Jirapramukpitak 2020.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Country: Thailand Setting: community/home visits Eligibility criteria: adults with alcohol dependence who have not engaged in alcohol treatment in the past 3 months Duration of follow‐up: 16 weeks Informed consent: all participants provided informed consent Ethical approval: study procedures were approved by the ethics committee of Thammasat University |
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Participants |
Sample size: 161 (80 intervention, 81 control) Description of the target population: People with alcohol dependence in the community Age: 50.1 years (SD = 11.5) Sex: 75.2% male Race/Ethnicity: not reported Marital status: 59.6% married Harmful alcohol use (baseline): 41% had a positive breathalyzer sample Co‐occurring disorders: 3.7% had a comorbid psychiatric illness |
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Interventions |
Type: non‐pharmacologic Description: home visits with contingency management (2 doses: high value prizes, low value prizes) Duration and frequency: 40 home visits (10‐15 minutes each) over 12 weeks Delivery and provider: Village health volunteers Comparison group: 40 home visits focused on giving advice on alcohol use |
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Outcomes |
Primary outcome(s): abstinence Primary outcome measurement tool(s): breathalyzer Secondary outcome(s): current psychological distress Secondary outcome measurement tool(s): Addiction Severity Index Time points: 2, 3, 8, 12, 16 weeks |
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Notes |
Study funding and conflicts of interest: Thai Health Promotion Foundation Linked study records: none |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote "The unit of randomization was the individual participant. Random‐ ization of participants to different arms was carried out at the Coor‐ dinating Centre in the Mental Health Clinic of Thammasat University Hospital using a standard randomization table (Pocock, 1983). Strat‐ ified randomization procedures were followed to randomly assign participants to HV, CM‐L and CM‐H arms in a 2:1:1 ratio. The variables on which groups were stratified included: age (greater than 50), gender and current psychological distress." Pg. 173 |
Allocation concealment (selection bias) | Unclear risk | Quote "In order to keep both the HV and CM groups of similar size, random allocation was done in blocks of 4." Pg. 173 |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not able to mask providers or participants given nature of the intervention |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Low attrition and levels of missing data |
Selective reporting (reporting bias) | Unclear risk | Not reported |