Gratitude Intervention in Promoting Self-care in Patients With Myocardial Infarction (GReATCARE)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Myocardial Infarction, Acute
• Intervention / Treatment: Behavioral: Gratitude list; Behavioral: List of any event

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 Type: Interventional
• Enrollment (Estimated): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90620-000
      • Marcia Moura Schmidt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ST-segment elevation myocardial infarction (STEMI) patients
• Undergoing primary percutaneous coronary intervention (pPCI).

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gratitude List; Participants must to write 3-5 words a day for 14 days about aspects of their daily experience that they are grateful for.	Behavioral: Gratitude list; Participants must to write 3-5 words a day for 14 days about aspects of their daily experience that they are grateful for.
Active Comparator: List of any event; 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.	Behavioral: List of any event; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in self-care scores	Changes in self-care scores assessed from Appraisal of Self-care Agency (ASA)	From baseline to 15 days and from baseline to 6 months
Changes in negative psychological states	Changes in DASS-21 scores	From baseline to 15 days and from baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in gratitude scores	Changes in Gratitude Questionnaire - GQ-6 scores	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.	From baseline to 15 days and from baseline to 6 months

Collaborators and Investigators

• Sponsor: Instituto de Cardiologia do Rio Grande do Sul
• Investigators: Principal Investigator: MARCIA M SCHMIDT, Institute of Cardiology of Rio Grande do Sul

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2022
• Primary Completion (Estimated): November 5, 2023
• Study Completion (Estimated): July 5, 2024

Study Registration Dates

• First Submitted: June 28, 2023
• First Submitted That Met QC Criteria: July 13, 2023
• First Posted (Actual): July 21, 2023

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Myocardial infarction; mental health; positive psychology; Psychosocial intervention; self-care,
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: UP 5797/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No