Stress Management in Patients With Coronary Artery Disease

NCT ID: NCT04223882

Last Updated: 2023-06-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-05
• Study Completion Date: 2023-10-05

Brief Summary

Introduction: Stress can cause hemodynamic and metabolic changes that contribute to endothelial dysfunction and there is a significant association between high stress and cardiovascular events. Objective: To evaluate the influence of stress management on endothelial function in patients undergoing percutaneous coronary intervention (PCI). Methods: Randomized, controlled, parallel, intention-to-treat clinical trial. Will be considered eligible patients who underwent percutaneous coronary intervention and who have high stress (above average for the Brazilian population) in the Perceived Stress Scale (PSS-10). Patients will be evaluated on PCI admission and stress management with cognitive behavioral techniques will be implemented one month after hospital discharge in the intervention group. Group sessions will be held between 6-9 people. There will be 4 1-hour meetings for 8 weeks. The primary outcome will be the difference in the variation of brachial artery flow-mediated dilatation (FMD) between the groups and at 3 months of baseline evaluation and at 6-month follow-up after the intervention and the secondary outcome will be the difference in the variation of the velocity of brachial artery. Pulse wave evaluated at the same time periods as DMF. Outcomes will be evaluated by Generalized Estimation Equations (GEE). Expected Results: In patients undergoing high-stress percutaneous coronary intervention, the use of cognitive behavioral techniques for stress management will improve endothelial function and vascular stiffness.

Conditions

Stress, Psychological

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group Intervention- Management of stress

Patients in the intervention group will receive usual medical care and more stress management intervention. Stress management with cognitive behavioral techniques will be implemented one month after hospital discharge in the intervention group. Group sessions will be held between 6-9 people. There will be 3 1-hour meetings for 3 weeks. The intervention will be performed by psychologist.

Group Type: EXPERIMENTAL

Management of Stress

Intervention Type: BEHAVIORAL

Psychoeducation:

Coronary artery disease, Percutaneous Coronary Intervention, traditional risk factors and emotional stress.

Stress: physiology, triggers, triad (thinking, emotion, action).

Skills training:

Identify warning signs - signs and symptoms; Monitoring of irrational automatic thoughts generating alternative interpretations of situations or unrealistic thinking patterns (Dysfunctional Thinking Records Sheet).

Self-control for stress management:

Assertiveness training, problem solving. Thought-stopping technique, designed for dysfunctional thoughts, such as, "I won't do it," "It won't work."

Stress Relief / Control Techniques:

Diaphragmatic Breathing: Expansion of the abdomen rather than the chest when breathing.

Progressive Muscle Relaxation: Maximize tension and alternately relax the muscles (legs, abdomen, chest, arms and face).

Group Control

Patients in the control group will receive usual medical care.

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: OTHER

outpatient medical appointments

Interventions

Management of Stress

Psychoeducation:

Coronary artery disease, Percutaneous Coronary Intervention, traditional risk factors and emotional stress.

Stress: physiology, triggers, triad (thinking, emotion, action).

Skills training:

Identify warning signs - signs and symptoms; Monitoring of irrational automatic thoughts generating alternative interpretations of situations or unrealistic thinking patterns (Dysfunctional Thinking Records Sheet).

Self-control for stress management:

Assertiveness training, problem solving. Thought-stopping technique, designed for dysfunctional thoughts, such as, "I won't do it," "It won't work."

Stress Relief / Control Techniques:

Diaphragmatic Breathing: Expansion of the abdomen rather than the chest when breathing.

Progressive Muscle Relaxation: Maximize tension and alternately relax the muscles (legs, abdomen, chest, arms and face).

Intervention Type: BEHAVIORAL

Usual care

outpatient medical appointments

Intervention Type: OTHER

Other Intervention Names

Patients in the control group will receive usual medical care

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years;
• Patients with CAD - obstruction of one or more epicardial arteries with at least 70% stenosis and / or Left Coronary Trunk (TBI) with at least 50% - measured by catheterization (CATE) and having performed elective PCI
• High stress: above average score for the Brazilian population in the Perceived Stress Scale (PSS-10)
• Signing of the Informed Consent.

Exclusion Criteria

• Age ≥ 80 years
• Patients with inpatient events (AMI, CABG, stroke)
• Indication of catheterization for valvulopathies or congenital heart disease
• Severe aortic stenosis / Ejection fraction <30%, cardiomyopathy, severe congestive heart disease
• Severe diseases with life expectancy <6 months
• Cognitive or mental difficulties to understand the instrument
• Inability to follow up visits

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Cardiologia do Rio Grande do Sul

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marcia Moura Schmidt, PhD

Role: STUDY_DIRECTOR

Instituto de Cardiologia do Rio Grande do Sul

Karine Elisa Schwarzer Schmidt

Role: PRINCIPAL_INVESTIGATOR

Instituto de Cardiologia do Rio Grande do Sul

Locations

Marcia Moura Schmidt

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

UP 5648/19

Identifier Type: -

Identifier Source: org_study_id