A Mindful Community for People With ALS and Their Primary Caregivers

Not Applicable

Recruiting

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.

Recruitment & Eligibility

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

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Mindfulness	Mindfulness	Three-week online mindfulness course followed by one-month social community online interaction.
Mindful Learning	Mindful Learning	Three-week online mindful learning course followed by one-month social community online interaction

Primary Outcome Measures

Name	Time	Method
ALS Specific QOL Short Form Quality of Life (ALSSQOL-SF) - For PALS (Persons with ALS)	3 months	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.
World Health Organization Quality of Life (Brief) WHO-QoL BREF - For Caregivers of PALS	3 months	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

Secondary Outcome Measures

Name	Time	Method
World Health Organization Quality of Life (Brief) WHO-QoL BREF	3 weeks, 3 months, 6 months after joining	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.
Functional Status	3 weeks, 3 months, 6 months after joining	Self-Administered Functional Rating Scale Revised
Hospital Anxiety and Depression Scale (HADS)	3 weeks, 3 months, 6 months after joining	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.
Zarit Burden Interview	3 weeks, 3 months, 6 months after joining	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.
ALS Specific QOL Short Form Quality of Life (ALSSQOL-SF)	3 weeks, 3 months, 6 months after joining	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.

Locations (1): Harvard University
🇺🇸
Cambridge, Massachusetts, United States