Online Self-Compassion Course for pALS (Compassion pALS)
Cultivating Self-Compassion Course for Persons Living With Amyotrophic Lateral Sclerosis
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Missouri
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Saint Louis, Missouri, Stati Uniti, 63110
- Washington University School of Medicine
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Quality of Life self-assessment with - Amyotrophic Lateral Sclerosis Assessment Questionnaire 5 (ALSA-5)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Self-compassion
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Investigatori
- Investigatore principale: Sean Smith, MD, Washington University School of Medicine
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 202110073
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