The Positive Emotions after Acute Coronary Events behavioral health intervention: Design, rationale, and preliminary feasibility of a factorial design study

Jeffery C. Huffman, Ariana M. Albanese, Kirsti A. Campbell, Christopher M. Celano, Rachel A. Millstein, Carol A. Mastromauro, Brian C. Healy, Wei Jean Chung, James L. Januzzi, Linda Marie Collins, Elyse R. Park

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

Background: Positive psychological constructs, such as optimism, are associated with greater participation in cardiac health behaviors and improved cardiac outcomes. Positive psychology interventions, which target psychological well-being, may represent a promising approach to improving health behaviors in high-risk cardiac patients. However, no study has assessed whether a positive psychology intervention can promote physical activity following an acute coronary syndrome. Objective: In this article we will describe the methods of a novel factorial design study to aid the development of a positive psychology-based intervention for acute coronary syndrome patients and aim to provide preliminary feasibility data on study implementation. Methods: The Positive Emotions after Acute Coronary Events III study is an optimization study (planned N = 128), subsumed within a larger multiphase optimization strategy iterative treatment development project. The goal of Positive Emotions after Acute Coronary Events III is to identify the ideal components of a positive psychology-based intervention to improve post-acute coronary syndrome physical activity. Using a 2 × 2 × 2 factorial design, Positive Emotions after Acute Coronary Events III aims to: (1) evaluate the relative merits of using positive psychology exercises alone or combined with motivational interviewing, (2) assess whether weekly or daily positive psychology exercise completion is optimal, and (3) determine the utility of booster sessions. The study's primary outcome measure is moderate-to-vigorous physical activity at 16 weeks, measured via accelerometer. Secondary outcome measures include psychological, functional, and adherence-related behavioral outcomes, along with metrics of feasibility and acceptability. For the primary study outcome, we will use a mixed-effects model with a random intercept (to account for repeated measures) to assess the main effects of each component (inclusion of motivational interviewing in the exercises, duration of the intervention, and inclusion of booster sessions) from a full factorial model controlling for baseline activity. Similar analyses will be performed on self-report measures and objectively-measured medication adherence over 16 weeks. We hypothesize that the combined positive psychology and motivational interviewing intervention, weekly exercises, and booster sessions will be associated with superior physical activity. Results: Thus far, 78 participants have enrolled, with 72% of all possible exercises fully completed by participants. Conclusion: The Positive Emotions after Acute Coronary Events III study will help to determine the optimal content, intensity, and duration of a positive psychology intervention in post-acute coronary syndrome patients prior to testing in a randomized trial. This study is novel in its use of a factorial design within the multiphase optimization strategy framework to optimize a behavioral intervention and the use of a positive psychology intervention to promote physical activity in high-risk cardiac patients.

Original languageEnglish (US)
Pages (from-to)128-139
Number of pages12
JournalClinical Trials
Volume14
Issue number2
DOIs
StatePublished - Apr 1 2017

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Emotions
Psychology
Exercise
Health
Acute Coronary Syndrome
Motivational Interviewing
Health Behavior
Outcome Assessment (Health Care)
Medication Adherence
Self Report

