Myocardial Infarction, AcuteGReATCARENCT05955950
Gratitude Intervention in Promoting Self-care in Patients With Myocardial Infarction
A study testing Gratitude list and List of any event in people with Myocardial Infarction, Acute, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
Trial summary
Introduction: Positive psychological's constructs have shown a direct effect on adherence to pharmacological treatment, diet, physical activity and general commitment to health, in the same way that negative ones, such as depression, anxiety and stress, are associated with worse cardiovascular outcomes and are… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Myocardial Infarction, Acute
- What is being tested?
- Gratitude list and List of any event
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Nov 2022to 5 Jul 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ST-segment elevation myocardial infarction (STEMI) patients
- Undergoing primary percutaneous coronary intervention (pPCI).
Who cannot join
- Patients in need of ventilatory support;
- Over 75 years of age;
- Delirium or dementia reported by the attending physician.
- Not able to answer the questionnaires.
- Very high depression scores requiring referral to psychological care services
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gratitude Intervention in Promoting Self-care and Improving Negative Psychological States in Patients With Acute Myocardial Infarction: a Randomized Clinical Trial
Introduction: Positive psychological's constructs have shown a direct effect on adherence to pharmacological treatment, diet, physical activity and general commitment to health, in the same way that negative ones, such as depression, anxiety and stress, are associated with worse cardiovascular outcomes and are prevalent in patients with infarction. Objective: To verify whether a gratitude intervention can improve self-care and improve negative psychological states in patients with recent myocardial infarction. Methods: Randomized, parallel clinical trial. The inclusion criteria will be patients with ST-segment elevation myocardial infarction (STEMI) with less than 12 hours of evolution and undergoing primary percutaneous coronary intervention (pPCI). Participants will respond to the socio-demographic and risk factors questionnaire and self-care (ASA-A), anxiety, depression and stress (DASS-21) and gratitude (QG-6) scales. They will be drawn into the gratitude intervention group or neutral events group according to the randomization list. Patients in the intervention group will be tasked with writing down 3 to 5 situations a day for which they are grateful, for 14 days. Patients in the control group will be asked to write down 3 to 5 situations a day that have impacted them, whether good or bad. Both groups will be reassessed after the intervention and after 6 months. Expected results: It is expected that the intervention group will improve self-care and the feeling of gratitude, modify behaviors and decrease negative affects, while the group without intervention will remain unchanged from the beginning of the study to 6 months.
Read the detailed description
Study design: Randomized, parallel clinical trial. The study will use a prospective experimental design with Condition and Time as independent variables. The condition has two levels that correspond to the experimental conditions: (a) Gratitude List (aspects of daily experience that one feels grateful for), (b) Any Event List (events of one's own choosing that impressed the participant during the day, whether positive or negative). Time is a repeated measures variable with three levels corresponding to the measurement times: (a) Pre-test (before the intervention), (b) Post-test (at 2 weeks after of the intervention - visit 1) and (c) ) Follow-up (from baseline to 6 months - visit 2).
This follow-up period is based on the previous studies. Patients will be invited to participate in the study during hospitalization for AMI. If they agree to participate, they must sign the Free and Informed Consent Form. They will answer the socio-demographic questionnaire and risk factors and self-care scales (ASA-A), anxiety, depression and stress (DASS-21) and gratitude (QG-6).
Envelopes will be opened after the initial interview. Participants will receive instructions for the intervention. Participants will be asked to allocate 10-20 minutes at the end of the day, before bed, for 14 days, to write the lists, according to their allocation group. Studies involving gratitude interventions generally last for two weeks as already explained.
In each group, participants will make a list of up to five items, evaluating the activities of that day. The instructions for the groups were adapted and translated.
For the intervention group (Gratitude List), the instructions will be:
"During the day, many things happen in our lives, big and small, for which we can be grateful. Think about your day and write down up to five things in your life that you are grateful for."
For the control group (List of any event), the instructions were:
"During the day, there are many events in our lives, big and small, that end up affecting us. Think about your day and write down up to five things in your life that affected you." Patients will receive a small notebook for daily notes, starting on the day of discharge. Upon discharge, text messages will be sent to their cell phones with reminders not to forget to start and continue making lists. At the end of 2 weeks of the intervention, patients will be invited to return for a reassessment interview (visit 1), and again at the end of 6 months (visit 2). A 6-month follow-up will be necessary so that we can assess changes in behavior.
To assess the improvement in self-care, the ASA-A scale will be used. To assess emotional factors, the DASS scale (which assesses anxiety, depression and stress) will be used. To assess gratitude in the face of life events, the QG-6 scale and for physical health, a dedicated questionnaire will be used. All scales will be used before and after.
