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Positive Psychology for ACS Patients: a Factorial Design Study (PEACEIII)

Primary Purpose

Acute Coronary Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Positive Psychology (PP)
Motivational Interviewing (MI)
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring acute coronary syndrome, health behavior, factorial design, positive psychology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

PP-weekly

PP-daily

Shortened PP-weekly plus MI

Shortened PP-daily plus MI

PP-weekly with boosters

PP-daily with boosters

Shortened PP-weekly plus MI + boosters

Shortened PP-daily plus MI with boosters

Arm Description

Participants will receive the positive psychology intervention and will be asked to complete a PP exercise once per week.

Participants will receive the positive psychology intervention and will be asked to complete a PP exercise once per day.

Participants will receive a shortened version of the positive psychology intervention in addition to motivational interviewing and will be asked to complete a PP exercise once per week.

Participants will receive a shortened version of the positive psychology intervention in addition to motivational interviewing and will be asked to complete a PP exercise once per day.

Participants will receive the positive psychology intervention and will be asked to complete a PP exercise once per week. Participants will also receive three "booster" phone calls following the completion of the 8 week intervention.

Participants will receive the positive psychology intervention and will be asked to complete a PP exercise once per day. Participants will also receive three "booster" phone calls following the completion of the 8 week intervention.

Participants will receive a shortened version of the positive psychology intervention in addition to motivational interviewing and will be asked to complete a PP exercise once per week. Participants will also receive three additional "booster" phone calls following the completion of the 8 week intervention.

Participants will receive a shortened version of the positive psychology intervention in addition to motivational interviewing and will be asked to complete a PP exercise once per day. Participants will also receive three additional "booster" phone calls following the completion of the 8 week intervention.

Outcomes

Primary Outcome Measures

Physical activity
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.

Secondary Outcome Measures

Change in adherence to health behaviors, main secondary outcome
Measured by the three items from the Medical Outcomes Study-Specific Adherence Scale (MOS SAS)
Change in self-report adherence to physical activity
Measured by one item from the Medical Outcomes Study-Specific Adherence Scale (MOS SAS) which specifically asks about physical activity.
Change in positive affect
Measured by the Positive and Negative Affect Schedule (PANAS)
Change in optimism
Measured by the Life Orientation Test-Revised (LOT-R)
Change in anxiety
Measured by the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS)
Change in depression
Measured by the depression subscale of the Hospital Anxiety and Depression Scale (HADS)
Change in physical function
Measured by the Duke Activity Status Index (DASI)
Change in health-related quality of life (HRQoL)
Measured by the Short Form 12 (SF-12)
Change in medication adherence
Measured by self-report
Change in dietary adherence
Measured by the MEDFICTS scale, a National Cholesterol Education Program-developed scale inquiring about saturated fat

