Gratitude Intervention in Promoting Self-care in Patients With Myocardial Infarction

NCT05955950 | Unknown

• 1 other identifier: UP 5797/22
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Myocardial Infarction, Acute

Keywords

Psychosocial intervention; positive psychology; mental health; self-care,; Myocardial infarction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Changes in gratitude scores

  From baseline to 15 days and from baseline to 6 months

• Behavioral changes (physical activity, diet...)

  From baseline to 15 days and from baseline to 6 months

Study Arms (2)

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.

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.

Behavioral: List of any event

Interventions

Gratitude list BEHAVIORAL

Participants must to write 3-5 words a day for 14 days about aspects of their daily experience that they are grateful for.

Gratitude List

List of any event BEHAVIORAL

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.

List of any event

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto de Cardiologia do Rio Grande do Sul: lead

Study Sites (1)

Marcia Moura Schmidt

Porto Alegre, Rio Grande do Sul, 90620-000, Brazil

Location

MeSH Terms

Conditions

Myocardial Infarction; Psychological Well-Being

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Personal Satisfaction; Behavior

Study Officials

• MARCIA M SCHMIDT

  Institute of Cardiology of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Neither the researcher nor the participants will be blind to the group to which they were allocated. Because the first will give the necessary guidance and the second will have knowledge of the existing groups through the TCLE and at the time they receive the instructions. Blinding will only occur for the research participant (scientific initiation scholarship holder or volunteer) who must carry out the return interviews and the application of the questionnaires soon after the end of the intervention and in the 6-month follow-up. Primary outcome: Self-care and negative psychological states Secondary outcomes: Change in behavior (physical activity, diet...) and gratitude.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: July 21, 2023
• Study Start: November 5, 2022
• Primary Completion: November 5, 2023
• Study Completion: July 5, 2024
• Last Updated: July 21, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)