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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03938116
• Other study ID #: 20190101-01H
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: March 2024

Study information

• Verified date: March 2023
• Source: Ottawa Heart Institute Research Corporation
• Contact: Heather Tulloch, PhD
• Phone: 613-696-7000
• Email: hetulloch[@]ottawaheart.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 608
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

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.

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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