Amyotrophic Lateral SclerosisNCT05595850
A Mindful Community for People With ALS and Their Primary Caregivers
A study testing Mindfulness and Mindful Learning in people with Amyotrophic Lateral Sclerosis and Caregiver Burden, run by Harvard University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Caregiver Burden
- What is being tested?
- Mindfulness and Mindful Learning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2020to 10 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Using shared devices. Patients and caregivers should have their own devices.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Amyotrophic Lateral Sclerosis, Caregiver Burden
- Being tested
- Mindfulness, Mindful Learning
- Keywords
- Mindfulness, Quality of Life
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindfulnessBehavioural
Online non-meditation mindfulness program
Mindful LearningBehavioural
Online learning program
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness | Experimental | Three-week online mindfulness course followed by one-month social community online interaction. Receives: Behavioral: Mindfulness |
| Mindful Learning | Active comparator | Three-week online mindful learning course followed by one-month social community online interaction Receives: Behavioral: Mindful Learning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 3 months
Secondary outcomes (5)
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.
Measured: 3 weeks, 3 months, 6 months after joining
Functional Status
Self-Administered Functional Rating Scale Revised
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 weeks, 3 months, 6 months after joining
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start15 May 2020
- Primary completion30 Apr 2024
- Study completion10 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard University
- Sponsor type
- University, hospital or other
- Collaborators
- Catholic University of the Sacred Heart
- Responsible party
- Principal investigator, Ellen Langer, Harvard University
- Investigators
- Ellen Langer, PhD, Principal investigator, Harvard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595850
- Sponsor's protocol ID
- IRB20-0629
- Status last verified
- Apr 2026
- First submitted
- 12 Sep 2022
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mindful Community for People With ALS and Their Primary Caregivers
- ClinicalTrials.gov ID
- NCT05595850
- Acronym / sponsor ID
- IRB20-0629
- Conditions
- Amyotrophic Lateral Sclerosis, Caregiver Burden
- Keywords
- Mindfulness, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Harvard UniversityUniversity, hospital or other
- Collaborators
- Catholic University of the Sacred Heart
- Study start
- 15 May 2020 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 10 Apr 2025 (actual)
- First posted
- 27 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness | Experimental | Behavioral: MindfulnessThree-week online mindfulness course followed by one-month social community online interaction. |
| Mindful Learning | Active comparator | Behavioral: Mindful LearningThree-week online mindful learning course followed by one-month social community online interaction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- Using shared devices. Patients and caregivers should have their own devices.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MindfulnessOnline non-meditation mindfulness program | Behavioural | Mindfulness |
| Mindful LearningOnline learning program | Behavioural | Mindful Learning |
Primary outcome
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
5 secondary outcomes
Hospital Anxiety and Depression Scale (HADS)
Time frame: 3 weeks, 3 months, 6 months after joining
Functional Status
Time frame: 3 weeks, 3 months, 6 months after joining
Zarit Burden Interview
Time frame: 3 weeks, 3 months, 6 months after joining
ALS Specific QOL Short Form Quality of Life (ALSSQOL-SF)
Time frame: 3 weeks, 3 months, 6 months after joining
World Health Organization Quality of Life (Brief) WHO-QoL BREF
Time frame: 3 weeks, 3 months, 6 months after joining
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen Langer, PhD principal investigator
Harvard University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness and Mindful Learning in people with Amyotrophic Lateral Sclerosis and Caregiver Burden, run by Harvard University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ALS Specific QOL Short Form Quality of Life (ALSSQOL-SF) - For PALS (Persons with ALS) (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.