Positive Psychology for Acute Coronary Syndrome Patients (PEACE-IV)
2020년 5월 6일 업데이트: Jeff C. Huffman, MD, Massachusetts General Hospital
Positive Psychology for Acute Coronary Syndrome Patients: a Randomized, Controlled Pilot Trial
This is a randomized controlled pilot trial in approximately 50 acute coronary syndrome patients to determine if a 12 week, telephone-delivered, combined positive psychology-motivational interviewing intervention is feasible and more effective than a motivational interviewing health education program at improving health behaviors and other outcomes.
The investigators hypothesize that the intervention will be associated with better mental and physical health outcomes and better health behavior adherence compared to the motivational interviewing health education program.
연구 개요
상태
완전한
상세 설명
The initial study visit will occur in-person two weeks after discharge from the hospital.
Participants will meet with a member of the study staff (the study "trainer") and complete self-report questionnaires assessing health behavior adherence and mental and physical health.
Then, participants will be randomized to receive the positive psychology + motivational interviewing or the motivational interviewing health education interventions.
A study interventionist will provide a treatment manual specific to their condition, review the rationale for the initial exercise, and assign the first exercise.
If the participant is in the positive psychology + motivational interviewing condition, the trainer will explain the rationale for both the positive psychology and goal-setting portions of the program, and will be assigned the first exercise.
Similarly, if the participant is randomized into the motivational interviewing health education program, the interventionist will introduce them to the program and assign the first exercise.
Participants in both groups will then be given an accelerometer, which they will be asked to wear for 7 days to ensure that they are comfortable with the device and that useable data can be obtained from the participant.
Participants in both groups will then complete twelve 30-minute weekly phone sessions with a study trainer.
The phone sessions primarily will include a review of the prior week's session content and a discussion of the rationale and assignment of the next week's exercise/assignment.
Upon the completion of these calls, and again at a final follow-up timepoint at 24 weeks, a blinded member of the study staff will call participants to administer self-report outcome measures.
Participants will also be asked to wear an accelerometer at each of these follow-up timepoints as an objective measure of physical activity, which they will return by mail to the study staff.
연구 유형
중재적
등록 (실제)
69
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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Massachusetts
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Boston, Massachusetts, 미국, 02114
- Massachusetts General Hospital
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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
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Adult patients admitted to Massachusetts General Hospital or Brigham and Women's Hospital inpatient units
- Diagnosis of acute coronary syndrome (using established criteria for myocardial infarction or unstable angina; confirmed via medical record and/or patient's treatment team)
- Age 18 or older
- Suboptimal adherence on MOS-SAS: Score < 15 OR Score = 15 with physical activity < 6
Exclusion Criteria:
- Cognitive deficits, assessed via a 6-item cognitive screen used to assess appropriate participation of medically ill patients in research studies.
- Medical conditions precluding interviews or likely to lead to death within 6 months, determined in consultation with the primary treatment team and cardiology co-investigator.
- Inability to perform moderate to vigorous physical activity, as defined by an inability to walk without aid of an assistive device such as a walker or cane, OR inability to walk at a steady pace for at least 5 minutes without stopping.
- Inability to communicate in English.
- Inability to participate in physical activity
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 긍정 심리학 + 동기 부여 인터뷰
참가자는 매주 긍정적인 심리 훈련을 완료하고 신체 활동과 관련된 목표를 체계적으로 설정합니다.
스터디 트레이너는 매주 전화로 긍정적인 심리 연습을 검토하고 목표 설정을 용이하게 하기 위해 동기 부여 인터뷰 기술을 사용할 것입니다.
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개입의 긍정적 심리학 부분에 대해 연구 트레이너는 (a) 그 주의 긍정적 심리학 연습을 검토하고, (b) 긍정적 심리학 매뉴얼의 안내된 검토를 통해 다음 주의 긍정적 심리학 연습의 근거를 논의하고, (c) 다음 주 긍정 심리 연습을 할당합니다.
