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 |
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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 |
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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 |
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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 |
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Notes |
Study funding and conflicts of interest: National Institute of Health and Fogarty International Center Linked study records: Vlasova 2005 |
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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 |