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- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01802554
Reducing CVD Risk in Caregivers: A Brief Behavioral Activation Intervention
10 de maio de 2016 atualizado por: Brent Mausbach, University of California, San Diego
Cardiovascular disease and depression are some of the most costly illnesses to society, and caring for a loved-one with Alzheimer's disease has been associated with increased risk for both depression and cardiovascular disease.
Indeed, depressive symptoms have been linked with elevated plasma concentrations of D-dimer and Interleukin-6 (IL-6), both of which are associated with increased risk for cardiovascular disease (CVD).
The present research tests a brief behavioral intervention for reducing both depressive symptoms and CVD biomarkers in Alzheimer caregivers.
We hypothesize that caregivers receiving a brief Behavioral Activation (BA) therapy will show greater reductions in depressive symptoms and in CVD biomarkers relative to those randomized to a time-equivalent Information and Support (IS) therapy.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
Due to an aging society, the number of people diagnosed with dementia is expected to increase dramatically over the next two decades, with a concomitant rise in the number of family members providing informal care for their loved ones.
The stresses associated with this care have been well-documented in the scientific literature, and are noted to be associated with increased risk for psychological and physical morbidity, particularly cardiovascular disease.
Indeed, caregiving is associated with elevations in negative affect (e.g., depressive and anxiety symptoms), which in turn is associated with biological indicators that are thought to predict CVD risk (e.g., markers of coagulation and inflammation).
The primary goal of this study is to examine the efficacy of a brief Behavioral Activation (BA) Treatment, called the Pleasant Events Program (PEP), for reducing biological CVD risk indicators in a sample of Alzheimer caregivers.
We will enroll 100 dementia caregivers and randomly assign them to receive 4-sessions of PEP or 4-sessions of support + information.
Our PEP intervention will be conducted in caregivers' homes and will emphasize the importance of monitoring and increasing activities that help individuals make contact with natural reinforcers in their environments, identifying and reducing negative coping responses, and selection and achievement of behavioral goals for healthier living.
Caregivers will be assessed for our biological outcomes at baseline, post-treatment, and 1-year to determine intervention efficacy.
Given the brief nature of the PEP intervention, the ease with which it can be applied in real-world settings (e.g., community agencies providing services to caregivers), and lack of difficult skills for interventionists and caregivers to acquire, we believe our PEP intervention will be easily transferred to "real-world" settings.
If our PEP intervention is efficacious, it may have a considerable impact on both the physical and mental health of caregivers, and will likely have public health implications.
Tipo de estudo
Intervencional
Inscrição (Real)
100
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
55 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Aged 55 or older and providing at-home care for a care recipient (CR) with a physician-diagnosis of Alzheimer's disease (AD) or related dementia.
Exclusion Criteria:
- Receiving beta-blocking medications at enrollment
- Receiving treatment with Anticoagulant medications
- Severe hypertension (>200/120 mmHg)
- Diagnosed with a terminal illness with a life expectancy <6 months
- Enrolled in another intervention study
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: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: Pleasant Events Program (PEP)
The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression.
Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities.
Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation.
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Behavioral Activation Therapy
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Comparador Ativo: Information-Support (IS)
Participants in the Information-Support (IS) control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies.
Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available.
Each IS session allowed caregivers to select issue(s) from the resource manual to discuss.
The therapist covered the material based on the caregivers' needs.
When requested by the caregiver, supportive psychotherapy was also provided.
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Information-Support (IS) condition consisted of supportive psychotherapy and informational brochures.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Brief Center for Epidemiologic Studies Depression Scale (CESD)
Prazo: Change from Baseline CESD at 8-weeks
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The Brief CESD is a measure of depressive symptoms.
The scale's minimum score is 0 and maximum score is 30.
Lower scores represent fewer depressive symptoms and thus better outcomes.
