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NCT06399991 | NOT YET RECRUITING | Anxiety


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

University of North Carolina, Chapel Hill

Brief 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.

Condition or disease

Anxiety

Depression

Intervention/treatment

Champion strategy

Adapted LOCI leadership and climate alignment strategy plus champion strategy

Phase

NA

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 1080 participants
Masking : NONE
Primary Purpose : HEALTH_SERVICES_RESEARCH
Official Title : Aligning Facility Leadership and Climate to Advance Mental Health Services Integration in Malawi (ALIGN)
Actual Study Start Date : 2025-04-01
Estimated Primary Completion Date : 2026-05-31
Estimated Study Completion Date : 2027-09-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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.

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

Location Details

NCT06399991


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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

Malawi,

Chiradzulu District Hospital

It's raining, Malawi,

Not yet recruiting

Malawi,

Dedza District Hospital

Red, Malawi,

Not yet recruiting

Malawi,

Kasungu District Hospital

Canker sores, Malawi,

Not yet recruiting

Malawi,

Machinga District Hospital

Chingya, Malawi,

Not yet recruiting

Malawi,

Mangochi District Hospital

Mangochi, Malawi,

Not yet recruiting

Malawi,

Mchinji District Hospital

Mchini, Malawi,

Not yet recruiting

Malawi,

Mulanje District Hospital

Orange, Malawi,

Not yet recruiting

Malawi,

Mzimba South District Hospital

The body, Malawi,

Not yet recruiting

Malawi,

Nkhata Bay District Hospital

Nkhata Bay, Malawi,

Not yet recruiting

Malawi,

Ntcheu District Hospital

Attention, Malawi,

Not yet recruiting

Malawi,

Phalombe District Hospital

The emperor, Malawi,

Not yet recruiting

Malawi,

Salima District Hospital

Salima, Malawi,

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