Cardiovascular DiseasesNCT04314583
Gratitude Intervention for Cardiac Rehabilitation Patients
A study testing Gratitude Journaling in people with Cardiovascular Diseases, run by Martha Biddle at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Gratitude Journaling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 17 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older
- able to consent
- patient at cardiac rehabilitation program at Gill Heart and Vascular Institute
Who cannot join
- under the age of 18
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiovascular Diseases
- Being tested
- Attention Control, Gratitude Journaling
- Keywords
- depression, pessimism, gratitude, nursing
- Medical subject headings
- Cardiovascular Diseases, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attention ControlBehavioural
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.
Gratitude JournalingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Attention Control Group | Active comparator | Adult patients attending cardiovascular rehabilitation. Receives: Behavioral: Attention Control |
| Gratitude Journaling Group | Experimental | Adult patients attending cardiovascular rehabilitation. Receives: Behavioral: Gratitude Journaling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Completion of Cardiac Rehabilitation Program
Percentage of patients in each arm who complete the cardiac rehabilitation program.
Measured: 12 weeks
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Hospital Readmission
Percent of patients readmitted to the hospital
Measured: one year
Mortality
Percent of patients deceased
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start1 Sep 2020
- Primary completion17 Mar 2023
- Study completion17 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martha Biddle
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Martha Biddle, University of Kentucky
- Investigators
- Martha Biddle, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314583
- Sponsor's protocol ID
- 57514
- Status last verified
- Apr 2023
- First submitted
- 13 Mar 2020
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Gratitude Intervention for Cardiac Rehabilitation Patients: A Nursing-based Intervention
- ClinicalTrials.gov ID
- NCT04314583
- Acronym / sponsor ID
- 57514
- Conditions
- Cardiovascular Diseases
- Keywords
- depression, pessimism, gratitude, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Martha BiddleUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 17 Mar 2023 (actual)
- Study completion
- 17 Mar 2023 (actual)
- First posted
- 19 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Attention Control Group | Active comparator | Behavioral: Attention ControlAdult patients attending cardiovascular rehabilitation. |
| Gratitude Journaling Group | Experimental | Behavioral: Gratitude JournalingAdult patients attending cardiovascular rehabilitation. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years and older
- able to consent
- patient at cardiac rehabilitation program at Gill Heart and Vascular Institute
Key exclusion criteria (1 listed)
- under the age of 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Attention ControlParticipants 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. | Behavioural | Attention Control Group |
| Gratitude JournalingThe 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. | Behavioural | Gratitude Journaling Group |
Primary outcome
Percent Completion of Cardiac Rehabilitation Program
Time frame: 12 weeks
Percentage of patients in each arm who complete the cardiac rehabilitation program.
5 secondary outcomes
Change in Gratitude
Time frame: 12 weeks
Change in Dispositional Optimism
Time frame: 12 weeks
Change in Resilience
Time frame: 12 weeks
Hospital Readmission
Time frame: one year
Mortality
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martha Biddle, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gratitude Journaling in people with Cardiovascular Diseases, run by Martha Biddle at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Completion of Cardiac Rehabilitation Program (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023; AzTrials last refreshed its copy on 6 Nov 2026.