Effectiveness of Internet-Based Self-Help ACT With Behavioral Activation in Improving Alcohol Use Abstinence Among Ethnic Minority Young Adults With Alcohol Use Disorder in Hong Kong, 2024: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Screening rate
研究概览
简要总结
The goal of this clinical trial is to examine the preliminary effectiveness and feasibility of internet-based self-help acceptance and commitment therapy with behavioral activation for ethnic minority young adults with alcohol use disorder. The main questions it aims to answer are:
- Is the internet-based self-help acceptance and commitment therapy with Behavioral activation (self-help iACT-BA) feasible and acceptable for ethnic minority young adults with AUD?
- Does the self-help iACT-BA promote greater abstinence from alcohol use compared to treatment as usual (TAU) in ethnic minority young adults diagnosed with AUD? Researchers will compare self-help iACT-BA to treatment as usual (TAU) to see if self-help iACT-BA works to treat alcohol use disorder in ethnic minority young adults.
Participants will:
- Received a self-help iACT-BA module every week for 6 weeks. or a placebo every day for 4 months
- Access the module every week, read the material, practice, and complete home assignments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Hong Kong ethnic minority young adults
- •They have to read, write, and speak English
- •Their age will range from 18 to 25
- •They will be voluntary to participate
- •Participants should have smartphones or other electronic devices to access the internet
- •They must have AUD based on DSM-5 criteria.
排除标准
- •Currently having psychiatric problems, other mental health problems, being actively involved in suicidal attempts, or immediate care
- •Having a plan to go out of Hong Kong during intervention implementation
- •Having no access to the internet, smart telephone, or other electronic devices
- •Have participated in another psychosocial or pharmacological intervention for AUD.
研究组 & 干预措施
Intervention Arm
The intervention group will receive online-based integrated ACT with BA therapy. The protocol of this therapy is adapted from the ACT manual, self-help protocols for mental health problems, and behavioral activation treatment for substance use and depression.
干预措施: Self-help acceptance and commitment therapy with behavioral activation (Behavioral)
Control Arm
The control group will be assigned to receive Treatment as Usual (TAU).
结局指标
主要结局
Screening rate
时间窗: 3 months
calculated as the number of Hong Kong ethnic minority young adults screened by the research assistant divided by the number of Hong Kong ethnic minority young adults available for screening during the recruitment period.
Eligibility rate
时间窗: 3 months
Calculated as the number of eligible ethnic minority young adults divided by the number of screened ethnic minority young adults.
Consent rate
时间窗: 3 months
calculated as the number of eligible ethnic minority young adults who join the study divided by the number of eligible ethnic minority young adults.
Randomization rate
时间窗: 2 weeks
calculated as the number of ethnic minority young adults who are randomized into the experimental and control groups, divided by the number of eligible ethnic minority young adults who consent to join the study
Attendance rate
时间窗: 6 weeks
calculated as the number of subjects in the experimental group who complete the intervention divided by the number of subjects randomized into the experimental group.
Adherence rate
时间窗: 6 weeks
calculated as the number of subjects in the experimental group who practice the ACT skills gained in the intervention divided by the number of subjects randomized into the experimental group
Retention rate
时间窗: 6 weeks
calculated the number of subjects who remain in the study, divided by the number of subjects who are randomized
Completion rate
时间窗: 6 weeks
calculated as the number of subjects who answer the questionnaires divided by the number of questionnaires distributed
Missing data
时间窗: 6 weeks
percentage of missing in the dataset. Unknown or blank values will be regarded
Adverse events
时间窗: 6 weeks
unfavorable and unintended events that are absent from baseline, or appear to worsen from baseline during the study period
次要结局
- Abstinence rate(6 weeks)
- Average number of drinks consumed per day(6 weeks)
- The number of drinking days(6 weeks)
- The number of heavy drinking days(6 weeks)
研究者
Dr Eva Ho
Associate professor
The Hong Kong Polytechnic University