Positive Psychology for ACS Patients: a Factorial Design Study

Acute Coronary Syndrome Clinical Trial

— PEACEIII  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02754895
• Other study ID #: 2014P001756
• Secondary ID: 4R01HL113272-04
• Status: Completed
• Phase: N/A
• First received: April 26, 2016
• Last updated: May 30, 2017
• Start date: October 2014
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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' 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Other:
• Positive Psychology (PP)
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)
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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feasibility of the intervention	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).	16 weeks
Other	Acceptability of the intervention	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.	16 weeks
Other	Overall effect of intervention	Measured by pre-post changes in self-reported adherence, depressive symptoms, anxiety, optimism, and positive affect.	16 weeks
Primary	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	Change in adherence to health behaviors, main secondary outcome	Measured by the three items from the Medical Outcomes Study-Specific Adherence Scale (MOS SAS)	Baseline, 8 week, 16 week
Secondary	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.	Baseline, 8 week, 16 week
Secondary	Change in positive affect	Measured by the Positive and Negative Affect Schedule (PANAS)	Baseline, 8 week, 16 week
Secondary	Change in optimism	Measured by the Life Orientation Test-Revised (LOT-R)	Baseline, 8 week, 16 week
Secondary	Change in anxiety	Measured by the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS)	Baseline, 8 week, 16 week
Secondary	Change in depression	Measured by the depression subscale of the Hospital Anxiety and Depression Scale (HADS)	Baseline, 8 week, 16 week
Secondary	Change in physical function	Measured by the Duke Activity Status Index (DASI)	Baseline, 8 week, 16 week
Secondary	Change in health-related quality of life (HRQoL)	Measured by the Short Form 12 (SF-12)	Baseline, 8 week, 16 week
Secondary	Change in medication adherence	Measured by self-report	Baseline, 8 week, 16 week
Secondary	Change in dietary adherence	Measured by the MEDFICTS scale, a National Cholesterol Education Program-developed scale inquiring about saturated fat	Baseline, 8 week, 16 week