All Science Journal Classification (ASJC) codes

  • Pharmacology

Cite this

Huffman, J. C., Albanese, A. M., Campbell, K. A., Celano, C. M., Millstein, R. A., Mastromauro, C. A., ... Park, E. R. (2017). The Positive Emotions after Acute Coronary Events behavioral health intervention: Design, rationale, and preliminary feasibility of a factorial design study. Clinical Trials, 14(2), 128-139. https://doi.org/10.1177/1740774516673365
Huffman, Jeffery C. ; Albanese, Ariana M. ; Campbell, Kirsti A. ; Celano, Christopher M. ; Millstein, Rachel A. ; Mastromauro, Carol A. ; Healy, Brian C. ; Chung, Wei Jean ; Januzzi, James L. ; Collins, Linda Marie ; Park, Elyse R. / The Positive Emotions after Acute Coronary Events behavioral health intervention : Design, rationale, and preliminary feasibility of a factorial design study. In: Clinical Trials. 2017 ; Vol. 14, No. 2. pp. 128-139.
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abstract = "Background: Positive psychological constructs, such as optimism, are associated with greater participation in cardiac health behaviors and improved cardiac outcomes. Positive psychology interventions, which target psychological well-being, may represent a promising approach to improving health behaviors in high-risk cardiac patients. However, no study has assessed whether a positive psychology intervention can promote physical activity following an acute coronary syndrome. Objective: In this article we will describe the methods of a novel factorial design study to aid the development of a positive psychology-based intervention for acute coronary syndrome patients and aim to provide preliminary feasibility data on study implementation. Methods: The Positive Emotions after Acute Coronary Events III study is an optimization study (planned N = 128), subsumed within a larger multiphase optimization strategy iterative treatment development project. The goal of Positive Emotions after Acute Coronary Events III is to identify the ideal components of a positive psychology-based intervention to improve post-acute coronary syndrome physical activity. Using a 2 × 2 × 2 factorial design, Positive Emotions after Acute Coronary Events III aims to: (1) evaluate the relative merits of using positive psychology exercises alone or combined with motivational interviewing, (2) assess whether weekly or daily positive psychology exercise completion is optimal, and (3) determine the utility of booster sessions. The study's primary outcome measure is moderate-to-vigorous physical activity at 16 weeks, measured via accelerometer. Secondary outcome measures include psychological, functional, and adherence-related behavioral outcomes, along with metrics of feasibility and acceptability. For the primary study outcome, we will use a mixed-effects model with a random intercept (to account for repeated measures) to assess the main effects of each component (inclusion of motivational interviewing in the exercises, duration of the intervention, and inclusion of booster sessions) from a full factorial model controlling for baseline activity. Similar analyses will be performed on self-report measures and objectively-measured medication adherence over 16 weeks. We hypothesize that the combined positive psychology and motivational interviewing intervention, weekly exercises, and booster sessions will be associated with superior physical activity. Results: Thus far, 78 participants have enrolled, with 72{\%} of all possible exercises fully completed by participants. Conclusion: The Positive Emotions after Acute Coronary Events III study will help to determine the optimal content, intensity, and duration of a positive psychology intervention in post-acute coronary syndrome patients prior to testing in a randomized trial. This study is novel in its use of a factorial design within the multiphase optimization strategy framework to optimize a behavioral intervention and the use of a positive psychology intervention to promote physical activity in high-risk cardiac patients.",
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Huffman, JC, Albanese, AM, Campbell, KA, Celano, CM, Millstein, RA, Mastromauro, CA, Healy, BC, Chung, WJ, Januzzi, JL, Collins, LM & Park, ER 2017, 'The Positive Emotions after Acute Coronary Events behavioral health intervention: Design, rationale, and preliminary feasibility of a factorial design study', Clinical Trials, vol. 14, no. 2, pp. 128-139. https://doi.org/10.1177/1740774516673365

The Positive Emotions after Acute Coronary Events behavioral health intervention : Design, rationale, and preliminary feasibility of a factorial design study. / Huffman, Jeffery C.; Albanese, Ariana M.; Campbell, Kirsti A.; Celano, Christopher M.; Millstein, Rachel A.; Mastromauro, Carol A.; Healy, Brian C.; Chung, Wei Jean; Januzzi, James L.; Collins, Linda Marie; Park, Elyse R.

In: Clinical Trials, Vol. 14, No. 2, 01.04.2017, p. 128-139.

Research output: Contribution to journalArticle

TY - JOUR

T1 - The Positive Emotions after Acute Coronary Events behavioral health intervention

T2 - Design, rationale, and preliminary feasibility of a factorial design study

AU - Huffman, Jeffery C.

AU - Albanese, Ariana M.

AU - Campbell, Kirsti A.

AU - Celano, Christopher M.

AU - Millstein, Rachel A.

AU - Mastromauro, Carol A.

AU - Healy, Brian C.

AU - Chung, Wei Jean

AU - Januzzi, James L.

AU - Collins, Linda Marie

AU - Park, Elyse R.

