Online Self-Compassion Course for pALS (Compassion pALS)

Completed

• Conditions: Amyotrophic Lateral Sclerosis

• Registration Number: NCT05202743
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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

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).

Study Timeline

• Study Start: 2021-12-17
• Study First Submitted: 2021-12-29
• Study First Submitted QC: 2022-01-18
• Study First Posted: 2022-01-21
• Primary Completion: 2022-05-30
• Status Verified: 2022-06
• Study Completion: 2022-06-01
• Last Update Submitted: 2022-06-10
• Last Update Posted: 2022-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States