Aligning Facility Leadership and Climate to Advance Mental Health Services Integration in Malawi

Last updated: May 1, 2025
Sponsor: University of North Carolina, Chapel Hill
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression

Treatment

Champion strategy

Adapted LOCI leadership and climate alignment strategy plus champion strategy

Clinical Study ID

NCT06399991
23-2722
R01MH133028
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The main objective of the proposed study is to evaluate the impact of the combined leadership alignment + champion implementation strategy compared to a champion strategy alone, on integration of an evidence-based mental health treatment model into multiple medical care settings.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 years old or older

  • Patient receiving medical care in participating district who screened positive forelevated common mental disorder symptoms that day or in the preceding month.

Exclusion

Exclusion Criteria:

  • <18 years old

  • Not currently a patient receiving medical care in participating district whoscreened positive for elevated common mental disorder symptoms that day or in thepreceding month.

Study Design

Total Participants: 1080
Treatment Group(s): 2
Primary Treatment: Champion strategy
Phase:
Study Start date:
April 08, 2025
Estimated Completion Date:
September 30, 2027

Study Description

Task-shared mental health interventions are effective in low- and middle-income countries (LMICs), yet they remain underutilized, and the mental health treatment gap remains substantial. Innovative implementation strategies are needed to successfully integrate evidence-based mental health treatments into medical care in LMICs.

A common component of many implementation efforts is a "champion" strategy which identifies and empowers an on-the-ground staff member as the implementation champion, in charge of focusing their colleagues' efforts on implementation of the evidence-based treatment model. Yet a growing body of research, including our own work in Malawi and elsewhere, highlights that the champion's success is strongly influenced by the strength of support from their line manager and other up-the-chain organization leaders, who are critical in aligning the organization's climate and priorities in support of the implementation effort.

Approaches to influencing leadership engagement to change organizational climate and align priorities has been developed over decades in the field of organizational and industrial psychology but only relatively recently applied to implementation science health research and primarily to implementation in high-income countries. The Leadership and Organizational Change for Implementation (LOCI) is a recently developed multi-level leadership coaching implementation strategy that has demonstrated effectiveness in changing organizational climate, aligning priorities, and enhancing mental health treatment model integration in the US and Norway, but has not been adapted to or tested in low-income country settings. LOCI has significant potential to address the gaps identified in our current research by aligning leadership priorities to support champions in advancing mental health integration.

The overall aim of the proposed study is to evaluate the impact of the combined leadership alignment + champion implementation strategy compared to a champion strategy alone, on integration of an evidence-based mental health treatment model into multiple medical care settings via a cluster-randomized randomized control trial(RCT).

Leadership alignment strategies are an understudied but essential ingredient for successful mental health integration efforts. This project will make a major contribution to our understanding of the role of leadership alignment in advancing evidence-based mental health integration in LMICs.

Connect with a study center

  • Chiradzulu District Hospital

    Chiradzulu,
    Malawi

    Active - Recruiting

  • Dedza District Hospital

    Dedza,
    Malawi

    Active - Recruiting

  • Kasungu District Hospital

    Kasungu,
    Malawi

    Active - Recruiting

  • Machinga District Hospital

    Machinga,
    Malawi

    Active - Recruiting

  • Mangochi District Hospital

    Mangochi,
    Malawi

    Active - Recruiting

  • Mchinji District Hospital

    Mchinji,
    Malawi

    Active - Recruiting

  • Mulanje District Hospital

    Mulanje,
    Malawi

    Active - Recruiting

  • Mzimba South District Hospital

    Mzimba,
    Malawi

    Active - Recruiting

  • Nkhata Bay District Hospital

    Nkhata Bay,
    Malawi

    Active - Recruiting

  • Ntcheu District Hospital

    Ntcheu,
    Malawi

    Active - Recruiting

  • Phalombe District Hospital

    Phalombe,
    Malawi

    Active - Recruiting

  • Salima District Hospital

    Salima,
    Malawi

    Active - Recruiting

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