Resiliency Intervention for ALS

(RT-ALS Trial)

Overseen By Christina Rush, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Terminal diagnosis, Severe mental disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Christina Rush, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for individuals recently diagnosed with ALS (Amyotrophic Lateral Sclerosis) and their primary informal caregivers. It aims to help them cope better emotionally.

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)

For dyad: at least one partner endorses clinically significant emotional distress during screening (>7 on either subscale of the HADS)

For patient with ALS: ability to communicate by writing, speaking, or assistive communication device

Exclusion Criteria

I have ALS and another serious health condition or severe mental health issue that makes it hard for me to take part in the study.

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)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in 6 sessions of a resiliency and coping intervention delivered over Zoom

6 weeks

6 sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Resilient Together ALS

Trial Overview The 'Resilient Together ALS' program, a resiliency and coping intervention, is being tested to see if it can support patients with ALS and their caregivers.

Participant Groups

Group I: RT-ALS Intervention Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+