Clinical trial NCT05595850: A Mindful Community for People With ALS and Their Primary Caregivers
Official title: A Mindful Community for People With ALS and Their Primary Caregivers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Caregiver Burden
Keywords: Mindfulness
Quality of Life
Lead sponsor: Harvard University
Sponsor class: OTHER
Collaborators: name: Catholic University of the Sacred Heart
First posted: 2022-10-27
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: ALS Specific QOL Short Form Quality of Life (ALSSQOL-SF) - For PALS (Persons with ALS)
timeFrame: 3 months
measure: World Health Organization Quality of Life (Brief) WHO-QoL BREF - For Caregivers of PALS
timeFrame: 3 months
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 3 weeks, 3 months, 6 months after joining
measure: Functional Status
timeFrame: 3 weeks, 3 months, 6 months after joining
measure: Zarit Burden Interview
timeFrame: 3 weeks, 3 months, 6 months after joining
measure: ALS Specific QOL Short Form Quality of Life (ALSSQOL-SF)
timeFrame: 3 weeks, 3 months, 6 months after joining
measure: World Health Organization Quality of Life (Brief) WHO-QoL BREF
timeFrame: 3 weeks, 3 months, 6 months after joining
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Harvard University
state: Massachusetts
Study officials:
affiliation: Harvard U
name: Ellen Langer, PhD
role: PRINCIPAL_INVESTIGATOR
References: