A Mindful Community for People With ALS and Their Primary Caregivers

President and Fellows of Harvard College

Status: Enrolling

Conditions: Caregiver Burden; Amyotrophic Lateral Sclerosis

Treatments: Behavioral: Mindful Learning; Behavioral: Mindfulness

Study type: Interventional

Funder types: Other

Identifiers

NCT05595850

IRB20-0629

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

---

300 participants in 2 patient groups

Mindfulness

Experimental group

Description:

Three-week online mindfulness course followed by one-month social community online interaction.

Treatment:

Behavioral: Mindfulness

Mindful Learning

Active Comparator group

Description:

Three-week online mindful learning course followed by one-month social community online interaction

Treatment:

Behavioral: Mindful Learning