Sustaining Recovery for People on Opioid Agonist Treatment With Conversational Agents

Обзор

This study aims to improve retention in buprenorphine treatment, a medication used for opioid use disorder, through the use of a smartphone-delivered recovery support intervention. The intervention involves an Embodied Conversational Agent (ECA), a virtual, animated computer agent designed to simulate natural face-to-face conversations. ECAs have been shown to help individuals manage their healthcare in other settings, and this study seeks to evaluate their potential in supporting patients on medication for opioid use disorder (MOUD).

Подробное описание

One hundred participants will be enrolled in the study from the Office-Based Addiction Treatment (OBAT) clinic at Boston Medical Center (BMC). The participants will be randomly assigned to one of two groups. In the intervention group, participants will engage in ECA use and will receive (1) technical support, (2) text message reminders, and (3) monetary incentives. Alternatively, participants will be randomized to the treatment as usual group where they do not access the ECA application. Assessments will be conducted in person at baseline and over the phone at 6 months and 12 months. At 3 and 9 months, research staff will make brief telephone contacts to confirm or update participant contact information. The primary outcome is retention in buprenorphine treatment over 12 months.

Вмешательства

• Другое Embodied conversational agent (ECA)
  The app with the ECA will be provided.
• Другое Technical support
  Technical support will include assistance downloading and setting up the app on the participant's phone, walking them through a brief demonstration, and answering any questions the participant has about how to use the app.
• Другое Additional ECA messages
  Weekly text messages will be provided reminding participants to use the app on behalf of OBAT clinical staff.
• Другое Additional incentives
  Additional incentives will be provided after logging into the app for 20 days followed by monthly lotteries for those who log in 15 days per month

Первичные конечные точки

• Number of participants that stay engaged in buprenorphine treatment [Срок оценки: 12 months]

Вторичные конечные точки (8)

• Treatment retention at 6 months [Срок оценки: 6 months]
• Treatment duration [Срок оценки: 6 months. 12 months]
• Opioid use [Срок оценки: 6 months]
• Changes in stigma based on the Substance Use Stigma Mechanism Scale (SU-SMS) [Срок оценки: Baseline, 6 months]
• Changes in stigma based on the Buprenorphine Treatment Stigma Mechanism Scale (BT-SMS) [Срок оценки: Baseline, 6 months]
• Changes in recovery capital [Срок оценки: Baseline, 6 months]
• Frequency of interaction with the ECA app [Срок оценки: 6 months, 12 months]
• User attitude and satisfaction toward the ECA [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Diagnosis of Opioid Use Disorder (OUD)
• Within 30 days of intake at recruitment site (BMC OBAT)
• Possession of a smartphone that has minimum requirements
• English-speaking and reading
• Willing to release electronic health record (EHR) data
• Able to provide at least two alternate contacts who usually know how to get in touch with them
• Currently prescribed buprenorphine from an outpatient clinic

Критерии исключения

• Incarceration anticipated within 12 months of enrollment
• Inability to comprehend the study protocol, defined as failing three times to answer correctly a set of questions during the consent process
• Inability to use the ECA app (i.e., due to markedly limited visual or auditory acuity or motor function required to interact with the ECA)

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

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Office-Based Addiction Treatment (OBAT) Clinic, BMC — Boston

Идентификаторы

NCT: NCT06732596 · H-45380 · 1R34DA058124-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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