Online Self-Compassion Course for pALS (Compassion pALS)
Cultivating Self-Compassion Course for Persons Living With Amyotrophic Lateral Sclerosis
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Optimizing quality of life for people with ALS is a primary goal of ALS multidisciplinary care, Therefore, it is especially important to conduct research into interventions to address the psychological needs and well-being of people with ALS.
Recent studies have shown that mindfulness-based interventions promote improved quality of life for people with ALS. It is essential that such strategies as mindfulness-based interventions consider the specific needs of the ALS population and potential barriers to participation.
Very few studies have evaluated mindfulness-based interventions in the ALS population and no studies to date have evaluated self-compassion people with ALS. Self-compassion has been linked to increased emotional resilience, psychological well-being, and quality of life in multiple populations.
The intervention will include a 2-part workshop entitled 'Introduction to Mindful Self-Compassion for Persons Living with Amyotrophic Lateral Sclerosis.' Experience and feedback gained from the workshop will be incorporated into the format for an 8-week course in Cultivating Self-Compassion for persons living with ALS (Compassion pALS). Compassion pALS will be adapted from the Mindful Self-Compassion (MSC) Program to accommodate ALS clinical features and limit potential barriers to participation.
The primary outcome will be quality of life assessed with the Amyotrophic Lateral Sclerosis Assessment Questionnaire 5 (ALSA-5). Participants will be assessed at the 2-part workshop (T0, baseline), start of the 8 week Compassion pALS course (T1 = pre-intervention); after completing the intervention (T2, post-intervention). Secondary outcomes will include Secondary outcome measures the Self-Compassion Scale Short Form (SCS-SF), Patient Health Questionnaire-9 (PHQ-9), General Anxiety Disorder-7 (GAD-7), Amyotrophic Lateral Sclerosis Functional Rating Scale-R (ALSFRS-R), Feasibility of Intervention Measure (FIM), Acceptability of Intervention Measure (AIM), and Intervention Appropriateness Measure (IAM).
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Missouri
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Saint Louis, Missouri, Estados Unidos, 63110
- Washington University School of Medicine
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Diagnosis of ALS within the last 18 months.
- 18 years or older
- Access to and the physical ability to use a computer with internet access with and/or without adaptive devices.
- Ability to communicate and understand tasks.
- A caregiver available to provide assistance.
- Ability to provide informed consent
Exclusion Criteria:
- More than one neuropsychological impairment such as (frontotemporal dementia) which may interfere with the study procedures.
- Severe medical condition that would reduce life expectancy to less than 6-12 months.
- No access to a computer with internet access
- Unsuitable for the study as determined by the Investigator.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Quality of Life self-assessment with - Amyotrophic Lateral Sclerosis Assessment Questionnaire 5 (ALSA-5)
Prazo: Baseline (T1); post 8-week intervention (T2)
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Amyotrophic Lateral Sclerosis Assessment Questionnaire 5 (ALSAQ-5; Jenkinson et al., 2001.
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Baseline (T1); post 8-week intervention (T2)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Self-compassion
Prazo: Baseline (T1); post 8-week intervention (T2)
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Self-Compassion Scale Short Form (SCS-SF; Raes et al., 2011)
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Baseline (T1); post 8-week intervention (T2)
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Participant functional rating self-assessment
Prazo: Baseline (T1); post 8-week intervention (T2)
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Self-Administered ALS Functional Rating Scale-Revised (SA-ALSFRS; Montes et al., 2006)
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Baseline (T1); post 8-week intervention (T2)
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Anxiety
Prazo: Baseline (T1); post 8-week intervention (T2)
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General Anxiety Disorder-7 (GAD-7; Spitzer et al., 2006)
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Baseline (T1); post 8-week intervention (T2)
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Depression
Prazo: Baseline (T1); post 8-week intervention (T2)
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Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2002)
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Baseline (T1); post 8-week intervention (T2)
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Feasibility of implementation
Prazo: Baseline (T1); post 8-week intervention (T2)
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Feasibility of Intervention Measure (FIM; Weiner et al., 2017)
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Baseline (T1); post 8-week intervention (T2)
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Acceptability
Prazo: Baseline (T1); post 8-week intervention (T2)
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Acceptability of Intervention Measure (AIM; Weiner et al., 2017)
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Baseline (T1); post 8-week intervention (T2)
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Appropriateness
Prazo: Baseline (T1); post 8-week intervention (T2)
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Intervention Appropriateness Measure (IAM; Weiner et al., 2017)
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Baseline (T1); post 8-week intervention (T2)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sean Smith, MD, Washington University School of Medicine
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 202110073
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