Amyotrophic Lateral Sclerosis (ALS)RT-ALSNCT06968468
Resiliency Intervention for Patients With ALS and Their Care-Partners
A study testing Resilient Together ALS in people with Amyotrophic Lateral Sclerosis (ALS) and Emotional Distress, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to pilot a resiliency and coping intervention for persons recently diagnosed with Amyotrophic Lateral Sclerosis (ALS) and their primary informal caregivers. The data investigators gather in this study will be used to further refine our intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis (ALS), Emotional Distress
- What is being tested?
- Resilient Together ALS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2026to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- recent (within ~2 months) of first appointment at Healey Center for diagnosis of ALS documented in Epic (based on recommendations from neurologists)
- ability to understand the study and research protocol as determined by a standardized teach-back method of assessment
- ability to communicate by writing, speaking, or assistive communication device
- English speaking adults
- dyad lives together
- at least one partner endorses clinically significant emotional distress during screening (>7 on either subscale of the HADS)
Who cannot join
- patient with ALS with comorbid terminal diagnosis or severe mental health disorder that limits ability to participate (by self-report, as determined by our clinical team);
- cognitive disorder that limits ability to participate (per neurologist)
- inability or unwillingness to use live video technology (will teach any dyads who have low technology literacy how to use live video technology)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Morgan Seward, BA contact
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Resilient Together-ALS (RT-ALS): A Dyadic Mind-body Meaning Intervention for People With ALS and Their Informal Care-partners
The purpose of this study is to pilot a resiliency and coping intervention for persons recently diagnosed with Amyotrophic Lateral Sclerosis (ALS) and their primary informal caregivers. The data investigators gather in this study will be used to further refine our intervention.
Read the detailed description
The goal of this study to refine our proposed intervention Resilient Together ALS (RT-ALS) through an open pilot. The investigators will deliver an open pilot of the intervention (N= up to10 dyads; up to 20 participants total) to evaluate initial feasibility and acceptability using exit interviews and pre-post assessments.
The open pilot will take place over Zoom, with participants recruited from the Massachusetts General Hospital's Sean M. Healey and AMG Center for ALS. Study clinicians will deliver 6, 30-45 minute sessions over Zoom. All participants will complete measures at baseline and after completion of the program (6 weeks). At the completion of the program, participants will engage in an exit interview where they will provide feedback on the intervention.
- Being tested
- Resilient Together ALS
- Keywords
- Amyotrophic Lateral Sclerosis, ALS, Caregiving, Coping
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resilient Together ALSBehavioural
This intervention will teach resiliency and coping skills (mindfulness, meaning making, etc) to dyads soon after ALS diagnosis in order to manage distress associated with an ALS diagnosis. These sessions will take place over Zoom with both the person diagnosed with ALS and their primary informal caregiver.
| Study group | Role | What they receive |
|---|---|---|
| RT-ALS Intervention | Experimental | Dyads will participate in 6 30-45-minute skills based sessions. A clinical psychologist will deliver all sessions. The main intervention goal is to provide dyads with coping and resiliency skills and resources to reduce emotional distress, prevent chronic distress, and preserve quality of life for both dyad members as ALS progresses. Receives: Behavioral: Resilient Together ALS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Feasibility
Percentage of eligible ALS patient-caregiver dyads that participate in the intervention (>70% acceptable; >80% excellent).
Measured: 0 weeks
Data Collection Feasibility
Percentage of dyads with no missing measures (>70% acceptable; >80% excellent)
Measured: Pre-test (0 weeks) to Post-test (6 weeks)
Adherence Feasibility
Percentage of RT-ALS dyads that complete 4/6 sessions (>70% acceptable; >80% excellent)
Measured: 6 weeks
Therapist Fidelity Feasibility
Percentage of adherence checklists completed; percentage of selected sessions (20%) with 100% adherence Fidelity Checks (>70% acceptable; >80% excellent).
