N/A N=357 Randomized Health Services Research

The Sub-Saharan Africa Regional Partnership for Mental Health Capacity Building

Depression

Bottom Line

View on ClinicalTrials.gov: NCT03711786 ↗

Enrolled (actual)

357

Serious AEs

4.4%

Results posted

Mar 2023

Primary outcome: Primary: Fidelity in Depression Screening: Number of Screening-eligible Visits at Which Depression Screening is Completed — 14712; 15888 Visits — p=0.836

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Basic implementation package (Other); Enhanced implementation package (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of North Carolina, Chapel Hill
Primary completion: Mar 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Fidelity in Depression Screening: Number of Screening-eligible Visits at Which Depression Screening is Completed	14712; 15888	0.836
PRIMARY Fidelity in Depression Treatment Initiation: Number of Treatment-eligible Visits for Which Depression Treatment Actually Starts Within 30 Days of Identification	601; 538	0.877
PRIMARY Fidelity in Following the Depression Treatment Algorithm: Number of Treatment Follow-up Appointments in the First Three Months of Depression Treatment for Which the Clinical Treatment Decision Follows the Depression Treatment Guidelines	14; 69	0.001 sig
SECONDARY Number of Participants Achieving Depression Remission at 3 Months	98; 138	0.017 sig
SECONDARY Number of Participants With Well Controlled NCD at 3 Months	35; 51	0.759

Summary

This is a 10-site cluster-randomized implementation science trial that compares two clinic-level implementation strategies to facilitate ongoing Ministry of Health efforts to scale up depression treatment within non-communicable diseases clinics in Malawi. Primary outcomes are clinical care indicators measured at the level of the visit (patient screened yes/no; depression treatment initiated if indicated yes/no; depression treatment algorithm followed at follow-up yes/no). Secondary outcomes are patient health outcomes measured at the level of the participant.

Eligibility Criteria

Inclusion Criteria

Patients who meet the following eligibility criteria will be invited to participate:

Ages 18-65 years (antidepressant treatment considerations differ for those 65 years, and these age groups are expected to be very rare in the target clinics),
Current or new patient receiving care for either hypertension or diabetes from a participating NCD clinic
Elevated depressive symptoms (PHQ-9 score ≥5)

Exclusion Criteria

Patients will be excluded if they have

a history of bipolar or psychotic disorder, or show emergent threat of self-harm.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03711786). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.