Integrating Treatment for Mental Disorders in Methadone Clinics in Ukraine

NCT05646212 | Active Not Recruiting

• 1 other identifier: R01DA045384
• Study Type: interventional
• Target: 1,350
• Locations: 1 country
• Sites: 9

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.

Conditions

Depression; Opioid Use Disorder

Keywords

depression; opioid use disorder; opioid agonist treatment; Ukraine

Outcome Measures

Primary Outcomes (4)

• Proportion of patients screened for depression by clinical staff using Patient Health Questionnaire-2 (PHQ-2)

  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

  Site-level indicator

  30 months (August 2019 - February 2022)

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

  Site-level indicator

  30 months (August 2019 - February 2022)

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

  Site-level indicator

  30 months (August 2019 - February 2022)

Secondary Outcomes (2)

• Number of participants who continue opioid agonist treatment at the assessment time point

  3, 6, 12, 18 and 24 months after enrollment for each patient

• Psychiatric Quality of Life (SF-12 mental component score) changes over time

  3, 6, 12, 18 and 24 months after enrollment for each patient

Study Arms (3)

Standard of Care

NO INTERVENTION

Standard of care (with SSRI medications provided for free).

SOC+ECHO

EXPERIMENTAL

Standard of care (with SSRI medications provided for free), plus Project ECHO facilitation (an evidence-based tele-education intervention) for physicians

Other: Project ECHO

SOC+ECHO+P4P

EXPERIMENTAL

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; Other: Payment for Performance

Interventions

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.

SOC+ECHO; SOC+ECHO+P4P

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."

SOC+ECHO+P4P

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients receiving OAT at participating sites

You may not qualify if:

• Not willing to participate
• Unable to sign informed consent

Sponsors & Collaborators

• Ukrainian Institute on Public Health Policy: lead
• Yale University: collaborator
• Alliance for the Public's Health: collaborator

Study Sites (9)

Kryvyi Rig psycho-neurological dispensary

Kryvyi Rih, Dnipropetrovsk Oblast, 01001, Ukraine

Location

Dnipropetrovsk narcological dispensary

Pavlohrad, Dnipropetrovsk Oblast, 51405, Ukraine

Location

Kropyvnitsky regional narcological dispensary

Kropyvnytskyi, Kirovohrad Oblast, 25000, Ukraine

Location

Mykolaiv regional narcological dispensary

Mykolayiv, Mykolaiv Oblast, 54052, Ukraine

Location

Ternopil regional narcological dispensary

Ternopil, Ternopil Oblast, 04050, Ukraine

Location

Ivano-Frankivsk regional narcological dispensary

Ivano-Frankivsk, 01001, Ukraine

Location

Kyiv city narcological clinic 'Sociotherapia'

Kyiv, 01054, Ukraine

Location

Mykolaiv City Hospital #5

Mykolayiv, 54051, Ukraine

Location

Vinnitsia regional narcological dispensary 'Sociotherapia'

Vinnytsia, 01001, Ukraine

Location

MeSH Terms

Conditions

Depression; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Sergiy Dvoryak, MD, PhD

  Ukrainian Institute on Public Health Policy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster-randomized trial

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: December 12, 2022
• Study Start: July 1, 2018
• Primary Completion: January 31, 2022
• Study Completion (Estimated): May 31, 2026
• Last Updated: January 9, 2026

Record last verified: 2026-01

Locations

UA (9)