NCT05827822

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
198

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 9, 2023

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

August 7, 2023

Status Verified

March 1, 2023

Enrollment Period

7 months

First QC Date

March 26, 2023

Last Update Submit

August 3, 2023

Conditions

Keywords

hazardous drinkingalcohol use disorders, AUDsWeChat-based digital interventionrandomized controlled trialmixed methods approach

Outcome Measures

Primary Outcomes (1)

  • Average number of risky drinking days per month

    standard drinks

    one month

Secondary Outcomes (9)

  • Average weekly alcohol consumption

    one month

  • craving level

    two weeks

  • Alcohol, Smoking, and Substance Use Involvement Screening Test (ASSIST) score

    three months

  • willingness and confidence to abstain

    one month

  • stages of motivation for abstinence change

    one month

  • +4 more secondary outcomes

Study Arms (2)

Punch-in Intervention Group

EXPERIMENTAL

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

Device: Sober Time ACT

Control Group

NO INTERVENTION

waiting list group

Interventions

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)

Punch-in Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2023

First Posted

April 25, 2023

Study Start

March 9, 2023

Primary Completion

October 1, 2023

Study Completion

December 1, 2023

Last Updated

August 7, 2023

Record last verified: 2023-03

Locations