A Mindful Community for People With ALS and Their Primary Caregivers

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.

Official Title
-----------------
A Mindful Community for People With ALS and Their Primary Caregivers

Conditions
-----------------
Amyotrophic Lateral Sclerosis, Caregiver Burden

Intervention / Treatment
-----------------
* Behavioral: Mindfulness
* Behavioral: Mindful Learning


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mindfulness, Quality of Life