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Идёт набор NCT06071858

Enhanced Coordinated Specialty Care for Early Psychosis

Без фазы С лечением Psychosis Schizophrenia Schizoaffective Disorder Psychosis Nos/Other

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: Care Coordination, Individual Peer Support, Digital Outreach, Cognitive Remediation.
Кому может быть актуально
Состояния в реестре: Psychosis, Schizophrenia, Schizoaffective Disorder, Psychosis Nos/Other. Базовые параметры: Без ограничений · 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

Cluster Randomized Trial of Enhanced Coordinated Specialty Care (CSC 2.0) for Early Psychosis

Обзор

The goal of this clinical trial is to compare engagement in treatment in coordinated specialty care (CSC) to five extra care elements (CSC 2.0) in first-episode psychosis. The main question it aims to answer is: • Does the addition of certain elements of care increase the number of visits in treatment for first-episode psychosis? Participants will either: * Receive care as usual (CSC) or * Receive care as usual (CSC) plus five additional care elements (CSC 2.0): 1. Individual peer support 2. Digital outreach 3. Care coordination 4. Multi-family group therapy 5. Cognitive remediation Researchers will compare the standard of care (CSC) to CSC 2.0 to see if participants receiving CSC 2.0 have more visits to their clinic in their first year.

Вмешательства

  • Поведенческое Care Coordination
    * The study staff clinician will review all medical issues for each patient and reach out to primary care providers (PCP), dieticians, and other medical providers as needed. * The study staff clinician will serve as point person for communication with emergency departments and inpatient providers if the patient requires those levels of care. * The clinician will communicate with outside providers to provide background and ensure health decision making by those providers, visit and support patien
  • Поведенческое Individual Peer Support
    • Patients will be offered weekly 1:1 sessions with a Peer Provider as part of routine care in a mixture of in-person and virtual formats as appropriate to support patients around treatment decisions, and recovery.
  • Поведенческое Digital Outreach
    • mindLAMP smartphone application for various kinds of outreach including but not limited to medication and/or appointment reminders, resources, and activities such as breathing and meditation exercises.
  • Поведенческое Cognitive Remediation
    * For participants identified as needing and/or wanting support around cognition. * The cognitive remediation program is available online or in-app and offers memory, attention, processing speed, executive functioning, and social cognition training activities.
  • Поведенческое Multi-Family Group Therapy
    * Families whose loved ones are in CSC clinic will be offered weekly group sessions with a study staff clinician. * Each group may include 5-8 families and include a mixture of in-person and virtual formats. * These groups will be open-ended, including psychoeducation, and practical problem-solving discussions around care and other topics.

Первичные конечные точки

  • Months Engaged in Care [Срок оценки: 12 months following clinic intake]
Вторичные конечные точки (4)
  • Clinic Visit Number [Срок оценки: 12 months following clinic intake]
  • Clinic Visit Type [Срок оценки: 12 months following clinic intake]
  • Duration of Treatment [Срок оценки: Up to 12 months - measured as time between clinic intake and detachment]
  • Proportion in Arm Still in Clinic [Срок оценки: 12 months following clinic intake]

Критерии участия

Критерии включения

  • People undergoing an intake evaluation to CSC for first-episode psychosis in one of the following outpatient clinics:
  • McLean Hospital OnTrack (OnTrack Clinic)
  • Massachusetts General Hospital (FEPP Clinic)
  • Boston Medical Center (WRAP Clinic)
  • Cambridge Health Alliance (RISE Clinic)
  • UMass Memorial Health Care (STEP Clinic)
  • ServiceNet (PREP West)

Критерии исключения

  • None

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 · 5 центров
  • McLean Hospital OnTrack Clinic — Belmont
  • Massachusetts General Hospital FEPP Clinic — Boston
  • Boston Medical Center WRAP — Boston
  • Cambridge Health Alliance RISE Clinic — Cambridge
  • UMass Memorial Community Healthlink STEP Clinic — Worcester

Идентификаторы

NCT: NCT06071858 · 2023P002612 · 2P50MH115846-05

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