PY - 2017/4/1

Y1 - 2017/4/1

N2 - Background: Positive psychological constructs, such as optimism, are associated with greater participation in cardiac health behaviors and improved cardiac outcomes. Positive psychology interventions, which target psychological well-being, may represent a promising approach to improving health behaviors in high-risk cardiac patients. However, no study has assessed whether a positive psychology intervention can promote physical activity following an acute coronary syndrome. Objective: In this article we will describe the methods of a novel factorial design study to aid the development of a positive psychology-based intervention for acute coronary syndrome patients and aim to provide preliminary feasibility data on study implementation. Methods: The Positive Emotions after Acute Coronary Events III study is an optimization study (planned N = 128), subsumed within a larger multiphase optimization strategy iterative treatment development project. The goal of Positive Emotions after Acute Coronary Events III is to identify the ideal components of a positive psychology-based intervention to improve post-acute coronary syndrome physical activity. Using a 2 × 2 × 2 factorial design, Positive Emotions after Acute Coronary Events III aims to: (1) evaluate the relative merits of using positive psychology exercises alone or combined with motivational interviewing, (2) assess whether weekly or daily positive psychology exercise completion is optimal, and (3) determine the utility of booster sessions. The study's primary outcome measure is moderate-to-vigorous physical activity at 16 weeks, measured via accelerometer. Secondary outcome measures include psychological, functional, and adherence-related behavioral outcomes, along with metrics of feasibility and acceptability. For the primary study outcome, we will use a mixed-effects model with a random intercept (to account for repeated measures) to assess the main effects of each component (inclusion of motivational interviewing in the exercises, duration of the intervention, and inclusion of booster sessions) from a full factorial model controlling for baseline activity. Similar analyses will be performed on self-report measures and objectively-measured medication adherence over 16 weeks. We hypothesize that the combined positive psychology and motivational interviewing intervention, weekly exercises, and booster sessions will be associated with superior physical activity. Results: Thus far, 78 participants have enrolled, with 72% of all possible exercises fully completed by participants. Conclusion: The Positive Emotions after Acute Coronary Events III study will help to determine the optimal content, intensity, and duration of a positive psychology intervention in post-acute coronary syndrome patients prior to testing in a randomized trial. This study is novel in its use of a factorial design within the multiphase optimization strategy framework to optimize a behavioral intervention and the use of a positive psychology intervention to promote physical activity in high-risk cardiac patients.

AB - Background: Positive psychological constructs, such as optimism, are associated with greater participation in cardiac health behaviors and improved cardiac outcomes. Positive psychology interventions, which target psychological well-being, may represent a promising approach to improving health behaviors in high-risk cardiac patients. However, no study has assessed whether a positive psychology intervention can promote physical activity following an acute coronary syndrome. Objective: In this article we will describe the methods of a novel factorial design study to aid the development of a positive psychology-based intervention for acute coronary syndrome patients and aim to provide preliminary feasibility data on study implementation. Methods: The Positive Emotions after Acute Coronary Events III study is an optimization study (planned N = 128), subsumed within a larger multiphase optimization strategy iterative treatment development project. The goal of Positive Emotions after Acute Coronary Events III is to identify the ideal components of a positive psychology-based intervention to improve post-acute coronary syndrome physical activity. Using a 2 × 2 × 2 factorial design, Positive Emotions after Acute Coronary Events III aims to: (1) evaluate the relative merits of using positive psychology exercises alone or combined with motivational interviewing, (2) assess whether weekly or daily positive psychology exercise completion is optimal, and (3) determine the utility of booster sessions. The study's primary outcome measure is moderate-to-vigorous physical activity at 16 weeks, measured via accelerometer. Secondary outcome measures include psychological, functional, and adherence-related behavioral outcomes, along with metrics of feasibility and acceptability. For the primary study outcome, we will use a mixed-effects model with a random intercept (to account for repeated measures) to assess the main effects of each component (inclusion of motivational interviewing in the exercises, duration of the intervention, and inclusion of booster sessions) from a full factorial model controlling for baseline activity. Similar analyses will be performed on self-report measures and objectively-measured medication adherence over 16 weeks. We hypothesize that the combined positive psychology and motivational interviewing intervention, weekly exercises, and booster sessions will be associated with superior physical activity. Results: Thus far, 78 participants have enrolled, with 72% of all possible exercises fully completed by participants. Conclusion: The Positive Emotions after Acute Coronary Events III study will help to determine the optimal content, intensity, and duration of a positive psychology intervention in post-acute coronary syndrome patients prior to testing in a randomized trial. This study is novel in its use of a factorial design within the multiphase optimization strategy framework to optimize a behavioral intervention and the use of a positive psychology intervention to promote physical activity in high-risk cardiac patients.

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