Jordans 2019.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Country: Nepal Setting: community‐ and facility‐based primary care Eligibility criteria: included were adults with alcohol use disorder. Excluded were individuals that were pregnant, needed urgent medical treatment, were diagnosed with psychosis or epilepsy, or were unable to communicate clearly. Duration of follow‐up: 12‐months Informed consent: all participants provided informed consent Ethical approvals: study procedures were approved by the Nepal Health Research Council (NHRC), the University of Cape Town, and the World Health Organization |
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Participants |
Sample size: 162 (80 Counseling for Alcohol Problems, 82 mhGAP/treatment as usual) Description of the target population: adults with alcohol problems in the community Age: 16‐30: 13.0%; 30‐50: 59.9%, >50: 26.5% Sex: 16.0% female Race/Ethnicity: not reported Marital status: 93.8% married Harmful alcohol use (baseline): AUDIT median between 26‐27 Co‐occurring disorders: PHQ‐9 median between 7.5‐9 |
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Interventions |
Type: non‐pharmacologic Description: counseling for alcohol problems: a motivational interviewing‐based intervention consisting of personal assessment, developing cognitive‐behavioral skills, and relapse prevention/management Duration and frequency: 4 individual sessions delivered weekly Delivery and provider: community‐based counselors Comparison group: treatment as usual (mhGAP), which includes assessment, psychoeducation, pharmacologic management, and referral |
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Outcomes |
Primary outcome(s): Hazardous alcohol use Primary outcome measurement tool(s): AUDIT Secondary outcome(s): disability, low‐risk drinking Secondary outcome measurement tool(s): WHODAS, AUDIT Time points: 3, 12‐months |
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Notes |
Study funding and conflicts of interest: UK Department of International Development, National Institutes of Health Linked study records: ISRCTN Protocol ISRCTN72875710 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "After each participant completed their baseline assessments for the cohort study (without imposing a randomisation constraint), randomisation was done by the research coordinator in Kathmandu (N.P.L.) by using computer‐generated random numbers (in SPSS Version 22 for Windows). A list of numbers (1–400) was randomised so that each number corresponded to either the treatment or control group." Pg. 486 |
Allocation concealment (selection bias) | Low risk | Quote:"The ID code of each new eligible participant was sent to the research coordinator, who then matched it to the next number on the list." Pg. 486 "For those allocated to the treatment condition, the ID code was send to the study field coordinator and clinical supervisor so that they could connect these respondents to research assistant and community counsellors, respectively." Pg. 486 |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote:"participants could not be blinded" Pg. 487 |
Blinding of outcome assessment (detection bias) All outcomes | High risk | "Research assessors were blinded to participants’ assignment to study arms" Pg. 487 Outcomes reported by participant not blind to intervention |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote:"In the AUD trial, participants retained in and lost to follow‐up from the study differed in terms of religion and education." Pg. 488 "All outcome analyses were on an intention‐to‐treat basis with use of multiple imputation for those with missing outcome data. Continuous variables were imputed using Poisson models, whereas binary variables were imputed using logistic regression. Sensitivity analyses were conducted by running the same analyses among all participants with available data, without imputation." Pg. 488 |
Selective reporting (reporting bias) | Low risk | Article reports on primary outcomes from study protocol |