Social Media Psychosocial Support Group to Reduce Alcohol Consumption in Women: a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Alcohol use
研究概览
简要总结
This proposed study aims to develop and examine the feasibility, acceptability, and preliminary effectiveness of a proactive intervention model that combines brief psychological counselling, Ecological Momentary Assessment (EMA) and social media psychosocial support group to reduce alcohol consumption in women.
详细描述
Targeted participants are adult women with a total a total score≥3 in Alcohol Use Disorders Identification Test - Consumption (AUDIT-C). Sixty participants will be actively recruited from the social media platform in Hong Kong.
This study will be a two-arm (allocation ratio:1:1; permutated block size of 2, 4, and 8), single blinded, parallel, pilot randomized controlled trial (RCT) with follow-ups at 4, 8, and 12 weeks post-enrollment using consolidated standards of reporting (CONSORT) to evaluate the effectiveness of the intervention. The control group will receive an evidence-based intervention composed of brief psychological counselling and health education, 4-week EMA and social media psychosocial support group, guided by comprehensive assessment. Surveys will be collected via telephone. Semi-structured individual telephone or face-to-face indepth interviews will be conducted with the participants in the intervention group to understand the experience and the perceptions towards the EMA data collection and ocial media psychosocial support group intervention on alcohol consumption.
The clinical outcome of this study will be the difference in the alcohol consumption, anxiety and depressive levels, stress levels, and family well-being between the two groups at 4, 8, and 12 weeks.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult women (age 18+),
- •Had a total score ≥3 in AUDIT-C [suggesting at-risk drinkers (i.e., binge drinking)]( potential distress symptoms),
- •Able to read and understand Chinese and use an instant messaging app weekly
排除标准
- •Women who are undergoing psychiatric/psychological treatment
研究组 & 干预措施
Conrtol group
Participatns in the control group will receive alcohol brief intervention according to their AUDIT score at baseline and 4 weeks 1-to-1 health education messages.
干预措施: Brief alcohol use counselling and health education (Behavioral)
Intervention group
A 4-week psychological support group for interactive counselling will be provided to encourage reducing alcohol consumption. MHealth messages will also be provided according to the stages of change for alcohol use.
干预措施: mHealth-based motivational counselling (Behavioral)
Intervention group
A 4-week psychological support group for interactive counselling will be provided to encourage reducing alcohol consumption. MHealth messages will also be provided according to the stages of change for alcohol use.
干预措施: Brief alcohol use counselling and health education (Behavioral)
Intervention group
A 4-week psychological support group for interactive counselling will be provided to encourage reducing alcohol consumption. MHealth messages will also be provided according to the stages of change for alcohol use.
干预措施: Social media group support with engagement management (Behavioral)
结局指标
主要结局
Alcohol use
时间窗: 4-, 8-, and 12-weeks after enrollment
Alcohol use is measured by the Alcohol Use Disorders Identification Test (AUDIT) scale. It is a standardized, 10-item self-report screening instrument developed by the World Health Organization (WHO) to identify hazardous alcohol consumption, harmful drinking behaviors, and alcohol use disorders (AUDs). Respondents rate each item on a 5-point Likert scale (0 = never to 4 = daily or almost daily), with total scores ranging from 0 to 40. The higher the score, the greater the risk of individual alcohol abuse and dependence. Established cutoff values guide interpretation: Scores 0-7: Generally indicates low-risk or abstinence. Scores 8-14: Suggests hazardous or harmful alcohol use. Scores 15-19: Indicates a high level of harmful alcohol use. Simple advice and periodic review are advised. Scores 20-40: Suggests a likely alcohol dependence syndrome and the need for further diagnostic evaluation and specialist treatment consideration.
次要结局
- Anxiety(4-, 8-, and 12-weeks after enrollment)
- Depressive symptoms(4-, 8-, and 12-weeks after enrollment)
- Stress(4-, 8-, and 12-weeks after enrollment)
- Perceived family well-being(4-, 8-, and 12-weeks after enrollment)