Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05955950 |
| Other study ID # |
UP 5797/22 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 5, 2022 |
| Est. completion date |
July 5, 2024 |
Study information
| Verified date |
June 2023 |
| Source |
Instituto de Cardiologia do Rio Grande do Sul |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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.
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.
