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

Deborah R Phillips, PhD / email hidden; JavaScript is required / 9739027938

Study Sponsor:

Harvard University

Estimated Enrollment:

300

Estimated Study Start Date:

10 / 30 / 2022

Estimated Study Completion Date:

03 / 31 / 2024

Posting Last Modified Date:

10 / 27 / 2022

Date Study Added to neals.org:

10 / 27 / 2022

Minimum Age:

18 Years

Maximum Age:

N/A

Inclusion Criteria:

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.

Exclusion criteria

- Using shared devices. Patients and caregivers should have their own devices.