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

NCT ID: NCT03938116

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

608 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Healing Hearts Together

Group Type EXPERIMENTAL

Healing Hearts Together

Intervention Type 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.

Usual Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ottawa Heart Institute Research Corporation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Heather Tulloch, PhD

Role: CONTACT

613-696-7000

Facility Contacts

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Heather Tulloch

Role: primary

613-696-7000 ext. 19705

Other Identifiers

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20190101-01H

Identifier Type: -

Identifier Source: org_study_id

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