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. 2023 May 9;2023(5):CD013350. doi: 10.1002/14651858.CD013350.pub2

Vlasova 2011.

Study characteristics
Methods Study design: Randomized controlled trial
Country: Ukraine
Setting: Alcohol and drug treatment center
Eligibility criteria: Included were new admissions 19 years and above to the treatment center with a primary diagnosis of alcohol dependence and willing to participate in 4 months of an outpatient treatment program following completion of 30+ days of inpatient treatment. Excluded were people with severe psychiatric disorder or organic brain syndrome preventing their ability to provide informed consent
Duration of follow‐up: 4 months
Informed consent: All participants provided written informed consent
Ethical approvals: University of Alabama Birmingham Instutional Review Board, Vinnitsya National Medical University‐Pirogov Ethics Board
Participants Sample size: 68 (34 intervention, 34 control)
Description of the target population: Patients admitted to inpatient treatment for alcohol use disorder
Age: 37.2 years (SD=11.8)
Sex: 14.7% female
Race/Ethnicity: Not reported
Marital status: Not reported
Harmful alcohol use (baseline): 100% reported past 30‐day alcohol use and met criteria for alcohol dependence
Co‐occurring disorders: Not reported
Interventions Type: Non‐pharmacologic
Description: Inpatient treatment followed by intensive outpatient treatment including individual sessions, 12‐step facilitation, weekly aftercare, and sponsors group
Duration and frequency: 30+ day inpatient medical treatment, 2 months of 12‐step oriented day treatment (8 hours per day), 1 month of aftercare (2 hours per week), and 1 month of sponsors group (2 hours per week)
Delivery and provider: Physicians, social workers, psychologists, nurses
Comparison group: Usual care (inpatient treatment) involving medical detoxification, acute medical care, primary medical care, and some counseling and social services for 30 days provided by physicians, social workers, psychologists, and nurses
Outcomes Primary outcome(s): Alcohol consumption (days)
Primary outcome measurement tool(s): Form 90
Secondary outcome(s): Drinks per day, Heavy drinking days, Alcohol‐related consequences, Mental health, Depression
Secondary outcome measurement tool(s): Form 90, Drinker Inventory of Consequences, Short Form‐36 Version 2 Health Survey, Beck Depression Inventory II
Time points: 2, 4 months
Notes Study funding and conflicts of interest: National Institute of Health and Fogarty International Center
Linked study records: Vlasova 2005
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "Participants were recruited from interested alcohol‐dependent patients admitted to the RND early in treatment. They were assessed and randomly assigned to 1 of the 2 intervention groups." Pg. 8
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
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Not described
Selective reporting (reporting bias) Unclear risk Protocol not available