동기 부여 인터뷰 부분에서 참가자는 (a) 이전 주의 신체 활동 목표를 검토하고, (b) 신체 활동을 개선하기 위한 기술을 논의하고, (c) 다음 주의 신체 활동 목표를 설정합니다.
학습 트레이너는 목표 설정을 용이하게 하기 위해 동기 부여 인터뷰 기술을 사용합니다.
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활성 비교기: Motivational Interviewing Health Education
Participants will speak on the telephone each week with a study trainer.
During these calls, the trainer will provide education about a health behavior (physical activity, medication adherence, diet, stress reduction) and assign an activity related to one health behavior each week.
Motivational interviewing techniques will be used throughout to facilitate health behavior changes.
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Each week, participants will learn about a different health behavior topic related to cardiac health.
They will also be introduced to motivational interviewing topics in concert with the health behavior education topics.
The intervention is divided into five sections, focusing on five different important cardiac health-related topics (recovery from an acute cardiac illness, physical activity, a heart-healthy diet, medication adherence, and stress reduction).
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Feasibility of the PP-MI Based Health Behavior Intervention
기간: 24 weeks
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Feasibility will be measured by examining the number of completed exercises.
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24 weeks
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Acceptability of the PP-MI Exercises: Utility Score
기간: Weeks 1-12
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Participants will provide ratings of utility after each exercise, measured on a 10-point Likert scale (0=not at all helpful; 10=very helpful).
Weekly utility ratings were averaged to provide an overall utility score of the exercises.
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Weeks 1-12
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Acceptability of the PP-MI Exercises: Ease Score
기간: Weeks 1-12
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Participants will provide ratings of ease after each exercise, measured on a 10-point Likert scale (0=very difficult; 10=very easy).
Weekly ratings were averaged to provide an overall ease of the exercises.
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Weeks 1-12
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Minutes of Moderate to Vigorous Physical Activity (Actigraph)
기간: MVPA at 12 weeks and 24 weeks
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ActiGraph GT3X+ step counters are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness.
In this trial, participants will wear the accelerometer for one week at 12 weeks, and another week at 24 weeks to assess the feasibility of doing so and to ensure adequate capture of physical activity.
In our analysis, data on pre-ACS activity was collected using the International Physical Activity Questionnaire (IPAQ) to control for baseline activity.
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MVPA at 12 weeks and 24 weeks
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Change in Medication Adherence
기간: Change in score from Baseline to 12 weeks, 24 weeks
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Measured by Self-Reported Medication Adherence (SRMA), a two-item self-report medication adherence scale measuring percentage of time (in 10% increments) patients report taking their heart medications in the past one and two weeks.
Minimum: 0, Maximum:100.
Change was calculated by subtracting the score at baseline from the score at 12 weeks and 24 weeks.
Higher score indicates greater levels of medication adherence.
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Change in score from Baseline to 12 weeks, 24 weeks
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Change in Dietary Adherence
기간: Change in score from Baseline to 12 weeks, 24 weeks
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Measured by the MEDFICTS scale, a National Cholesterol Education Program-developed scale inquiring about saturated fat.
Minimum= 0; Maximum= 216.
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate lower levels of dietary adherence.
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Change in score from Baseline to 12 weeks, 24 weeks
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Change in Positive Affect
기간: Change in score from Baseline to 12 weeks, 24 weeks
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The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with medical illnesses, will be used to measure positive affect.
(Range: 10-50).
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate higher levels of positive affect.
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Change in score from Baseline to 12 weeks, 24 weeks
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Change in Trait Optimism
기간: Change in score from baseline to 12 week, 24 week
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Life Orientation Test-Revised is a well-validated 6-item instrument used to measure dispositional optimism.
(Range: 0-24) Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate higher levels of optimism.
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Change in score from baseline to 12 week, 24 week
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Change in State Optimism
기간: Change of score from Baseline to 12 weeks, 24 weeks
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Measured by the State Optimism Scale developed by our team (SOM), which aims to capture the changeable nature of optimism based on time and situation.
Minimum:7, Maximum:35.
The higher number indicates a greater level of optimism.
