Table 1 Primary and Secondary Outcome Measures and Data Collection
Variable | Description | Frequency of Assessment |
|---|---|---|
Primary Outcome Measures | ||
 Major Depressive Disorder (MDD) | MINI v. 5.0 MDD module [70] | Prior to enrollment (inclusion criteria), 1.5, 3, 6, 9, 12, 18, 24 and 30 months |
 Posttraumatic Stress Disorder (PTSD) | MINI v. 5.0 PTSD module | Prior to enrollment (inclusion criteria), 1.5, 3, 6, 9, 12, 18, 24 and 30 months |
Secondary Outcome Measures | ||
 Suicidality, mania/hypomania (exclusion-referral) | MINI v. 5.0, suicidality, (hypo) mania modules [70] | Prior to enrollment (exclusion criteria) |
 Detailed alcohol use (exclusion-referral) | Alcohol Use Disorders Identification Test (AUDIT) [71] | Prior to enrollment (exclusion criteria) |
 Pregnancy and breast-feeding (exclusion-referral) | Self-report | Prior to enrollment (exclusion criteria) |
 Drug use (exclusion-referral) | Drug Abuse Screening Test (DAST-10) [72] | Prior to enrollment (exclusion criteria) |
 Demographics | Age, gender, marital status | Baseline |
 Highest education | (1) None; (2) primary; (3) secondary; (4) tertiary and beyond | Baseline |
 Time and cost of transport to KCH | Minutes and KSH for transport between residence and KCH | Baseline |
 Trauma history | Trauma History Screen (THS) [73] | Baseline |
 Depression symptoms | Beck Depression Scale (BDI) [74] | Baseline, 1.5, 3, 6, 9, 12, 18, 24 and 30 months |
 PTSD symptoms | Posttraumatic Stress Checklist (PCL) [75] | Baseline, 1.5, 3, 6, 9, 12, 18, 24 and 30 months |
 Emotional Reactivity | Self-Assessment Manikin (SAM) [76] | Baseline, 1.5, 3, 6, 9, 12, 18, 24 and 30 months |
 Domestic violence | Revised conflict tactics scale (CTS2) [77] | Baseline, 1.5, 3, 6, 9, 12, 18, 24 and 30 months |
 Social Support | Multi-dimensional Scale of Perceived Social Support [78] | Baseline, 1.5, 3, 6, 9, 12, 18, 24 and 30 months |
 Individual and household income | Assessment of individual and household formal and informal income in the last 30 days | Baseline, 1.5, 3, 6, 9, 12, 18, 24 and 30 months |
 Health co-morbidities | HIV, Malaria, HTN, DM | Baseline, 1.5, 3, 6, 9, 12, 18, 24 and 30 months |
 Health-related disability | World Health Organization Disability Assessment Schedule (WHODAS) [79] | Baseline, 1.5, 3, 6, 9, 12, 18, 24 and 30 months |
 Mood symptoms | PHQ-2 | Every IPT and Fluoxetine treatment visit |
 Risk assessment | Suicidality and homicidality | As needed and if PHQ-2 increases |
 Adverse events | Any untoward medical occurrence that does not necessarily have a causal relationship with the study intervention | As needed |