A Mindful Community for People With ALS and Their Primary Caregivers

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 Overview

• Status: Recruiting
• Conditions: Amyotrophic Lateral Sclerosis; Caregiver Burden
• Intervention / Treatment: Behavioral: Mindfulness; Behavioral: Mindful Learning

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Deborah R Phillips, PhD; Phone Number: 9739027938; Email: dphillips@fas.harvard.edu
• Study Contact Backup: Name: Francesco Pagnini, PhD; Email: francesco.pagnini@unicatt.it

Study Locations

• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02138
      • Recruiting
      • Harvard University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness; Three-week online mindfulness course followed by one-month social community online interaction.	Behavioral: Mindfulness; Online non-meditation mindfulness program
Active Comparator: Mindful Learning; Three-week online mindful learning course followed by one-month social community online interaction	Behavioral: Mindful Learning; Online learning program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Anxiety and Depression Scale (HADS)	The HADS measures anxiety and depression in a general medical population of patients. It has seven items each for depression and anxiety sub scales. Scoring ranges from 0 to 3, with 3 denoting the highest anxiety or depression level. A total sub scale score of over 8 out of 21 denotes considerable symptoms of either.	3 weeks, 3 months, 6 months after joining
Functional Status	Self-Administered Functional Rating Scale Revised	3 weeks, 3 months, 6 months after joining
Zarit Burden Interview	The ZBI consists of 22 items rated on a 5-point Likert scale that ranges from 0 (never) to 4 (nearly always) with the sum of scores ranging between 0-88. Higher scores indicate greater burden. A score of 17 or more has been considered high burden.	3 weeks, 3 months, 6 months after joining
ALS Specific QOL Short Form Quality of Life (ALSSQOL-SF)	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 weeks, 3 months, 6 months after joining
World Health Organization Quality of Life (Brief) WHO-QoL BREF	The WHO-QoL BREF is a 16 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.	3 weeks, 3 months, 6 months after joining

Collaborators and Investigators

• Sponsor: Harvard University
• Collaborators: Catholic University of the Sacred Heart
• Investigators: Principal Investigator: Ellen Langer, PhD, Harvard U

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: September 12, 2022
• First Submitted That Met QC Criteria: October 22, 2022
• First Posted (Actual): October 27, 2022

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 13, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Quality of Life; Mindfulness
• Additional Relevant MeSH Terms: Behavioral Symptoms; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Stress, Psychological; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Caregiver Burden
• Other Study ID Numbers: IRB20-0629

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No