AzTrials
AzTrials

Acute Coronary SyndromePEACEIIINCT02754895

Positive Psychology for ACS Patients: a Factorial Design Study

A study testing Positive Psychology (PP) and Motivational Interviewing (MI) in people with Acute Coronary Syndrome, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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'… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Coronary Syndrome
What is being tested?
Positive Psychology (PP) and Motivational Interviewing (MI)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
1 siteUnited States
Study dates
Oct 2014to May 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

Other trials in United States

About this study

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

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).

Read the 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.

Being tested
Positive Psychology (PP), Motivational Interviewing (MI)
Keywords
acute coronary syndrome, health behavior, factorial design, positive psychology
Medical subject headings
Acute Coronary Syndrome, Health Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Positive Psychology (PP)Other

    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).

  • Motivational Interviewing (MI)Other

    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.

Study groups in NCT02754895
Study groupRoleWhat they receive
PP-weeklyExperimentalParticipants will receive the positive psychology intervention and will be asked to complete a PP exercise once per week.
Receives: Other: Positive Psychology (PP)
PP-dailyExperimentalParticipants will receive the positive psychology intervention and will be asked to complete a PP exercise once per day.
Receives: Other: Positive Psychology (PP)
Shortened PP-weekly plus MIExperimentalParticipants 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.
Receives: Other: Positive Psychology (PP); Other: Motivational Interviewing (MI)
Shortened PP-daily plus MIExperimentalParticipants 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.
Receives: Other: Positive Psychology (PP); Other: Motivational Interviewing (MI)
PP-weekly with boostersExperimentalParticipants 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.
Receives: Other: Positive Psychology (PP)
PP-daily with boostersExperimentalParticipants 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.
Receives: Other: Positive Psychology (PP)
Shortened PP-weekly plus MI + boostersExperimentalParticipants 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.
Receives: Other: Positive Psychology (PP); Other: Motivational Interviewing (MI)
Shortened PP-daily plus MI with boostersExperimentalParticipants 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.
Receives: Other: Positive Psychology (PP); Other: Motivational Interviewing (MI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 16 weeks (primary outcome for all analyses)

Secondary outcomes (10)
  1. Change in adherence to health behaviors, main secondary outcome

    Measured by the three items from the Medical Outcomes Study-Specific Adherence Scale (MOS SAS)

    Measured: Baseline, 8 week, 16 week

  2. 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.

    Measured: Baseline, 8 week, 16 week

  3. Change in positive affect

    Measured by the Positive and Negative Affect Schedule (PANAS)

    Measured: Baseline, 8 week, 16 week

  4. Change in optimism

    Measured by the Life Orientation Test-Revised (LOT-R)

    Measured: Baseline, 8 week, 16 week

  5. Change in anxiety

    Measured by the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS)

    Measured: Baseline, 8 week, 16 week

  6. Change in depression

    Measured by the depression subscale of the Hospital Anxiety and Depression Scale (HADS)

    Measured: Baseline, 8 week, 16 week

  7. Change in physical function

    Measured by the Duke Activity Status Index (DASI)

    Measured: Baseline, 8 week, 16 week

  8. Change in health-related quality of life (HRQoL)

    Measured by the Short Form 12 (SF-12)

    Measured: Baseline, 8 week, 16 week

  9. Change in medication adherence

    Measured by self-report

    Measured: Baseline, 8 week, 16 week

  10. Change in dietary adherence

    Measured by the MEDFICTS scale, a National Cholesterol Education Program-developed scale inquiring about saturated fat

    Measured: Baseline, 8 week, 16 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2016 (estimated)
  2. Study startOct 2014
  3. Primary completionMay 2017
  4. Study completionMay 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02754895
Sponsor's protocol ID
2014P001756
Other IDs
4R01HL113272-04
Acronym
PEACEIII
Status last verified
May 2017
First submitted
26 Apr 2016
Last updated
1 Jun 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 31280918
  • 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.

    PubMed 29624523

Questions about this trial

What is this clinical trial studying?

A study testing Positive Psychology (PP) and Motivational Interviewing (MI) in people with Acute Coronary Syndrome, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical activity (time frame: 16 weeks (primary outcome for all analyses)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02754895, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2017.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in