Preventing Chronic Depression and PTSD in Stroke Patients Admitted to the Neuroscience Intensive Care Unit (NICU) and Their Family Caregivers
15 de agosto de 2018 atualizado por: Ana-Maria Vranceanu, PhD, Massachusetts General Hospital
Preventing Chronic Depression and PTSD in Patients With Stroke Admitted to the Neuroscience ICU and Their Family Caregivers
The current study has the following objectives:
- To determine additional stroke patient (SP) and stroke caregiver (SC) factors including their perceptions of the stroke experience, hospitalization, and how they cope with its challenges; identify additional appropriate points to intervene (maladaptive coping styles, unrealistic expectations, inappropriate prioritization, misinformation about illness, and self care), and assess SP and SC preferences for the structure, mode of delivery (including potential for phone, video or a combination of these) and timing of an intervention.
- To develop, [using the preliminary data and information from aim 1], and test the feasibility and acceptability (primary outcomes) of a skills-based intervention for preventing chronic depression, anxiety, PTSD and decreased QoL in dyads at risk.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
15
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
-
-
Massachusetts
-
Boston, Massachusetts, Estados Unidos, 02114
- Massachusetts General Hospital
-
-
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
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Eligible dyads (stroke patients and stroke caregivers) must meet the following inclusion criteria:
- Age 18 or older
- English fluency and literacy
- Hospitalized with an acute stroke (hemorrhagic and ischemic) within the past 2 weeks (patient) OR primary stroke caregiver of a stroke patient currently admitted with an acute stroke
- Stroke patient or stroke caregiver screens in for depression and/or PTSD
One or more of the following exclusion criteria will render a stroke patient (only) ineligible:
- Stroke patients who cannot participate due to the severity of stroke, cognitive impairment and/or aphasia, and are anticipated to not be able to participate due to permanent impairment as judged by the medical team.
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: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Psychosocial Skills-Based Intervention
Based on information from Phase I (semi-structured interviews), the investigators will develop a detailed psychosocial intervention manual.
The intervention will be tailored consistent with American Heart Association (AHA) recommendations for stroke skills based interventions and will include 2 general and 4 specific modules (selected from 7 available).
Generally, in the intervention, stroke patients and stroke caregivers will learn skills to cope and manage stroke-related stressors.
It is anticipated that the intervention will have 6 sessions with 2 general sessions delivered within the NICU face to face and 4 tailored specific sessions to be delivered via live video using Vidyo.
Participants in the intervention group will also receive treatment as usual.
|
Subjects will attend group skills-based sessions once weekly (either in-person or via Vidyo) for 6 weeks and learn skills to cope and manage stroke-related stressors.
|
|
Sem intervenção: Minimally Enhanced Usual Care (MEUC)
Those in the MEUC will continue with their current care.
This may include meeting with nurses, physical therapist, medical doctors, and other members of the stroke patient's medical team.
Treatment as usual may also involve administration of Selective Serotonin Reuptake Inhibitors (SSRIs) to those patients with motor problems.
They will also received a pamphlet with educational information on stroke and recovery
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Feasibility of the Intervention
Prazo: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
|
Demonstration of feasibility will be assessed by the number of individuals who drop out of the study prior to completing the post- intervention assessment and the rate of missed sessions.
If drop-out rate or missed-session rate exceeds 25%, revisions to the intervention may be needed.
|
Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
|
|
Client Satisfaction Questionnaire (CSQ-8)
Prazo: Change between post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
|
Measures how satisfied the participant is with the intervention.
|
Change between post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Measure of Current Status (MOCS-A)
Prazo: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
|
Measures participants' current self-perceived status on several skills that are targeted by the intervention: the ability to relax at will, recognize stress-inducing situations, restructure maladaptive thoughts, be assertive about needs, and choose appropriate coping responses as needed.
|
Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
|
|
Cognitive and Affective Mindfulness Scale (CAMS)
Prazo: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
|
Measures the degree to which individuals experience their thoughts and feelings.
|
Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
|
|
World Health Organization QOL Questionnaire (WHOQOL-BREF)
Prazo: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
|
Measures one's perceptions in the context of their culture and value systems, and their personal goals, standards and concerns.
|
Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
|
|
Modified Rankin Scale (mRS)
Prazo: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
|
Measures the patient's prior stroke status and stroke severity.
|
Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
|
|
Hospital Anxiety and Depression Scale (HADS)
Prazo: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
|
Measures symptoms of anxiety and depression.
|
Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
|
|
Posttraumatic Stress (PCL-S)
Prazo: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
|
Measures symptoms of posttraumatic stress disorder
|
Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
|
|
Current psychotropic meds and comorbid medical conditions,
Prazo: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
|
Study staff will collect information on patient's medical history and current medications to measure their mental health throughout the study.
|
Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
|
|
Barthel Index
Prazo: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
|
Measures the patient's prior stroke status and stroke severity.
|
Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Idade, sexo, raça, etnia, estado civil, escolaridade e emprego de pacientes/cuidadores na UTI
Prazo: Linha de base (semana 0)
|
Este questionário solicita aos pacientes/cuidadores de UTI que informem sua idade, sexo, raça, etnia, estado civil, nível de escolaridade mais alto e situação de emprego principal nos últimos 12 meses.
|
Linha de base (semana 0)
|
|
Questionário de Credibilidade
Prazo: Linha de base (semana 0)
|
Mede o quanto o participante acredita que a intervenção funcionará.
|
Linha de base (semana 0)
|
|
Prior Mental Health Questionnaire
Prazo: Baseline (week 0)
|
This questionnaire asks ICU patients/caregivers to report any previous or current mental health conditions that they have been diagnosed with in the past.
|
Baseline (week 0)
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
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.
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 (Real)
1 de julho de 2016
Conclusão Primária (Real)
1 de junho de 2018
Conclusão do estudo (Real)
1 de agosto de 2018
Datas de inscrição no estudo
Enviado pela primeira vez
2 de junho de 2016
Enviado pela primeira vez que atendeu aos critérios de CQ
7 de junho de 2016
Primeira postagem (Estimativa)
13 de junho de 2016
Atualizações de registro de estudo
Última Atualização Postada (Real)
17 de agosto de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
15 de agosto de 2018
Última verificação
1 de agosto de 2018
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2016P001190
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Indeciso
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .