Alcohol Use DisorderNCT05827822
Effectiveness of a WeChat-based Alcohol Consumption Intervention Mini-program ("Sober Time ACT") in China
A study testing Sober Time ACT in people with Alcohol Use Disorder and Alcohol Abuse, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
The purpose of this study is to explore whether "Sober Time ACT", a digital intervention tool for alcohol use developed based on wechat mini program, is effective in improving risky alcohol use among Chinese local drinkers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder, Alcohol Abuse
- What is being tested?
- Sober Time ACT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteChina
- Study dates
- 9 Mar 2023to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Above the age of 18
- The total score in line with the AUDIT scale ≧8
- Provide at least one backup contact information
- Non-illiterate, able to use smart phones without barriers
- Wechat version support small program function (6.5.3 and above)
- Understand the nature of this study and sign the informed consent
Who cannot join
- Other interventions and treatments to reduce alcohol use were given during the trial
- Severe primary or secondary cognitive dysfunction, unable to complete the screening scale and baseline questionnaire
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200000
Jiang Du, 021-64906315, dujiangdou@163.com
About this study
Official title: Effectiveness of a WeChat-based Alcohol Consumption Intervention Mini-program ("Sober Time ACT") Among Hazardous and Problematic Drinkers in China
The purpose of this study is to explore whether "Sober Time ACT", a digital intervention tool for alcohol use developed based on wechat mini program, is effective in improving risky alcohol use among Chinese local drinkers.
- Conditions
- Alcohol Use Disorder, Alcohol Abuse
- Being tested
- Sober Time ACT
- Keywords
- hazardous drinking, alcohol use disorders, AUDs, WeChat-based digital intervention, randomized controlled trial, mixed methods approach
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sober Time ACTDevice
Mental health assessment (regular assessment and reporting feedback), daily clock-in (reporting alcohol use and providing encouragement and reinforcement), mental knowledge base (Tips for the Day based on cognitive behavioral techniques, popular alcohol withdrawal courses, alcohol health education manuals) and self-assistance tools (mindfulness meditation training and emergency help buttons)
| Study group | Role | What they receive |
|---|---|---|
| Punch-in Intervention Group | Experimental | 4 weeks of alcohol-related daily tracking + brief assessment and intervention Receives: Device: Sober Time ACT |
| Control Group | No intervention | waiting list group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average number of risky drinking days per month
standard drinks
Measured: one month
Secondary outcomes (9)
Average weekly alcohol consumption
standard drinks
Measured: one month
craving level
Pennsylvania Alcohol Craving Scale (PACS) is a single factor, multidimensional scale, Chinese version of the reliability and validity has been verified. The five items assessed frequency, intensity, duration, ability to cope with drinking and average craving on a scale of 0 to 6 points, with higher scores indicating higher craving levels.
Measured: two weeks
Alcohol, Smoking, and Substance Use Involvement Screening Test (ASSIST) score
ASSIST(alcohol) was developed by the World Health Organization, based on existing screening tools, to assess risk levels for psychoactive substance use, the Chinese version has been validated for reliability and validity. There are 7 entries in the ASSIST alcohol section, and question 1 does not count towards the total score; Questions 2-5 0= never, 2= once or twice, 3= once a month, 4= once a week, 6= almost every day; Questions 6- 7,0 = never, 3= Yes but three months ago, 6= Yes in the past three months. Scores for questions 2-7 were added together to obtain an overall score for alcohol use, with 0-10 being low risk, 11-26 moderate risk, and 27+ high risk, with tertiary risk corresponding to no treatment, brief intervention, and referral to a specialist for evaluation and treatment.
Measured: three months
willingness and confidence to abstain
The 4-item Assessment Scale of awareness, readiness and confidence in the importance of behavioral change in psychoactive substance use in the Intervention manual is scored from 0 to 10. The higher the score, the higher the degree.
Measured: one month
stages of motivation for abstinence change
Developed by Dong Wang (2013) based on Prochaska and DiClemente's cross-theoretical model of behavioral change, It includes three dimensions: the precontemplation stage (P), the contemplation stage (C) and the action stage (A). There are 4 questions in each dimension. 1-5 points are scored. 1= strongly disagree, 2= disagree, 3= not sure, 4= agree, 5= strongly agree.
Measured: one month
Depression, PHQ-9
Kroenke and Spitzer (2002) revised depression screening Scale Patient Health Questionnaire, PHQ-9 based on DSM-IV diagnostic criteria, and the reliability and validity of the Chinese version have been verified (Xiaoyan Sun, Yixue Li, Canqing Yu, Liming Li, 2017). There are 9 entries, 0 to 3 on a four-point scale, 0= never at all, 1= days, 2= less than half of days, 3= almost every day. Total score 0-4 for clinically insignificant depression, 5-9 for mild depression, 10-14 for moderate depression, and 15+ for major depression.
