Gratitude Intervention in Promoting Self-care and Improving Negative Psychological States in Patients With Acute Myocardial Infarction: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Changes in self-care scores
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ST-segment elevation myocardial infarction (STEMI) patients
- •Undergoing primary percutaneous coronary intervention (pPCI).
排除标准
- •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
结局指标
主要结局
Changes in self-care scores
时间窗: 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
时间窗: From baseline to 15 days and from baseline to 6 months
Changes in DASS-21 scores
次要结局
- 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)