Remotely-delivered Mindfulness-Based Cognitive Therapy for Acute Coronary Syndrome Patients with Depressive Symptoms: Protocol for a Feasibility RCT

Maria Lopes, BA

Massachusetts General Hospital – Clinical Research Coordinator
Lopes_Maria poster

Scientific Abstract

Background

Depression is common after acute coronary syndrome (ACS) and increases mortality risk through behavioral and biological mechanisms (e.g., increased inflammation). We adapted Mindfulness-Based Cognitive Therapy (UpBeat-MBCT) for group videoconferencing delivery to target the needs of patients with depressive symptoms after ACS. The aim of this study is to report the protocol for a pilot feasibility RCT of UpBeat-MBCT.

Methods

Participants will be 1:1 randomized to UpBeat-MBCT or a time and attention-matched cardiac health enhancement control intervention. Eight weekly 1.5-hour sessions will be audio-video recorded to assess intervention fidelity. Assessments will be conducted at baseline, post-intervention, and 3-month follow-up to assess emotional and behavioral health variables. After-session surveys will assess acceptability of session components, and post-intervention individual exit interviews will assess intervention likes, dislikes, and suggestions for improvement. Participants will be asked to self-collect dried blood spot samples at home for analysis of biomarkers of inflammation (CRP, IL-6, TNF-a).

Results

Consistent with the intended purpose of pilot feasibility RCTs, the primary outcomes are feasibility and acceptability. Feasibility outcomes will include feasibility of recruitment, eligibility criteria, MBCT and health education groups, videoconferencing delivery, and blood spot sample collection. Acceptability outcomes will include MBCT and health education intervention satisfaction, videoconferencing satisfaction, and blood spot collection ease and comfort. Exploratory outcomes will include clinically meaningful changes in depression symptoms, defined as change >3 points on the PHQ-9.

Conclusions

This trial protocol will allow us to explore the initial feasibility, acceptability, and health changes of our adapted intervention, providing information about how to optimize the intervention and research components for a future efficacy trial. We are currently completing the first round of randomized interventions and will have preliminary data for presentation at the conference.

Live Zoom Session – March 9th

research Areas

Authors

Maria Lopes, BA, Ariel Brathwaite, Loretta Akpala, MD, Huilin Li, Elyse Park, PhD, Jeff Huffman, MD, Christopher Celano, MD, Gloria Yeh, MD, MPH, Bettina Hoeppner, PhD, David Victorson, PhD, Christina Luberto, PhD

Principal Investigator

Christina Luberto, PhD