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Life sciences · Interventional Study
ClinicalTrials.gov · September 15, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT05646212). This is a study registration, not published results. Lead sponsor: Ukrainian Institute on Public Health Policy. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 1350 participants (ACTUAL). Conditions: Depression, Opioid Use Disorder. Interventions: OTHER: Project ECHO; OTHER: Payment for Performance. Primary outcome measures: Proportion of patients screened for depression by clinical staff using Patient Health Questionnaire-2 (PHQ-2) , 30 months (August 2019 - February 2022); Proportion of patients assessed by physician using Montgomery-Asberg Depression Rating Scale (MADRS) and motivated for treatment , 30 months (August 2019 - February 2022); Proportion of patients initiated on Selective serotonin reuptake inhibitors (SSRIs) , 30 months (August 2019 - February 2022); Proportion of patients retained on Selective serotonin reuptake inhibitors (SSRIs) , 30 months (August 2019 - February 2022). Brief summary: The MEDIUM study (U01DA045384) is a cluster-randomized trial based in Ukraine. The main goal of the study is to test the implementation strategies for mental health treatment services in OAT clinics. The study enrolled 12 OAT clinics from 12 geographically and epidemiologically diverse regions and randomized them 1:1:1 to three implementation arms: standard of care (SoC), ECHO facilitation, and ECHO plus pay-for-performance (P4P) incentives. Project ECHO, is an evidence-based telehealth intervention, connecting clinicians with national experts for short thematic didactic sessions and case discussions. All sites are provided with a modified Screening, Brief Intervention and Referral to Treatment (mSBIRT) intervention manual for mental disorders and regular supply of two selective serotonin reuptake inhibitors (SSRI) medications. All current and new patients at participating sites (N\~2000 at study start) are automatically eligible for SSRI prescription. The main outcomes of the study are the elements of mental health continuum of care (screening, diagnosis, treatment and retention). These outcomes are assessed in the entire patient population using de-personalized data extracted from the electronic medical record system. A sub-sample of patients (N=1,350) was recruited into a cohort and consented to assess prevalence and severity of mental disorders, various factors related to the uptake of and retention in mental health treatment (addiction severity, other substance use, co-morbidities), as well as other important covariates. These assessments are done at baseline, 6, 12, 18 and 24 months after enrollment.