Coronary Artery Disease (CAD)
Conditions
Keywords
Anxiety, Depression, Stress, Cardiac Rehabilitation
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.
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.
Interventions
BEHAVIORALProgressive 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.
Sponsors
şeyda candeniz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Perceived Stress Scale (PSS) Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Score | 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. |
| Change in Hospital Anxiety and Depression Scale (HADS) Depression Score | 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. |
| Change in COPE Coping Strategies Scale Scores | 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. |
Countries
Turkey (Türkiye)
Contacts
STUDY_DIRECTORŞeyda Candeniz, PhD
Ankara University
Outcome results
None listed