The Effects of Journaling on Health-Related Mood and Clinical Outcomes in Post-MI Patients (GRAT2015)
7 de octubre de 2019 actualizado por: Paul J. Mills, University of California, San Diego
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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
108
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
California
-
La Jolla, California, Estados Unidos, 92093
- University of California, San Diego
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
35 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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."
|
|
|
Comparador falso: 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.
|
|
|
Sin intervención: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
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.
Periodo de tiempo: 2 years
|
2 years
|
|
Treatment Expectancy & Satisfaction assessed by Treatment expectancy and satisfaction - 6 item credibility/ expectancy questionnaire (CEQ) will be utilized
Periodo de tiempo: 2 years
|
2 years
|
|
Retention assessed by Retention (% of drop-outs) will be recorded, and exit interviews will be administered to determine reasons for drop-out.
Periodo de tiempo: 2 years
|
2 years
|
|
Adherence assessed by Adherence to intervention will be derived from gratitude journals.
Periodo de tiempo: 2 years
|
2 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Gratitude
Periodo de tiempo: 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.
|
2 years
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de abril de 2015
Finalización primaria (Actual)
1 de diciembre de 2018
Finalización del estudio (Actual)
1 de enero de 2019
Fechas de registro del estudio
Enviado por primera vez
23 de junio de 2015
Primero enviado que cumplió con los criterios de control de calidad
24 de junio de 2015
Publicado por primera vez (Estimar)
25 de junio de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
8 de octubre de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
7 de octubre de 2019
Última verificación
1 de octubre de 2019
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1R21AT008033-01A1 (Subvención/contrato del NIH de EE. UU.)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .