Integrating Treatment for Mental Disorders in Methadone Clinics in Ukraine (MEDIUM)

September 12, 2026 updated by: Ukrainian Institute on Public Health Policy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ukraine
    • Dnipropetrovsk Oblast
      • Kryvyi Rih, Dnipropetrovsk Oblast, Ukraine, 01001
        • Kryvyi Rig psycho-neurological dispensary
      • Pavlohrad, Dnipropetrovsk Oblast, Ukraine, 51405
        • Dnipropetrovsk narcological dispensary
    • Ivano-Frankivs'k
      • Ivano-Frankivsk, Ivano-Frankivs'k, Ukraine, 01001
        • Ivano-Frankivsk regional narcological dispensary
    • Kirovohrad Oblast
      • Kropyvnytskyi, Kirovohrad Oblast, Ukraine, 25000
        • Kropyvnitsky regional narcological dispensary
    • Kyiv Oblast
      • Kyiv, Kyiv Oblast, Ukraine, 01054
        • Kyiv city narcological clinic 'Sociotherapia'
    • Mykolaiv Oblast
      • Mykolayiv, Mykolaiv Oblast, Ukraine, 54052
        • Mykolaiv regional narcological dispensary
    • Mykolayiv
      • Mykolayiv, Mykolayiv, Ukraine, 54051
        • Mykolaiv City Hospital #5
    • Ternopil Oblast
      • Ternopil, Ternopil Oblast, Ukraine, 04050
        • Ternopil regional narcological dispensary
    • Vinnytsia Oblast
      • Vinnytsia, Vinnytsia Oblast, Ukraine, 01001
        • Vinnitsia regional narcological dispensary 'Sociotherapia'

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All patients receiving OAT at participating sites

Exclusion Criteria:

  • Not willing to participate
  • Unable to sign informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of Care
Standard of care (with SSRI medications provided for free).
Experimental: SOC+ECHO
Standard of care (with SSRI medications provided for free), plus Project ECHO facilitation (an evidence-based tele-education intervention) for physicians
Other: Project ECHO
Project Extension for Community Healthcare Outcomes® (ECHO): This EBP, tested originally to facilitate HCV care into non-specialty settings, is based on established educational theories of social learning & behavior change in where non-specialists collaborate with specialists, resulting in an innovative healthcare delivery model that results in equivalent quality care for patients in non-specialty settings.
Experimental: SOC+ECHO+P4P
Standard of care (with SSRI medications provided for free), plus Project ECHO facilitation (an evidence-based tele-education intervention) for physicians, plus Payment for Performance intervention
Other: Project ECHO
Project Extension for Community Healthcare Outcomes® (ECHO): This EBP, tested originally to facilitate HCV care into non-specialty settings, is based on established educational theories of social learning & behavior change in where non-specialists collaborate with specialists, resulting in an innovative healthcare delivery model that results in equivalent quality care for patients in non-specialty settings.
Other: Payment for Performance
P4P in healthcare, endorsed by 3 IOM reports, gives financial incentives to clinicians for adhering to clinical guidelines and achieving better health outcomes. One 2007 IOM report recommended "physician incentives so that profitability and improved healthcare delivery is aligned with patient safety goals and strengthen the business case for healthcare quality and safety."

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients screened for depression by clinical staff using Patient Health Questionnaire-2 (PHQ-2)
Time Frame: 30 months (August 2019 - February 2022)
Site-level indicator
30 months (August 2019 - February 2022)
Proportion of patients assessed by physician using Montgomery-Asberg Depression Rating Scale (MADRS) and motivated for treatment
Time Frame: 30 months (August 2019 - February 2022)
Site-level indicator
30 months (August 2019 - February 2022)
Proportion of patients initiated on Selective serotonin reuptake inhibitors (SSRIs)
Time Frame: 30 months (August 2019 - February 2022)
Site-level indicator
30 months (August 2019 - February 2022)
Proportion of patients retained on Selective serotonin reuptake inhibitors (SSRIs)
Time Frame: 30 months (August 2019 - February 2022)
Site-level indicator
30 months (August 2019 - February 2022)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who continue opioid agonist treatment at the assessment time point
Time Frame: 3, 6, 12, 18 and 24 months after enrollment for each patient
Retention on opioid agonist treatment
3, 6, 12, 18 and 24 months after enrollment for each patient
Psychiatric Quality of Life (SF-12 mental component score) changes over time
Time Frame: 3, 6, 12, 18 and 24 months after enrollment for each patient
Change in the mental component score of the Short-Form Health Survey version 2 (SF-12v2) scale (0-100, higher means better health).
3, 6, 12, 18 and 24 months after enrollment for each patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ukrainian Institute on Public Health Policy

Collaborators

Yale University
Alliance for the Public's Health

Investigators

  • Principal Investigator: Sergiy Dvoryak, MD, PhD, Ukrainian Institute on Public Health Policy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2018

Primary Completion (Actual)

May 1, 2026

Study Completion (Actual)

May 31, 2026

Study Registration Dates

First Submitted

April 8, 2022

First Submitted That Met QC Criteria

December 1, 2022

First Posted (Actual)

December 12, 2022

Study Record Updates

Last Update Posted (Actual)

September 15, 2026

Last Update Submitted That Met QC Criteria

September 12, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01DA045384 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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