- Conditions
- Myocardial Infarction, Acute
- Being tested
- Gratitude list, List of any event
- Keywords
- Psychosocial intervention, positive psychology, mental health, self-care,, Myocardial infarction
- Medical subject headings
- Myocardial Infarction, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gratitude listBehavioural
Participants must to write 3-5 words a day for 14 days about aspects of their daily experience that they are grateful for.
List of any eventBehavioural
Participants must to write 3-5 words a day for 14 days about events of your own choosing that impressed the participant during the day, whether positive or negative.
| Study group | Role | What they receive |
|---|---|---|
| Gratitude List | Experimental | Participants must to write 3-5 words a day for 14 days about aspects of their daily experience that they are grateful for. Receives: Behavioral: Gratitude list |
| List of any event | Active comparator | Participants must to write 3-5 words a day for 14 days about events of your own choosing that impressed the participant during the day, whether positive or negative. Receives: Behavioral: List of any event |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in self-care scores
Changes in self-care scores assessed from Appraisal of Self-care Agency (ASA)
Measured: From baseline to 15 days and from baseline to 6 months
Changes in negative psychological states
Changes in DASS-21 scores
Measured: From baseline to 15 days and from baseline to 6 months
Secondary outcomes (2)
Changes in gratitude scores
Changes in Gratitude Questionnaire - GQ-6 scores
Measured: From baseline to 15 days and from baseline to 6 months
Behavioral changes (physical activity, diet...)
Changes in modifiable cardiovascular risk factors: cholesterol, triglycerides, smoking cessation, etc.
Measured: From baseline to 15 days and from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start5 Nov 2022
- Primary completion5 Nov 2023 (estimated)
- Study completion5 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Infarction, AcuteStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, parallel clinical trial. The study will use a prospective experimental design with Condition and Time as independent variables. The condition has two levels that correspond to the experimental conditions: (a) Gratitude List (aspects of daily experience that one feels grateful for), (b) Any Event List (events of one's own choosing that impressed the participant during the day, whether positive or negative). Time is a repeated measures variable with three levels corresponding to the measurement times: (a) Pre-test (before the intervention), (b) Post-test (at 2 weeks after of the intervention - visit 1) and (c) ) Follow-up (from baseline to 6 months - visit 2).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 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 M SCHMIDT, Principal investigator, Institute of Cardiology of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05955950
- Sponsor's protocol ID
- UP 5797/22
- Acronym
- GReATCARE
- Status last verified
- Jun 2023
- First submitted
- 28 Jun 2023
- Last updated
- 21 Jul 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 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gratitude Intervention in Promoting Self-care and Improving Negative Psychological States in Patients With Acute Myocardial Infarction: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05955950
- Acronym / sponsor ID
- GReATCARE / UP 5797/22
- Conditions
- Myocardial Infarction, Acute
- Keywords
- Psychosocial intervention, positive psychology, mental health, self-care,, Myocardial infarction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Study start
- 5 Nov 2022 (actual)
- Primary completion
- 5 Nov 2023 (estimated)
- Study completion
- 5 Jul 2024 (estimated)
- First posted
- 21 Jul 2023 (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: Positive psychological's constructs have shown a direct effect on adherence to pharmacological treatment, diet, physical activity and general commitment to health, in the same way that negative ones, such as depression, anxiety and stress, are associated with worse cardiovascular outcomes and are prevalent in patients with infarction. Objective: To verify whether a gratitude intervention can improve self-care and improve negative psychological states in patients with recent myocardial infarction. Methods: Randomized, parallel clinical trial. The inclusion criteria will be patients with ST-segment elevation myocardial infarction (STEMI) with less than 12 hours of evolution and undergoing primary percutaneous coronary intervention (pPCI). Participants will respond to the socio-demographic and risk factors questionnaire and self-care (ASA-A), anxiety, depression and stress (DASS-21) and gratitude (QG-6) scales. They will be drawn into the gratitude intervention group or neutral events group according to the randomization list. Patients in the intervention group will be tasked with writing down 3 to 5 situations a day for which they are grateful, for 14 days. Patients in the control group will be asked to write down 3 to 5 situations a day that have impacted them, whether good or bad. Both groups will be reassessed after the intervention and after 6 months. Expected results: It is expected that the intervention group will improve self-care and the feeling of gratitude, modify behaviors and decrease negative affects, while the group without intervention will remain unchanged from the beginning of the study to 6 months.
