Positive Psychology for Acute Coronary Syndrome Patients (PEACE-IV)
2020年5月6日 更新者：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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
69
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Massachusetts
-
Boston、Massachusetts、美国、02114
- Massachusetts General Hospital
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：积极心理学+励志访谈
参与者将每周完成积极心理学练习，并系统地设定与身体活动相关的目标。
学习培训师每周都会在电话中复习积极心理学练习，并将使用动机性访谈技巧来促进目标设定。
|
对于干预的积极心理学部分，研究培训师将 (a) 回顾本周的积极心理学练习，(b) 通过积极心理学手册的指导回顾讨论下周积极心理学练习的基本原理，以及 (c)分配下周的积极心理学练习。
对于动机性访谈部分，参与者将 (a) 回顾他们前一周的身体活动目标，(b) 讨论改善身体活动的技巧，以及 (c) 设定下周的身体活动目标。
研究培训师将使用动机性访谈技巧来促进目标设定。
|
|
有源比较器：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.
|
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).
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Feasibility of the PP-MI Based Health Behavior Intervention
大体时间：24 weeks
|
Feasibility will be measured by examining the number of completed exercises.
|
24 weeks
|
|
Acceptability of the PP-MI Exercises: Utility Score
大体时间：Weeks 1-12
|
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.
|
Weeks 1-12
|
|
Acceptability of the PP-MI Exercises: Ease Score
大体时间：Weeks 1-12
|
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.
|
Weeks 1-12
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Minutes of Moderate to Vigorous Physical Activity (Actigraph)
大体时间：MVPA at 12 weeks and 24 weeks
|
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.
|
MVPA at 12 weeks and 24 weeks
|
|
Change in Medication Adherence
大体时间：Change in score from Baseline to 12 weeks, 24 weeks
|
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.
|
Change in score from Baseline to 12 weeks, 24 weeks
|
|
Change in Dietary Adherence
大体时间：Change in score from Baseline to 12 weeks, 24 weeks
|
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.
|
Change in score from Baseline to 12 weeks, 24 weeks
|
|
Change in Positive Affect
大体时间：Change in score from Baseline to 12 weeks, 24 weeks
|
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.
|
Change in score from Baseline to 12 weeks, 24 weeks
|
|
Change in Trait Optimism
大体时间：Change in score from baseline to 12 week, 24 week
|
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.
|
Change in score from baseline to 12 week, 24 week
|
|
Change in State Optimism
大体时间：Change of score from Baseline to 12 weeks, 24 weeks
|
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.
|
Change of score from Baseline to 12 weeks, 24 weeks
|
|
Changes in HADS-A Scores
大体时间：Change in score from Baseline to 12 week, 24 week
|
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.
|
Change in score from Baseline to 12 week, 24 week
|
|
Change in HADS-D Scores
大体时间：Change in score from Baseline to 12 week, 24 week
|
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).
|
Change in score from Baseline to 12 week, 24 week
|
|
Change in Physical Function
大体时间：Change of score from Baseline to 12 week, 24 week
|
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.
|
Change of score from Baseline to 12 week, 24 week
|
|
Change in SF-12 Scores (Physical)
大体时间：Change of score from Baseline to 12 week, 24 week
|
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.
|
Change of score from Baseline to 12 week, 24 week
|
|
Change in SF-12 Scores (Mental)
大体时间：Change of score from baseline to 12 and 24 weeks.
|
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.
|
Change of score from baseline to 12 and 24 weeks.
|
|
Change in Adherence to Health Behaviors
大体时间：Change of score from Baseline to 12 week, 24 week
|
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.
|
Change of score from Baseline to 12 week, 24 week
|
|
Change in Cardiac Symptoms
大体时间：Change of score from Baseline to 12 week, 24 week
|
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.
|
Change of score from Baseline to 12 week, 24 week
|
|
Change in Physical Activity
大体时间：Change of score from Baseline to 12 week, 24 week
|
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.
|
Change of score from Baseline to 12 week, 24 week
|
|
Change in Perceived Stress
大体时间：Change of score from Baseline to 12 week, 24 week
|
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.
|
Change of score from Baseline to 12 week, 24 week
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Jeff Huffman, MD、Massachusetts General Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年5月1日
初级完成 (实际的)
2018年7月10日
研究完成 (实际的)
2018年11月26日
研究注册日期
首次提交
2017年4月6日
首先提交符合 QC 标准的
2017年4月17日
首次发布 (实际的)
2017年4月20日
研究记录更新
最后更新发布 (实际的)
2020年5月14日
上次提交的符合 QC 标准的更新
2020年5月6日
最后验证
2020年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.