Gratitude Intervention for Cardiac Rehabilitation Patients

Feasibility of a Gratitude Intervention for Cardiac Rehabilitation Patients: A Nursing-based Intervention

This is a single-center cohort study of patients in a cardiac rehabilitation program with a diagnosis of cardiovascular disease (CVD), including heart failure, coronary artery disease, post myocardial infarction, post percutaneous coronary intervention and post cardiac surgery. Participants will be randomized to the gratitude intervention or an attention control group. This study is a pilot study to determine the feasibility and acceptability of administering the gratitude intervention in a cardiac rehabilitation setting.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Behavioral: Attention Control; Behavioral: Gratitude Journaling

Detailed Description

Nursing-led interventions of chronic diseases, including cardiovascular disease (CVD), have been proved to be successful. Appropriately trained nurses produce high-quality care and good health outcomes for patients equivalent to that achieved by physicians with higher levels of patient satisfaction. CVD, including coronary artery disease and heart failure, is a major and rapidly growing public health problem. Despite advances in its treatment, it remains the leading cause of death in the U.S. Furthermore, the prevalence of CVD in adults is estimated to continue to rise and that by 2035, 45.1% of the U.S. population will have some form of CVD with total costs expected to reach $1.1 trillion with direct medical costs projects to reach $748.7 billion. Therefore, novel preventive efforts are needed.

Negative psychological states, including depression and pessimism (negative future expectation), have been linked with poor CVD outcomes. Despite the fact that optimism (positive future expectation) and other positive affective states have been associated with superior cardiovascular outcomes, little research has focused on interventions designed to increase positive psychological states in patients at risk for CVD. In the current trial, patients in an academic medical center cardiac rehabilitation program will be approached. Cardiac rehabilitation is an integral component in the treatment of patients with cardiovascular disease including coronary artery disease, heart failure with reduced ejection fraction, following heart valve surgery or cardiac transplantation.

One of its core components is psychological support and management. In this nursing-led study, participants will be randomized to a gratitude intervention or an attention control group. The gratitude intervention, which encourages participants to notice and appreciate the positive features of life, is based on the work of Emmons and McCullough, and involves participants writing (or if unable to write, speaking) things for which they are grateful. Much of the existing research on gratitude (noticing and appreciating the positive features of life) has focused primarily on outcomes associated with psychological factors and social interactions.

The primary aim of this feasibility study will be to determine if a gratitude intervention is acceptable and feasible in a cohort of patients attending cardiac rehabilitation.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University Of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years and older
• able to consent
• patient at cardiac rehabilitation program at Gill Heart and Vascular Institute

Exclusion Criteria:

- under the age of 18

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Attention Control Group; Adult patients attending cardiovascular rehabilitation.	Behavioral: Attention Control; Participants in this group will be asked to recall 3 to 5 events from the prior day of the intervention and write, or if unable to write, speak about these events.
Experimental: Gratitude Journaling Group; Adult patients attending cardiovascular rehabilitation.	Behavioral: Gratitude Journaling; The gratitude journaling intervention involves participants writing or speaking 3-5 things for which they are grateful and focusing on these attributes. Participants will do this weekly for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Completion of Cardiac Rehabilitation Program	Percentage of patients in each arm who complete the cardiac rehabilitation program.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Gratitude	The Gratitude Questionaire (GQ6) will be used to assess gratitude at baseline and following the intervention. The GQ6 is a 6 item questionnaire with scales ranging from 1-7. Cumulative scores range from 6-42; higher scores indicate increased gratitude.	12 weeks
Change in Dispositional Optimism	The Life Orientation Test-Revised (LOT-R) will be used to assess optimism at baseline and following the intervention. The LOT-R is a 10-item survey, with scales ranging from 1-5. (Not all questions are scored). Cumulative scores range from 6-30; higher scores indicate increased optimism.	12 weeks
Change in Resilience	The Brief Resilience Scale (BRS) will be used to measure resilience at baseline and after the intervention. The BRS is a 6 item survey, with each item scored from 1-5. Raw total scores range from 6-30; final scores will be calculated as the mean of all scores. Higher scores indicate increased resiliency.	12 weeks
Hospital Readmission	Percent of patients readmitted to the hospital	one year
Mortality	Percent of patients deceased	one year

Collaborators and Investigators

• Sponsor: Martha Biddle
• Investigators: Principal Investigator: Martha Biddle, PhD, University Of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): March 17, 2023
• Study Completion (Actual): March 17, 2023

Study Registration Dates

• First Submitted: March 13, 2020
• First Submitted That Met QC Criteria: March 18, 2020
• First Posted (Actual): March 19, 2020

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: April 3, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: depression; nursing; gratitude; pessimism
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 57514

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No