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

Ottawa Heart Institute Research Corporation1 site in 1 country608 target enrollmentOctober 1, 2019

ConditionsCardiovascular Diseases

Overview

Phase: N/A
Intervention: Not specified
Conditions: Cardiovascular Diseases
Sponsor: Ottawa Heart Institute Research Corporation
Enrollment: 608
Locations: 1
Primary Endpoint: Relationship quality: DAS
Status: Recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 1, 2019

End Date

March 1, 2026

Last Updated

5 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ottawa Heart Institute Research Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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.

Outcomes

Primary Outcomes

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.