Stress, PsychologicalNCT04223882
Stress Management in Patients With Coronary Artery Disease
A study testing Management of Stress in people with Stress, Psychological, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- Management of Stress
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Oct 2022to 5 Oct 2023
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stress Management in Patients With Coronary Artery Disease: a Randomized Clinical Trial
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
- Being tested
- Management of Stress, Usual care
- Keywords
- Stress, Psychological;, Coronary Artery Disease;, Percutaneous Coronary Intervention;, Endothelium;
- Medical subject headings
- Stress, Psychological, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Management of StressBehavioural
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).
Usual careOther
Also called Patients in the control group will receive usual medical care
outpatient medical appointments
| Study group | Role | What they receive |
|---|---|---|
| Group Intervention- Management of stress | Experimental | 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. Receives: Behavioral: Management of Stress |
| Group Control | Active comparator | Patients in the control group will receive usual medical care. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Flow-mediated Dilation in the Brachial Artery in the Base and After the Treatment.
Inter group difference in flow-mediated dilation in the brachial artery in the baseline and after the treatment (about Three months after the first).
Vasodilatation of the endothelium-dependent brachial artery was evaluated by ultrasound using a 3-12 MHz linear transducer. Three images of the basal diameter (BD) of the brachial artery at the end of the diastole were acquired, as well as the mean velocity of the baseline arterial flow, with the linear transducer positioned 5 cm above the antecubital fossa. Subsequently, the sphygmomanometer was placed in the arm and inflated 50 mmHg above baseline systolic blood pressure for five minutes. After that, 3 images of the arterial diameter were acquired up to 80 seconds of the deflation of the cuff (post-occlusion diameter- PD), as well as the average of the arterial flow velocity. Flow-dependent vasodilation responses were expressed as a percentage variation from the baseline brachial diameter (PD-BD/ BD x 100).
Measured: Three months after the first evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start5 Oct 2022
- Primary completion5 Jan 2023
- Study completion5 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcia Moura Schmidt, PhD, Study director, Instituto de Cardiologia do Rio Grande do SulKarine Elisa Schwarzer Schmidt, Principal investigator, Instituto de Cardiologia do Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04223882
- Sponsor's protocol ID
- UP 5648/19
- Status last verified
- Jun 2023
- First submitted
- 8 Jan 2020
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Management in Patients With Coronary Artery Disease: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04223882
- Acronym / sponsor ID
- UP 5648/19
- Conditions
- Stress, Psychological
- Keywords
- Stress, Psychological;, Coronary Artery Disease;, Percutaneous Coronary Intervention;, Endothelium;
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 5 Jan 2023 (actual)
- Study completion
- 5 Oct 2023 (estimated)
- First posted
- 10 Jan 2020 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Intervention- Management of stress | Experimental | Behavioral: Management of StressPatients 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 Control | Active comparator | Other: Usual carePatients in the control group will receive usual medical care. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Management of StressPsychoeducation: 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). | Behavioural | Group Intervention- Management of stress |
| Usual careAlso: Patients in the control group will receive usual medical careoutpatient medical appointments | Other | Group Control |
Primary outcome
Difference in Flow-mediated Dilation in the Brachial Artery in the Base and After the Treatment.
Time frame: Three months after the first evaluation
Inter group difference in flow-mediated dilation in the brachial artery in the baseline and after the treatment (about Three months after the first). Vasodilatation of the endothelium-dependent brachial artery was evaluated by ultrasound using a 3-12 MHz linear transducer. Three images of the basal diameter (BD) of the brachial artery at the end of the diastole were acquired, as well as the mean velocity of the baseline arterial flow, with the linear transducer positioned 5 cm above the antecubital fossa. Subsequently, the sphygmomanometer was placed in the arm and inflated 50 mmHg above baseline systolic blood pressure for five minutes. After that, 3 images of the arterial diameter were acquired up to 80 seconds of the deflation of the cuff (post-occlusion diameter- PD), as well as the average of the arterial flow velocity. Flow-dependent vasodilation responses were expressed as a percentage variation from the baseline brachial diameter (PD-BD/ BD x 100).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Marcia Moura Schmidt, PhD study director
Instituto de Cardiologia do Rio Grande do Sul
Karine Elisa Schwarzer Schmidt principal investigator
Instituto de Cardiologia do Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Management of Stress in people with Stress, Psychological, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 29 Jun 2023. 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 Brazil. 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?
Results are not available in the source record.
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?
Difference in Flow-mediated Dilation in the Brachial Artery in the Base and After the Treatment. (time frame: Three months after the first evaluation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2023.