Online Self-Compassion Course for pALS (Compassion pALS)
Cultivating Self-Compassion Course for Persons Living With Amyotrophic Lateral Sclerosis
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Missouri
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Saint Louis, Missouri, Estados Unidos, 63110
- Washington University School of Medicine
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Quality of Life self-assessment with - Amyotrophic Lateral Sclerosis Assessment Questionnaire 5 (ALSA-5)
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Self-compassion
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Enfermedades metabólicas
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades Neuromusculares
- Enfermedades neurodegenerativas
- Enfermedades de la médula espinal
- Proteinopatías TDP-43
- Deficiencias de proteostasis
- Esclerosis
- Enfermedad de la neuronas motoras
- La esclerosis lateral amiotrófica
Otros números de identificación del estudio
- 202110073
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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