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Active, Not Recruiting

NCT Number: NCT05646212

Integrating Treatment for Mental Disorders in Methadone Clinics in Ukraine

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kryvyi Rig psycho-neurological dispensary, Kryvyi Rih, Dnipropetrovsk Oblast, Ukraine

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients receiving OAT at participating sites

Exclusion criteria

  • Not willing to participate
  • Unable to sign informed consent

Treatment and study plan

Project ECHO

Other

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.

Payment for Performance

Other

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."

Primary outcomes

  1. 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

  2. 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

  3. Proportion of patients initiated on Selective serotonin reuptake inhibitors (SSRIs)

    Time frame: 30 months (August 2019 - February 2022)

    Site-level indicator

  4. Proportion of patients retained on Selective serotonin reuptake inhibitors (SSRIs)

    Time frame: 30 months (August 2019 - February 2022)

    Site-level indicator

Secondary outcomes

  1. 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

  2. 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).

Sponsors and collaborators

Lead sponsor

Ukrainian Institute on Public Health Policy

Other

Collaborators

  • Alliance for the Public's Health
  • Yale University

Registry information

Acronym: MEDIUM

Important dates

Study start
2018
Primary completion
2022
Study completion
2026
First posted
Dec 12, 2022
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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