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Online Self-Compassion Course for pALS (Compassion pALS)

10. juni 2022 opdateret af: Washington University School of Medicine

Cultivating Self-Compassion Course for Persons Living With Amyotrophic Lateral Sclerosis

This study is designed to be a pragmatic, single-arm trial to evaluate the efficacy, implementation, and feasibility of an online ALS-specific self-compassion training program to enhance self-compassion and improve quality of life.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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).

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

5

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Missouri
      • Saint Louis, Missouri, Forenede Stater, 63110
        • Washington University School of Medicine

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

N/A

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

ALS participants will be recruited from a Neuromuscular clinic.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Quality of Life self-assessment with - Amyotrophic Lateral Sclerosis Assessment Questionnaire 5 (ALSA-5)
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Self-compassion
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline (T1); post 8-week intervention (T2)
Feasibility of Intervention Measure (FIM; Weiner et al., 2017)
Baseline (T1); post 8-week intervention (T2)
Acceptability
Tidsramme: Baseline (T1); post 8-week intervention (T2)
Acceptability of Intervention Measure (AIM; Weiner et al., 2017)
Baseline (T1); post 8-week intervention (T2)
Appropriateness
Tidsramme: Baseline (T1); post 8-week intervention (T2)
Intervention Appropriateness Measure (IAM; Weiner et al., 2017)
Baseline (T1); post 8-week intervention (T2)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Washington University School of Medicine

Efterforskere

  • Ledende efterforsker: Sean Smith, MD, Washington University School of Medicine

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

17. december 2021

Primær færdiggørelse (Faktiske)

30. maj 2022

Studieafslutning (Faktiske)

1. juni 2022

Datoer for studieregistrering

Først indsendt

29. december 2021

Først indsendt, der opfyldte QC-kriterier

18. januar 2022

Først opslået (Faktiske)

21. januar 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. juni 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juni 2022

Sidst verificeret

1. juni 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 202110073

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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