Clinical trial NCT02481544: The Effects of Journaling on Health-Related Mood and Clinical Outcomes in Post-MI Patients
Official title: The Effects of Journaling on Health-Related Mood and Clinical Outcomes in Post-MI Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Psychosocial Factors
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: San Diego Veterans Healthcare System
First posted: 2015-06-25
Enrollment: 108
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 2 years
measure: Treatment Expectancy & Satisfaction assessed by Treatment expectancy and satisfaction - 6 item credibility/ expectancy questionnaire (CEQ) will be utilized
timeFrame: 2 years
measure: Retention assessed by Retention (% of drop-outs) will be recorded, and exit interviews will be administered to determine reasons for drop-out.
timeFrame: 2 years
measure: Adherence assessed by Adherence to intervention will be derived from gratitude journals.
timeFrame: 2 years
Secondary outcomes:
measure: Gratitude
timeFrame: 2 years
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
Study officials:
References:
citation: Peterson CT, Lucas J, John-Williams LS, Thompson JW, Moseley MA, Patel S, Peterson SN, Porter V, Schadt EE, Mills PJ, Tanzi RE, Doraiswamy PM, Chopra D. Identification of Altered Metabolomic Profiles Following a Panchakarma-based Ayurvedic Intervention in Healthy Subjects: The Self-Directed Biological Transformation Initiative (SBTI). Sci Rep. 2016 Sep 9;6:32609. doi: 10.1038/srep32609.