The Effects of Journaling on Health-Related Mood and Clinical Outcomes in Post-MI Patients (GRAT2015)
7 de outubro de 2019 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Antecipado)
108
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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California
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La Jolla, California, Estados Unidos, 92093
- University of California, San Diego
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
35 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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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."
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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.
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Sem intervenção: 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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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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.
Prazo: 2 years
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2 years
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Treatment Expectancy & Satisfaction assessed by Treatment expectancy and satisfaction - 6 item credibility/ expectancy questionnaire (CEQ) will be utilized
Prazo: 2 years
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2 years
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Retention assessed by Retention (% of drop-outs) will be recorded, and exit interviews will be administered to determine reasons for drop-out.
Prazo: 2 years
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2 years
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Adherence assessed by Adherence to intervention will be derived from gratitude journals.
Prazo: 2 years
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2 years
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Gratitude
Prazo: 2 years
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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.
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2 years
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Colaboradores e Investigadores
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Patrocinador
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Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de abril de 2015
Conclusão Primária (Real)
1 de dezembro de 2018
Conclusão do estudo (Real)
1 de janeiro de 2019
Datas de inscrição no estudo
Enviado pela primeira vez
23 de junho de 2015
Enviado pela primeira vez que atendeu aos critérios de CQ
24 de junho de 2015
Primeira postagem (Estimativa)
25 de junho de 2015
Atualizações de registro de estudo
Última Atualização Postada (Real)
8 de outubro de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
7 de outubro de 2019
Última verificação
1 de outubro de 2019
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 1R21AT008033-01A1 (Concessão/Contrato do NIH dos EUA)
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