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

Myocardial Infarction Clinical Trial

— GRAT2015  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02481544
• Other study ID #: 1R21AT008033-01A1
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: January 2019

Study information

• Verified date: October 2019
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: January 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

Inclusion criteria:

1. 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;

2. An EF less than 50% on echocardiogram;

3. Clinically stable defined as, no active arrhythmia, no residual ischemia;

4. Able to perform light to moderate exercise;

5. Able to give informed consent in English;

6. Medical clearance by their cardiologist;

7. > 35 years of age.

Exclusion criteria:

1. Unstable angina;

2. Severe valvular disease;

3. Oxygen-dependent COPD;

4. Recent stroke or significant cerebral neurologic impairment;

5. Suicidality with intent or plan;

6. Current cancer;

7. Currently taking mood stabilizers, benzodiazepines or antipsychotics;

8. Medications (e.g., systemic steroids) and conditions affecting immune status (e.g., rheumatoid arthritis, hepatitis C, HIV) (Anti-depressant medication is allowed);

9. Currently enrolled in another clinical trial.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Psychosocial Factors

Intervention

Behavioral:
• Gratitude Journaling Plus SOC

• Memorable Events Journaling Plus SOC

Locations

Country	Name	City	State
United States	University of California, San Diego	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	San Diego Veterans Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Treatment Expectancy & Satisfaction assessed by Treatment expectancy and satisfaction - 6 item credibility/ expectancy questionnaire (CEQ) will be utilized		2 years
Primary	Retention assessed by Retention (% of drop-outs) will be recorded, and exit interviews will be administered to determine reasons for drop-out.		2 years
Primary	Adherence assessed by Adherence to intervention will be derived from gratitude journals.		2 years
Secondary	Gratitude	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.	2 years