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Active Not Recruiting
NCT05646212
Integrating Treatment for Mental Disorders in Methadone Clinics in Ukraine
Conditions: Depression, Opioid Use Disorder
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 1350
Sponsor: Ukrainian Institute on Public Health Policy
Location: Ukraine
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.
Eligibility Criteria
Inclusion Criteria:All patients receiving OAT at participating sitesExclusion Criteria:Not willing to participateUnable to sign informed consent
Source: ClinicalTrials.gov (NCT05646212). StuddyBuddy aggregates publicly available trial information.