A Mindful Community for People With ALS and Their Primary Caregivers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Harvard University
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- ALS Specific QOL Short Form Quality of Life (ALSSQOL-SF) - For PALS (Persons with ALS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Mindful Learning
Three-week online mindful learning course followed by one-month social community online interaction
Intervention: Mindful Learning (Behavioral)
Mindfulness
Three-week online mindfulness course followed by one-month social community online interaction.
Intervention: Mindfulness (Behavioral)
Outcomes
Primary Outcomes
ALS Specific QOL Short Form Quality of Life (ALSSQOL-SF) - For PALS (Persons with ALS)
Time Frame: 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
Time Frame: 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 Outcomes
- World Health Organization Quality of Life (Brief) WHO-QoL BREF(3 weeks, 3 months, 6 months after joining)
- Functional Status(3 weeks, 3 months, 6 months after joining)
- Hospital Anxiety and Depression Scale (HADS)(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)
Investigators
Ellen Langer
Professor of Psychology
Harvard University