The Effects of Journaling on Health-Related Mood and Clinical Outcomes in Post-MI Patients (GRAT2015)
2019年10月7日 更新者：Paul J. Mills、University of California, San Diego
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.
調査の概要
状態
完了
研究の種類
介入
入学 (予想される)
108
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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California
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La Jolla、California、アメリカ、92093
- University of California, San Diego
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
35年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion criteria:
- Suffered an MI (ST Elevation MI (STEMI) or Non-ST Elevation MI (NSTEMI) with creatine kinase MB fraction elevation 3 times the upper limits of normal and with ischemic ECG changes within 12 months of baseline testing;
- An EF less than 50% on echocardiogram;
- Clinically stable defined as, no active arrhythmia, no residual ischemia;
- Able to perform light to moderate exercise;
- Able to give informed consent in English;
- Medical clearance by their cardiologist;
- > 35 years of age.
Exclusion criteria:
- Unstable angina;
- Severe valvular disease;
- Oxygen-dependent COPD;
- Recent stroke or significant cerebral neurologic impairment;
- Suicidality with intent or plan;
- Current cancer;
- Currently taking mood stabilizers, benzodiazepines or antipsychotics;
- Medications (e.g., systemic steroids) and conditions affecting immune status (e.g., rheumatoid arthritis, hepatitis C, HIV) (Anti-depressant medication is allowed);
- Currently enrolled in another clinical trial.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Gratitude Journaling Plus Standard of Care
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."
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偽コンパレータ：Memorable Events Journaling Plus Standard of Care
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.
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介入なし：Standard of Care
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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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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.
時間枠：2 years
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2 years
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Treatment Expectancy & Satisfaction assessed by Treatment expectancy and satisfaction - 6 item credibility/ expectancy questionnaire (CEQ) will be utilized
時間枠：2 years
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2 years
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Retention assessed by Retention (% of drop-outs) will be recorded, and exit interviews will be administered to determine reasons for drop-out.
時間枠：2 years
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2 years
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Adherence assessed by Adherence to intervention will be derived from gratitude journals.
時間枠：2 years
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2 years
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Gratitude
時間枠：2 years
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There are three scales that have been developed to measure gratitude, the Gratitude Questionnaire (GQ-6) (McCullough et al., 2002), Appreciation Scale (Adler & Fagley, 2005), and Gratitude, Appreciation, and Resentment Test (GRAT).
Each scale came from a different concept of gratitude, and in concert they provide a broad definition of gratitude.
According to Wood, Maltby, Stewart and Joseph (2008) the three scales comprise 12 sub-scales which measure eight different components of gratitude: (1) grateful affect, (2) appreciation of other people, (3) a focus on what the person has, (4) feelings of awe when encountering beauty, (4) behaviors to express gratitude, (5) focusing on the positive in the present moment, (6) appreciation rising from understanding life is short, (7) a focus on the positive in the present moment, and (8) positive social comparisons.
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2 years
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2015年4月1日
一次修了 (実際)
2018年12月1日
研究の完了 (実際)
2019年1月1日
試験登録日
最初に提出
2015年6月23日
QC基準を満たした最初の提出物
2015年6月24日
最初の投稿 (見積もり)
2015年6月25日
学習記録の更新
投稿された最後の更新 (実際)
2019年10月8日
QC基準を満たした最後の更新が送信されました
2019年10月7日
最終確認日
2019年10月1日
詳しくは
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