SUpport From PEeRs to Expand Access Study - Community

Официальное название

SUPERA: Supporting Peer Interactions to Expand Access to Digital Cognitive Behavioral Therapy for Spanish-speaking in the San Francisco Mission Community

Обзор

Investigators will evaluate the implementation of an evidence-based, Spanish-language, digital, cognitive-behavioral therapy (dCBT) intervention (SilverCloud) in the Mission community for Latino patients with depression and/or anxiety. 213 participants will be enrolled in a one-armed trial comparing self-guided vs. supported dCBT (SilverCloud).

Вмешательства

• Устройство Behavioral: Supported dCBT
  In the supported dCBT condition, each patient will receive complete access to the SilverCloud platform. In addition, patients will be assigned a supporter who will provide regular support based on an established coaching support protocol. Supporters will conduct a brief engagement call (30-40 minutes) to provide an overview of SilverCloud, identify goals, and set expectations, introduce themselves, and orient the participant to the role of the peer supporter. Supporters will then provide weekly
• Устройство Behavioral: Unsupported dCBT
  Unsupported dCBT provides all features of the SilverCloud platform with the exception of support features (structured interactions with supporter and share features). Patients will be provided complete access to SilverCloud and instructed to use it for 8-weeks. Patients will receive weekly automated messages to encourage engagement.

Первичные конечные точки

• Change in Depression at 8 Weeks [Срок оценки: Change from Baseline to Week 8]
• Change in Anxiety at 8 Weeks [Срок оценки: Change from Baseline to Week 8]

Критерии участия

Критерии включения

• PHQ-9 ≥ 10 or GAD-7 ≥ 8
• Has access to the Internet via smartphone and/or broadband at home, and basic level of technological literacy or willingness to undergo a brief technology use training
• ≥18 years of age
• Preference for receiving medical care in Spanish
• Not in concurrent psychotherapy
• If currently taking an antidepressant medication, patient must have been on a stable dose for at least 6 weeks, and have no plans to change the dose. We will permit patients on antidepressants to enter the study, as this will increase generalizability. Antidepressant status will be monitored at each assessment to control for those effects, if necessary.

Критерии исключения

• Currently receiving psychotherapy, as this treatment will be offered as a frontline treatment for depression and anxiety, however, patients are allowed to be referred to treatment while participating in this study and initiation of treatment will be monitored and considered in analyses
• Visual, hearing, voice, or motor impairment or illiteracy that would prevent completion of study procedures
• Diagnosis of a psychotic disorder, bipolar disorder, dissociative disorder, or substance use disorder
• Severe suicidality (as assessed by expressing suicidal ideation, plan, and intent). Although procedures with back-up plans are in place for patients who develop suicidality (see Human Subjects Section), patients assessed with severe suicidality will be referred to more-intensive treatment resources.

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 · 1 центр

• Zuckerberg San Francisco General — San Francisco

Идентификаторы

NCT: NCT07186816 · 22-36825

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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