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

Depression Clinical Trial

— ALIGN  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06399991
• Other study ID #: 23-2722
• Secondary ID: R01MH133028
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2025
• Est. completion date: September 30, 2027

Study information

• Verified date: April 2024
• Source: University of North Carolina, Chapel Hill
• Contact: Brian Pence, PhD, MPH
• Phone: 1-919-966-7446
• Email: bpence[@]unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1080
• Est. completion date: September 30, 2027
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Depression

Intervention

Behavioral:
• Champion strategy
The champion strategy involves identifying champions within each district who are trained and supported as change agents through training and supervision.
• Adapted LOCI leadership and climate alignment strategy plus champion strategy
The LOCI strategy involves engaging with district health leadership through data and feedback, leadership development trainings, coaching, and alignment strategy activities to align leadership and climate in support of implementing the evidence-based mental health package. The champion strategy involves identifying champions within each district who are trained and supported as change agents through training and supervision.

Locations

Country	Name	City	State
Malawi	Chiradzulu District Hospital	Chiradzulu
Malawi	Dedza District Hospital	Dedza
Malawi	Kasungu District Hospital	Kasungu
Malawi	Machinga District Hospital	Machinga
Malawi	Mangochi District Hospital	Mangochi
Malawi	Mchinji District Hospital	Mchinji
Malawi	Mulanje District Hospital	Mulanje
Malawi	Mzimba South District Hospital	Mzimba
Malawi	Nkhata Bay District Hospital	Nkhata Bay
Malawi	Ntcheu District Hospital	Ntcheu
Malawi	Phalombe District Hospital	Phalombe
Malawi	Salima District Hospital	Salima

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of screening-eligible visits at which patients were screened for mental health	Fidelity of mental health screening will be defined as the proportion of visits eligible for anxiety and depression screening that included the screening. Screening-eligible visits are visits where the patient is not currently receiving mental health treatment. Completion of anxiety and depression screening is defined as completing both the GAD-2 and the Patient Health Questionnaire-2 (PHQ-2), and, if one or both are =3, also completing the relevant longer instrument(s) - GAD-7 and PHQ-9. This will be measured utilizing clinical administrative data abstraction.	Over the 12 months of the randomized period
Primary	Proportion of visits at which patients endorsed suicidal ideation at which a suicide risk assessment was completed	Fidelity of safety assessment will be defined as the proportion of patient visits with a PHQ-9 question 9 score >0 that included a documented Suicide Risk Assessment result. This will be measured utilizing clinical administrative data abstraction.	Over the 12 months of the randomized period
Primary	Proportion of patients who were appropriately initiated on mental health treatment	Fidelity of mental health treatment initiation will be defined as the proportion of patients eligible for mental health treatment who actually started either Friendship Bench counseling or medication within 30 days of identification. Eligibility for mental health treatment is defined as having a GAD-7 or PHQ-9 total score of 5 or above. This will be measured utilizing clinical administrative data abstraction.	Over the 12 months of the randomized period
Primary	Proportion of follow-up visits at which clinical decisions followed mental health treatment guidelines	Fidelity of follow-up treatment will be defined as the proportion of follow-up appointments in the first three months of mental health treatment where the clinical treatment decision follows the mental health treatment guidelines. For Friendship Bench (FB) counseling, fidelity is achieved by continuing FB until completion or switching to medication. For medication, if the follow-up GAD-7/PHQ-9 score is <5, fidelity is achieved by continuing treatment; if the follow-up GAD-7/PHQ-9 score is =5, fidelity is achieved by continuing treatment and increasing dose. This will be measured utilizing clinical administrative data abstraction.	Over the 12 months of the randomized period
Primary	Proportion of Counseling sessions meeting Fidelity Threshold	Fidelity of Friendship Bench counseling will be defined as the proportion of Friendship Bench counseling sessions receiving a score of =3 (Satisfactory) on =8 of 10 fidelity checklist items.	Over the 12 months of the randomized period
Secondary	Proportion of patients achieving mental health remission	Mental health remission will be defined as the proportion of patients who achieve depression and anxiety remission at 3 months.; Anxiety severity is determined using the Generalized Anxiety Disorder scale-7 (GAD-7) which is a seven-item diagnostic tool with total scores ranging from 0 to 21 where higher scores indicate greater self-reported anxiety. Anxiety remission is defined as a score <5.; Depressive severity is determined using the Patient Health Questionnaire-9 (PHQ-9) which is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression with scores ranging from 0 to 27 where higher scores indicate greater self-reported depression. Depression remission is defined as a score <5.; Overall remission is defined as both a GAD-7 score <5 and a PHQ-9 score <5, regardless of which score or scores was elevated at baseline.	3 months after participant enrollment
Secondary	Proportion of patients achieving chronic condition control	Chronic condition control will be defined as the proportion of patients whose chronic condition biomarker indicates good control. Patients from the HIV clinic will complete a viral load. Patients from the Non-Communicable Diseases (NCD) clinic will complete a blood pressure measure (hypertension) or HbA1c measure (diabetes). Patients from the Tuberculosis (TB) clinic will complete a sputum smear. Control will be defined for HIV as HIV RNA viral load <1000 c/mL; for hypertension patients as systolic blood pressure <140 mmHg AND diastolic blood pressure <90 mmHg, for diabetes patients as HbA1c < 7.0%; and for TB patients as sputum smear negative.	6 months after participant enrollment