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Change from Baseline CESD at 8-weeks
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D-dimer
Prazo: Change from Baseline D-dimer at 8-weeks
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D-dimer is an indicator of fibrin formation and its subsequent lysis and is a useful biomarker representing overall activation of blood coagulation.
High concentrations of D-dimer have been linked prospectively to onset of Coronary Heart Disease.
Blood was collected by a research nurse in the caregivers' homes through a 22 gauge forearm catheter after a 20 minute rest.
Blood for D-dimer was dispensed into polypropylene tubes with 3.8 percent sodium citrate and spun at 1600 g for 10 minutes at room temperature.
Obtained plasma was stored at minus 80 degrees Celsius until analyzed.
Plasma D-dimer (Asserachrom Stago, Asnieres, France) was determined via high sensitive enzyme-linked immunosorbent assays.
Intra- and interassay coefficients of variation were less than 5 percent.
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Change from Baseline D-dimer at 8-weeks
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Interleukin-6 (IL-6)
Prazo: Change from Baseline IL-6 at 8-weeks
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IL-6 is one of many biomarkers represented in the inflammatory cascade which is initiated during an immune response.
Prospectively, increased plasma IL-6 is also associated with future myocardial infarction in healthy men and increasing concentrations of IL-6 have been associated with both nonfatal myocardial infarction and fatal Coronary Heart Disease (CHD) in longitudinal studies of population-based cohorts.
Higher concentrations of IL-6 raise CHD risk.
Blood was collected by a research nurse in the caregivers' homes through a 22-gauge forearm catheter after a 20 min rest.
Blood for IL-6 was dispensed in Ethylenediaminetetraacetic acid (EDTA) tubes and spun at 3000 g for 10 minutes at 4 to 8 degrees Celsius.
Obtained plasma was stored at minus 80 degrees Celsius until analyzed.
Plasma IL-6 (Meso Scale Discovery, Gaithersburg, MD) was determined via highsensitive enzyme-linked immunosorbent assays.
Intra- and interassay coefficients of variation were less than 5 percent.
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Change from Baseline IL-6 at 8-weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Positive and Negative Affect Schedule
Prazo: Change from Baseline Positive Affect at 8-weeks
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This scales contains ten items assessing Positive Affect.
Items included are adjectives, such as "interested," "strong," and "inspired".
Participants rated each adjective based on how they felt over the past few weeks using a 5-point scale with responses ranging from 1 (very slightly to not at all) to 5 (extremely).
The scale's minimum score is 10 and maximum score is 50.
Higher scores represent better outcomes.
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Change from Baseline Positive Affect at 8-weeks
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Positive and Negative Affect Schedule
Prazo: Change from Baseline Negative Affect at 8-weeks
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This scales contains ten items assessing Negative Affect.
Items included are adjectives, such as "distressed," "ashamed," and Participants rated each adjective based on how they felt over the past few weeks using a 5-point scale with responses ranging from 1 (very slightly to not at all) to 5 (extremely).
The scale's minimum score is 10 and maximum score is 50.
Lower scores represent better outcomes.
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Change from Baseline Negative Affect at 8-weeks
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Brent Mausbach, PhD, University of California, San Diego
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Mausbach BT, Chattillion E, Roepke SK, Ziegler MG, Milic M, von Kanel R, Dimsdale JE, Mills PJ, Patterson TL, Allison MA, Ancoli-Israel S, Grant I. A longitudinal analysis of the relations among stress, depressive symptoms, leisure satisfaction, and endothelial function in caregivers. Health Psychol. 2012 Jul;31(4):433-40. doi: 10.1037/a0027783. Epub 2012 Apr 9.
- Chattillion EA, Mausbach BT, Roepke SK, von Kanel R, Mills PJ, Dimsdale JE, Allison M, Ziegler MG, Patterson TL, Ancoli-Israel S, Grant I. Leisure activities, caregiving demands and catecholamine levels in dementia caregivers. Psychol Health. 2012;27(10):1134-49. doi: 10.1080/08870446.2011.637559. Epub 2011 Dec 12.
