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NCT05595850 · ClinicalTrials.gov registry record · NA
A Mindful Community for People With ALS and Their Primary Caregivers
A NA study, sponsored by Harvard University.
- Completed
- Registry status
- NA
- Development phase
- 100
- Enrollment target
NCT05595850: Completed NA study, sponsored by Harvard University.
NCT05595850 is a NA study that has completed, run by Harvard University. The registered enrollment target is 100 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05595850, a NA study, has completed, sponsored by Harvard University.
- COMPLETED
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
Study Summary
The psychological impact of ALS on patients and caregivers is high, significantly affecting their quality of life (QOL). Despite this impact, there is not much research about psychological interventions that could reduce psychological distress and improve QOL. The efficacy of mindfulness-based treatments for the improvement of QOL was previously demonstrated by the investigator's group. Despite preliminary positive results, treatment efficacy tends to weaken over time. The investigators believe that a robust solution to maintain efficacy is to maximize the utilization of technology and emerging social platforms, establishing a "mindful community" to promote and continuously reinforce mindfulness. This project's primary aims are 1) to develop a "mindful" online community of people with ALS and their caregivers, and 2) to test its efficacy in QOL improvement. This two-part intervention consists of 1) optimizing the investigator's prior e-learning platform with a three-week program including cognitive exercises, videos and lectures to increase participants' mindfulness; and 2) involving participants in a "mindfulness community" within a social sharing forum. Assessments will be performed before and immediately post-treatment as well as 3- and 6-months post-program comparing subjects undergoing the intervention to a control group.
Primary Outcome
The ALSSQOL-SF is a 20 item quality of life instrument for patients. It has a 0-10 rating scale with higher scores denoting higher QOL.
Interventions
- BEHAVIORAL Mindfulness
- BEHAVIORAL Mindful Learning
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2020-05-15 |
| Est. Completion | 2025-04-10 |
| Phase | NA |
What the finished NCT05595850 record still lists
NCT05595850 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Mindfulness is the first listed.
NCT05595850 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05595850 about?
NCT05595850 is a clinical study titled "A Mindful Community for People With ALS and Their Primary Caregivers". The psychological impact of ALS on patients and caregivers is high, significantly affecting their quality of life (QOL). Despite this impact, there is not much research about psychological interventions that could reduce psychological distress and improve QOL. The efficacy of mindfulness-based trea...
What is the current status of trial NCT05595850?
This trial is currently completed. It is a NA study. The enrollment target is 100 participants. The study started on 2020-05-15. Estimated completion is 2025-04-10.
What interventions are being tested in trial NCT05595850?
The interventions under investigation include: Mindfulness (BEHAVIORAL), Mindful Learning (BEHAVIORAL).
Who is sponsoring clinical trial NCT05595850?
This trial is sponsored by Harvard University, which has 37 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05595850's enrollment target sits among peer trials
100 840th of 2000 higher than 1,081 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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