Online Self-Compassion Course for pALS (Compassion pALS)

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Amyotrophic Lateral Sclerosis

Intervention / Treatment
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* Other: Observational for ALS patients


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Observational for ALS patients|Open to ALS patients interested in mindfulness training.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life self-assessment with - Amyotrophic Lateral Sclerosis Assessment Questionnaire 5 (ALSA-5) | Amyotrophic Lateral Sclerosis Assessment Questionnaire 5 (ALSAQ-5; Jenkinson et al., 2001. | Baseline (T1); post 8-week intervention (T2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-compassion | Self-Compassion Scale Short Form (SCS-SF; Raes et al., 2011) | Baseline (T1); post 8-week intervention (T2) | 
| Participant functional rating self-assessment | Self-Administered ALS Functional Rating Scale-Revised (SA-ALSFRS; Montes et al., 2006) | Baseline (T1); post 8-week intervention (T2) | 
| Anxiety | General Anxiety Disorder-7 (GAD-7; Spitzer et al., 2006) | Baseline (T1); post 8-week intervention (T2) | 
| Depression | Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2002) | Baseline (T1); post 8-week intervention (T2) | 
| Feasibility of implementation | Feasibility of Intervention Measure (FIM; Weiner et al., 2017) | Baseline (T1); post 8-week intervention (T2) | 
| Acceptability | Acceptability of Intervention Measure (AIM; Weiner et al., 2017) | Baseline (T1); post 8-week intervention (T2) | 
| Appropriateness | Intervention Appropriateness Measure (IAM; Weiner et al., 2017) | Baseline (T1); post 8-week intervention (T2) |