Healing Hearts Together: Evaluating a Couples-based Intervention to Improve Health Outcomes

Overview

The purpose of this study is to test the efficacy of the 8-week Healing Hearts Together (HHT) program to improve relationship quality, mental health, quality of life (QoL), and cardiovascular health. This is a randomized controlled trial in which couples are randomly assigned to the HHT group or usual care. Changes in the outcomes of interest will be assessed at the end of the intervention (8 weeks) and 6 months later.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: March 2024

Interventions

  • Other: Healing Hearts Together
    • Participants in the HHT group will be assembled in groups and attend 8 weekly 2-hr sessions at UOHI led by 2 facilitators with psychology training. Sessions: 1) focus on understanding love, attachment, and their relationship to heart health; 2) provide an opportunity to share experiences related to cardiovascular disease with partners and peers; and 3) assist in identifying and improving communication patterns that may inhibit positive interactions and healthy behaviours. Participants are introduced to concepts through didactic presentations, videos, group and couple discussion and homework exercises. Participants will receive a folder containing copies of in-session and take-home exercises as well as the Hold Me Tight book to review between sessions.

Arms, Groups and Cohorts

  • Experimental: Healing Hearts Together
  • No Intervention: Usual Care

Clinical Trial Outcome Measures

Primary Measures

  • Relationship quality: DAS
    • Time Frame: 8 weeks
    • Relationship quality will be assessed using the DAS. The DAS is a validated 32-item questionnaire that measures couple satisfaction, cohesion, consensus and affectionate expression. Scores ≥108 are indicative of couple satisfaction, while scores ≤107 indicate distress.

Participating in This Clinical Trial

Inclusion Criteria

1. University of Ottawa Heart Institute (UOHI) patients and their partners 2. Participants in a romantic relationship who are cohabiting (married, common-law or committed relationship for ≥1 year). No restrictions will be placed on sexual orientation. 3. Participants are ≥ 18 years of age 4. Participants are able to read and understand English (HHT materials are only available in English; once efficacy has been established, all materials will be translated to French). 5. Patients and partners are available to participate for the next 6 months (intervention and follow-up). 6. Patients and partners are able to provide informed consent. Exclusion Criteria:

1. Participants who, in the opinion of the study psychologist, manifest psychiatric illness or cognitive impairment that would preclude participation in HHT (i.e. unable to benefit from the intervention; to prevent disruption of other participants). 2. Participants who are engaging in couples therapy or plan to engage in couples therapy in the next 6 months.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Ottawa Heart Institute Research Corporation
  • Provider of Information About this Clinical Study
    • Principal Investigator: Heather Tulloch, Psychologist – Ottawa Heart Institute Research Corporation
  • Overall Contact(s)
    • Heather Tulloch, PhD, 613-696-7000, hetulloch@ottawaheart.ca

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