Measured: 6 weeks
Treatment Satisfaction
Percentage of dyads who score above the midpoint on Client Satisfaction Questionnaire (> 70% acceptable; > 80% excellent)
Measured: 6 weeks
Credibility and Expectancy
Percentage of dyads who score above midpoint on the Credibility/Expectancy Questionnaire (> 70% acceptable; > 80% excellent)
Measured: Pre-test (0 weeks)
Adverse Events
None or minimal adverse events
Measured: 6 weeks
Secondary outcomes (7)
Hospital Anxiety and Depression Scale (HADS)
Report of emotional distress at baseline and post-test as measured by the Hospital Anxiety and Depression Scale (HADS). Minimum score: 0 Maximum score: 21 for both the Anxiety and Depression sub-scales. Higher scores indicate higher levels of reported anxiety and depression.
Measured: Pre-test (0 weeks) to Post-test (6 weeks)
The World Health Organization Quality of Life abbreviated (WHOQOL-BREF)
Quality of life of RT-ALS dyads reported at both baseline and post-test as measured by the World Health Organization Quality of Life - abbreviated measure (WHOQOL-BREF). Maximum score: 20 Minimum score: 4 on each domain. Higher scores indicate higher quality of life.
Measured: Pre-test (0 weeks) to Post-test (6 weeks)
Cognitive and Affective Mindfulness Scale (CAMS)
The Cognitive and Affective Mindfulness Scale (CAMS) measures dispositional mindfulness, higher values reflect higher levels of mindfulness. Maximum score: 48 Minimum score: 12.
Measured: Pre-test (0 weeks) to Post-test (6 weeks)
Measure of Current Status Part A (MOCS-A)
Assesses ability to engage in a series of healthy coping skills (e.g., relaxation, social support, adaptive thinking). Maximum score: 52 Minimum score: 0; higher scores indicate a greater perceived ability to employ adaptive coping strategies.
Measured: Pre-test (0 weeks) to Post-test (6 weeks)
Multidimensional Scale of Perceived Social Support (MSPSS)
A measure of perceived social support. Higher scores indicate greater perceived social support. Minimum score: 1 Maximum score: 7.
Measured: Pre-test (0 weeks) to Post-test (6 weeks)
Dyadic Coping Inventory (DCI)
Assesses self-reported coping behaviors when dyad faces stressors. Higher scores reflect more adaptive coping. Maximum score: 35 Minimum score: 1.
Measured: Pre-test (0 weeks) to Post-test (6 weeks)
The Meaning in Life Questionnaire (MLQ)
A measure of sense of meaning and purpose in life. A higher score on the presence of meaning items indicates higher presence of meaning. A higher score on the search for meaning items indicates greater active search for meaning. Maximum score: 70 Minimum score: 10.
Measured: Pre-test (0 weeks) to Post-test (6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start13 May 2026 (estimated)
- Primary completion13 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral Sclerosis (ALS)Studies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Rush, PhD, Massachusetts General Hospital
- Investigators
- Christina Rush, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968468
- Sponsor's protocol ID
- 2023P001058
- Acronym
- RT-ALS
- Status last verified
- Nov 2025
- First submitted
- 5 May 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resilient Together-ALS (RT-ALS): A Dyadic Mind-body Meaning Intervention for People With ALS and Their Informal Care-partners
- ClinicalTrials.gov ID
- NCT06968468
- Acronym / sponsor ID
- RT-ALS / 2023P001058
- Keywords
- Amyotrophic Lateral Sclerosis, ALS, Caregiving, Coping
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 13 May 2026 (estimated)
- Primary completion
- 13 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 13 May 2025 (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 purpose of this study is to pilot a resiliency and coping intervention for persons recently diagnosed with Amyotrophic Lateral Sclerosis (ALS) and their primary informal caregivers. The data investigators gather in this study will be used to further refine our intervention.
Detailed description
The goal of this study to refine our proposed intervention Resilient Together ALS (RT-ALS) through an open pilot. The investigators will deliver an open pilot of the intervention (N= up to10 dyads; up to 20 participants total) to evaluate initial feasibility and acceptability using exit interviews and pre-post assessments.
