Schaub 2021.
Study characteristics | ||
Methods |
Study design: Randomized controlled trial Country: Belarus, Brazil, India, Mexico Setting: Online Eligibility criteria: Adults (18‐75 years) who reside in one of the participating countries, screen positive for hazardous or harmful alcohol use, and have weekly internet access were included. Individuals were excluded if they reported current use of opioids, inhalants, cocaine/crack, amphetamine/amphetamine‐like stimulants, or sedatives over the past month. Individuals were also excluded if they reported cannabis or synthetic cannabinoid use for more than four days in the past month. Duration of follow‐up: 6 months Informed consent: Online informed consent document was submitted by all participants prior to baseline Ethical approvals: Study procedures were approved by the WHO Ethics Review Committee and four ethics committees in the participating countries. |
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Participants |
Sample size: 1400 (687 intervention, 713 control) Description of the target population: Adults with hazardous alcohol use in Belarus, Brazil, India, and Mexico Age: 37.6 years (SD=10.5) Sex: 70.1% male Race/Ethnicity: Not reported Marital status: Not reported Harmful alcohol use (baseline): Mean AUDIT=23.0 (SD=7.7); Average number of standard drinks in past week=43.7 (SD=41.4) Co‐occurring disorders: Not reported |
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Interventions |
Type: Non‐pharmacologic Description: Web‐based self‐help program that aimed to help people reduce or discontinue their alcohol use. The Alcohol e‐Health program encouraged people to think about their drinking habits, decide whether the change their behaviors and set goals, take action toward their goals and monitor progress, and manage relapses. Duration and frequency: 6 weeks Delivery and provider: Self‐guided Comparison: Referred to a website with information about alcohol use, wait list control |
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Outcomes |
Primary outcome(s): Hazardous alcohol use Primary outcome measurement tool(s): AUDIT Secondary outcome(s): Alcohol consumption, alcohol‐free days, cessation of harmful/hazardous drinking Secondary outcome measurement tool(s): Single question asking about alcohol use each day in the past week; AUDIT Time points: 0, 6 months |
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Notes |
Study funding and conflicts of interest: World Health Organization; Associacao Fundo de Incentivo a Pesquisa, CNPq, CAPES, and the Sao Paulo Research Foundation (FAPESP) Linked study records: Formigoni 2018; Schaub 2018 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "randomized, by a computer, to either the Alcohol e‐Health program or control group, in a 1:1 ratio in each country" |
Allocation concealment (selection bias) | Unclear risk | "This nonblinded assignment was registered automatically in the background database" |
Blinding of participants and personnel (performance bias) All outcomes | High risk | "This nonblinded assignment was registered automatically in the background database" |
Blinding of outcome assessment (detection bias) All outcomes | High risk | "This nonblinded assignment was registered automatically in the background database" |
Incomplete outcome data (attrition bias) All outcomes | High risk | High levels of attrition (>50%) |
Selective reporting (reporting bias) | Low risk | Outcomes are consistent with study protocol |