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Идёт набор NCT07655232

Pilot Study of a Behavioral Program for Resident Depression in Skilled Nursing Facilities

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 (InSTILL) for Individuals.
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: Open Pilot for a Behavioral Health Intervention

Обзор

The goal of this clinical trial is to test a behavioral health program (Interventions for Stressful Transitions in Later Life, InSTILL, for Individuals) for skilled nursing facility residents. The main questions it aims to answer is whether the program is program is feasible, satisfactory, and helpful. Participants will join 6 bi-weekly sessions of the InSTILL program. Participants will complete assessments at three timepoints (all) and a brief-exit interview.

Вмешательства

  • Поведенческое Interventions for Stressful Transitions in Later Life (InSTILL) for Individuals
    The Interventions for Stressful Transitions in Later Life (InSTILL) intervention is for skilled nursing facility residents experiencing elevated levels of psychological distress. The intervention is designed to improve life management skills and emotion regulation skill with the goal of reducing depression symptoms.

Первичные конечные точки

  • Mean Total Score Treatment Credibility [Срок оценки: After session 1 of intervention, an average of 1 week after baseline]
  • Mean Total Score Client Satisfaction Questionnaire [Срок оценки: Post intervention, an average of 4 weeks after baseline]
  • Percentage of Eligible Participants Enrolled [Срок оценки: Post intervention, an average of 4 weeks after baseline]
  • Percentage of Participants with Missing Data [Срок оценки: 4 weeks after post-intervention]
  • Attendance Rate [Срок оценки: Post intervention, an average of 4 weeks after baseline]
  • Clinician Fidelity [Срок оценки: Post intervention, an average of 4 weeks after baseline]
  • Number of Adverse Events [Срок оценки: 4 weeks after post-intervention]
  • Treatment Acceptability Survey [Срок оценки: Post intervention, an average of 4 weeks after baseline]
  • Percentage of Participants Meeting Participant Comprehension Criterion [Срок оценки: Post intervention, an average of 4 weeks after baseline]
Вторичные конечные точки (9)
  • Patient Health Questionnaire-9 [Срок оценки: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention]
  • Selection, Optimization, and Compensation (SOC) in Everyday Use [Срок оценки: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention]
  • Committed Action Questionnaire [Срок оценки: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention]
  • General Anxiety Disorder-7 [Срок оценки: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention]
  • Euro QoL-5D 5L [Срок оценки: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention]
  • COREQ [Срок оценки: Post intervention, an average of 4 weeks after baseline]
  • University of Washington Resilience Scale Short Form [Срок оценки: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention]
  • Psychotropic medication use [Срок оценки: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention]
  • Re-hospitalization [Срок оценки: Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention]

Критерии участия

Критерии включения

  • Psychological distress, as indicated by a score Patient Health Questionnaire- 2 ≥ 2 OR Patient Health Questionnaire-9 ≥ 5
  • 5+ chronic conditions based on Elixhauser Comorbidity Index
  • Aged ≥ 18 years
  • Able and willing to participate in the study

Критерии исключения

  • Intended length of SNF stay < 7 days
  • More than mild cognitive impairment, as indicted by Brief Interview for Mental Status (BIMS) <13
  • Participant's roommate is already enrolled in study/intervention
  • High risk of suicide/active documented SI per the PHQ-9, item 9 or otherwise
  • Participation in newly initiated psychotherapy

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: NCT07655232 · 2024P001945B

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