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

Not Applicable

Recruiting

• Conditions: Cardiovascular Diseases
• Interventions: Other: Healing Hearts Together

• Registration Number: NCT03938116
• Lead Sponsor: Ottawa Heart Institute Research Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-25
• Study First Submitted QC: 2019-05-03
• Study First Posted: 2019-05-06
• Study Start: 2019-10-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-03
• Last Update Posted: 2023-03-06
• Primary Completion: 2024-03
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 608

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healing Hearts Together	Healing Hearts Together	-

Primary Outcome Measures

Name	Time	Method
Relationship quality: DAS	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.

Trial Locations

Locations (1)

University of Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada