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

May 1, 2025 updated by: University of North Carolina, Chapel Hill

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

1080

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Brian Pence, PhD, MPH
  • Phone Number: 1-919-966-7446
  • Email: bpence@unc.edu

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adapted LOCI leadership and climate alignment strategy plus champion strategy
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).
Behavioral: 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.
Active Comparator: Champion strategy
Enhanced usual care. Continue with usual outpatient care, enhanced with use of trained champions.
Behavioral: Champion strategy
The champion strategy involves identifying champions within each district who are trained and supported as change agents through training and supervision.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of screening-eligible visits at which patients were screened for mental health
Time Frame: Over the 12 months of the randomized period
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
Proportion of visits at which patients endorsed suicidal ideation at which a suicide risk assessment was completed
Time Frame: Over the 12 months of the randomized period
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
Proportion of patients who were appropriately initiated on mental health treatment
Time Frame: Over the 12 months of the randomized period
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
Proportion of follow-up visits at which clinical decisions followed mental health treatment guidelines
Time Frame: Over the 12 months of the randomized period
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
Proportion of Counseling sessions meeting Fidelity Threshold
Time Frame: Over the 12 months of the randomized period
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients achieving mental health remission
Time Frame: 3 months after participant enrollment

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
Proportion of patients achieving chronic condition control
Time Frame: 6 months after participant enrollment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Brian Pence, University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2025

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

May 1, 2024

First Submitted That Met QC Criteria

May 1, 2024

First Posted (Actual)

May 6, 2024

Study Record Updates

Last Update Posted (Actual)

May 4, 2025

Last Update Submitted That Met QC Criteria

May 1, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

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

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified individual data will be uploaded to the National Institute of Mental Health (NIMH) Data Archive (NDA) following a 6-month upload schedule. Data will be available for request from the NDA beginning one year after the grant end date specified on the first Notice of Award. Any subject-level data and the associated analyzed data used in a journal publication will be shared at the time of publication, if the publication occurs before the one-year automatic share date.

IPD Sharing Time Frame

All NIMH National Data Archive collection data are shared automatically one year after the grant end date specified on the first Notice of Award.

IPD Sharing Access Criteria

Access to data for research purposes will be provided through an NIMH Data Archive Data Access Committee. Investigators and institutions seeking data from NDA will be expected to meet data security measures and will be asked to submit a Data Use Certification, which is cosigned by the investigator and the designated Institutional Official(s) at the NIH-recognized sponsoring institution with a current Federal Wide Assurance.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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