GRAT2015: The Effects of Journaling on Health-Related Mood and Clinical Outcomes in Post-MI Patients

Sponsor

University of California, San Diego (Other)

Overall Status

Completed

CT.gov ID

NCT02481544

Collaborator

San Diego Veterans Healthcare System (U.S. Fed)

108

Enrollment

Location

Arms

Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Psychosocial factors, including positive affect, finding meaning in the event, and managing emotional distress, influence prognosis following a heart attack or myocardial infarction (MI). Gratitude, typically defined as a feeling or attitude in acknowledgment of a benefit that one has received or will receive, is associated with higher levels of well-being, and people who are more grateful experience less stress, are less depressed, have higher levels of control over their environment, and more positive ways of coping. The present project will examine the potential benefits of a gratitude intervention (i.e., 8 weeks of gratitude journaling) to increase positive health behaviors, psychological health, and physical functioning in post-MI patients as compared to journaling about memorable events as well as care as usual alone. The investigators will study psychological and physical functioning at baseline, following 8 weeks of gratitude journaling or care as usual, and at 4-month follow-up.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction Psychosocial Factors	Behavioral: Gratitude Journaling Plus SOC Behavioral: Memorable Events Journaling Plus SOC	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

108 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

The Effects of Journaling on Health-Related Mood and Clinical Outcomes in Post-MI Patients

Study Start Date :

Apr 1, 2015

Actual Primary Completion Date :

Dec 1, 2018

Actual Study Completion Date :

Jan 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Gratitude Journaling Plus Standard of Care The most often used gratitude intervention consists of journaling, writing lists of things for which the individual is grateful. This technique was first employed and found to be effectual for enhancing wellbeing by Emmons and McCullough and has been suggested to be as effective as methods frequently used in clinical therapy. We are proposing an 8-week intervention in which the participant records 3-5 things for which they are grateful most days of the week. A longer intervention was chosen because Emmons and McCullough (2003) suggest that healthy behavior changes only occurred in a prolonged multi-week intervention. To ensure some conformity in the intervention, instructions that will be used will be similar to Emmons and McCullough (2003): "There are many things in our lives, both large and small, that we might be grateful about. Think back over your day (week) and write down on the lines below up to five things in your life that you are grateful or thankful for."	Behavioral: Gratitude Journaling Plus SOC
Sham Comparator: Memorable Events Journaling Plus Standard of Care In the sham control condition, individuals will record "memorable events" with methods identical to the gratitude journaling condition: Patients will be asked to record 3-5 memorable events in a given day, on most days of the week. Patients will be contacted once per week to remind them to continue with the memorable events journal. Patients will be given 2 journals during their first testing session (one journal is for the first four weeks and the second is for the second four weeks of journaling). Patients will be contacted once per week to remind them to continue with gratitude journal writing. Patients will be instructed to record the date of each journal entry next to each new day of journaling Patients will be provided with materials to return their first journal by mail and will and return their second journal at the T2 laboratory testing session.	Behavioral: Memorable Events Journaling Plus SOC
No Intervention: Standard of Care SOC consists of medical care that is included in post-MI treatment, such as physician visits and medication adjustments and cardiac rehabilitation. These patients will not have any active intervention, but will undergo the same testing routine as the gratitude intervention group. These patients will be given the opportunity to participate in the gratitude journaling intervention after they have completed the study. Patient records will be evaluated at each timepoint for changes in medications and medical treatment.

Arm

Intervention/Treatment

Experimental: Gratitude Journaling Plus Standard of Care

The most often used gratitude intervention consists of journaling, writing lists of things for which the individual is grateful. This technique was first employed and found to be effectual for enhancing wellbeing by Emmons and McCullough and has been suggested to be as effective as methods frequently used in clinical therapy. We are proposing an 8-week intervention in which the participant records 3-5 things for which they are grateful most days of the week. A longer intervention was chosen because Emmons and McCullough (2003) suggest that healthy behavior changes only occurred in a prolonged multi-week intervention. To ensure some conformity in the intervention, instructions that will be used will be similar to Emmons and McCullough (2003): "There are many things in our lives, both large and small, that we might be grateful about. Think back over your day (week) and write down on the lines below up to five things in your life that you are grateful or thankful for."

