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

Sheikh 2017.

Study characteristics
Methods Study design: Randomized controlled trial
Country: Zambia
Setting: Hospital
Eligibility criteria: Included were individuals who met DSM‐IV‐TR criteria for alcohol dependence and were admitted to a hospital with primary alcohol problems
Duration of follow‐up: 8‐weeks
Informed consent: All participants provided consent
Ethical approvals: Biomedical Research Ethics Committee of the University of Zambia
Participants Sample size: 114 (58 intervention, 56 control)
Description of the target population: Patients seeking treatment for alcohol problems at a hospital
Age: Mean=32 years, Range=18‐65 years
Sex: 3.5% female
Race/Ethnicity: Not reported
Marital status: 30% married
Harmful alcohol use (baseline): All scored >15 on the AUDIT
Co‐occurring disorders: Not reported
Interventions Type: Non‐pharmacologic
Description: Family‐based brief relapse prevention intervention from mhGAP with involvement from a close family member following detoxification with diazepam and vitamin supplementation. The brief relapse prevention intervention included discussion of alcohol‐related problems, attitudes toward alcohol and the problems it has caused, actively educating and involving the family, and self‐help groups.
Duration and frequency: One 20‐minute interview with the patient and family member
Delivery and provider: Psychosocial counselor
Comparison group: Detoxification only with diazepam and vitamin supplementation
Outcomes Primary outcome(s): Hazardous alcohol use
Primary outcome measurement tool(s): AUDIT‐C and questions about drinking habits
Secondary outcome(s): Time to first drink
Secondary outcome measurement tool(s): AUDIT‐C and questions about drinking habits
Time points: 0‐, 8‐weeks
Notes Study funding and conflicts of interest: Not reported
Linked study records: None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Randomization and statistical analyses were performed using sealed envelopes containing patient assignment devised from the randomization facility of the statistics program, Statistical Package for the Social Sciences (SPSS), version 20." Pg. 114
Allocation concealment (selection bias) Low risk "sealed envelopes containing patient assignment" Pg. 114
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 Low risk "All 114 consecutive admissions with primary alcohol problems agreed to take part, and follow‐up information was obtained for all participants at 8 weeks (refusal rate 0%; follow‐up rate 100%)." Pg. 115
Selective reporting (reporting bias) Unclear risk Protocol not available