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Идёт набор NCT05544344

Healthy ReStart Intervention to Improve Health and Functioning

Без фазы С лечением Mental Disorder

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: Healthy ReStart, Services as Usual.
Кому может быть актуально
Состояния в реестре: Mental Disorder. 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
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Обзор

This study tests an intervention that uses health coaching, motivational interviewing, positive psychology, and online wellness tools to help adults with mental illness return to active lives after major disruptions such as the COVID-19 pandemic.

Подробное описание

This study is testing the efficacy of a brief intervention delivered to adults with mental illness by trained health coaches, designed to help recipients engage in health and mental health self-management, while setting goals to return to an active life after major disruptions such as a pandemic. Adult clients of collaborating community mental health agencies are randomly assigned to the intervention plus services as usual, versus services as usual alone. They are assessed at baseline and 6 months later. Analysis of covariance (ANCOVA) models are used to assess the primary outcome of changes in mental and physical health, functioning, perceived competence for life self-management, and mental health recovery. Also examined are study condition differences in self-advocacy skills, access to services, and disruptions from COVID-19.

Hypothesis 1: Compared to services as usual (SAU), intervention recipients will report better health, well-being, and service use.

Hypothesis 2: Compared to SAU, intervention recipients will have more perceived competence and self-advocacy.

Hypothesis 3: Healthy ReStart recipients will report high levels of satisfaction with the intervention.

Вмешательства

  • Поведенческое Healthy ReStart
    In addition to receiving mental health services as usual, subjects receive services from health coaches over a four-month period to assist them in creating a Restart plan and attaining related life goals.
  • Другое Services as Usual
    Subjects receive mental health services as usual.

Первичные конечные точки

  • Change in Perceived Competence [Срок оценки: Study entry (pre-intervention), 6 months post-study entry]
  • Change in Depressive Symptoms [Срок оценки: Study entry (pre-intervention), 6 months post-study entry]
  • Change in Anxiety Symptoms [Срок оценки: Study entry (pre-intervention), 6 months post-study entry]
  • Change in Coping Mastery [Срок оценки: Study entry (pre-intervention), 6 months post-study entry]
  • Change in Empowerment [Срок оценки: Study entry (pre-intervention), 6 months post-study entry]
  • Change in Recovery [Срок оценки: Study entry (pre-intervention), 6 months post-study entry]
Вторичные конечные точки (2)
  • Change in Physical and Mental Functioning [Срок оценки: Study entry (pre-intervention), 6 months post-study entry]
  • Change in Ability to Self-Advocate [Срок оценки: Study entry (pre-intervention), 6 months post-study entry]

Критерии участия

Критерии включения

  • Age 18 and older
  • Diagnosis of serious mental illness defined as a DSM 5 psychiatric disorder and moderate to severe functional impairment
  • Membership in a collaborating community mental health agency
  • Access to the Internet for online meetings
  • Able to provide informed consent

Критерии исключения

  • A cognitive impairment preventing informed consent
  • Unable to communicate in English

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Trilogy Behavioral Health Care — Chicago

Идентификаторы

NCT: NCT05544344 · 2021-0125 · 90RTHF0004-01-00

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