A Mindful Community for People With ALS and Their Primary Caregivers

NCT ID: NCT05595850

Last Updated: 2024-01-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-12
• Study Completion Date: 2024-07-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Mindfulness

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

Group Type: EXPERIMENTAL

Mindfulness

Intervention Type: BEHAVIORAL

Online non-meditation mindfulness program

Mindful Learning

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

Group Type: ACTIVE_COMPARATOR

Mindful Learning

Intervention Type: BEHAVIORAL

Online learning program

Interventions

Mindfulness

Online non-meditation mindfulness program

Intervention Type: BEHAVIORAL

Mindful Learning

Online learning program

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catholic University of the Sacred Heart

OTHER

Sponsor Role: collaborator

Harvard University

OTHER

Sponsor Role: lead

Responsible Party

Ellen Langer

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ellen Langer, PhD

Role: PRINCIPAL_INVESTIGATOR

Harvard U

Locations

Harvard University

Cambridge, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Deborah R Phillips, PhD

Role: CONTACT

dphillips@fas.harvard.edu

9739027938

Francesco Pagnini, PhD

Role: CONTACT

francesco.pagnini@unicatt.it

Other Identifiers

IRB20-0629

Identifier Type: -

Identifier Source: org_study_id