A Mindful Community for People With ALS and Their Primary Caregivers

Study Purpose:

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.

Study Status:

Not yet recruiting

Disease:

Amyotrophic Lateral Sclerosis , Caregiver Burden

Study Type:

Interventional

Type of Intervention:

Behavioral

Intervention Name:

Mindfulness, Mindful Learning

Placebo:

Phase:

N/A

Study Chair(s)/Principal Investigator(s):

Ellen Langer, PhD, Harvard U

Clinicaltrials.gov ID:

NCT05595850

Neals Affiliated?

No

Coordinating Center Contact Information

Study Sponsor:

Harvard University

Estimated Enrollment:

300

Estimated Study Start Date:

04 / 01 / 2023

Estimated Study Completion Date:

03 / 31 / 2024

Posting Last Modified Date:

03 / 14 / 2023

Date Study Added to neals.org:

10 / 27 / 2022