Healing Hearts Together — an emotionally focused intervention for couples after a cardiac event: a randomized controlled trial protocol

Introduction: Couple relationships are important for health. Relationship distress is associated with increased incident and prognostic cardiovascular risk, while positive support is linked to heart-healthy behaviors and improved outcomes. This paper describes the study rationale, objectives, design, and methods of the Healing Hearts Together (HHT) randomized controlled trial (RCT). Objectives: The primary objective is to examine the difference in relationship quality between the 8-week HHT intervention group and usual care (UC) at program completion. Secondary objectives include evaluating the impact of HHT on relationship quality at 6 months, and mental health, quality of life, and cardiovascular risk factors measured at 8 weeks and 6 months post-intervention, as compared to usual care. Methods: Patients and their partners are recruited within 6 months of a cardiac event, procedure, or hospitalization and randomized 1:1 to HHT or UC. Assessments occur at baseline, 8 weeks, and 6 months follow-up. Analyses are planned as intention-to-treat, with multi-level analyses of covariance (ANCOVA) for the primary outcome: 8-week relationship quality as measured by the Dyadic Adjustment Scale. Secondary objectives will be evaluated using multi-level modeling for repeated measures. Anticipated results: It is expected that participants randomized to HHT will report higher relationship quality and improved secondary outcomes than will participants in UC. Conclusion: As the first study to evaluate a relationship-enhancement program for couples with cardiac disease, findings will have important clinical implications regarding the effect of relationship interventions on heart health.