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临床试验/NCT02754895
NCT02754895已完成不适用

Positive Psychology for Acute Coronary Syndrome Patients: a Factorial Design Study

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2014年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
128
试验地点
2
主要终点
Physical activity

研究概览

简要总结

This trial is part of a multi-phase study to develop and test positive psychology (PP) interventions in patients hospitalized for an acute coronary syndrome (ACS).Using a factorial design, the investigators will: (a) assess the optimal frequency of exercise completion, (b) determine the utility of 'booster sessions' after an initial 8-week intervention, and (c) determine the relative merits of utilizing PP exercises alone versus an intervention combining PP with motivational interviewing (MI).

详细描述

The investigators have completed the intervention development and pilot phases (PEACE and PEACEII), and are now aiming to optimize our PP intervention for the target population prior to testing it in a randomized, controlled trial.

The investigators will recruit patients from MGH and Brigham and Women's Hospital (BWH) inpatient units who are admitted with a primary cardiac diagnosis of ACS. Following the completion of baseline outcome measures, participants will be randomized to one of eight treatment conditions. All participants will complete PP exercises at least weekly and will speak with a study trainer weekly for eight weeks. Those receiving the PP-only intervention (conditions 1, 2, 5, 6) will speak to a study trainer for 30 minutes each week. Participants in Conditions 3, 4, 7, and 8 will be enrolled in a combined PP plus motivational interviewing (MI)/goal setting program. Accordingly, their weekly phone sessions will focus on the PP program for 15 minutes, then the MI/goal setting program for an additional 15 minutes. These calls will be recorded, and a percentage of calls will be reviewed to ensure that the PP and MI/goal setting portions of the intervention are being delivered as described in the protocol and trainer manual. Half of the participants (conditions 1, 3, 5, 7) will be instructed to perform the PP exercises once per week while the other half (conditions 2, 4, 6, 8) will be asked to perform them once daily. Finally, half of the participants (those in conditions 5-8) will receive three additional 'booster' phone sessions during weeks 10, 12, and 14. These sessions will focus on integrating PP-related skills into daily life. For participants in the PP+MI condition, booster sessions also will focus on maintaining the health behavior changes that they made during the main portion of the study.

The PP exercises used in this study were selected based on their superior performance in our pre-pilot research and others' work: Gratitude for Positive Events (Week 1), Using personal strengths (Week 2), Gratitude letter/Expressions of Gratitude (Week 3), Capitalizing on Positive Events (Week 4), Remembering past success/Remembering daily successes (Week 5), Enjoyable and meaningful activities (Week 6), Humor in everyday life (Week 7), and Performing acts of kindness & Next Steps (Week 8). Participants in conditions 5-8 will have three additional bi-weekly "maintaining your gains" sessions (week 10, 12, and 14) in order to identify favorite exercises, explore the skills derived from doing the exercises, and learn how to integrate the exercises in their daily lives.

For the MI/goal setting portion of the intervention, each session follows the same structure. Study trainers will: (a) ask participants about their health goals, (b) advise them about current health guidelines and/or refer them to their treatment team, (c) assess readiness to set a goal by identifying how important participants feel the goal is, how confident participants are about making a change, and what the participants' pros and cons are for making a change, (d) assist participants in clarifying their goals and problem-solving barriers to reaching those goals, and (e) arrange for the next session by summarizing the participant's plan and scheduling the next session. The structure of the sessions will follow the PP structure according to each condition.

At Weeks 8 and 16, a member of the study staff will call participants to repeat the self-report questionnaires that were administered at baseline. Furthermore, at Weeks 8 and 16, participants will wear an ActiGraph step counter for 10 days as a measure of physical activity. At 3 and 6 months post enrollment, a research coordinator will call participants to ask some brief questions concerning their health, well-being, adherence to health behaviors, and the application of positive psychology and motivational interviewing skills in everyday life.

研究设计

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

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 MGH or BWH 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 with 6-item screen
  • Inability to participate in physical activity
  • Medical conditions precluding interviews or likely to lead to death within 6 months
  • Inability to read/write in English

结局指标

主要结局

Physical activity

时间窗: 16 weeks (primary outcome for all analyses)

To assess which components of the intervention (daily vs. weekly exercise completion, booster vs. no booster sessions, PP only vs. PP + MI) are associated with the greatest physical activity measured by the Actigraph accelerometer (steps) at 16 weeks.

次要结局

  • Change in adherence to health behaviors, main secondary outcome(Baseline, 8 week, 16 week)
  • Change in anxiety(Baseline, 8 week, 16 week)
  • Change in dietary adherence(Baseline, 8 week, 16 week)
  • Change in depression(Baseline, 8 week, 16 week)
  • Change in medication adherence(Baseline, 8 week, 16 week)
  • Change in self-report adherence to physical activity(Baseline, 8 week, 16 week)
  • Change in positive affect(Baseline, 8 week, 16 week)
  • Change in optimism(Baseline, 8 week, 16 week)
  • Change in physical function(Baseline, 8 week, 16 week)
  • Change in health-related quality of life (HRQoL)(Baseline, 8 week, 16 week)

研究者

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

Jeff C. Huffman, MD

Medical Director of Inpatient Psychiatric Unit

Massachusetts General Hospital

研究点 (2)

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