Clinical trial NCT06968468: Resiliency Intervention for Patients With ALS and Their Care-Partners
Official title: Resilient Together-ALS (RT-ALS): A Dyadic Mind-body Meaning Intervention for People With ALS and Their Informal Care-partners
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis (ALS)
Emotional Distress
Keywords: Amyotrophic Lateral Sclerosis
ALS
Caregiving
Coping
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Recruitment Feasibility
timeFrame: 0 weeks
measure: Data Collection Feasibility
timeFrame: Pre-test (0 weeks) to Post-test (6 weeks)
measure: Adherence Feasibility
timeFrame: 6 weeks
measure: Therapist Fidelity Feasibility
timeFrame: 6 weeks
measure: Treatment Satisfaction
timeFrame: 6 weeks
measure: Credibility and Expectancy
timeFrame: Pre-test (0 weeks)
measure: Adverse Events
timeFrame: 6 weeks
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Pre-test (0 weeks) to Post-test (6 weeks)
measure: The World Health Organization Quality of Life abbreviated (WHOQOL-BREF)
timeFrame: Pre-test (0 weeks) to Post-test (6 weeks)
measure: Cognitive and Affective Mindfulness Scale (CAMS)
timeFrame: Pre-test (0 weeks) to Post-test (6 weeks)
measure: Measure of Current Status Part A (MOCS-A)
timeFrame: Pre-test (0 weeks) to Post-test (6 weeks)
measure: Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: Pre-test (0 weeks) to Post-test (6 weeks)
measure: Dyadic Coping Inventory (DCI)
timeFrame: Pre-test (0 weeks) to Post-test (6 weeks)
measure: The Meaning in Life Questionnaire (MLQ)
timeFrame: Pre-test (0 weeks) to Post-test (6 weeks)
Other outcomes:
measure: FACIT Spiritual Well-Being Scale
timeFrame: Pre-test (0 weeks) to Post-test (6 weeks)
measure: Concern with Dying Scale
timeFrame: Pre-test (0 weeks) to Post-test (6 weeks)
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Christina Rush, PhD
role: PRINCIPAL_INVESTIGATOR
References: