda candeniz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, şeyda candeniz, Ankara University
- Investigators
- Şeyda Candeniz, PhD, Study director, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07633132
- Sponsor's protocol ID
- UFUK-SAGBIL-BADEK-2026/05
- Acronym
- MBI-CAD
- Status last verified
- Sep 2026
- First submitted
- 3 Jun 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 28452408
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combined Mind-Body Interventions in Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT07633132
- Acronym / sponsor ID
- MBI-CAD / UFUK-SAGBIL-BADEK-2026/05
- Conditions
- Coronary Artery Disease (CAD)
- Keywords
- Anxiety, Depression, Stress, Cardiac Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- şeyda candenizUniversity, hospital or other
- Study start
- 9 Jun 2026 (actual)
- Primary completion
- 4 Sep 2026 (actual)
- Study completion
- 4 Sep 2026 (actual)
- First posted
- 8 Jun 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either an intervention group or a control group in a parallel design. The intervention group will receive an eight-session individualized mind-body program consisting of progressive muscle relaxation and guided imagery, while the control group will receive standard medical care only. Outcomes will be assessed at baseline and post-intervention to evaluate between-group and within-group changes over time.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Progressive Muscle Relaxation and Guided ImageryParticipants 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 intervention | –Participants in this arm will receive standard medical care only without any additional psychological or behavioral intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Progressive Muscle Relaxation and Guided ImageryA structured mind-body intervention consisting of progressive muscle relaxation and guided imagery techniques delivered in eight individualized sessions over four weeks. | Behavioural | Intervention Group |
Primary outcome
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.
3 secondary outcomes
Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Score
Time frame: Baseline and 4 weeks
Change in Hospital Anxiety and Depression Scale (HADS) Depression Score
Time frame: Baseline and 4 weeks
Change in COPE Coping Strategies Scale Scores
Time frame: Baseline and 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Background: PubMed 28452408Richards 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.
- Individual participant dataSharing planned: Yes. 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.
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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. This study is not recruiting at the moment.
Şeyda Candeniz, PhD study director
Ankara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Muscle Relaxation and Guided Imagery in people with Coronary Artery Disease (CAD), run by şeyda candeniz 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 16 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Perceived Stress Scale (PSS) Score (time frame: Baseline and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07633132, which also lists 1 linked publication.
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 16 Sep 2026.