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Online Self-Compassion Course for pALS (Compassion pALS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05202743
Recruitment Status : Active, not recruiting
First Posted : January 21, 2022
Last Update Posted : April 11, 2022
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment
Amyotrophic Lateral Sclerosis Other: Observational for ALS patients

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).

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Cultivating Self-Compassion Course for Persons Living With Amyotrophic Lateral Sclerosis
Actual Study Start Date : December 17, 2021
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022



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


Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Self-compassion [ Time Frame: Baseline (T1); post 8-week intervention (T2) ]
    Self-Compassion Scale Short Form (SCS-SF; Raes et al., 2011)

  2. Participant functional rating self-assessment [ Time Frame: Baseline (T1); post 8-week intervention (T2) ]
    Self-Administered ALS Functional Rating Scale-Revised (SA-ALSFRS; Montes et al., 2006)

  3. Anxiety [ Time Frame: Baseline (T1); post 8-week intervention (T2) ]
    General Anxiety Disorder-7 (GAD-7; Spitzer et al., 2006)

  4. Depression [ Time Frame: Baseline (T1); post 8-week intervention (T2) ]
    Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2002)

  5. Feasibility of implementation [ Time Frame: Baseline (T1); post 8-week intervention (T2) ]
    Feasibility of Intervention Measure (FIM; Weiner et al., 2017)

  6. Acceptability [ Time Frame: Baseline (T1); post 8-week intervention (T2) ]
    Acceptability of Intervention Measure (AIM; Weiner et al., 2017)

  7. Appropriateness [ Time Frame: Baseline (T1); post 8-week intervention (T2) ]
    Intervention Appropriateness Measure (IAM; Weiner et al., 2017)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
ALS participants will be recruited from a Neuromuscular clinic.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05202743


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Sean Smith, MD Washington University School of Medicine
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT05202743    
Other Study ID Numbers: 202110073
First Posted: January 21, 2022    Key Record Dates
Last Update Posted: April 11, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases