Clinical trial NCT05646212: Integrating Treatment for Mental Disorders in Methadone Clinics in Ukraine
Official title: Integrating Treatment for Mental Disorders in Methadone Clinics in Ukraine
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depression
Opioid Use Disorder
Keywords: depression
opioid use disorder
opioid agonist treatment
Ukraine
Lead sponsor: Ukrainian Institute on Public Health Policy
Sponsor class: OTHER
Collaborators: name: Yale University
name: Alliance for the Public's Health
First posted: 2022-12-12
Enrollment: 1350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster-randomized trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: Inclusion Criteria:

* All patients receiving OAT at participating sites

Exclusion Criteria:

* Not willing to participate
* Unable to sign informed consent

Primary outcomes:
measure: Proportion of patients screened for depression by clinical staff using Patient Health Questionnaire-2 (PHQ-2)
timeFrame: 30 months (August 2019 - February 2022)
measure: Proportion of patients assessed by physician using Montgomery-Asberg Depression Rating Scale (MADRS) and motivated for treatment
timeFrame: 30 months (August 2019 - February 2022)
measure: Proportion of patients initiated on Selective serotonin reuptake inhibitors (SSRIs)
timeFrame: 30 months (August 2019 - February 2022)
measure: Proportion of patients retained on Selective serotonin reuptake inhibitors (SSRIs)
timeFrame: 30 months (August 2019 - February 2022)
Secondary outcomes:
measure: Number of participants who continue opioid agonist treatment at the assessment time point
timeFrame: 3, 6, 12, 18 and 24 months after enrollment for each patient
measure: Psychiatric Quality of Life (SF-12 mental component score) changes over time
timeFrame: 3, 6, 12, 18 and 24 months after enrollment for each patient
Other outcomes:
Locations:
city: Kryvyi Rih
country: Ukraine
facility: Kryvyi Rig psycho-neurological dispensary
state: Dnipropetrovsk
city: Pavlograd
country: Ukraine
facility: Dnipropetrovsk narcological dispensary
state: Dnipropetrovsk
city: Kropyvnytskyi
country: Ukraine
facility: Kropyvnitsky regional narcological dispensary
state: Kirovohrad
city: Mykolayiv
country: Ukraine
facility: Mykolaiv regional narcological dispensary
state: Mykolaiv
city: Ternopil'
country: Ukraine
facility: Ternopil regional narcological dispensary
state: Ternopil
city: Ivano-Frankivs'k
country: Ukraine
facility: Ivano-Frankivsk regional narcological dispensary
city: Kyiv
country: Ukraine
facility: Kyiv city narcological clinic 'Sociotherapia'
city: Mykolayiv
country: Ukraine
facility: Mykolaiv City Hospital #5
city: Vinnytsia
country: Ukraine
facility: Vinnitsia regional narcological dispensary 'Sociotherapia'
Study officials:
affiliation: Ukrainian Institute on Public Health Policy
name: Sergiy Dvoryak, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: