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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control Group | No Intervention | Participants in this arm will receive standard medical care only without any additional psychological or behavioral intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seyda Candeniz, PhD | Contact | +905367923404 | seydacuma15@gmail.com | |
| Gamze Ekici, PhD | Contact | +905323246924 | fztgamze@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Şeyda Candeniz, PhD | Ankara University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ufuk University Faculty of Medicine, Department of Cardiology | Recruiting | Ankara | 06000 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28452408 | Background | 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. |
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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.
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
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.
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D001326 | Autogenic Training |
| D019018 | Imagery, Psychotherapy |
| ID | Term |
|---|---|
| D006990 | Hypnosis |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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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.
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No additional masking is applied. This is an open-label study.
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| 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. |
| 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. | Baseline and 4 weeks |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D011613 |
| Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |