Online Self-Compassion Course for pALS (Compassion pALS)

NCT05202743 | Completed

• 1 other identifier: 202110073
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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)

• Feasibility of implementation

  Baseline (T1); post 8-week intervention (T2)

Interventions

Observational for ALS patients OTHER

Open to ALS patients interested in mindfulness training.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ALS participants will be recruited from a Neuromuscular clinic.

You may qualify if:

• Diagnosis of ALS within the last 18 months.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Sean Smith, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: January 21, 2022
• Study Start: December 17, 2021
• Primary Completion: May 30, 2022
• Study Completion: June 1, 2022
• Last Updated: June 13, 2022

Record last verified: 2022-06

Locations

US (1)