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Clinical Trials/NCT05202743
NCT05202743
Completed
N/A

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

Washington University School of Medicine1 site in 1 country5 target enrollmentDecember 17, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Amyotrophic Lateral Sclerosis
Sponsor
Washington University School of Medicine
Enrollment
5
Locations
1
Primary Endpoint
Quality of Life self-assessment with - Amyotrophic Lateral Sclerosis Assessment Questionnaire 5 (ALSA-5)
Status
Completed
Last Updated
3 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
December 17, 2021
End Date
June 1, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Quality of Life self-assessment with - Amyotrophic Lateral Sclerosis Assessment Questionnaire 5 (ALSA-5)

Time Frame: Baseline (T1); post 8-week intervention (T2)

Amyotrophic Lateral Sclerosis Assessment Questionnaire 5 (ALSAQ-5; Jenkinson et al., 2001.

Secondary Outcomes

  • Feasibility of implementation(Baseline (T1); post 8-week intervention (T2))
  • Acceptability(Baseline (T1); post 8-week intervention (T2))
  • Self-compassion(Baseline (T1); post 8-week intervention (T2))
  • Participant functional rating self-assessment(Baseline (T1); post 8-week intervention (T2))
  • Anxiety(Baseline (T1); post 8-week intervention (T2))
  • Depression(Baseline (T1); post 8-week intervention (T2))
  • Appropriateness(Baseline (T1); post 8-week intervention (T2))

Study Sites (1)

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