Anxiety, Coronary Artery Disease, Stress
Conditions
Keywords
Secondary Prevention, Meditation
Brief summary
The aim of this pilot randomized controlled trial was to evaluate whether adding a 16-week structured meditation intervention to a long-term (phase III) cardiac rehabilitation program reduces perceived stress and improves anxiety, depression, and health-related quality of life in patients with stable coronary artery disease. Patients were randomized 1:1 to standard cardiac rehabilitation plus meditation (experimental group) or standard cardiac rehabilitation alone (control group). The meditation intervention consisted of four weekly 90-minute group sessions followed by 12 weeks of daily individual practice supported by weekly follow-up calls. Outcomes were assessed at baseline and after 16 weeks.
Detailed description
Despite advances in cardiac care, psychological stress, anxiety, and depression remain common in patients with coronary artery disease (CAD) and contribute to worse cardiovascular outcomes. Exercise-based cardiac rehabilitation (CR) programs are effective in reducing physical risk factors but often do not adequately address the psychological burden of CAD. Mind-body interventions such as meditation have been suggested as cost-effective adjuncts to CR, but evidence in long-term phase III CR programs remains limited. This pilot randomized controlled trial was designed to evaluate the additive effect of a structured meditation intervention combining Karuna (compassion) and Metta (loving-kindness) practices, integrated into a long-term CR program. The intervention included four weekly 90-minute group sessions led by a physiotherapist trained in meditation techniques, followed by 12 weeks of daily individual practice (20 minutes/day) supported by recorded video material and weekly follow-up telephone calls. Outcomes were measured at baseline (M0) and after 16 weeks (M1), using validated psychometric instruments administered by telephone interview by a blinded health professional.
Interventions
OTHERMeditation Program
A 16-week structured meditation program added to standard cardiac rehabilitation. During the first month, participants attended four weekly 90-minute group sessions led by a physiotherapist trained in meditation techniques. Each session included: (1) a 30-minute thought-sharing and Q\&A moment; (2) a 30-minute conscious breathing protocol combining diaphragmatic abdominal breathing in a 1:2 inhale-to-exhale ratio and heart-focused breathing; and (3) a 30-minute guided meditation combining Karuna (compassion) and Metta (loving-kindness) practices. During the subsequent 12 weeks, participants practised individually for 20 minutes per day, supported by a recorded video by the same instructor and weekly follow-up telephone calls to maintain engagement and address questions.
OTHERExercise-based Cardiac Rehabilitation (standard)
Standard long-term (phase III) exercise-based cardiac rehabilitation program delivered three times per week (60 minutes per session) on non-consecutive days, supervised by exercise physiologists. Each session included a 10-minute warm-up and cool-down. Moderate continuous aerobic training was prescribed at 40-75% of heart rate reserve for 20-25 minutes per session using cycle ergometers or treadmills. Resistance training was performed after the aerobic component (1-2 sets of 8-12 repetitions at approximately 60-80% of one-repetition maximum, with 2-3 minutes rest between sets), according to European Society of Cardiology guidelines. Heart rate was monitored with a chest band.
Sponsors
Universidad Rey Juan Carlos
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years (male or female). * Clinically stable coronary artery disease, documented by previous myocardial infarction, coronary artery bypass grafting, percutaneous coronary intervention, or angina pectoris. * Active participation in the long-term cardiac rehabilitation program for at least 3 months. * Access to a smartphone, tablet, or computer for telephone follow-up and meditation video materials. * Written informed consent.
Exclusion criteria
* Cognitive impairment that prevents informed consent or questionnaire completion. * Symptomatic heart failure. * Cardiac implantable defibrillators or resynchronization devices. * Lack of access to the technology required for the intervention.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Stress (PSS-10) | baseline and 16 weeks | The Perceived Stress Scale is a 10-item self-report questionnaire (score range 0-40) assessing the extent to which life events over the previous month are perceived as unpredictable, uncontrollable, and overloading. Higher scores indicate greater perceived stress. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety (Beck Anxiety Inventory, BAI) | baseline and 16 weeks | 21-item self-report measure of anxiety symptom severity, score range 0-63. Severity categories: minimal (0-7), mild (8-15), moderate (16-25), severe (26-63). |
| Depression (Beck Depression Inventory-II, BDI-II) | baseline and 16 weeks | 21-item self-report measure of depressive symptom severity, score range 0-63. Severity categories: minimal (0-13), mild (14-19), moderate (20-28), severe (29-63) |
| Health-Related Quality of Life (HeartQoL) | baseline and 16 weeks | 14-item disease-specific HRQoL questionnaire for ischaemic heart disease, providing Physical (10 items), Emotional (4 items), and Global scores. Higher scores indicate better HRQoL. |
| Physical Activity Level (IPAQ-SF) | baseline and 16 weeks | International Physical Activity Questionnaire - Short Form. 9-item self-report measure categorizing participants into low, moderate, or high physical activity levels based on the past 7 days. |
Countries
Portugal
Outcome results
None listed