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
| Type | Name | Description |
|---|---|---|
| OTHER | Observational for ALS patients | Open 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.