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Идёт набор NCT06940843

A Pilot Randomized Controlled Trial of the Hopeful and Healthy Living Program

Без фазы С лечением Serious Mental Illness Older Adults

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: Hopeful and Healthy Living (HHL).
Кому может быть актуально
Состояния в реестре: Serious Mental Illness, Older Adults. Базовые параметры: от 50 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
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Официальное название

Enhancing Social Connection, Health, and Aging in Older Persons: A Pilot Randomized Trial of the Hopeful and Healthy Living (HHL) Program

Обзор

The goal of this clinical trial is to learn if a novel psychosocial intervention is effective in helping adults over 50 with serious mental illness (SMI) increase their social connections and participate in more healthy lifestyle activities. The Hopeful and Healthy Living (HHL) intervention combines social skills training and training in cognitive self-management strategies in order to help older adults build healthy lifestyle and social routines. We predict that: * Individuals who participate in the HHL intervention will improve more in perceived social support (i.e., what people get from relationships such as reliance, reassurance of worth, attachment) and loneliness at the 4-, 8-, and 12-month follow-up assessments than those who receive treatment as usual (TAU). * Individuals who participate in the HHL intervention will improve more in overall psychosocial functioning at the 4-, 8-, and 12-month follow-up assessments than those who receive TAU. * Individuals who participate in the HHL intervention will improve more in cognitive functioning at the 4-, 8-, and 12-month follow-up assessments than those who receive TAU. * Individuals who participate in the HHL intervention will improve more in healthy behaviors (sleep, activity, diet) at the 4-, 8-, and 12-month follow-up assessments than those who receive TAU. In this trial, participants will be either receive the HHL intervention or participate in their regular treatment activities (treatment as usual). HHL vs. TAU will be compared to see if there are any differences in social support, cognition, loneliness, psychosocial functioning, or healthy lifestyle activities including physical activity, sleep, and diet. Participants will be asked to complete an interview-based assessment at baseline, 4-months, 8-months, and 12-months. After completing the baseline assessment, those who are in the experimental group will participate in the 16-week long HHL group intervention.

Вмешательства

  • Поведенческое Hopeful and Healthy Living (HHL)
    The HHL intervention is a 16-week long, manualized group intervention. Classes will be held weekly for 90 minutes. The class covers 15 topics centered on building social connections, developing healthy lifestyle routines around eating, exercise, and sleep. Each class will target one social skill (i.e. starting conversations) and one cognitive self-management strategy (i.e. memory tips), which will be taught and practiced in class. Each class also includes a facilitated exercise component and ind

Первичные конечные точки

  • Montreal Cognitive Assessment (MOCA) [Срок оценки: Baseline, 4-, 8-, 12- month followup]
  • The Cognitive Self-Efficacy Scale [Срок оценки: Baseline, 4-, 8-, 12- month followup]
  • The DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure [Срок оценки: Baseline, 4-, 8-, 12- month followup]
  • The UCLA Loneliness Scale-3-item instrument [Срок оценки: Baseline, 4-, 8-, 12- month followup]
  • The Social Provisions Scale [Срок оценки: Baseline, 4-, 8-, 12- month followup]
  • The Physical Activity Scale for the Elderly (PASE) [Срок оценки: Baseline, 4-, 8-, 12- month followup]
  • Starting the Conversation [Срок оценки: Baseline, 4-, 8-, 12- month followup]
  • Pittsburg Sleep Quality Index (PSQI) [Срок оценки: Baseline, 4-, 8-, 12- month followup]
Вторичные конечные точки (1)
  • HHL Group Satisfaction and Feedback Survey [Срок оценки: 4-month assessment only]

Критерии участия

Критерии включения

50 years or older, diagnosis of a serious mental illness, and a member of Center Club or Transitions of Boston

Критерии исключения

Diagnosis of dementia or other progressive neurological disorder

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
Простое слепое
Основная цель
Лечение

Центры проведения

США · 2 центра
  • Bay Cove Center Club — Boston
  • Bay Cove Transitions of Boston — Boston

Идентификаторы

NCT: NCT06940843 · 7458B · 90RTHF0007

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