Clinical trial NCT05202743: Online Self-Compassion Course for pALS (Compassion pALS)
Official title: Cultivating Self-Compassion Course for Persons Living With Amyotrophic Lateral Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2022-01-21
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ALS participants will be recruited from a Neuromuscular clinic.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Quality of Life self-assessment with - Amyotrophic Lateral Sclerosis Assessment Questionnaire 5 (ALSA-5)
timeFrame: Baseline (T1); post 8-week intervention (T2)
Secondary outcomes:
measure: Self-compassion
timeFrame: Baseline (T1); post 8-week intervention (T2)
measure: Participant functional rating self-assessment
timeFrame: Baseline (T1); post 8-week intervention (T2)
measure: Anxiety
timeFrame: Baseline (T1); post 8-week intervention (T2)
measure: Depression
timeFrame: Baseline (T1); post 8-week intervention (T2)
measure: Feasibility of implementation
timeFrame: Baseline (T1); post 8-week intervention (T2)
measure: Acceptability
timeFrame: Baseline (T1); post 8-week intervention (T2)
measure: Appropriateness
timeFrame: Baseline (T1); post 8-week intervention (T2)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Sean Smith, MD
role: PRINCIPAL_INVESTIGATOR
References: