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

Sponsor
Ottawa Heart Institute Research Corporation (Other)
Overall Status
Recruiting
CT.gov ID
NCT03938116
Collaborator
(none)
608
1
2
53
11.5

Study Details

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 Intervention/Treatment Phase
  • Other: Healing Hearts Together
N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Oct 1, 2019
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 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.

No Intervention: Usual Care

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 University of Ottawa Heart Institute Ottawa Ontario Canada K1Y4W7

Sponsors and Collaborators

  • Ottawa Heart Institute Research Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Heather Tulloch, Psychologist, Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier:
NCT03938116
Other Study ID Numbers:
  • 20190101-01H
First Posted:
May 6, 2019
Last Update Posted:
Jan 18, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Heather Tulloch, Psychologist, Ottawa Heart Institute Research Corporation
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 18, 2022