An interventional study of Champion strategy and Adapted LOCI leadership and climate alignment strategy plus champion strategy in Anxiety and Depression, sponsored by University of North Carolina, Chapel Hill. Recruiting at 12 sites in Malawi. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Health services research
Among 44 studies in Depression by University of North Carolina, Chapel Hill — 11 open to participants now, 13 under way, 1 of them phase 3. Depression · University of North Carolina, Chapel Hill.
Among the 44 studies in Depression by University of North Carolina, Chapel Hill, this one is the 3rd largest by planned enrollment of the 41 interventional ones, is one of 5 that started in 2025, is one of 30 with no phase, reaches primary completion later than 1 of the 12 other live ones, and was the 35th registered.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 1,080 is above the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →11 of the 44 studies in Depression by University of North Carolina, Chapel Hill are open now, in 3 countries. Each count lists the studies.
Of the 1,088 Depression studies recruiting now, 469 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 310 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →44 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 5 started in 2025.
Median enrollment 60 across the 41 interventional studies, 55 across the 3 observational. Of the 30 that completed or were terminated, 18 (60%) have results posted.
University of North Carolina, Chapel Hill is the lead sponsor of 1,372 studies on the registry; 133 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
4 of the studies in Depression by University of North Carolina, Chapel Hill that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05282277University of North Carolina, Chapel HillExamining the Effects of Estradiol on Neural and Molecular Response to Reward | 2026-12-31 |
| NCT06248203University of North Carolina, Chapel HillTeachers Leading the Front Lines - Adolescent | 2027-02-01 |
| NCT06060860University of North Carolina, Chapel HillComparing Cognitive-Behavioral Therapy Versus Mindfulness-Based Therapy for Autistic Adults | 2027-03-01 |
| NCT06696001University of North Carolina, Chapel HillNeuroscience of Psychotherapy for Depression | 2027-06-01 |
Among the 44 studies in Depression by University of North Carolina, Chapel Hill, from their registry updates:
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.
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.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 1,080 is above the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,372 studies on the registry; 133 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
Compared within Depression, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Over the 12 months of the randomized period
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.
Time frame: 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.
Time frame: 6 months after participant enrollment
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
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.
Data sharing details ↗ · nda.nih.gov
Ran from May 2025 to primary completion in May 2026, 12 months.
Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 12 months is below that.
Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of North Carolina, Chapel Hill →