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NCT Number: NCT06968468

Resiliency Intervention for Patients With ALS and Their 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.

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Key information

Conditions

Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral Sclerosis Central Nervous System Diseases Emotional Distress Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

for patient with ALS:

  • 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

Inclusion criteria

for dyad:

  • English speaking adults
  • dyad lives together
  • at least one partner endorses clinically significant emotional distress during screening (>7 on either subscale of the HADS)

Exclusion criteria

  • 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)

Treatment and study plan

Resilient Together ALS

Behavioral

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.

Primary outcomes

  1. Recruitment Feasibility

    Time frame: 0 weeks

    Percentage of eligible ALS patient-caregiver dyads that participate in the intervention (>70% acceptable; >80% excellent).

  2. 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)

  3. Adherence Feasibility

    Time frame: 6 weeks

    Percentage of RT-ALS dyads that complete 4/6 sessions (>70% acceptable; >80% excellent)

  4. 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).

  5. Treatment Satisfaction

    Time frame: 6 weeks

    Percentage of dyads who score above the midpoint on Client Satisfaction Questionnaire (> 70% acceptable; > 80% excellent)

  6. 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)

  7. Adverse Events

    Time frame: 6 weeks

    None or minimal adverse events

Secondary outcomes

  1. Hospital Anxiety and Depression Scale (HADS)

    Time frame: Pre-test (0 weeks) to Post-test (6 weeks)

    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.

  2. The World Health Organization Quality of Life abbreviated (WHOQOL-BREF)

    Time frame: Pre-test (0 weeks) to Post-test (6 weeks)

    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.

  3. Cognitive and Affective Mindfulness Scale (CAMS)

    Time frame: Pre-test (0 weeks) to Post-test (6 weeks)

    The Cognitive and Affective Mindfulness Scale (CAMS) measures dispositional mindfulness, higher values reflect higher levels of mindfulness. Maximum score: 48 Minimum score: 12.

  4. Measure of Current Status Part A (MOCS-A)

    Time frame: Pre-test (0 weeks) to Post-test (6 weeks)

    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.

  5. Multidimensional Scale of Perceived Social Support (MSPSS)

    Time frame: Pre-test (0 weeks) to Post-test (6 weeks)

    A measure of perceived social support. Higher scores indicate greater perceived social support. Minimum score: 1 Maximum score: 7.

  6. Dyadic Coping Inventory (DCI)

    Time frame: Pre-test (0 weeks) to Post-test (6 weeks)

    Assesses self-reported coping behaviors when dyad faces stressors. Higher scores reflect more adaptive coping. Maximum score: 35 Minimum score: 1.

  7. The Meaning in Life Questionnaire (MLQ)

    Time frame: Pre-test (0 weeks) to Post-test (6 weeks)

    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.

Other outcomes

  1. FACIT Spiritual Well-Being Scale

    Time frame: Pre-test (0 weeks) to Post-test (6 weeks)

    The spiritual well-being of RT-ALS dyads reported at baseline and post-test as measured by the FACIT Spiritual Well-Being scale. Maximum score: 4 Minimum score: 0 on each sub scale. Higher scores indicate higher spiritual well-being.

  2. Concern with Dying Scale

    Time frame: Pre-test (0 weeks) to Post-test (6 weeks)

    Measure of concern with dying in RT-ALS dyads reported at baseline and post-test as measured by the Concern with Dying Scale. Maximum score: 20 Minimum score: 6. Higher scores indicate higher levels of concern with death and dying.

Study contacts

Contact information is provided by the study sponsor or research team.

Christina Rush, PhD

CONTACT

[email protected]

617-643-7641

Morgan Seward, BA

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Resilient Together-ALS (RT-ALS): A Dyadic Mind-body Meaning Intervention for People With ALS and Their Informal Care-partners

Acronym: RT-ALS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 13, 2025
Registry last updated
Nov 17, 2025

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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