Online Self-Compassion Course for pALS (Compassion pALS)

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.

Study Overview

• Status: Completed
• Conditions: Amyotrophic Lateral Sclerosis
• Intervention / Treatment: Other: Observational for ALS patients

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 Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

ALS participants will be recruited from a Neuromuscular clinic.

Description

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 Plan

How is the study designed?

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Sean Smith, MD, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2021
• Primary Completion (Actual): May 30, 2022
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: December 29, 2021
• First Submitted That Met QC Criteria: January 18, 2022
• First Posted (Actual): January 21, 2022

Study Record Updates

• Last Update Posted (Actual): June 13, 2022
• Last Update Submitted That Met QC Criteria: June 10, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Sclerosis; Motor Neuron Disease; Amyotrophic Lateral Sclerosis
• Other Study ID Numbers: 202110073

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No