(002) A positive psychology-motivational interviewing intervention to promote adherence in heart failure: Design and methods of a randomized, controlled clinical trial

Abstract: Background/Significance: Among patients with heart failure (HF), adherence to physical activity, a healthy diet, and medication recommendations is associated with improved medical outcomes; however, most patients with HF struggle to adhere to these behaviors. Positive psychological constructs (e.g., optimism, positive affect) are associated with greater adherence, and positive psychology- (PP-) based interventions increase these constructs in healthy and medically ill populations. However, there has been limited study of PP-based interventions in patients with HF.

Methods: Using the NIH Stage Model of behavioral intervention development, we created a 12-week, phone-delivered, combined positive psychology and motivational interviewing (PP-MI) intervention for patients with HF. In this randomized trial (N=280), we aim to examine its impact on health behavior adherence and psychological, functional, and medical outcomes. Participants will be 280 patients with New York Heart Association (NYHA) class I-III HF and suboptimal adherence to physical activity, medication, and/or dietary recommendations. Following completion of baseline outcome measures, participants will be randomized to receive the PP-MI program or a time- and attention-matched, MI-based educational intervention. Participants in the PP-MI group will engage in weekly phone sessions with a study trainer, then will complete a PP activity and work towards one or more health behavior goals between sessions. Those in the MI-based educational condition will similarly complete weekly phone sessions and learn to set goals related to these health behaviors. Participants in both groups will also receive 24 weeks of text messages to promote skill use and health behavior engagement. Outcomes will be assessed at 12, 24, and 48 weeks, and the primary outcome will be a composite score of accelerometer-measured physical activity, urine sodium excretion, and medication adherence (Medication Event Monitoring System electronic pill bottles). Additionally, we will assess the intervention’s impact on psychological, functional, and medical outcomes, including hospitalizations and mortality. To assess the impact of the intervention, we will perform mixed effects regression analyses, adjusting for sex, race/ethnicity, recruitment site, medical illness severity, and NYHA class. Assuming a moderate effect of the intervention on adherence (Cohen’s d=0.45), we will have 92% power to detect between-group differences in composite health behavior adherence.

Results: Recruitment began in November 2021 and is ongoing. We hypothesize that the PP-MI intervention will lead to significantly greater improvements in health behavior adherence and psychological and functional outcomes, as well as non-significantly greater improvements in medical variables.

Discussion: The results of this intervention will provide us with critical information about the intervention’s efficacy prior to a larger trial that will be powered to detect differences in more distal clinical outcomes (e.g., hospitalizations).

Conclusion/Implications: If effective, this intervention has the potential to have a significant impact on both mental and physical health in patients with HF, a high-risk population.

Presenting Author(s)
CC

Christopher Celano, MD, FACLP

Associate Director, Cardiac Psychiatry Research Program
Massachusetts General Hospital
Boston, Massachusetts, United States

Co-Author(s)
CM

Christina Massey, PhD

Licensed Clinical Psychologist
Massachusetts General Hospital
Boston, Massachusetts, United States

Audrey C. Kelly, n/a

Study Coordinator
Massachusetts General Hospital
Boston, Massachusetts, United States

BH

Brian C. Healy, PhD

Associate Professor
Harvard Medical School
Boston, Massachusetts, United States

RM

Rachel Millstein, PhD

Psychologist
Massachusetts General Hospital
Boston, Massachusetts, United States

EF

Emily Feig, PhD

Assistant Professor
Massachusetts General Hospital
Boston, Massachusetts, United States

WC

Wei-Jean Chung, PhD

Staff Psychologist, Massachusetts General Hospital / Instructor in Psychiatry, Harvard Medical Schoo
Massachusetts General Hospital
Boston, Massachusetts, United States

Monika Sadlonova, MD

Research Fellow
Massachusetts General Hospital and Harvard Medical School
Boston, Massachusetts, United States

Alba Carrillo, PhD

Postdoctoral research fellow
University of Valencia
Valencia, Comunidad Valenciana, Spain

JH

Jeff Huffman, MD

Professor of Psychiatry
MGH
LEXINGTON, Massachusetts, United States