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临床试验/NCT03122184
NCT03122184已完成不适用

Positive Psychology for Acute Coronary Syndrome Patients: a Randomized, Controlled Pilot Trial

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2017年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
69
试验地点
2
主要终点
Feasibility of the PP-MI Based Health Behavior Intervention

研究概览

简要总结

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.

详细描述

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.

研究设计

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

盲法说明

Participants and treating study staff will be aware of the patient's treatment condition. However, follow-up assessments will be performed by a study staff member that is masked to the participant's treatment condition.

入排标准

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

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Feasibility of the PP-MI Based Health Behavior Intervention

时间窗: 24 weeks

Feasibility will be measured by examining the number of completed exercises.

Acceptability of the PP-MI Exercises: Utility Score

时间窗: 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.

Acceptability of the PP-MI Exercises: Ease Score

时间窗: 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.

次要结局

  • Minutes of Moderate to Vigorous Physical Activity (Actigraph)(MVPA at 12 weeks and 24 weeks)
  • Change in Medication Adherence(Change in score from Baseline to 12 weeks, 24 weeks)
  • Change in Dietary Adherence(Change in score from Baseline to 12 weeks, 24 weeks)
  • Change in Positive Affect(Change in score from Baseline to 12 weeks, 24 weeks)
  • Change in Trait Optimism(Change in score from baseline to 12 week, 24 week)
  • Change in State Optimism(Change of score from Baseline to 12 weeks, 24 weeks)
  • Changes in HADS-A Scores(Change in score from Baseline to 12 week, 24 week)
  • Change in HADS-D Scores(Change in score from Baseline to 12 week, 24 week)
  • Change in Physical Function(Change of score from Baseline to 12 week, 24 week)
  • Change in SF-12 Scores (Physical)(Change of score from Baseline to 12 week, 24 week)
  • Change in SF-12 Scores (Mental)(Change of score from baseline to 12 and 24 weeks.)
  • Change in Adherence to Health Behaviors(Change of score from Baseline to 12 week, 24 week)
  • Change in Cardiac Symptoms(Change of score from Baseline to 12 week, 24 week)
  • Change in Physical Activity(Change of score from Baseline to 12 week, 24 week)
  • Change in Perceived Stress(Change of score from Baseline to 12 week, 24 week)

研究者

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

Jeff C. Huffman, MD

Associate Chief of Psychiatry for Clinical Services

Massachusetts General Hospital

研究点 (2)

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