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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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

  • Clinicaltrials.gov identifier

    NCT03938116

  • Recruitment Status

    Recruiting

  • First Posted

    May 6, 2019

  • Last update posted

    December 17, 2020

Study Description

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.

  • Condition or Disease:Cardiovascular Diseases
  • Intervention/Treatment: Other: Healing Hearts Together
  • Phase: N/A

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 608 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: Healing Hearts Together: Evaluating a Couples-based Intervention to Improve Health Outcomes
  • Actual Study Start Date: October 2019
  • Estimated Primary Completion Date: March 2024
  • Estimated Study Completion Date: March 2024

Arms and interventions

Arm Intervention/treatment
Experimental: Healing Hearts Together
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.

Outcome Measures

  • Primary Outcome Measures: 1. 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.

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Contacts

Contact: Heather Tulloch, PhD 613-696-7000 hetulloch@ottawaheart.ca

Locations

Canada, Ontario
University of Ottawa Heart Institute
Ottawa

Sponsors and Collaborators

Ottawa Heart Institute Research Corporation

More Information

  • Responsible Party: Ottawa Heart Institute Research Corporation
  • ClinicalTrials.gov Identifier: NCT03938116 History of Changes
  • Other Study ID Numbers: 20190101-01H
  • First Posted: May 6, 2019 Key Record Dates
  • Last Update Posted: December 17, 2020
  • Last Verified: December 2020
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Ottawa Heart Institute Research Corporation: couple relationship heart disease
  • Additional relevant MeSH terms: Cardiovascular Diseases