Resiliency Intervention for Patients With ALS and Their Care-Partners

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Recruitment Feasibility [Срок оценки: 0 weeks]
• Data Collection Feasibility [Срок оценки: Pre-test (0 weeks) to Post-test (6 weeks)]
• Adherence Feasibility [Срок оценки: 6 weeks]
• Therapist Fidelity Feasibility [Срок оценки: 6 weeks]
• Treatment Satisfaction [Срок оценки: 6 weeks]
• Credibility and Expectancy [Срок оценки: Pre-test (0 weeks)]
• Adverse Events [Срок оценки: 6 weeks]

Вторичные конечные точки (7)

• Hospital Anxiety and Depression Scale (HADS) [Срок оценки: Pre-test (0 weeks) to Post-test (6 weeks)]
• The World Health Organization Quality of Life abbreviated (WHOQOL-BREF) [Срок оценки: Pre-test (0 weeks) to Post-test (6 weeks)]
• Cognitive and Affective Mindfulness Scale (CAMS) [Срок оценки: Pre-test (0 weeks) to Post-test (6 weeks)]
• Measure of Current Status Part A (MOCS-A) [Срок оценки: Pre-test (0 weeks) to Post-test (6 weeks)]
• Multidimensional Scale of Perceived Social Support (MSPSS) [Срок оценки: Pre-test (0 weeks) to Post-test (6 weeks)]
• Dyadic Coping Inventory (DCI) [Срок оценки: Pre-test (0 weeks) to Post-test (6 weeks)]
• The Meaning in Life Questionnaire (MLQ) [Срок оценки: Pre-test (0 weeks) to Post-test (6 weeks)]

Критерии участия

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)

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Massachusetts General Hospital — Boston

Идентификаторы

NCT: NCT06968468 · 2023P001058

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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