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Идёт набор NCT07220486

Behavioral Health Program for Short-Stay Nursing Facility Residents & Care Partners

Без фазы С лечением Nursing Home Resident Skilled Nursing Facility Depression Feasibility Studies

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Interventions for Stressful Transitions in Later Life.
Кому может быть актуально
Состояния в реестре: Nursing Home Resident, Skilled Nursing Facility, Depression, Feasibility Studies. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Building Resilience in Skilled Nursing Care: A Behavioral Health Intervention for Residents & Care Partners

Обзор

The goal of this clinical trial is to test a behavioral health program (Interventions for Stressful Transitions in Later Life, InSTILL) for skilled nursing facility residents and their primary support person. The main questions it aims to answer is whether the program is program is feasible, satisfactory, and helpful. The researchers will compare the InSTILL program to minimally enhanced usual care. Participants will be randomly assigned to receive either the InSTILL program or minimally enhanced usual care. Participants will complete assessments at three timepoints (all) and a brief-exit interview.

Вмешательства

  • Поведенческое Interventions for Stressful Transitions in Later Life
    The Interventions for Stressful Transitions in Later Life (InSTILL) intervention is for skilled nursing facility residents and their care partners experiencing elevated levels of psychological distress. The intervention is designed to improve life management skills, emotion regulation skills, and dyadic coping skills with the goal of reducing depression symptoms among both dyad members (i.e., resident and care partner).

Первичные конечные точки

  • Treatment Credibility [Срок оценки: peri-intervention]
  • Client Satisfaction Questionnaire [Срок оценки: immediately after the intervention]
  • Feasibility of Recruitment [Срок оценки: baseline, pre-intervention]
  • Feasibility of Data Collection [Срок оценки: 1 month follow-up]
  • Treatment Adherence [Срок оценки: immediately after the intervention]
  • Clinician Fidelity [Срок оценки: immediately after the intervention]
  • Adverse Events [Срок оценки: 1 month follow-up]
  • Treatment Acceptability Survey [Срок оценки: immediately after the intervention]
Вторичные конечные точки (12)
  • PHQ-9 [Срок оценки: baseline, pre-intervention; immediately after the intervention; 1 month follow-up]
  • Selection, Optimization, and Compensation in Everyday Use [Срок оценки: baseline, pre-intervention; immediately after the intervention; 1 month follow-up]
  • Committed Action Questionnaire [Срок оценки: baseline, pre-intervention; immediately after the intervention; 1 month follow-up]
  • Perceptions of Collaboration Questionnaire [Срок оценки: baseline, pre-intervention; immediately after the intervention; 1 month follow-up]
  • General Anxiety Disorder-7 [Срок оценки: baseline, pre-intervention; immediately after the intervention; 1 month follow-up]
  • Euro QoL-5D 5L [Срок оценки: baseline, pre-intervention; immediately after the intervention; 1 month follow-up]
  • Relationship Assessment Scale [Срок оценки: baseline, pre-intervention; immediately after the intervention; 1 month follow-up]
  • Preparedness for Future Care [Срок оценки: baseline, pre-intervention; immediately after the intervention; 1 month follow-up]
  • COREQ [Срок оценки: immediately after the intervention]
  • University of Washington Resilience Scale Short Form [Срок оценки: baseline, pre-intervention; immediately after the intervention; 1 month follow-up]
  • Zarit Burden Interview [Срок оценки: baseline, pre-intervention; immediately after the intervention; 1 month follow-up]
  • Psychotropic medication use [Срок оценки: baseline, pre-intervention; immediately after the intervention; 1 month follow-up]

Критерии участия

Критерии включения

  • Patient and care partner both aged ≥ 18 years
  • Patient with care partner (known person providing regular health-related, socioemotional, or practical support) willing to participate
  • Patient reporting depression symptoms on a screening tool (Patient Health Questionnaire)

Критерии исключения

  • Patient intended length of nursing facility stay < 7 days
  • Patient evidencing more than mild impairment on a cognitive screen (Brief Interview for Mental Status)
  • Patient's roommate in skilled nursing facility already enrolled in study/intervention
  • Either patient or care partner reporting high risk of suicidality, based on a standardized safety assessment tool
  • Either patient or care partner participating in newly initiated psychotherapy

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
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Massachusetts General Hospital — Boston

Идентификаторы

NCT: NCT07220486 · 2025P0001624 · K23AG078410

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