Addressing Emotional Distress in Dyads of Persons With a Young Onset Dementia (YOD) and Their Care-partners

Обзор

The purpose of the present investigation is to test the efficacy of a virtual, brief (6 sessions) dyadic (patient and care-partner together) intervention to prevent chronic emotional distress in dyads where one person is diagnosed with Young Onset Dementia (YOD). Through this study, we seek to address the unmet need of preventing chronic emotional distress in YOD dyads through a feasible, acceptable and credible program, and ideally enhance resiliency and improve wellbeing and quality of life in both members of the dyad.

Вмешательства

• Поведенческое Resilient Together-YOD
  This is a 6 session dyadic (patient and spousal care-partner) intervention that teaches resiliency and interpersonal communication skills early after YOD diagnoses. It aims to decrease heightened symptoms of depression and anxiety among dyads to help them engage in important decisions around long term care-planning and optimize adjustment. The goal is to equip dyads with the necessary skills to cope and engage in meaningful, challenging conversations around care-planning, symptom deterioration,
• Поведенческое Health Enhancement Program-YOD
  This is a 6 session program that will deliver educational information to dyads and will mimic the dose and duration of Resilient Together. The program will not teach any individual and dyadic interpersonal skills, but will contain education on psychological distress and healthy behaviors. Sessions will also be delivered virtually.

Первичные конечные точки

• Change in Emotional Distress [Срок оценки: 0 weeks, 6 weeks, 12 weeks]

Вторичные конечные точки (6)

• Change in Resiliency Factors (Mindfulness) [Срок оценки: 0 weeks, 6 weeks, 12 weeks]
• Change in Resiliency Factors (Individual Coping) [Срок оценки: 0 week, 6 weeks, 12 weeks]
• Change in Resiliency Factors (Mindfulness Utilization) [Срок оценки: 0 weeks, 6 weeks, 12 weeks]
• Changes in Interpersonal Factors (Dyad Coping) [Срок оценки: 0 weeks, 6 weeks, 12 weeks]
• Changes in Resiliency Factors (Perceived Social Support) [Срок оценки: 0 weeks, 6 weeks, 12 weeks]
• Changes in Resiliency Factors (Values-based Living) [Срок оценки: 0 weeks, 6 weeks, 12 weeks]

Критерии участия

Критерии включения

• Between the ages of 18-65 at the time of enrollment \[both patient and care-partner\]
• Diagnosis of young-onset dementia (FTD, PPA, AD, PCA, etc.) with symptom onset prior to age 65 \[patient\]
• A designated care-partner willing and interested to participate \[both patient and care-partner\]
• Received YOD diagnosis in the past 6 month \[patient\]
• English fluency and literacy \[both patient and care-partner\]
• Cognitive ability to understand study and research protocol in order to consent to study participation per referring neurologist \[both patient and care-partner\]
• Patient and/or caregiver exhibit emotional distress on screening (using HADS D and/or HADS A scores > 7)

Критерии исключения

• An additional, terminal diagnosis such as cancer
• Lack of access to internet and/or a device with a camera
• Current untreated or unstable severe mental health conditions like bipolar disorder, schizophrenia, or active substance use

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Massachusetts General Hospital (MGH) — Boston

Идентификаторы

NCT: NCT07018726 · 2025P001534

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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