Detailed description
Study design: Randomized, parallel clinical trial. The study will use a prospective experimental design with Condition and Time as independent variables. The condition has two levels that correspond to the experimental conditions: (a) Gratitude List (aspects of daily experience that one feels grateful for), (b) Any Event List (events of one's own choosing that impressed the participant during the day, whether positive or negative). Time is a repeated measures variable with three levels corresponding to the measurement times: (a) Pre-test (before the intervention), (b) Post-test (at 2 weeks after of the intervention - visit 1) and (c) ) Follow-up (from baseline to 6 months - visit 2).
This follow-up period is based on the previous studies. Patients will be invited to participate in the study during hospitalization for AMI. If they agree to participate, they must sign the Free and Informed Consent Form. They will answer the socio-demographic questionnaire and risk factors and self-care scales (ASA-A), anxiety, depression and stress (DASS-21) and gratitude (QG-6).
Envelopes will be opened after the initial interview. Participants will receive instructions for the intervention. Participants will be asked to allocate 10-20 minutes at the end of the day, before bed, for 14 days, to write the lists, according to their allocation group. Studies involving gratitude interventions generally last for two weeks as already explained.
In each group, participants will make a list of up to five items, evaluating the activities of that day. The instructions for the groups were adapted and translated.
For the intervention group (Gratitude List), the instructions will be:
"During the day, many things happen in our lives, big and small, for which we can be grateful. Think about your day and write down up to five things in your life that you are grateful for."
For the control group (List of any event), the instructions were:
"During the day, there are many events in our lives, big and small, that end up affecting us. Think about your day and write down up to five things in your life that affected you." Patients will receive a small notebook for daily notes, starting on the day of discharge. Upon discharge, text messages will be sent to their cell phones with reminders not to forget to start and continue making lists. At the end of 2 weeks of the intervention, patients will be invited to return for a reassessment interview (visit 1), and again at the end of 6 months (visit 2). A 6-month follow-up will be necessary so that we can assess changes in behavior.
To assess the improvement in self-care, the ASA-A scale will be used. To assess emotional factors, the DASS scale (which assesses anxiety, depression and stress) will be used. To assess gratitude in the face of life events, the QG-6 scale and for physical health, a dedicated questionnaire will be used. All scales will be used before and after.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, parallel clinical trial. The study will use a prospective experimental design with Condition and Time as independent variables. The condition has two levels that correspond to the experimental conditions: (a) Gratitude List (aspects of daily experience that one feels grateful for), (b) Any Event List (events of one's own choosing that impressed the participant during the day, whether positive or negative). Time is a repeated measures variable with three levels corresponding to the measurement times: (a) Pre-test (before the intervention), (b) Post-test (at 2 weeks after of the intervention - visit 1) and (c) ) Follow-up (from baseline to 6 months - visit 2).
| Arm | Type | Receives |
|---|---|---|
| Gratitude List | Experimental | Behavioral: Gratitude listParticipants must to write 3-5 words a day for 14 days about aspects of their daily experience that they are grateful for. |
| List of any event | Active comparator | Behavioral: List of any eventParticipants must to write 3-5 words a day for 14 days about events of your own choosing that impressed the participant during the day, whether positive or negative. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ST-segment elevation myocardial infarction (STEMI) patients
- Undergoing primary percutaneous coronary intervention (pPCI).
Key exclusion criteria (5 listed)
- Patients in need of ventilatory support;
- Over 75 years of age;
- Delirium or dementia reported by the attending physician.
- Not able to answer the questionnaires.
- Very high depression scores requiring referral to psychological care services
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 |
|---|---|---|
| Gratitude listParticipants must to write 3-5 words a day for 14 days about aspects of their daily experience that they are grateful for. | Behavioural | Gratitude List |
| List of any eventParticipants must to write 3-5 words a day for 14 days about events of your own choosing that impressed the participant during the day, whether positive or negative. | Behavioural | List of any event |
Primary outcome
Changes in self-care scores
Time frame: From baseline to 15 days and from baseline to 6 months
Changes in self-care scores assessed from Appraisal of Self-care Agency (ASA)
Changes in negative psychological states
Time frame: From baseline to 15 days and from baseline to 6 months
Changes in DASS-21 scores
2 secondary outcomes
Changes in gratitude scores
Time frame: From baseline to 15 days and from baseline to 6 months
Behavioral changes (physical activity, diet...)
Time frame: From baseline to 15 days and from baseline to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 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 M SCHMIDT principal investigator
Institute of Cardiology of 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 Gratitude list and List of any event in people with Myocardial Infarction, Acute, 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 2 inclusion and 5 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 21 Jul 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?
Changes in self-care scores (time frame: From baseline to 15 days and from baseline to 6 months). The study lists 2 primary outcomes in all. 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 21 Jul 2023.