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
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Change of score from Baseline to 12 weeks, 24 weeks
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Changes in HADS-A Scores
기간: Change in score from Baseline to 12 week, 24 week
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The Hospital Anxiety and Depression Scale will be used to measure depression and anxiety.
This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients.
(Range: 0-21) Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate higher levels of anxiety.
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Change in score from Baseline to 12 week, 24 week
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Change in HADS-D Scores
기간: Change in score from Baseline to 12 week, 24 week
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The Hospital Anxiety and Depression Scale will be used to measure depression and anxiety.
This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients.(Range:
0-21).
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate worse outcome (i.e.
greater levels of depression).
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Change in score from Baseline to 12 week, 24 week
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Change in Physical Function
기간: Change of score from Baseline to 12 week, 24 week
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Measured by the Duke Activity Status Index (DASI), a 12-item questionnaire that inquires about activities of daily living, basic physical activity, and more strenuous physical function to gauge overall functional capacity.
Minimum: 0, Maximum: 58.2.
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate greater levels of functional capacity.
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Change of score from Baseline to 12 week, 24 week
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Change in SF-12 Scores (Physical)
기간: Change of score from Baseline to 12 week, 24 week
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The Medical Outcomes Study Short Form-12 (SF-12) will be used to measure quality of life.
This is an instrument which has been used in multiple cardiac studies in the past.
(SF-12 Mental Composite Score and Physical Composite Score Range: 0-100 each).
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate higher level of health related QoL.
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Change of score from Baseline to 12 week, 24 week
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Change in SF-12 Scores (Mental)
기간: Change of score from baseline to 12 and 24 weeks.
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The Medical Outcomes Study Short Form-12 (SF-12) will be used to measure quality of life.
This is an instrument which has been used in multiple cardiac studies in the past.
(SF-12 Mental Composite Score and Physical Composite Score Range: 0-100 each).
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate higher level of health related QoL.
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Change of score from baseline to 12 and 24 weeks.
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Change in Adherence to Health Behaviors
기간: Change of score from Baseline to 12 week, 24 week
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Three Medical Outcomes Study Specific Adherence Scale (MOS SAS) items assessing medication, diet, and exercise, will be measured individually and as a composite score.
(Range: 3-18) Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate better adherence to health behaviors.
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Change of score from Baseline to 12 week, 24 week
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Change in Cardiac Symptoms
기간: Change of score from Baseline to 12 week, 24 week
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Measured by a checklist taken from the Women and Ischemia Syndrome Evaluation Study (WISE) to assess the presence and intensity of ten cardiac symptoms felt to best capture the range of symptoms experienced by ACS patients.
Minimum: 0, Maximum: 30.
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate greater levels of cardiac symptoms.
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Change of score from Baseline to 12 week, 24 week
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Change in Physical Activity
기간: Change of score from Baseline to 12 week, 24 week
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Measured by the self-report International Physical Activity Questionnaire (IPAQ).
The measure asseses the types of intensity of physical activity that people do as part of their daily lives.
All activities are converted to multiples of resting energy expenditure (MET) minutes per week.
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
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Change of score from Baseline to 12 week, 24 week
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Change in Perceived Stress
기간: Change of score from Baseline to 12 week, 24 week
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Measured by the Perceived Stress Scale (PSS-4) measure.
Minimum: 0, Maximum: 16.
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks Higher scores indicate greater levels of stress.
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Change of score from Baseline to 12 week, 24 week
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Jeff Huffman, MD, Massachusetts General Hospital
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 (실제)
2017년 5월 1일
기본 완료 (실제)
2018년 7월 10일
연구 완료 (실제)
2018년 11월 26일
연구 등록 날짜
최초 제출
2017년 4월 6일
QC 기준을 충족하는 최초 제출
2017년 4월 17일
처음 게시됨 (실제)
2017년 4월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 5월 14일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 5월 6일
마지막으로 확인됨
2020년 5월 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. .
긍정 심리학 + 동기 부여 인터뷰에 대한 임상 시험
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