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NCT04110405

Scaling-Up Stepped Care for Women's Mental Health in Primary Care in an LMIC

Status unknown NA Last updated 27 June 2023
What this trial tests

NA trial testing Stepped Care in Depression in 630 participants. Status unknown.

Timeline
14 August 2020
Primary endpoint
1 April 2023
1 October 2024

Quick facts

Lead sponsorUniversity of Illinois at Chicago
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment630
Start date14 August 2020
Primary completion1 April 2023
Estimated completion1 October 2024
Sites20 locations across Tajikistan

Drugs / interventions tested

Conditions studied

Sponsor

University of Illinois at Chicago

Who can join

Adults 18 to 45, female only, with Depression or Anxiety. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study examines: 1) short-term and longitudinal impacts of stepped care on women with depression and the possible roles of mediators and moderators; 2) clinic- (readiness to adopt an innovation, leadership support and climate) and provider-level (preparedness, motivation and fidelity) factors that may affect stepped care implementation; and 3) the differential impact of two implementation approaches (a clinic implementation teams versus implementation training by the research team). It utilizes Curran's hybrid effectiveness implementation design, mixed methods, and a longitudinal design with assessments at pre, 3 months, 6 months, and 12 months. A total of 18 primary care clinics, set in both rural and urban communities in Tajikistan, will be involved, with 12 delivering the intervention and 6 acting as controls. 8 providers (3 nurses, 3 peers, and 2 doctors) will be recruited at each of the 12 intervention clinics for a total of 96 providers; 35 women with depression will be recruited from each clinic for a total of 630 women.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Primary-level worker interventions for the care of people living with mental disorders and distress in low- and middle-income countries.
    van Ginneken N, Chin WY, Lim YC, Ussif A, et al · · 2021 · cited 89× · PMID 34352116 · DOI 10.1002/14651858.cd009149.pub3

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Other trials of Stepped Care

Trials testing the same drug.

Other recruiting trials for Depression

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Trials by the same sponsor.

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