Online Self-Compassion Course for pALS (Compassion pALS)
Cultivating Self-Compassion Course for Persons Living With Amyotrophic Lateral Sclerosis
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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).
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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-
Missouri
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Saint Louis, Missouri, Vereinigte Staaten, 63110
- Washington University School of Medicine
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Quality of Life self-assessment with - Amyotrophic Lateral Sclerosis Assessment Questionnaire 5 (ALSA-5)
Zeitfenster: Baseline (T1); post 8-week intervention (T2)
|
Amyotrophic Lateral Sclerosis Assessment Questionnaire 5 (ALSAQ-5; Jenkinson et al., 2001.
|
Baseline (T1); post 8-week intervention (T2)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Self-compassion
Zeitfenster: Baseline (T1); post 8-week intervention (T2)
|
Self-Compassion Scale Short Form (SCS-SF; Raes et al., 2011)
|
Baseline (T1); post 8-week intervention (T2)
|
|
Participant functional rating self-assessment
Zeitfenster: Baseline (T1); post 8-week intervention (T2)
|
Self-Administered ALS Functional Rating Scale-Revised (SA-ALSFRS; Montes et al., 2006)
|
Baseline (T1); post 8-week intervention (T2)
|
|
Anxiety
Zeitfenster: Baseline (T1); post 8-week intervention (T2)
|
General Anxiety Disorder-7 (GAD-7; Spitzer et al., 2006)
|
Baseline (T1); post 8-week intervention (T2)
|
|
Depression
Zeitfenster: Baseline (T1); post 8-week intervention (T2)
|
Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2002)
|
Baseline (T1); post 8-week intervention (T2)
|
|
Feasibility of implementation
Zeitfenster: Baseline (T1); post 8-week intervention (T2)
|
Feasibility of Intervention Measure (FIM; Weiner et al., 2017)
|
Baseline (T1); post 8-week intervention (T2)
|
|
Acceptability
Zeitfenster: Baseline (T1); post 8-week intervention (T2)
|
Acceptability of Intervention Measure (AIM; Weiner et al., 2017)
|
Baseline (T1); post 8-week intervention (T2)
|
|
Appropriateness
Zeitfenster: Baseline (T1); post 8-week intervention (T2)
|
Intervention Appropriateness Measure (IAM; Weiner et al., 2017)
|
Baseline (T1); post 8-week intervention (T2)
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Sean Smith, MD, Washington University School of Medicine
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Pathologische Prozesse
- Stoffwechselerkrankungen
- Erkrankungen des zentralen Nervensystems
- Erkrankungen des Nervensystems
- Neuromuskuläre Erkrankungen
- Neurodegenerative Krankheiten
- Erkrankungen des Rückenmarks
- TDP-43 Proteinopathien
- Proteostase-Mängel
- Sklerose
- Motoneuron-Krankheit
- Amyotrophe Lateralsklerose
Andere Studien-ID-Nummern
- 202110073
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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