Behavioral: Gratitude Journaling Plus SOC

Sham Comparator: Memorable Events Journaling Plus Standard of Care

In the sham control condition, individuals will record "memorable events" with methods identical to the gratitude journaling condition: Patients will be asked to record 3-5 memorable events in a given day, on most days of the week. Patients will be contacted once per week to remind them to continue with the memorable events journal. Patients will be given 2 journals during their first testing session (one journal is for the first four weeks and the second is for the second four weeks of journaling). Patients will be contacted once per week to remind them to continue with gratitude journal writing. Patients will be instructed to record the date of each journal entry next to each new day of journaling Patients will be provided with materials to return their first journal by mail and will and return their second journal at the T2 laboratory testing session.

Behavioral: Memorable Events Journaling Plus SOC

No Intervention: Standard of Care

SOC consists of medical care that is included in post-MI treatment, such as physician visits and medication adjustments and cardiac rehabilitation. These patients will not have any active intervention, but will undergo the same testing routine as the gratitude intervention group. These patients will be given the opportunity to participate in the gratitude journaling intervention after they have completed the study. Patient records will be evaluated at each timepoint for changes in medications and medical treatment.

Outcome Measures

Primary Outcome Measures

Feasibility assessed by Recruitment rates will be recorded and new recruitment strategies will be formulated to overcome barriers presented by decliners for a future study. [2 years]
Treatment Expectancy & Satisfaction assessed by Treatment expectancy and satisfaction - 6 item credibility/ expectancy questionnaire (CEQ) will be utilized [2 years]
Retention assessed by Retention (% of drop-outs) will be recorded, and exit interviews will be administered to determine reasons for drop-out. [2 years]
Adherence assessed by Adherence to intervention will be derived from gratitude journals. [2 years]

Secondary Outcome Measures

Gratitude [2 years]
There are three scales that have been developed to measure gratitude, the Gratitude Questionnaire (GQ-6) (McCullough et al., 2002), Appreciation Scale (Adler & Fagley, 2005), and Gratitude, Appreciation, and Resentment Test (GRAT). Each scale came from a different concept of gratitude, and in concert they provide a broad definition of gratitude. According to Wood, Maltby, Stewart and Joseph (2008) the three scales comprise 12 sub-scales which measure eight different components of gratitude: (1) grateful affect, (2) appreciation of other people, (3) a focus on what the person has, (4) feelings of awe when encountering beauty, (4) behaviors to express gratitude, (5) focusing on the positive in the present moment, (6) appreciation rising from understanding life is short, (7) a focus on the positive in the present moment, and (8) positive social comparisons.

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

Suffered an MI (ST Elevation MI (STEMI) or Non-ST Elevation MI (NSTEMI) with creatine kinase MB fraction elevation 3 times the upper limits of normal and with ischemic ECG changes within 12 months of baseline testing;
An EF less than 50% on echocardiogram;
Clinically stable defined as, no active arrhythmia, no residual ischemia;
Able to perform light to moderate exercise;
Able to give informed consent in English;
Medical clearance by their cardiologist;
35 years of age.

Exclusion criteria:

Unstable angina;
Severe valvular disease;
Oxygen-dependent COPD;
Recent stroke or significant cerebral neurologic impairment;
Suicidality with intent or plan;
Current cancer;
Currently taking mood stabilizers, benzodiazepines or antipsychotics;
Medications (e.g., systemic steroids) and conditions affecting immune status (e.g., rheumatoid arthritis, hepatitis C, HIV) (Anti-depressant medication is allowed);
Currently enrolled in another clinical trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Diego	La Jolla	California	United States	92093

Sponsors and Collaborators

University of California, San Diego
San Diego Veterans Healthcare System

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Paul J. Mills, Professor IR, University of California, San Diego

ClinicalTrials.gov Identifier:

NCT02481544

Other Study ID Numbers:

1R21AT008033-01A1

First Posted:

Jun 25, 2015

Last Update Posted:

Oct 8, 2019

Last Verified:

Oct 1, 2019

Additional relevant MeSH terms:

Myocardial Infarction

Infarction

Study Results

No Results Posted as of Oct 8, 2019