Tulloch Heather E, Greenman Paul S, Reed Jennifer, Susinski Stephanie, Kasos Eniko, Tasca Giorgio A, Mielniczuk Lisa, Wells George, Sun Louise Y, Johnson Susan M
University of Ottawa Heart Institute, Ottawa, ON, Canada.
Department of Medicine and School of Psychology, University of Ottawa, Ottawa, ON, Canada.
Front Psychol. 2025 Jul 22;16:1564666. doi: 10.3389/fpsyg.2025.1564666. eCollection 2025.
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).
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.
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.
It is expected that participants randomized to HHT will report higher relationship quality and improved secondary outcomes than will participants in UC.
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.
伴侣关系对健康至关重要。关系困扰与心血管疾病的发病风险和预后风险增加相关，而积极的支持则与有益心脏健康的行为及更好的预后相关。本文介绍了“携手治愈心灵”（HHT）随机对照试验（RCT）的研究原理、目标、设计和方法。
主要目标是在项目结束时，研究为期8周的HHT干预组与常规护理（UC）组在关系质量上的差异。次要目标包括评估HHT在6个月时对关系质量的影响，以及与常规护理相比，在干预后8周和6个月时测量的心理健康、生活质量和心血管危险因素。
在心脏事件、手术或住院后的6个月内招募患者及其伴侣，并以1:1的比例随机分配至HHT组或UC组。在基线、8周和6个月随访时进行评估。分析计划采用意向性分析，对主要结局采用多水平协方差分析（ANCOVA）：用二元调适量表测量的8周关系质量。次要目标将使用重复测量的多水平模型进行评估。
预计随机分配至HHT组的参与者报告的关系质量将高于UC组参与者，且次要结局也会得到改善。
作为第一项评估针对心脏病患者伴侣的关系改善项目的研究，研究结果将对关系干预对心脏健康的影响具有重要的临床意义。