- Mausbach BT, Chattillion EA, Roepke SK, Patterson TL, Grant I. A comparison of psychosocial outcomes in elderly Alzheimer caregivers and noncaregivers. Am J Geriatr Psychiatry. 2013 Jan;21(1):5-13. doi: 10.1016/j.jagp.2012.10.001. Epub 2013 Jan 2.
- Chattillion EA, Ceglowski J, Roepke SK, von Kanel R, Losada A, Mills PJ, Romero-Moreno R, Grant I, Patterson TL, Mausbach BT. Pleasant events, activity restriction, and blood pressure in dementia caregivers. Health Psychol. 2013 Jul;32(7):793-801. doi: 10.1037/a0029412. Epub 2012 Aug 13.
- Mausbach BT, Roepke SK, Chattillion EA, Harmell AL, Moore R, Romero-Moreno R, Bowie CR, Grant I. Multiple mediators of the relations between caregiving stress and depressive symptoms. Aging Ment Health. 2012;16(1):27-38. doi: 10.1080/13607863.2011.615738.
- Mausbach BT, Chattillion EA, Moore RC, Roepke SK, Depp CA, Roesch S. Activity restriction and depression in medical patients and their caregivers: a meta-analysis. Clin Psychol Rev. 2011 Aug;31(6):900-8. doi: 10.1016/j.cpr.2011.04.004. Epub 2011 Apr 28.
- Moore RC, Harmell AL, Chattillion E, Ancoli-Israel S, Grant I, Mausbach BT. PEAR model and sleep outcomes in dementia caregivers: influence of activity restriction and pleasant events on sleep disturbances. Int Psychogeriatr. 2011 Nov;23(9):1462-9. doi: 10.1017/S1041610211000512. Epub 2011 Mar 24.
- Harmell AL, Chattillion EA, Roepke SK, Mausbach BT. A review of the psychobiology of dementia caregiving: a focus on resilience factors. Curr Psychiatry Rep. 2011 Jun;13(3):219-24. doi: 10.1007/s11920-011-0187-1.
- Mausbach BT, Roepke SK, Depp CA, Moore R, Patterson TL, Grant I. Integration of the pleasant events and activity restriction models: development and validation of a "PEAR" model of negative outcomes in Alzheimer's caregivers. Behav Ther. 2011 Mar;42(1):78-88. doi: 10.1016/j.beth.2009.11.006. Epub 2010 Oct 15.
- Mausbach BT, Harmell AL, Moore RC, Chattillion EA. Influence of caregiver burden on the association between daily fluctuations in pleasant activities and mood: A daily diary analysis. Behav Res Ther. 2011 Jan;49(1):74-9. doi: 10.1016/j.brat.2010.11.004. Epub 2010 Nov 22.
- Moore RC, Chattillion EA, Ceglowski J, Ho J, von Kanel R, Mills PJ, Ziegler MG, Patterson TL, Grant I, Mausbach BT. A randomized clinical trial of Behavioral Activation (BA) therapy for improving psychological and physical health in dementia caregivers: results of the Pleasant Events Program (PEP). Behav Res Ther. 2013 Oct;51(10):623-32. doi: 10.1016/j.brat.2013.07.005. Epub 2013 Jul 19.
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 2008
Conclusão Primária (Real)
1 de fevereiro de 2013
Conclusão do estudo (Real)
1 de fevereiro de 2013
Datas de inscrição no estudo
Enviado pela primeira vez
20 de fevereiro de 2013
Enviado pela primeira vez que atendeu aos critérios de CQ
27 de fevereiro de 2013
Primeira postagem (Estimativa)
1 de março de 2013
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
13 de junho de 2016
Última atualização enviada que atendeu aos critérios de controle de qualidade
10 de maio de 2016
Última verificação
1 de maio de 2016
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- R01AG031090 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
INDECISO
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