Full Information

First Posted
April 26, 2016
Last Updated
May 30, 2017
Sponsor
Massachusetts General Hospital
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT02754895
Brief Title
Positive Psychology for ACS Patients: a Factorial Design Study
Acronym
PEACEIII
Official Title
Positive Psychology for Acute Coronary Syndrome Patients: a Factorial Design Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
acute coronary syndrome, health behavior, factorial design, positive psychology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PP-weekly
Arm Type
Experimental
Arm Description
Participants will receive the positive psychology intervention and will be asked to complete a PP exercise once per week.
Arm Title
PP-daily
Arm Type
Experimental
Arm Description
Participants will receive the positive psychology intervention and will be asked to complete a PP exercise once per day.
Arm Title
Shortened PP-weekly plus MI
Arm Type
Experimental
Arm Description
Participants will receive a shortened version of the positive psychology intervention in addition to motivational interviewing and will be asked to complete a PP exercise once per week.
Arm Title
Shortened PP-daily plus MI
Arm Type
Experimental
Arm Description
Participants will receive a shortened version of the positive psychology intervention in addition to motivational interviewing and will be asked to complete a PP exercise once per day.
Arm Title
PP-weekly with boosters
Arm Type
Experimental
Arm Description
Participants will receive the positive psychology intervention and will be asked to complete a PP exercise once per week. Participants will also receive three "booster" phone calls following the completion of the 8 week intervention.
Arm Title
PP-daily with boosters
Arm Type
Experimental
Arm Description
Participants will receive the positive psychology intervention and will be asked to complete a PP exercise once per day. Participants will also receive three "booster" phone calls following the completion of the 8 week intervention.
Arm Title
Shortened PP-weekly plus MI + boosters
Arm Type
Experimental
Arm Description
Participants will receive a shortened version of the positive psychology intervention in addition to motivational interviewing and will be asked to complete a PP exercise once per week. Participants will also receive three additional "booster" phone calls following the completion of the 8 week intervention.
Arm Title
Shortened PP-daily plus MI with boosters
Arm Type
Experimental
Arm Description
Participants will receive a shortened version of the positive psychology intervention in addition to motivational interviewing and will be asked to complete a PP exercise once per day. Participants will also receive three additional "booster" phone calls following the completion of the 8 week intervention.
Intervention Type
Other
Intervention Name(s)
Positive Psychology (PP)
Intervention Description
Positive psychology (PP) interventions aim to improve the frequency and intensity of positive emotional experiences. This positive psychology intervention focuses on targeted activities in several domains, including altruism (e.g., performing acts of kindness), gratitude (e.g., systematically recalling positive life events), using one's personal strengths in a deliberate manner, and optimism (e.g., thinking about past successes and applying these skills to the future).
Intervention Type
Other
Intervention Name(s)
Motivational Interviewing (MI)
Intervention Description
MI is a goal-oriented, patient-centered approach to helping patients resolve their ambivalence to change their health behaviors. 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 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.
Primary Outcome Measure Information:
Title
Physical activity
Description
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.
Time Frame
16 weeks (primary outcome for all analyses)
Secondary Outcome Measure Information:
Title
Change in adherence to health behaviors, main secondary outcome
Description
Measured by the three items from the Medical Outcomes Study-Specific Adherence Scale (MOS SAS)
Time Frame
Baseline, 8 week, 16 week
Title
Change in self-report adherence to physical activity
Description
Measured by one item from the Medical Outcomes Study-Specific Adherence Scale (MOS SAS) which specifically asks about physical activity.
Time Frame
Baseline, 8 week, 16 week
Title
Change in positive affect
Description
Measured by the Positive and Negative Affect Schedule (PANAS)
Time Frame
Baseline, 8 week, 16 week
Title
Change in optimism
Description
Measured by the Life Orientation Test-Revised (LOT-R)
Time Frame
Baseline, 8 week, 16 week
Title
Change in anxiety
Description
Measured by the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS)
Time Frame
Baseline, 8 week, 16 week
Title
Change in depression
Description
Measured by the depression subscale of the Hospital Anxiety and Depression Scale (HADS)
Time Frame
Baseline, 8 week, 16 week
Title
Change in physical function
Description
Measured by the Duke Activity Status Index (DASI)
Time Frame
Baseline, 8 week, 16 week
Title
Change in health-related quality of life (HRQoL)
Description
Measured by the Short Form 12 (SF-12)
Time Frame
Baseline, 8 week, 16 week
Title
Change in medication adherence
Description
Measured by self-report
Time Frame
Baseline, 8 week, 16 week
Title
Change in dietary adherence
Description
Measured by the MEDFICTS scale, a National Cholesterol Education Program-developed scale inquiring about saturated fat
Time Frame
Baseline, 8 week, 16 week
Other Pre-specified Outcome Measures:
Title
Feasibility of the intervention
Description
Measured using rates of session completion (i.e., completion of both the prior week's PP activity and the session call) and completion of study follow-up assessments (including self-report phone assessments, accelerometer use, and use of the electronic pillcaps).
Time Frame
16 weeks
Title
Acceptability of the intervention
Description
Measured by weekly 0-10 ratings of each PP exercise. Positive affect and optimism are rated immediately prior to completing the assigned PP exercise for that week and then immediately following completion of the exercise. Also, the participants provide post-exercise ratings of the exercise's ease of completion and utility.
Time Frame
16 weeks
Title
Overall effect of intervention
Description
Measured by pre-post changes in self-reported adherence, depressive symptoms, anxiety, optimism, and positive affect.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Huffman, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31280918
Citation
Duque L, Brown L, Celano CM, Healy B, Huffman JC. Is it better to cultivate positive affect or optimism? Predicting improvements in medical adherence following a positive psychology intervention in patients with acute coronary syndrome. Gen Hosp Psychiatry. 2019 Nov-Dec;61:125-129. doi: 10.1016/j.genhosppsych.2019.06.001. Epub 2019 Jun 4.
Results Reference
derived
PubMed Identifier
29624523
Citation
Celano CM, Albanese AM, Millstein RA, Mastromauro CA, Chung WJ, Campbell KA, Legler SR, Park ER, Healy BC, Collins LM, Januzzi JL, Huffman JC. Optimizing a Positive Psychology Intervention to Promote Health Behaviors After an Acute Coronary Syndrome: The Positive Emotions After Acute Coronary Events III (PEACE-III) Randomized Factorial Trial. Psychosom Med. 2018 Jul/Aug;80(6):526-534. doi: 10.1097/PSY.0000000000000584.
Results Reference
derived

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Positive Psychology for ACS Patients: a Factorial Design Study

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