LDART for Alcohol Use Disorder

Официальное название

A Pilot Randomized Controlled Trial of LDART, a Social Support Intervention for Alcohol Use Disorder

Обзор

This study is a pilot randomized controlled trial to evaluate feasibility, acceptability, and preliminary efficacy of a digital intervention called Let's Do Addiction Recovery Together! (LDART) in adults with alcohol use disorder, relative to a control group.

Вмешательства

• Устройство LDART
  Let's Do Addiction Recovery Together! (LDART) is a web-based intervention grounded in social cognitive theory that is designed to reduce hazardous alcohol use. It has three active ingredients: 1) daily recovery goal setting and tracking, 2) motivational video, audio, and written messages from individuals in recovery, and 3) information on several community-based recovery groups (e.g., mutual-help groups, recovery community centers) that provide free, publicly available meetings and activities. P
• Поведенческое Psychoeducational control
  This is a 20-page psychoeducational booklet created by the National Institute on Alcohol Abuse \& Alcoholism (NIAAA) called "Rethinking Drinking". It contains several suggestions, strategies and resources for helping people who want to reduce their alcohol use. Participants will be encouraged to access the booklet for a few minutes each night over the 4-week intervention period.

Первичные конечные точки

• Recruitment rate [Срок оценки: From enrollment to the final assessment time point (Day 56)]
• Accrual rate [Срок оценки: From enrollment to the final assessment time point (Day 56)]
• Retention rate [Срок оценки: From enrollment to the final assessment time point (Day 56)]
• Intervention engagement [Срок оценки: From beginning the intervention (Day 1) to the end of the intervention period (Day 28)]
• Intervention acceptability [Срок оценки: The second assessment time point (post-intervention, Day 28)]

Вторичные конечные точки (3)

• Change from baseline in number of drinking days [Срок оценки: Baseline (Day 0), Post-intervention (Day 28), 1-month post-intervention (Day 56)]
• Change from baseline in number of heavy drinking days [Срок оценки: Baseline (Day 0), Post-intervention (Day 28), 1-month post-intervention (Day 56)]
• Change from baseline in number of hours spent engaging with recovery groups [Срок оценки: Baseline (Day 0), Post-intervention (Day 28), 1-month post-intervention (Day 56)]

Критерии участия

Критерии включения

• Currently reside in Connecticut, USA
• Have a smartphone that can send and receive text messages and have internet access that can be access over the course of a month
• Had ≥5 heavy drinking days (defined as ≥4 or ≥5 drinks in one sitting for women and men, respectively) in the past 28 days
• Alcohol Symptom Checklist ≥4, indicating moderate/severe AUD
• Have some self-reported desire to cut down or quit drinking

Критерии исключения

• Unable to provide informed consent, as assessed by the consent quiz
• Unable to speak, read, or write in English
• Vulnerable population status
• Unlikely to be able to complete study procedures in the next 2-3 months

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

Лечение

Центры проведения

США · 1 центр

• Yale University — New Haven

Идентификаторы

NCT: NCT07221383 · 2000040798 · K12DA000167

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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