AnxietyALIGNNCT06399991
Aligning Facility Leadership and Climate to Advance Mental Health Services Integration in Malawi
A study testing Champion strategy and Adapted LOCI leadership and climate alignment strategy plus champion strategy in people with Anxiety and Depression, run by University of North Carolina, Chapel Hill at 12 sites in Malawi.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- Champion strategy and Adapted LOCI leadership and climate alignment strategy plus champion strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,080 participants
- Where
- 12 sitesMalawi
- Study dates
- 1 May 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- <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 locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
Malawi12 sites, 12 recruiting
- Recruiting
Chiradzulu District Hospital
Chiradzulu
Kelvin Maziya, kmaziya@unclilongwe.org
- Recruiting
Dedza District Hospital
Dedza
Kelvin Maziya, kmaziya@unclilongwe.org
- Recruiting
Kasungu District Hospital
Kasungu
Kelvin Maziya, kmaziya@unclilongwe.org
- Recruiting
Machinga District Hospital
Machinga
Kelvin Maziya, kmaziya@unclilongwe.org
- Recruiting
Mangochi District Hospital
Mangochi
Kelvin Maziya, kmaziya@unclilongwe.org
- Recruiting
Mchinji District Hospital
Mchinji
Kelvin Maziya, kmaziya@unclilongwe.org
- Recruiting
Mulanje District Hospital
Mulanje
Kelvin Maziya, kmaziya@unclilongwe.org
- Recruiting
Mzimba South District Hospital
Mzimba
Kelvin Maziya, kmaziya@unclilongwe.org
- Recruiting
Nkhata Bay District Hospital
Nkhata Bay
Kelvin Maziya, kmaziya@unclilongwe.org
- Recruiting
Ntcheu District Hospital
Ntcheu
Kelvin Maziya, kmaziya@unclilongwe.org
- Recruiting
Phalombe District Hospital
Phalombe
Kelvin Maziya, kmaziya@unclilongwe.org
- Recruiting
Salima District Hospital
Salima
Kelvin Maziya, kmaziya@unclilongwe.org
About this study
Official title: 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.
Read the 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.
- Conditions
- Anxiety, Depression
- Being tested
- Champion strategy, Adapted LOCI leadership and climate alignment strategy plus champion strategy
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Champion strategyBehavioural
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 strategyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: Champion strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Over the 12 months of the randomized period
Secondary outcomes (2)
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.
Measured: 3 months after participant enrollment
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.
Measured: 6 months after participant enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start1 May 2025
- Primary completion31 May 2026
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,080 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Brian Pence, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06399991
- Sponsor's protocol ID
- 23-2722
- Other IDs
- R01MH133028
- Acronym
- ALIGN
- Status last verified
- Jul 2026
- First submitted
- 1 May 2024
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aligning Facility Leadership and Climate to Advance Mental Health Services Integration in Malawi (ALIGN)
- ClinicalTrials.gov ID
- NCT06399991
- Acronym / sponsor ID
- ALIGN / 23-2722
- Conditions
- Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,080 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adapted LOCI leadership and climate alignment strategy plus champion strategy | Experimental | Behavioral: Adapted LOCI leadership and climate alignment strategy plus champion strategyImplementation of LOCI strategy (adapted for the Malawian context) plus the champion strategy (enhanced usual care- usual outpatient care enhanced with use of trained champions). |
| Champion strategy | Active comparator | Behavioral: Champion strategyEnhanced usual care. Continue with usual outpatient care, enhanced with use of trained champions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- <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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Champion strategyThe champion strategy involves identifying champions within each district who are trained and supported as change agents through training and supervision. | Behavioural | Champion strategy |
| Adapted LOCI leadership and climate alignment strategy plus champion strategyThe 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. | Behavioural | Adapted LOCI leadership and climate alignment strategy plus champion strategy |
Primary outcome
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.
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.
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.
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.
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.
2 secondary outcomes
Proportion of patients achieving mental health remission
Time frame: 3 months after participant enrollment
Proportion of patients achieving chronic condition control
Time frame: 6 months after participant enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brian Pence principal investigator
University of North Carolina, Chapel Hill
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Champion strategy and Adapted LOCI leadership and climate alignment strategy plus champion strategy in people with Anxiety and Depression, run by University of North Carolina, Chapel Hill at 12 sites in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brian Pence, PhD, MPH (1-919-966-7446, bpence@unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of screening-eligible visits at which patients were screened for mental health (time frame: Over the 12 months of the randomized period). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.