- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05202743
Online Self-Compassion Course for pALS (Compassion pALS)
Cultivating Self-Compassion Course for Persons Living With Amyotrophic Lateral Sclerosis
연구 개요
상세 설명
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).
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Missouri
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Saint Louis, Missouri, 미국, 63110
- Washington University School of Medicine
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Quality of Life self-assessment with - Amyotrophic Lateral Sclerosis Assessment Questionnaire 5 (ALSA-5)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Self-compassion
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Sean Smith, MD, Washington University School of Medicine
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .