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Completed

NCT Number: NCT02481544

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

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.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Psychosocial Factors Vascular Diseases

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Diego

La Jolla, California, 92093, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gratitude Journaling Plus SOC

Behavioral

Memorable Events Journaling Plus SOC

Behavioral

Primary outcomes

  1. 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.

    Time frame: 2 years

  2. Treatment Expectancy & Satisfaction assessed by Treatment expectancy and satisfaction - 6 item credibility/ expectancy questionnaire (CEQ) will be utilized

    Time frame: 2 years

  3. Retention assessed by Retention (% of drop-outs) will be recorded, and exit interviews will be administered to determine reasons for drop-out.

    Time frame: 2 years

  4. Adherence assessed by Adherence to intervention will be derived from gratitude journals.

    Time frame: 2 years

Secondary outcomes

  1. Gratitude

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • San Diego Veterans Healthcare System

Registry information

Acronym: GRAT2015

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Jun 25, 2015
Registry last updated
Oct 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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