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Идёт набор NCT06864715

Behavioral Activation for the PreVention of Post-strokE Depression in LoW-incomE Older Stroke Survivors

Без фазы С лечением Post-stroke Depression Subthreshold Depression

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: Tele-delivered Behavioral Activation by lay counselors after Stroke (Tele-BA-S), Treatment as Usual.
Кому может быть актуально
Состояния в реестре: Post-stroke Depression, Subthreshold Depression. Базовые параметры: от 55 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

Behavioral Activation for the PreVention of Post-strokE Depression in LoW-incomE Older Stroke Survivors (LIVE-WEL)

Обзор

The overall objective of the project is to determine the effectiveness of tele-delivered behavioral activation (BA) by trained lay counselors (Tele-BA-S) to prevent Post-stroke depression (PSD) in low-income, older stroke survivors with subthreshold depression (SD).

Вмешательства

  • Поведенческое Tele-delivered Behavioral Activation by lay counselors after Stroke (Tele-BA-S)
    The Tele-BA-S intervention will comprise 5 weekly video-conferenced BA sessions delivered by trained lay counselors, homework, and 2 monthly follow-up booster calls. Participants will receive the standard hospital discharge post-stroke educational packet and a scheduled follow-up appointment with a stroke practitioner to evaluate patients at 7-14 days and 3 months ±14 days, according to current standard of care. They will be seen over video or in-person, according to their preference and capabil
  • Поведенческое Treatment as Usual
    Participants will receive the standard hospital discharge post-stroke educational packet and a scheduled follow-up appointment with a stroke practitioner to evaluate patients at 7-14 days and 3 months ±14 days, according to current standard of care. They will be seen over video or in-person, according to their preference and capabilities.

Первичные конечные точки

  • Post-Stroke Depression as Assessed by Score on the Hamilton Depression Rating Scale (HDRS) 24-item [Срок оценки: baseline, 2 months, 4 months, 6 months, 9 months]
  • Subthreshold Depression (Depressive Symptoms) as Assessed by the Patient Health Questionnaire (PHQ-9) [Срок оценки: baseline, 1 month, 2 months, 4 months, 6 months, 9 months]
Вторичные конечные точки (9)
  • Anxiety as Assessed by the Generalized Anxiety Disorder- 7 Item (GAD-7) [Срок оценки: baseline, 2 months, 4 months, 6 months, 9 months]
  • Change in Emotional Distress as Assessed by the Ryff Psychological Well-being Scale (PWB) [Срок оценки: baseline, 2 months, 4 months, 6 months, 9 months]
  • Quality of Life (QOL) as Assessed by the Short Form Stroke Specific Quality of Life Scale (SS-QOL) [Срок оценки: baseline, 2 months, 4 months, 6 months, 9 months]
  • Number of Self-Reported Emergency Room Visits Over the Course of the Study [Срок оценки: From baseline to 9 months]
  • Number of Hospitalizations Over the Course of the Study [Срок оценки: From baseline to 9 months]
  • Disability as Assessed by the Modified Rankin Scale (mRS) [Срок оценки: baseline, 2 months, 4 months, 6 months, 9 months]
  • Medication Adherence Report Scale-5 [Срок оценки: baseline, 2 months, 4 months, 6 months, 9 months]
  • Rehabilitation Adherence Inventory [Срок оценки: baseline, 2 months, 4 months, 6 months, 9 months]
  • Barthel Index [Срок оценки: baseline, 2 months, 4 months, 6 months, 9 months]

Критерии участия

Критерии включения

  • Enrollment within 3-months +2 weeks of a first-time ischemic or hemorrhagic stroke
  • 24-item HDRS score < 15 indicating subthreshold depression defined as the absence of depressive symptoms or presence of mild symptoms of depression
  • Single person income less than or equal to $45,000
  • Residing in a community residence
  • Ability to speak and read in English or Spanish
  • Mini-MoCA score > or equal to 11

Критерии исключения

  • Stroke event unrelated to vascular risk factors (e.g., drug use) or transient ischemic attack
  • 24-item HDRS score > or equal to 15 indicating moderate to severe depression
  • Actively participating in psychotherapy
  • high suicide risk or severe psychiatric illness (e.g., bipolar disorder and active psychosis) and/or actively taking antipsychotics
  • Diagnosed dementia and/or currently taking cognitive enhancers, amyloid-targeting medications, or orexin receptor antagonists
  • Patient Health Questionnaire 9 score > or equal to 10 and/or answers positive to Q9
  • Diagnosed aphasia and/or severe cognitive impairments
  • high-risk alcohol or drug misuse
  • receiving medications for mood disorders and a change in dose or type within the last 4 weeks

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
Профилактика

Центры проведения

США · 1 центр
  • The University of Texas Health Science Center at Houston — Houston

Публикации

  • Beauchamp JES, Savitz SI, Sharrief A, Reininger BM, Acierno R, Suchting R, Burnett J, Rosales L, Albaqali JA, Rajan R, Choi NG. Behavioural activation for the prevention of poststroke depression in low-income older stroke survivors (LIVE WEL): protocol for a randomised controlled trial. BMJ Open. 2026 Jun 7;16(6):e120452. doi: 10.1136/bmjopen-2026-120452. PMID 42252135

Идентификаторы

NCT: NCT06864715 · HSC-SN-25-0265

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