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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program called Resilient Together ALS, designed to help people recently diagnosed with Amyotrophic Lateral Sclerosis (ALS) and their primary caregivers build coping and resiliency skills. The goal is to reduce emotional stress and maintain quality of life as ALS progresses. Participants will engage in six short sessions with a clinical psychologist to learn these skills. Ideal candidates are those recently diagnosed with ALS at the Healey Center and living with a caregiver who feels emotionally stressed. As an unphased trial, this study offers patients a unique opportunity to access innovative support strategies early.

Do I need to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this intervention is safe for ALS patients and their caregivers?

Research shows that the Resilient Together ALS program supports people with ALS and their caregivers by helping them manage the emotional and practical challenges of the disease. A clinical psychologist leads the program, focusing on teaching coping and resilience-building skills.

Past studies indicate that this type of program carries no known risks or negative effects. It involves no drugs or medical procedures, only sessions to support emotional well-being. As a result, the program is safe and well-tolerated by participants. Those who join are likely to receive positive support without major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for ALS focus on managing symptoms with medications like Riluzole or Edaravone. However, the Resilient Together ALS intervention is unique because it provides coping and resiliency skills through structured sessions with a clinical psychologist. This approach is tailored specifically for dyads, meaning both the ALS patient and a partner or caregiver participate. By teaching practical skills to handle emotional and psychological challenges, this intervention aims to reduce emotional distress and improve the quality of life as ALS progresses. Researchers are excited about this treatment because it addresses the emotional well-being of both the patient and their support system, which is often overlooked in traditional ALS care.

What evidence suggests that this intervention is effective for ALS?

Research shows that the "Resilient Together ALS" program, offered to participants in this trial, supports people with ALS and their caregivers by teaching coping and resilience-building skills. Early results suggest that similar programs have successfully reduced emotional distress and improved quality of life for both patients and caregivers. The program includes sessions with a psychologist focused on managing stress and preventing long-term distress. Although specific data on "Resilient Together ALS" remains limited, evidence from similar programs is promising for improving mental health for those affected by ALS. ^{1 2 3 4 6}

Who Is on the Research Team?

Christina Rush, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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

For dyad: dyad lives together

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37345437/

Resilient together-ALS: leveraging the NDD ... An evidence-based early dyadic psychosocial intervention, Recovering Together, for the unique needs of people with ALS and their care-partners.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06968468

Resiliency Intervention for Patients With ALS and Their ... The purpose of this study is to pilot a resiliency and coping intervention for persons recently diagnosed with Amyotrophic Lateral Sclerosis (ALS) and their ...

3. mghpsychnews.org mghpsychnews.org/resilient-together-als/

Improving Psychosocial Interventions for Patients with ... Resilient Together - ALS is an early dyadic psychosocial intervention designed to address the unique needs of people with ALS and their care-partners.

4. researchgate.net researchgate.net/publication/371782261_Resilient_together-ALS_leveraging_the_NDD_transdiagnostic_framework_to_develop_an_early_dyadic_intervention_for_people_with_amyotrophic_lateral_sclerosis_and_their_informal_care-partners

Resilient together-ALS: leveraging the NDD ... This study evaluated the effectiveness of a psychological intervention in amyotrophic lateral sclerosis patients, consisting of four semi ...

5. bmcnurs.biomedcentral.com bmcnurs.biomedcentral.com/articles/10.1186/s12912-024-01721-6

Psychosocial interventions for people with amyotrophic lateral ... This review aims to inform healthcare practitioners, researchers, and policymakers about the current state of psychosocial interventions for ALS ...

6. link.springer.com link.springer.com/article/10.1007/s00415-023-12141-y

Health-related quality of life across disease stages in ... Amyotrophic lateral sclerosis (ALS) is characterized by a rapid disease course, with disease severity being associated with declining health- ...