A Mindful Community for People With ALS and Their Primary Caregivers

NCT05595850 | Completed

• 1 other identifier: IRB20-0629
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Mindfulness; Quality of Life

Outcome Measures

Primary Outcomes (2)

• ALS Specific QOL Short Form Quality of Life (ALSSQOL-SF) - For PALS (Persons with ALS)

  The ALSSQOL-SF is a 20 item quality of life instrument for patients. It has a 0-10 rating scale with higher scores denoting higher QOL.

  3 months

• World Health Organization Quality of Life (Brief) WHO-QoL BREF - For Caregivers of PALS

  The WHO-QoL BREF is a 26 item quality of life scale covering four domains of QOL. Each item is scored from 1-5 with higher response employing a higher quality of life. Items are scored from 1-5

  3 months

Secondary Outcomes (5)

• Hospital Anxiety and Depression Scale (HADS)

  3 weeks, 3 months, 6 months after joining

• Functional Status

  3 weeks, 3 months, 6 months after joining

• Zarit Burden Interview

  3 weeks, 3 months, 6 months after joining

• ALS Specific QOL Short Form Quality of Life (ALSSQOL-SF)

  3 weeks, 3 months, 6 months after joining

• World Health Organization Quality of Life (Brief) WHO-QoL BREF

  3 weeks, 3 months, 6 months after joining

Study Arms (2)

Mindfulness

EXPERIMENTAL

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

Behavioral: Mindfulness

Mindful Learning

ACTIVE COMPARATOR

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

Behavioral: Mindful Learning

Interventions

Mindfulness BEHAVIORAL

Online non-meditation mindfulness program

Mindfulness

Mindful Learning BEHAVIORAL

Online learning program

Mindful Learning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Harvard University: lead
• Catholic University of the Sacred Heart: collaborator

Study Sites (1)

Harvard University

Cambridge, Massachusetts, 02138, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Caregiver Burden

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Ellen Langer, PhD

  Harvard University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: October 27, 2022
• Study Start: May 15, 2020
• Primary Completion: April 30, 2024
• Study Completion: April 10, 2025
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

US (1)