Online Self-Compassion Course for pALS (Compassion pALS)
Cultivating Self-Compassion Course for Persons Living With Amyotrophic Lateral Sclerosis
調査の概要
詳細な説明
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).
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
Missouri
-
Saint Louis、Missouri、アメリカ、63110
- Washington University School of Medicine
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Quality of Life self-assessment with - Amyotrophic Lateral Sclerosis Assessment Questionnaire 5 (ALSA-5)
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Self-compassion
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Baseline (T1); post 8-week intervention (T2)
|
Feasibility of Intervention Measure (FIM; Weiner et al., 2017)
|
Baseline (T1); post 8-week intervention (T2)
|
|
Acceptability
時間枠：Baseline (T1); post 8-week intervention (T2)
|
Acceptability of Intervention Measure (AIM; Weiner et al., 2017)
|
Baseline (T1); post 8-week intervention (T2)
|
|
Appropriateness
時間枠：Baseline (T1); post 8-week intervention (T2)
|
Intervention Appropriateness Measure (IAM; Weiner et al., 2017)
|
Baseline (T1); post 8-week intervention (T2)
|
協力者と研究者
捜査官
- 主任研究者：Sean Smith, MD、Washington University School of Medicine
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。