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

Primary Purpose

Alcohol Use Disorder, Alcohol Abuse

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Sober Time ACT
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Alcohol Use Disorder focused on measuring hazardous drinking, alcohol use disorders, AUDs, WeChat-based digital intervention, randomized controlled trial, mixed methods approach

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shanghai Mental Health CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Punch-in Intervention Group

Control Group

Arm Description

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

waiting list group

Outcomes

Primary Outcome Measures

Average number of risky drinking days per month
standard drinks

Secondary Outcome Measures

Average weekly alcohol consumption
standard drinks
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
March 26, 2023
Last Updated
August 3, 2023
Sponsor
Shanghai Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT05827822
Brief Title
Effectiveness of a WeChat-based Alcohol Consumption Intervention Mini-program ("Sober Time ACT") in China
Official Title
Effectiveness of a WeChat-based Alcohol Consumption Intervention Mini-program ("Sober Time ACT") Among Hazardous and Problematic Drinkers in China
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2023 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Mental Health Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder, Alcohol Abuse
Keywords
hazardous drinking, alcohol use disorders, AUDs, WeChat-based digital intervention, randomized controlled trial, mixed methods approach

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
198 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Punch-in Intervention Group
Arm Type
Experimental
Arm Description
4 weeks of alcohol-related daily tracking + brief assessment and intervention
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
waiting list group
Intervention Type
Device
Intervention Name(s)
Sober Time ACT
Intervention Description
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)
Primary Outcome Measure Information:
Title
Average number of risky drinking days per month
Description
standard drinks
Time Frame
one month
Secondary Outcome Measure Information:
Title
Average weekly alcohol consumption
Description
standard drinks
Time Frame
one month
Title
craving level
Description
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.
Time Frame
two weeks
Title
Alcohol, Smoking, and Substance Use Involvement Screening Test (ASSIST) score
Description
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.
Time Frame
three months
Title
willingness and confidence to abstain
Description
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.
Time Frame
one month
Title
stages of motivation for abstinence change
Description
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.
Time Frame
one month
Title
Depression, PHQ-9
Description
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.
Time Frame
one month
Title
Anxiety, GAD-7
Description
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.
Time Frame
one month
Title
Sleep status, ISI
Description
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.
Time Frame
one month
Title
Stress perception, PSS-10
Description
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.
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiang Du
Phone
021-64906315
Email
dujiangdou@163.com
Facility Information:
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiang Du
Phone
021-64906315
Email
dujiangdou@163.com

12. IPD Sharing Statement

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

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