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

Study Purpose:

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 Status:

Not recruiting


Amyotrophic Lateral Sclerosis

Study Type:


Type of Intervention:


Intervention Name:






Study Chair(s)/Principal Investigator(s):

Sean Smith, MD, Washington University School of Medicine ID:


Neals Affiliated?


Coordinating Center Contact Information

Washington University School of Medicine

Saint Louis, Missouri, 63110 United States

Full Study Summary:

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 Sponsor:

Washington University School of Medicine

Estimated Enrollment:


Estimated Study Start Date:

12 / 17 / 2021

Estimated Study Completion Date:

06 / 01 / 2022

Posting Last Modified Date:

06 / 13 / 2022

Date Study Added to

01 / 21 / 2022

Minimum Age:

18 Years

Maximum Age:


Can participants use Riluzole?


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.

Washington University School of Medicine

Saint Louis, Missouri 63110
United States