Positive Psychology for ACS Patients: a Factorial Design Study
PEACEIII
Positive Psychology for Acute Coronary Syndrome Patients: a Factorial Design Study
2 other identifiers
interventional
128
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 26, 2016
CompletedFirst Posted
Study publicly available on registry
April 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedJune 1, 2017
May 1, 2017
2.6 years
April 26, 2016
May 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
16 weeks (primary outcome for all analyses)
Secondary Outcomes (10)
Change in adherence to health behaviors, main secondary outcome
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 anxiety
Baseline, 8 week, 16 week
- +5 more secondary outcomes
Other Outcomes (3)
Feasibility of the intervention
16 weeks
Acceptability of the intervention
16 weeks
Overall effect of intervention
16 weeks
Study Arms (8)
PP-weekly
EXPERIMENTALParticipants will receive the positive psychology intervention and will be asked to complete a PP exercise once per week.
PP-daily
EXPERIMENTALParticipants will receive the positive psychology intervention and will be asked to complete a PP exercise once per day.
Shortened PP-weekly plus MI
EXPERIMENTALParticipants 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.
Shortened PP-daily plus MI
EXPERIMENTALParticipants 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.
PP-weekly with boosters
EXPERIMENTALParticipants 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.
PP-daily with boosters
EXPERIMENTALParticipants 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.
Shortened PP-weekly plus MI + boosters
EXPERIMENTALParticipants 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.
Shortened PP-daily plus MI with boosters
EXPERIMENTALParticipants 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.
Interventions
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).
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (2)
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.
PMID: 31280918DERIVEDCelano 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.
PMID: 29624523DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeff Huffman, MD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Director of Inpatient Psychiatric Unit
Study Record Dates
First Submitted
April 26, 2016
First Posted
April 28, 2016
Study Start
October 1, 2014
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
June 1, 2017
Record last verified: 2017-05