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OpenTrials
Completed

NCT Number: NCT05595850

A Mindful Community for People With ALS and Their Primary Caregivers

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.

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Key information

Conditions

Amyotrophic Lateral Sclerosis Behavior Behavioral Symptoms Caregiver Burden Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases Stress, Psychological TDP-43 Proteinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harvard University

Cambridge, Massachusetts, 02138, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness

Behavioral

Online non-meditation mindfulness program

Mindful Learning

Behavioral

Online learning program

Primary outcomes

  1. 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.

  2. 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

  1. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 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.

  2. Functional Status

    Time frame: 3 weeks, 3 months, 6 months after joining

    Self-Administered Functional Rating Scale Revised

  3. Zarit Burden Interview

    Time frame: 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.

  4. ALS Specific QOL Short Form Quality of Life (ALSSQOL-SF)

    Time frame: 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.

  5. World Health Organization Quality of Life (Brief) WHO-QoL BREF

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Harvard University

Other

Collaborators

  • Catholic University of the Sacred Heart

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Oct 27, 2022
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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