Clinical Trials Directory

Trials / Completed

CompletedNCT05202743

Online Self-Compassion Course for pALS (Compassion pALS)

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

Status
Completed
Phase
Study type
Observational
Enrollment
5 (actual)
Sponsor
Washington University School of Medicine · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers

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).

Conditions

Interventions

TypeNameDescription
OTHERObservational for ALS patientsOpen to ALS patients interested in mindfulness training.

Timeline

Start date
2021-12-17
Primary completion
2022-05-30
Completion
2022-06-01
First posted
2022-01-21
Last updated
2022-06-13

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05202743. Inclusion in this directory is not an endorsement.