- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05827822
Effectiveness of a WeChat-based Alcohol Consumption Intervention Mini-program ("Sober Time ACT") in China
August 3, 2023 updated by: Shanghai Mental Health Center
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
198
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jiang Du
- Phone Number: 021-64906315
- Email: dujiangdou@163.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200000
- Recruiting
- Shanghai Mental Health Center
-
Contact:
- Jiang Du
- Phone Number: 021-64906315
- Email: dujiangdou@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Punch-in Intervention Group
4 weeks of alcohol-related daily tracking + brief assessment and intervention
|
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)
|
No Intervention: Control Group
waiting list group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average number of risky drinking days per month
Time Frame: one month
|
standard drinks
|
one month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average weekly alcohol consumption
Time Frame: one month
|
standard drinks
|
one month
|
craving level
Time Frame: two weeks
|
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.
|
two weeks
|
Alcohol, Smoking, and Substance Use Involvement Screening Test (ASSIST) score
Time Frame: three months
|
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.
|
three months
|
willingness and confidence to abstain
Time Frame: one month
|
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.
|
one month
|
stages of motivation for abstinence change
Time Frame: one month
|
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.
|
one month
|
Depression, PHQ-9
Time Frame: one month
|
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.
|
one month
|
Anxiety, GAD-7
Time Frame: one month
|
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.
|
one month
|
Sleep status, ISI
Time Frame: one month
|
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.
|
one month
|
Stress perception, PSS-10
Time Frame: one month
|
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.
|
one month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 9, 2023
Primary Completion (Estimated)
October 1, 2023
Study Completion (Estimated)
December 1, 2023
Study Registration Dates
First Submitted
March 26, 2023
First Submitted That Met QC Criteria
April 12, 2023
First Posted (Actual)
April 25, 2023
Study Record Updates
Last Update Posted (Actual)
August 7, 2023
Last Update Submitted That Met QC Criteria
August 3, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- JDu-011
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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