Online Self-Compassion Course for pALS (Compassion pALS)

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05202743
• Other study ID #: 202110073
• Status: Completed
• Start date: December 17, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: June 2022
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: June 1, 2022
• Est. primary completion date: May 30, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Other:
• Observational for ALS patients
Open to ALS patients interested in mindfulness training.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Self-compassion	Self-Compassion Scale Short Form (SCS-SF; Raes et al., 2011)	Baseline (T1); post 8-week intervention (T2)
Secondary	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)
Secondary	Anxiety	General Anxiety Disorder-7 (GAD-7; Spitzer et al., 2006)	Baseline (T1); post 8-week intervention (T2)
Secondary	Depression	Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2002)	Baseline (T1); post 8-week intervention (T2)
Secondary	Feasibility of implementation	Feasibility of Intervention Measure (FIM; Weiner et al., 2017)	Baseline (T1); post 8-week intervention (T2)
Secondary	Acceptability	Acceptability of Intervention Measure (AIM; Weiner et al., 2017)	Baseline (T1); post 8-week intervention (T2)
Secondary	Appropriateness	Intervention Appropriateness Measure (IAM; Weiner et al., 2017)	Baseline (T1); post 8-week intervention (T2)