跳至主要内容
临床试验/NCT02481544
NCT02481544已完成不适用

The Effects of Journaling on Health-Related Mood and Clinical Outcomes in Post-MI Patients

University of California, San Diego2 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2015年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
108
试验地点
2
主要终点
Treatment Expectancy & Satisfaction assessed by Treatment expectancy and satisfaction - 6 item credibility/ expectancy questionnaire (CEQ) will be utilized

研究概览

简要总结

Psychosocial factors, including positive affect, finding meaning in the event, and managing emotional distress, influence prognosis following a heart attack or myocardial infarction (MI). Gratitude, typically defined as a feeling or attitude in acknowledgment of a benefit that one has received or will receive, is associated with higher levels of well-being, and people who are more grateful experience less stress, are less depressed, have higher levels of control over their environment, and more positive ways of coping. The present project will examine the potential benefits of a gratitude intervention (i.e., 8 weeks of gratitude journaling) to increase positive health behaviors, psychological health, and physical functioning in post-MI patients as compared to journaling about memorable events as well as care as usual alone. The investigators will study psychological and physical functioning at baseline, following 8 weeks of gratitude journaling or care as usual, and at 4-month follow-up.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
35 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Gratitude Journaling Plus Standard of Care

Experimental

The most often used gratitude intervention consists of journaling, writing lists of things for which the individual is grateful. This technique was first employed and found to be effectual for enhancing wellbeing by Emmons and McCullough and has been suggested to be as effective as methods frequently used in clinical therapy. We are proposing an 8-week intervention in which the participant records 3-5 things for which they are grateful most days of the week. A longer intervention was chosen because Emmons and McCullough (2003) suggest that healthy behavior changes only occurred in a prolonged multi-week intervention. To ensure some conformity in the intervention, instructions that will be used will be similar to Emmons and McCullough (2003): "There are many things in our lives, both large and small, that we might be grateful about. Think back over your day (week) and write down on the lines below up to five things in your life that you are grateful or thankful for."

干预措施: Gratitude Journaling Plus SOC (Behavioral)

Memorable Events Journaling Plus Standard of Care

Sham Comparator

In the sham control condition, individuals will record "memorable events" with methods identical to the gratitude journaling condition: Patients will be asked to record 3-5 memorable events in a given day, on most days of the week. Patients will be contacted once per week to remind them to continue with the memorable events journal. Patients will be given 2 journals during their first testing session (one journal is for the first four weeks and the second is for the second four weeks of journaling). Patients will be contacted once per week to remind them to continue with gratitude journal writing. Patients will be instructed to record the date of each journal entry next to each new day of journaling Patients will be provided with materials to return their first journal by mail and will and return their second journal at the T2 laboratory testing session.

干预措施: Memorable Events Journaling Plus SOC (Behavioral)

Standard of Care

No Intervention

SOC consists of medical care that is included in post-MI treatment, such as physician visits and medication adjustments and cardiac rehabilitation. These patients will not have any active intervention, but will undergo the same testing routine as the gratitude intervention group. These patients will be given the opportunity to participate in the gratitude journaling intervention after they have completed the study. Patient records will be evaluated at each timepoint for changes in medications and medical treatment.

结局指标

主要结局

Treatment Expectancy & Satisfaction assessed by Treatment expectancy and satisfaction - 6 item credibility/ expectancy questionnaire (CEQ) will be utilized

时间窗: 2 years

Feasibility assessed by Recruitment rates will be recorded and new recruitment strategies will be formulated to overcome barriers presented by decliners for a future study.

时间窗: 2 years

Adherence assessed by Adherence to intervention will be derived from gratitude journals.

时间窗: 2 years

Retention assessed by Retention (% of drop-outs) will be recorded, and exit interviews will be administered to determine reasons for drop-out.

时间窗: 2 years

次要结局

  • Gratitude(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Paul J. Mills

Professor IR

University of California, San Diego

研究点 (2)

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