Effectiveness of a WeChat-based Alcohol Consumption Intervention Mini-program ("Sober Time ACT") in China

Sponsor
Shanghai Mental Health Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05827822
Collaborator
(none)
198
1
2
8.8
22.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Sober Time ACT
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
198 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Single (Investigator)
Primary Purpose:
Supportive Care
Official Title:
Effectiveness of a WeChat-based Alcohol Consumption Intervention Mini-program ("Sober Time ACT") Among Hazardous and Problematic Drinkers in China
Actual Study Start Date :
Mar 9, 2023
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Punch-in Intervention Group

4 weeks of alcohol-related daily tracking + brief assessment and intervention

Device: Sober Time ACT
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

Outcome Measures

Primary Outcome Measures

  1. Average number of risky drinking days per month [one month]

    standard drinks

Secondary Outcome Measures

  1. Average weekly alcohol consumption [one month]

    standard drinks

  2. craving level [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.

  3. Alcohol, Smoking, and Substance Use Involvement Screening Test (ASSIST) score [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.

  4. willingness and confidence to abstain [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.

  5. stages of motivation for abstinence change [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.

  6. Depression, PHQ-9 [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.

  7. Anxiety, GAD-7 [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.

  8. Sleep status, ISI [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.

  9. Stress perception, PSS-10 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shanghai Mental Health Center Shanghai Shanghai China 200000

Sponsors and Collaborators

  • Shanghai Mental Health Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shanghai Mental Health Center
ClinicalTrials.gov Identifier:
NCT05827822
Other Study ID Numbers:
  • JDu-011
First Posted:
Apr 25, 2023
Last Update Posted:
Apr 25, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Shanghai Mental Health Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 25, 2023