The Use of Telephone-based ACT for Quitting Alcohol in the Young Population With Hazardous or Harmful Alcohol Use.

Официальное название

A Randomized Controlled Trial of Telephone-based Acceptance and Commitment Therapy to Assist Young Adults With Hazardous or Harmful Alcohol Use to Quit Drinking

Обзор

Objectives: To investigate the effectiveness of a telephone-based acceptance and commitment therapy (ACT) in assisting young adult drinkers with hazardous or harmful alcohol use (HH drinkers) to quit drinking. Hypothesis to be tested: Primary hypothesis: 1) those who receive telephone-based ACT will report a significantly higher biochemical validated abstinence than the control groups. Secondary hypotheses are that compared with the control groups, those who receive telephone-based ACT will show: 2) significantly higher self-reported 30-day abstinence, 3) significantly greater reduction in drinking, and 4) significantly higher psychological flexibility. Design and subjects: A Hong Kong randomized controlled trial with 2-arm waitlist controlled trial design on 288 individuals (aged 18-35 years, able to read Chinese and speak Cantonese, and with AUDIT scores≥8). Study instruments: Biochemical-validated abstinence (Urine strips), timeline Follow-Back questionnaire, self-reported 30-day abstinence and Personalized Psychological Flexibility Index, Short-Form 6 Dimensions and semi-structured interviews. Interventions: The intervention group(n=144) will receive 6-weekly telephone-based ACT. The waitlist control group (n=144) will receive 6-weekly telephone-based social support intervention. Main outcome measures: Primary outcome is biochemical-validated abstinence at the 6-month follow-up. Secondary outcomes include self-reported 30-day abstinence alcohol reduction, and psychological flexibility at baseline, post-program, 1-, 3-, and 6-month follow-ups. Data analysis: Descriptive statistics, generalized estimating equations, multiple imputation, intention-to-treat, per protocol analyses, and cost-effectiveness analysis. Expected results: The telephone-based ACT is effective in assisting HH drinkers to quit drinking.

Вмешательства

• Поведенческое Telephone-based ACT
  Each participant will join a six-session weekly telephone-based ACT programme conducted by the interventionists. Each session will last approximately 45-60 minutes.
• Поведенческое Telephone-based social support
  Participants will receive weekly 45-minute telephone-based social support from an interventionist(not involved in the intervention group) for 6 weeks, which mimics the time and attention received by those in the intervention group.

Первичные конечные точки

• biochemically-validated abstinence [Срок оценки: at the 6-month follow-up]

Вторичные конечные точки (3)

• self-reported 30-day alcohol abstinence [Срок оценки: at post-programme(T1) and at the 1-month(T2), 3-month(T3) and 6-month(T4) follow-ups]
• self-reported 30-day reduction in alcohol consumption [Срок оценки: at post-programme(T1) and at the 1-month(T2), 3-month(T3) and 6-month(T4) follow-ups]
• psychological flexibility [Срок оценки: at post-programme(T1) and at the 1-month(T2), 3-month(T3) and 6-month(T4) follow-ups]

Критерии участия

Критерии включения

• (1)aged 18-35 years,37-38
• (2)able to read Chinese and speak Cantonese
• (3)have AUDIT scores≥8.

Критерии исключения

• (1) those who have a serious mental illness (Kessler Psychological Distress Scale7 with a score of ≥13)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07450248 · telephone-based ACT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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