608 Participants Needed

Couples-based Intervention for Cardiovascular Disease

HT
Overseen ByHeather Tulloch, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Ottawa Heart Institute Research Corporation
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if the Healing Hearts Together program, a couples-based intervention, can improve relationship quality, mental health, quality of life, and heart health for couples. Participants will either engage in this program or continue with their usual care for comparison. The study examines changes after 8 weeks and again 6 months later. This trial suits couples living together, with one partner receiving care at the University of Ottawa Heart Institute, who can participate in the program for 6 months. As an unphased trial, it offers couples a unique opportunity to enhance their relationship and health while contributing to valuable research.

What prior data suggests that the Healing Hearts Together program is safe?

Research shows that the Healing Hearts Together (HHT) program is designed to assist couples managing heart disease. Studies have found that supportive relationships can reduce the risk of chronic illnesses, including heart disease. Thus, the program aims to strengthen relationships, offering a generally safe and non-invasive approach. No reports of negative effects from the HHT program have emerged in the studies available. Participants in similar programs have found them manageable. As this trial does not involve testing a medical drug or device, it is likely safe for participants.12345

Why are researchers excited about this trial?

Researchers are excited about the "Healing Hearts Together" program because it takes a unique couples-based approach to managing cardiovascular disease. Unlike standard treatments that often focus solely on medication and lifestyle changes for the individual, this intervention involves both partners working together to improve heart health. The program emphasizes mutual support and communication, potentially enhancing adherence to healthy behaviors and reducing stress, which can significantly impact cardiovascular health. By addressing the emotional and relational aspects of heart disease, "Healing Hearts Together" offers a holistic way to improve outcomes for patients and their partners.

What evidence suggests that the Healing Hearts Together program could be effective for cardiovascular disease?

Research has shown that the Healing Hearts Together (HHT) program, which participants in this trial may receive, can enhance relationship satisfaction, mental health, and overall quality of life for couples dealing with heart disease. Studies have found that couples participating in emotionally focused programs like HHT often experience lower heart rates and reduced levels of the stress hormone cortisol during challenging times. Supportive couple relationships are linked to a lower risk of developing long-term illnesses, including heart disease. Specifically, one study found that patients in happy relationships were more than three times as likely to survive 15 years after heart bypass surgery. These findings suggest that HHT could effectively improve both relationship and heart health.12467

Are You a Good Fit for This Trial?

This trial is for couples over 18 years old where one partner has cardiovascular disease. They must be cohabiting, able to commit for 6 months, and understand English. Couples already in therapy or with psychiatric illness/cognitive impairment that affects participation are excluded.

Inclusion Criteria

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).
I have been living with my partner for at least a year.
Patients and partners are able to provide informed consent.
See 2 more

Exclusion Criteria

I am currently in couples therapy or plan to start within 6 months.
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).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the 8-week Healing Hearts Together (HHT) program or receive usual care

8 weeks

Follow-up

Participants are monitored for changes in relationship quality, mental health, quality of life, and cardiovascular health

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Healing Hearts Together
Trial Overview The Healing Hearts Together (HHT) program aims to improve relationship quality, mental health, life quality, and heart health over an 8-week course compared to usual care. Outcomes will be measured after the program ends and at a 6-month follow-up.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Healing Hearts TogetherExperimental Treatment1 Intervention
Group II: Usual CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ottawa Heart Institute Research Corporation

Lead Sponsor

Trials
200
Recruited
95,800+

Citations

an emotionally focused intervention for couples after a cardiac ...These interventions have produced improved relationship satisfaction and health outcomes (e.g., reduce heart rate and cortisol levels) during stressful ...
Healing Hearts Together: Evaluating a Couples-based ...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 ...
The Healing Hearts Together Randomized Controlled Trial ...Healing Hearts Together (HHT) is an 8-week couples-based intervention designed to improve relationship quality, mental health, quality of life, ...
The Healing Hearts Together Randomized Controlled Trial ...Supportive couple relationships are associated with reduced risk of chronic illness development, such as cardiovascular disease, as well as ...
Healing Hearts TogetherFor example, one study found that patients who were in satisfying and supportive relationships were over 3 times as likely to be alive 15 years after bypass ...
The Healing Hearts Together Randomized Controlled Trial and ...ABSTRACT: Supportive couple relationships are associated with reduced risk of chronic illness development, such as cardiovascular disease, ...
an emotionally focused intervention for couples after a ...This paper describes the study rationale, objectives, design, and methods of the Healing Hearts Together (HHT) randomized controlled trial (RCT) ...
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