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Идёт набор NCT04770025

A Pilot Study of Non-invasive Brain Stimulation to Boost the Efficacy of Psychotherapy in a Community Sample of People Who Drink Alcohol

Фаза II С лечением Alcohol Use 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: High-density transcranial alternating current stimulation, Sham stimulation, Motivational interviewing.
Кому может быть актуально
Состояния в реестре: Alcohol Use Disorder. Базовые параметры: 21 лет — 60 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

Transcranial Alternating Current Stimulation to Boost the Efficacy of Motivational Interviewing

Обзор

The goal of this small (n=75) proof-of-concept randomized clinical trial is to test the effects of transcranial alternating current stimulation (tACS) during motivational interviewing (MI) sessions with participants who drink at above the low-risk level. Participants will be randomized to receive either MI with active stimulation, MI with sham stimulation, or a delayed treatment group that receives MI with no stimulation. Measures will include brain imaging, alcohol use, cannabis use, risk-taking behavior, emotions, and others. Participants who are randomized to the delayed-treatment group will not receive brain imaging.

Подробное описание

This proof-of-concept randomized clinical trial will recruit n=75 people with problematic levels of drinking who are considering treatment for their alcohol use. These participants will be randomized to one of three conditions: a condition that applies active tACS during an MI session (MI+tACS), a condition that applies sham stimulation during an MI session (MI+sham), or a waitlist control condition (MI-only). Only participants the MI+tACS and MI+sham conditions will be included in the brain imaging portion of the study. One month after their intervention session, all participants will report their use of alcohol in the prior 30 days via an online assessment battery. This will allow us to test the effects of tACS on within-session client speech and outcomes.

Participants will have magnetoencephalography (MEG) scans including rest and an alcohol cue task to measure the acute effects of brain stimulation. Participants will also have MRI scans including structure and rest. The Motivational Interviewing Skill Code (MISC 2.5) and the CASAA Application for Coding Treatment Interactions (CACTI) will be used to assess counselor and participant speech in the recorded MI sessions and to ensure that sessions comply with the principles of MI.

Вмешательства

  • Устройство High-density transcranial alternating current stimulation
    High-density electrode configuration with transcranial alternating current stimulation in the beta (15-40Hz) frequency range
  • Устройство Sham stimulation
    High-density electrode configuration with sham stimulation
  • Поведенческое Motivational interviewing
    Motivational interviewing session focused on alcohol use, approximately 30 minutes in length

Первичные конечные точки

  • Heavy drinking days [Срок оценки: One month]
Вторичные конечные точки (2)
  • Drinks per drinking day [Срок оценки: One month]
  • Percent days abstinent [Срок оценки: One month]

Критерии участия

Критерии включения

  • Self-identify as having problem drinking
  • Right-handed
  • Age 21-60 years
  • AUDIT score indicating risky drinking

Критерии исключения

  • Left-handed or ambidextrous
  • Currently engaged in treatment for alcohol use disorder
  • Receiving treatment for alcohol use disorder within the prior 12 months
  • History of brain injury or neurological diagnosis
  • Evidence of current psychosis
  • Past-year substance use disorder other than alcohol, marijuana, or nicotine
  • Current or history of severe alcohol withdrawal
  • MRI/tACS contraindications including pregnancy
  • Impaired hearing (psychotherapy using American Sign Language is not possible within the scope of the proposed study)
  • Insufficient corrected visual acuity to complete the assessment instruments
  • Unable to read/speak English fluently
  • Unable to provide valid informed consent

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
Двойное слепое
Основная цель
Другое

Центры проведения

США · 1 центр
  • The Mind Research Network — Albuquerque

Идентификаторы

NCT: NCT04770025 · 20-010 · P30GM122734

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