The open pilot will take place over Zoom, with participants recruited from the Massachusetts General Hospital's Sean M. Healey and AMG Center for ALS. Study clinicians will deliver 6, 30-45 minute sessions over Zoom. All participants will complete measures at baseline and after completion of the program (6 weeks). At the completion of the program, participants will engage in an exit interview where they will provide feedback on the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RT-ALS Intervention | Experimental | Behavioral: Resilient Together ALSDyads will participate in 6 30-45-minute skills based sessions. A clinical psychologist will deliver all sessions. The main intervention goal is to provide dyads with coping and resiliency skills and resources to reduce emotional distress, prevent chronic distress, and preserve quality of life for both dyad members as ALS progresses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- recent (within ~2 months) of first appointment at Healey Center for diagnosis of ALS documented in Epic (based on recommendations from neurologists)
- ability to understand the study and research protocol as determined by a standardized teach-back method of assessment
- ability to communicate by writing, speaking, or assistive communication device
- English speaking adults
- dyad lives together
Key exclusion criteria (3 listed)
- patient with ALS with comorbid terminal diagnosis or severe mental health disorder that limits ability to participate (by self-report, as determined by our clinical team);
- cognitive disorder that limits ability to participate (per neurologist)
- inability or unwillingness to use live video technology (will teach any dyads who have low technology literacy how to use live video technology)
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 |
|---|---|---|
| Resilient Together ALSThis intervention will teach resiliency and coping skills (mindfulness, meaning making, etc) to dyads soon after ALS diagnosis in order to manage distress associated with an ALS diagnosis. These sessions will take place over Zoom with both the person diagnosed with ALS and their primary informal caregiver. | Behavioural | RT-ALS Intervention |
Primary outcome
Recruitment Feasibility
Time frame: 0 weeks
Percentage of eligible ALS patient-caregiver dyads that participate in the intervention (>70% acceptable; >80% excellent).
Data Collection Feasibility
Time frame: Pre-test (0 weeks) to Post-test (6 weeks)
Percentage of dyads with no missing measures (>70% acceptable; >80% excellent)
Adherence Feasibility
Time frame: 6 weeks
Percentage of RT-ALS dyads that complete 4/6 sessions (>70% acceptable; >80% excellent)
Therapist Fidelity Feasibility
Time frame: 6 weeks
Percentage of adherence checklists completed; percentage of selected sessions (20%) with 100% adherence Fidelity Checks (>70% acceptable; >80% excellent).
Treatment Satisfaction
Time frame: 6 weeks
Percentage of dyads who score above the midpoint on Client Satisfaction Questionnaire (> 70% acceptable; > 80% excellent)
Credibility and Expectancy
Time frame: Pre-test (0 weeks)
Percentage of dyads who score above midpoint on the Credibility/Expectancy Questionnaire (> 70% acceptable; > 80% excellent)
Adverse Events
Time frame: 6 weeks
None or minimal adverse events
7 secondary outcomes
Hospital Anxiety and Depression Scale (HADS)
Time frame: Pre-test (0 weeks) to Post-test (6 weeks)
The World Health Organization Quality of Life abbreviated (WHOQOL-BREF)
Time frame: Pre-test (0 weeks) to Post-test (6 weeks)
Cognitive and Affective Mindfulness Scale (CAMS)
Time frame: Pre-test (0 weeks) to Post-test (6 weeks)
Measure of Current Status Part A (MOCS-A)
Time frame: Pre-test (0 weeks) to Post-test (6 weeks)
Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: Pre-test (0 weeks) to Post-test (6 weeks)
Dyadic Coping Inventory (DCI)
Time frame: Pre-test (0 weeks) to Post-test (6 weeks)
The Meaning in Life Questionnaire (MLQ)
Time frame: Pre-test (0 weeks) to Post-test (6 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Morgan Seward, BA contact
Christina Rush, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resilient Together ALS in people with Amyotrophic Lateral Sclerosis (ALS) and Emotional Distress, run by Massachusetts General Hospital 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 6 inclusion and 3 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: opening soon, as of the sponsor's last update on 17 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christina Rush, PhD (617-643-7641, crush2@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Feasibility (time frame: 0 weeks). The study lists 7 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 17 Nov 2025.