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

University of North Carolina (UNC) logo

University of North Carolina (UNC)

Status

Enrolling

Conditions

Depression
Anxiety

Treatments

Behavioral: Champion strategy
Behavioral: Adapted LOCI leadership and climate alignment strategy plus champion strategy

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06399991
R01MH133028 (U.S. NIH Grant/Contract)
23-2722

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,080 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 18 years old or older
  • Patient receiving medical care in participating district who screened positive for elevated common mental disorder symptoms that day or in the preceding month.

Exclusion criteria

  • <18 years old
  • Not currently a patient receiving medical care in participating district who screened positive for elevated common mental disorder symptoms that day or in the preceding month.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,080 participants in 2 patient groups

Adapted LOCI leadership and climate alignment strategy plus champion strategy
Experimental group
Description:
Implementation of LOCI strategy (adapted for the Malawian context) plus the champion strategy (enhanced usual care- usual outpatient care enhanced with use of trained champions).
Treatment:
Behavioral: Adapted LOCI leadership and climate alignment strategy plus champion strategy
Champion strategy
Active Comparator group
Description:
Enhanced usual care. Continue with usual outpatient care, enhanced with use of trained champions.
Treatment:
Behavioral: Champion strategy

Trial contacts and locations

12

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Central trial contact

Brian Pence, PhD, MPH; Kazione Kulisewa, MBBS MMed

Data sourced from clinicaltrials.gov

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