The Effects of Journaling on Health-Related Mood and Clinical Outcomes in Post-MI Patients (GRAT2015)
2019년 10월 7일 업데이트: 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.
연구 개요
상태
완전한
연구 유형
중재적
등록 (예상)
108
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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California
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La Jolla, California, 미국, 92093
- University of California, San Diego
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
35년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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가짜 비교기: 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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간섭 없음: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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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.
기간: 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
기간: 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.
기간: 2 years
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2 years
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Adherence assessed by Adherence to intervention will be derived from gratitude journals.
기간: 2 years
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2 years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Gratitude
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2015년 4월 1일
기본 완료 (실제)
2018년 12월 1일
연구 완료 (실제)
2019년 1월 1일
연구 등록 날짜
최초 제출
2015년 6월 23일
QC 기준을 충족하는 최초 제출
2015년 6월 24일
처음 게시됨 (추정)
2015년 6월 25일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 10월 8일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 10월 7일
마지막으로 확인됨
2019년 10월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .