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Not yet recruiting NCT06968468

Resiliency Intervention for Patients With ALS and Their Care-Partners

No phase Interventional Amyotrophic Lateral Sclerosis (ALS) Emotional Distress

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Resilient Together ALS.
Who it may be relevant to
Registry conditions: Amyotrophic Lateral Sclerosis (ALS), Emotional Distress. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Resilient Together-ALS (RT-ALS): A Dyadic Mind-body Meaning Intervention for People With ALS and Their Informal Care-partners

Overview

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.

Interventions

  • Behavioral Resilient Together ALS
    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.

Primary outcome measures

  • Recruitment Feasibility [Time frame: 0 weeks]
  • Data Collection Feasibility [Time frame: Pre-test (0 weeks) to Post-test (6 weeks)]
  • Adherence Feasibility [Time frame: 6 weeks]
  • Therapist Fidelity Feasibility [Time frame: 6 weeks]
  • Treatment Satisfaction [Time frame: 6 weeks]
  • Credibility and Expectancy [Time frame: Pre-test (0 weeks)]
  • Adverse Events [Time frame: 6 weeks]
Secondary outcome measures (7)
  • Hospital Anxiety and Depression Scale (HADS) [Time frame: Pre-test (0 weeks) to Post-test (6 weeks)]
  • The World Health Organization Quality of Life abbreviated (WHOQOL-BREF) [Time frame: Pre-test (0 weeks) to Post-test (6 weeks)]
  • Cognitive and Affective Mindfulness Scale (CAMS) [Time frame: Pre-test (0 weeks) to Post-test (6 weeks)]
  • Measure of Current Status Part A (MOCS-A) [Time frame: Pre-test (0 weeks) to Post-test (6 weeks)]
  • Multidimensional Scale of Perceived Social Support (MSPSS) [Time frame: Pre-test (0 weeks) to Post-test (6 weeks)]
  • Dyadic Coping Inventory (DCI) [Time frame: Pre-test (0 weeks) to Post-test (6 weeks)]
  • The Meaning in Life Questionnaire (MLQ) [Time frame: Pre-test (0 weeks) to Post-test (6 weeks)]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Massachusetts General Hospital — Boston

Identifiers

NCT: NCT06968468 · 2023P001058

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