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

NCT03938116 | Completed

• 1 other identifier: 20190101-01H
• Study Type: interventional
• Target: 474
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Diseases

Keywords

couple relationship; heart disease

Outcome Measures

Primary Outcomes (1)

• Relationship quality: DAS

  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.

  8 weeks

Study Arms (2)

Healing Hearts Together

EXPERIMENTAL

Other: Healing Hearts Together

Usual Care

NO INTERVENTION

Interventions

Healing Hearts Together OTHER

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.

Healing Hearts Together

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• University of Ottawa Heart Institute (UOHI) patients and their partners
• 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.
• Participants are ≥ 18 years of age
• 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).
• Patients and partners are available to participate for the next 6 months (intervention and follow-up).
• Patients and partners are able to provide informed consent.

You may not qualify if:

• 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).
• Participants who are engaging in couples therapy or plan to engage in couples therapy in the next 6 months.

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y4W7, Canada

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: May 6, 2019
• Study Start: October 1, 2019
• Primary Completion: April 17, 2025
• Study Completion: April 17, 2025
• Last Updated: May 6, 2026

Record last verified: 2025-11

Locations

CA (1)