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

NCT06399991 | Recruiting DMC

• 2 other identifiers: 23-2722R01MH133028
• Study Type: interventional
• Target: 1,080
• Locations: 1 country
• Sites: 12

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.

Conditions

Anxiety; Depression

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (2)

• Proportion of patients achieving mental health remission

  3 months after participant enrollment

• Proportion of patients achieving chronic condition control

  6 months after participant enrollment

Study Arms (2)

Adapted LOCI leadership and climate alignment strategy plus champion strategy

EXPERIMENTAL

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

Champion strategy

ACTIVE COMPARATOR

Enhanced usual care. Continue with usual outpatient care, enhanced with use of trained champions.

Behavioral: Champion strategy

Interventions

Champion strategy BEHAVIORAL

The champion strategy involves identifying champions within each district who are trained and supported as change agents through training and supervision.

Champion strategy

Adapted LOCI leadership and climate alignment strategy plus champion strategy BEHAVIORAL

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.

Adapted LOCI leadership and climate alignment strategy plus champion strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \<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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (12)

Chiradzulu District Hospital

Chiradzulu, Malawi

RECRUITING

Dedza District Hospital

Dedza, Malawi

RECRUITING

Kasungu District Hospital

Kasungu, Malawi

RECRUITING

Machinga District Hospital

Machinga, Malawi

RECRUITING

Mangochi District Hospital

Mangochi, Malawi

RECRUITING

Mchinji District Hospital

Mchinji, Malawi

RECRUITING

Mulanje District Hospital

Mulanje, Malawi

RECRUITING

Mzimba South District Hospital

Mzimba, Malawi

RECRUITING

Nkhata Bay District Hospital

Nkhata Bay, Malawi

RECRUITING

Ntcheu District Hospital

Ntcheu, Malawi

RECRUITING

Phalombe District Hospital

Phalombe, Malawi

RECRUITING

Salima District Hospital

Salima, Malawi

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Brian Pence

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian Pence, PhD, MPH

CONTACT

1-919-966-7446; bpence@unc.edu

Kazione Kulisewa, MBBS MMed

CONTACT

+265-997-210-381; kkulisewa@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 6, 2024
• Study Start: April 8, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• 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.
• 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.

Locations

MA (12)