Skip to main content
. 2023 May 9;2023(5):CD013350. doi: 10.1002/14651858.CD013350.pub2

Signor 2013.

Study characteristics
Methods Study design: Randomized controlled trial
Country: Brazil
Setting: Telephone‐based intervention
Eligibility criteria: Included were self‐reported alcohol users from Brazil who had consumed alcohol in the past month and who were seeking help for alcohol use problems through a hotline or a health provider. Excluded were individuals who were unable to answer interview questions due to cognitive difficulties or the effects of alcohol/drugs and those who could not be contacted for a follow‐up interview.
Duration of follow‐up: 6‐months
Informed consent: Not reported
Ethical approvals: Universidade Federal de Ciencias de Saude de Porto Alegre (UFCSPA) Ethics Committee
Participants Sample size: 637 (293 intervention, 344 control)
Description of the target population: Help‐seeking individuals in general population
Age: 27 years (Range 21‐37)
Sex: 29% female
Race/Ethnicity: Not reported
Marital status: 30% married or cohabitating
Harmful alcohol use (baseline): 84% met criteria for dependence
Co‐occurring disorders: Not reported
Interventions Type: Non‐pharmacologic
Description: Brief motivational intervention including self‐help material sent by mail, a 20‐minute brief motivational interview session by phone along with a 10‐minute assessment, and 7 follow‐up calls over a 6‐month period
Duration and frequency: One 30‐minute session and 7 follow‐up calls at 1 day, 3 days, 7 days, 1 month, 2 months, 3 months and 6 months
Delivery and provider: Trained university students from health programs
Comparison group: Necessary advice provided by phone from trained university students from health programs and self‐help material sent by mail
Outcomes Primary outcome(s): Abstinence
Primary outcome measurement tool(s): Not reported
Secondary outcome(s): Not reported
Secondary outcome measurement tool(s): N/A
Time points: 6‐months
Notes Study funding and conflicts of interest: Brazilian National Secretariat on Drug Policies (Secretaria Nacional Antidrogas, SENAD), Associacao Mario Tannhauser de Ensino Pesquisa e Assistencia (AMTEPA), Conselho Nacional de Desenvolvimento Cientifico e Tecnologico (CNPq), Coordenacao de Aperfeicoamento de Pessoal d Nivel Superior
Linked study records: None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Group allocation was performed using a Microsoft H software application that applied a random number technique." Pg. 255
Allocation concealment (selection bias) Unclear risk Not described
Blinding of participants and personnel (performance bias)
All outcomes High risk Participants and personnel cannot be blinded for this type of intervention
Blinding of outcome assessment (detection bias)
All outcomes High risk Outcomes reported by participant not blind to intervention
"Counselors were blinded to the collection of follow‐up data by a random assignment that used scripts to guide the telephone interviews." Pg. 256
Incomplete outcome data (attrition bias)
All outcomes High risk "Based on continuous abstinence time and the ITT principle, in which dropouts are considered people who relapse, a Cox proportional hazards model detected a significant difference between the BMI and control groups" Pg. 256
"The study attrition rate was 76.9% (490 participants dropped out)." Pg. 256
Selective reporting (reporting bias) Unclear risk Protocol not available