Resiliency Intervention for Patients With ALS and Their Care-Partners

NCT06968468 | Not Yet Recruiting

• 1 other identifier: 2023P001058
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyotrophic Lateral Sclerosis (ALS); Emotional Distress

Keywords

Amyotrophic Lateral Sclerosis; ALS; Caregiving; Coping

Outcome Measures

Primary Outcomes (7)

• Recruitment Feasibility

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

  0 weeks

• Data Collection Feasibility

  Percentage of dyads with no missing measures (\>70% acceptable; \>80% excellent)

  Pre-test (0 weeks) to Post-test (6 weeks)

• Adherence Feasibility

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

  6 weeks

• Therapist Fidelity Feasibility

  Percentage of adherence checklists completed; percentage of selected sessions (20%) with 100% adherence Fidelity Checks (\>70% acceptable; \>80% excellent).

  6 weeks

• Treatment Satisfaction

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

  6 weeks

• Credibility and Expectancy

  Percentage of dyads who score above midpoint on the Credibility/Expectancy Questionnaire (\> 70% acceptable; \> 80% excellent)

  Pre-test (0 weeks)

• Adverse Events

  None or minimal adverse events

  6 weeks

Secondary Outcomes (7)

• Hospital Anxiety and Depression Scale (HADS)

  Pre-test (0 weeks) to Post-test (6 weeks)

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

  Pre-test (0 weeks) to Post-test (6 weeks)

• Cognitive and Affective Mindfulness Scale (CAMS)

  Pre-test (0 weeks) to Post-test (6 weeks)

• Measure of Current Status Part A (MOCS-A)

  Pre-test (0 weeks) to Post-test (6 weeks)

• Multidimensional Scale of Perceived Social Support (MSPSS)

  Pre-test (0 weeks) to Post-test (6 weeks)

Other Outcomes (2)

• FACIT Spiritual Well-Being Scale

  Pre-test (0 weeks) to Post-test (6 weeks)

• Concern with Dying Scale

  Pre-test (0 weeks) to Post-test (6 weeks)

Study Arms (1)

RT-ALS Intervention

EXPERIMENTAL

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.

Behavioral: Resilient Together ALS

Interventions

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.

RT-ALS Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Christina Rush, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Rush, PhD

CONTACT

617-643-7641; crush2@mgh.harvard.edu

Morgan Seward, BA

CONTACT

mseward1@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 13, 2025
• Study Start (Estimated): May 13, 2026
• Primary Completion (Estimated): February 13, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)