Resiliency Intervention for Patients With ALS and Their Care-Partners (RT-ALS)

Mass General Brigham

Status: Begins enrollment in 3 months

Conditions: Emotional Distress; Amyotrophic Lateral Sclerosis (ALS)

Treatments: Behavioral: Resilient Together ALS

Study type: Interventional

Funder types: Other

Identifiers

NCT06968468

2023P001058

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

RT-ALS Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Resilient Together ALS