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

NCT02481544 | Completed

• 1 other identifier: 1R21AT008033-01A1
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction; Psychosocial Factors

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Gratitude

  2 years

Study Arms (3)

Gratitude Journaling Plus Standard of Care

EXPERIMENTAL

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

Memorable Events Journaling Plus Standard of Care

SHAM COMPARATOR

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

Standard of Care

NO INTERVENTION

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.

Interventions

Gratitude Journaling Plus SOC BEHAVIORAL

Gratitude Journaling Plus Standard of Care

Memorable Events Journaling Plus SOC BEHAVIORAL

Memorable Events Journaling Plus Standard of Care

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead
• San Diego Veterans Healthcare System: collaborator

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

Location

Related Publications (1)

• 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.

  PMID: 27611967 DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor IR

Study Record Dates

• First Submitted: June 23, 2015
• First Posted: June 25, 2015
• Study Start: April 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: January 1, 2019
• Last Updated: October 8, 2019

Record last verified: 2019-10

Locations

US (1)