Measured: one month
Anxiety, GAD-7
Generalized Anxiety Disorder, GAD-7's reliability and validity of the Chinese version of the module used to screen for generalized anxiety disorder in the Patient Health Questionnaire (PHQ) developed by Spitzer et al. (2006) (Wang Yu, Chen Ran, Zhang LAN, 2018). There are 7 entries, 0 to 3 on a four-point scale, 0= never at all, 1= days, 2= less than half of days, 3= almost every day. Total score 0-4 for clinically insignificant anxiety, 5-9 for mild anxiety, 10-14 for moderate anxiety, and 15+ for severe anxiety.
Measured: one month
Sleep status, ISI
Insomnia Severity Index, ISI was compiled by Morin et al. (2001), the Chinese version of ISI-C has been tested to have good reliability and validity, and is suitable for the evaluation of insomnia in clinical patients in China (Bai Chunjie et al., 2018), with a total of 7 items, scoring 0-4 and 5 points. Total scores were 0-7 for nonclinically significant insomnia, 8-14 for subclinical insomnia, 15-21 for moderate clinical insomnia, and 22-28 for severe clinical insomnia.
Measured: one month
Stress perception, PSS-10
Perceived Stress Scale, PSS-10 is the most widely used self-assessment tool for stress feeling has high reliability and validity for the version of 10 items, 0-4 points score, 0= never, 1= rarely, 2= sometimes, 3= more, 4= very common, questions 4, 5, 7, 8 score in reverse, the higher the score indicates the higher the level of perceived stress.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start9 Mar 2023
- Primary completionOct 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05827822
- Sponsor's protocol ID
- JDu-011
- Status last verified
- Mar 2023
- First submitted
- 26 Mar 2023
- Last updated
- 7 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wu C, Yang P, Tang Y, Chen T, Li S, Huang S, Du J. Effectiveness of the WeChat-based mini-program ("Sober Time ACT") on individuals with hazardous drinking in China: a randomized controlled trial. BMC Med. 2025 Jul 1;23(1):385. doi: 10.1186/s12916-025-04217-5.
PubMed 40598563
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a WeChat-based Alcohol Consumption Intervention Mini-program ("Sober Time ACT") Among Hazardous and Problematic Drinkers in China
- ClinicalTrials.gov ID
- NCT05827822
- Acronym / sponsor ID
- JDu-011
- Conditions
- Alcohol Use Disorder, Alcohol Abuse
- Keywords
- hazardous drinking, alcohol use disorders, AUDs, WeChat-based digital intervention, randomized controlled trial, mixed methods approach
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to explore whether "Sober Time ACT", a digital intervention tool for alcohol use developed based on wechat mini program, is effective in improving risky alcohol use among Chinese local drinkers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Punch-in Intervention Group | Experimental | Device: Sober Time ACT4 weeks of alcohol-related daily tracking + brief assessment and intervention |
| Control Group | No intervention | –waiting list group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Above the age of 18
- The total score in line with the AUDIT scale ≧8
- Provide at least one backup contact information
- Non-illiterate, able to use smart phones without barriers
- Wechat version support small program function (6.5.3 and above)
Key exclusion criteria (2 listed)
- Other interventions and treatments to reduce alcohol use were given during the trial
- Severe primary or secondary cognitive dysfunction, unable to complete the screening scale and baseline questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sober Time ACTMental health assessment (regular assessment and reporting feedback), daily clock-in (reporting alcohol use and providing encouragement and reinforcement), mental knowledge base (Tips for the Day based on cognitive behavioral techniques, popular alcohol withdrawal courses, alcohol health education manuals) and self-assistance tools (mindfulness meditation training and emergency help buttons) | Device | Punch-in Intervention Group |
Primary outcome
Average number of risky drinking days per month
Time frame: one month
standard drinks
9 secondary outcomes
Average weekly alcohol consumption
Time frame: one month
craving level
Time frame: two weeks
Alcohol, Smoking, and Substance Use Involvement Screening Test (ASSIST) score
Time frame: three months
willingness and confidence to abstain
Time frame: one month
stages of motivation for abstinence change
Time frame: one month
Depression, PHQ-9
Time frame: one month
Anxiety, GAD-7
Time frame: one month
Sleep status, ISI
Time frame: one month
Stress perception, PSS-10
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Derived from this study: PubMed 40598563Wu C, Yang P, Tang Y, Chen T, Li S, Huang S, Du J. Effectiveness of the WeChat-based mini-program ("Sober Time ACT") on individuals with hazardous drinking in China: a randomized controlled trial. BMC Med. 2025 Jul 1;23(1):385. doi: 10.1186/s12916-025-04217-5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sober Time ACT in people with Alcohol Use Disorder and Alcohol Abuse, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiang Du (021-64906315, dujiangdou@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average number of risky drinking days per month (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05827822, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2023.