NCT05595850Completed
A Mindful Community for People With ALS and Their Primary Caregivers
Source: ClinicalTrials.gov · Last updated 21 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 12 Sept 2022
- Start date
- 15 May 2020
- Primary completion date
- 30 Apr 2024
- Lead sponsor
- Harvard University
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT05595850
What you commit to
- Study type: Interventional
- Participants enrolled: 100
- From 15 May 2020 to the primary completion date, 30 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- \- Using shared devices. Patients and caregivers should have their own devices.
Who the study is looking for
- For the ALS patients
- a definite, probable, laboratory-supported, or possible ALS by revised El-Escorial criteria
- they must have the physical ability, with or without adaptive devices, to use a smartphone, a tablet, or a computer
- have access to the Internet.
- For the caregivers
- be the person who resides with the ALS patient and is the major provider of unpaid care and assistance (typically, the spouse or another close relative)
- s/he must be able to use the application
- have access to the Internet.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Harvard University Coordinator of this site? Confirm its status | Cambridge | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.