A Mindful Community for People With ALS and Their Primary Caregivers

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

A Mindful Community for People With ALS and Their Primary Caregivers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05595850
• Other study ID #: IRB20-0629
• Status: Recruiting
• Phase: N/A
• Start date: October 12, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: January 2024
• Source: Harvard University
• Contact: Deborah R Phillips, PhD
• Phone: 9739027938
• Email: dphillips[@]fas.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 31, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Caregiver Burden
• Motor Neuron Disease

Intervention

Behavioral:
• Mindfulness
Online non-meditation mindfulness program
• Mindful Learning
Online learning program

Locations

Country	Name	City	State
United States	Harvard University	Cambridge	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Harvard University	Catholic University of the Sacred Heart

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Functional Status	Self-Administered Functional Rating Scale Revised	3 weeks, 3 months, 6 months after joining
Secondary	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
Secondary	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
Secondary	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