NCT05646212: MEDIUM

Integrating Treatment for Mental Disorders in Methadone Clinics in Ukraine

Active, enrolled NA Last updated 9 January 2026

What this trial tests

NA trial testing Project ECHO in Depression in 1,350 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 July 2018

Primary endpoint
31 January 2022

31 May 2026

Quick facts

Lead sponsor	Ukrainian Institute on Public Health Policy
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	1,350
Start date	1 July 2018
Primary completion	31 January 2022
Estimated completion	31 May 2026
Sites	9 locations across Ukraine

Drugs / interventions tested

• Project ECHO
• Payment for Performance

Conditions studied

• Depression — all drugs for Depression →
• Opioid Use Disorder — all drugs for Opioid Use Disorder →

Sponsor

Ukrainian Institute on Public Health Policy

Who can join

18 and older, any sex, with Depression or Opioid Use Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Design, implementation and preliminary results of a type-2 hybrid cluster-randomized trial of integrating screening and treatment for major depressive disorder into specialty clinics providing opioid agonist therapies in Ukraine.
   Machavariani E, Bromberg DJ, Dumchev K, Dvoriak S, et al · · 2023 · cited 3× · PMID 37263492 · DOI 10.1016/j.cct.2023.107248
2. Prevalence and Correlates of Depression and Bipolar Disorder Among Patients Maintained on Methadone and Buprenorphine in Ukraine.
   Morozova O, Dvoriak V, Dumchev K, Machavariani E, et al · · 2024 · PMID 40823203 · DOI 10.1007/s11469-024-01353-6