A Mindful Community for People With ALS and Their Primary Caregivers
Completed · Not applicable
Conditions studied: Amyotrophic Lateral Sclerosis, Caregiver Burden
In brief
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.
Key facts
- Study ID
- NCT05595850
- Run by
- Harvard University
- People needed
- 100
- Starts
- 2020-05-15
- Expected to finish
- 2025-04-10
- Last updated by the study team
- 2026-04-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Using shared devices. Patients and caregivers should have their own devices.
Where it is running
- Harvard University — Cambridge, Massachusetts, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.