NCT05595850

A Mindful Community for People With ALS and Their Primary Caregivers

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Harvard University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Amyotrophic Lateral Sclerosis
• Caregiver Burden

Interventions

Type	Name	Description
BEHAVIORAL	Mindfulness	Online non-meditation mindfulness program
BEHAVIORAL	Mindful Learning	Online learning program

Timeline

• Start date: 2023-10-12
• Primary completion: 2024-06-01
• Completion: 2024-07-31
• First posted: 2022-10-27
• Last updated: 2024-01-17

Locations

1 site across 1 country: United States