An interventional study of psychiatric medications and evidence-based psychotherapies in Common Mental Disorders and Severe Mental Disorder, sponsored by New York State Psychiatric Institute. Completed at 1 site in Mozambique. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-06.
Sponsored by New York State Psychiatric Institute · Not applicable, Interventional, and Health services research
Global mental health (MH) and substance use disorders prevention, treatment and research gaps require that efficacious treatments be scaled-up, leveraging existing platforms. In tandem, participation of Ministries ready to apply evidence-inform policies must sustain them over time. PRIDE SSA may generate templates for other low- and middle-income countries (LMICs) by conducting a state of the art scale up study in Mozambique and by establishing a collaborative research network of nascent research "Seed Teams." Such "Seed Teams," trained by the capacity building component, may work across the region to build capacity and conduct implementation research to sustainably scale-up MH services. Scale Up Research (Mozambique) in MH and substance use disorders will evaluate strategies and costs of scaling up an innovative, integrated, sustainable, stepped-care community approach. The scale up study will leverage: (1) Mozambique's task-shifting strategy of training psychiatric technicians (PsyTs) to provide MH care, (2) the WHO-funded epilepsy community care program successfully implemented in 5 Provinces, now primed for scale-up by the Health Ministry. The cost-effective approach redefines work roles without requiring new human resources. Importantly, it comports with the Health Ministry's plan to implement prevention and treatment for all MH conditions, rather than single disorders. The model employs evidence-based practices (EBPs; e.g. Psychopharmacology; Interpersonal Therapy), already in use by PsyTs to: a) establish a sustainable program delivered and supervised by non-MH professionals, overseen by MH specialists; b) provide community screening, care and/or referrals for all MH disorders; and c) use implementation tools to monitor sustainability. This collaborative network will scale-up a cost-effective, sustainable program and inform policy.
Working in three geographically separate Mozambican provinces and in rural (N=24), peri-urban (i.e., rural urban transition zone; N=6), and urban (N=6) clinics, the scale-up study first will conduct a two-year (12 months implementation, 12 months sustainability), cluster-randomized, three-arm hybrid effectiveness-implementation type 1 trial, guided by Proctor's implementation framework. The delivery pathway showing the highest overall effectiveness after this two-year trial in 36 clinics will then be implemented in clinics from the other two arms for two additional "cross-over" years. Throughout the trial and the "cross-over" years, qualitative and other process data will complement structured assessments to examine implementation, sustainability, and scale-up.
Scale-up PRIDES Mozambique has the following Specific Aims:
Aim 1. To determine the most effective delivery pathway in terms of 1) implementation outcomes (reach, retention, pathway fidelity, cost-effectiveness); 2) service-level outcomes (efficiency); and 3) patient-level outcomes (function/disability, comprehensive MH screener, patient satisfaction). As an Exploratory Sub-Aim: To assess the impact of: pre-implementation stage factors (acceptability, adoption); mediators (work self-efficacy, MH literacy); and moderators (clinic characteristics: rural, peri-urban, urban, epilepsy program implementation) on implementation, services, and patient outcomes.
Aim 2. To evaluate implementation, sustainability, and scale-up requirements of the most effective pathway (determined in Aim 1) in order to inform regional policies. A rigorous process evaluation mixed-methods approach will identify barriers and facilitators to implementing, sustaining, and scaling-up the most effective pathway in all clinics during the "cross-over" two years using purposive sampling for mixed-methods evaluation in a subset of 18 clinics (6 per Province).
Aim 3. To develop an implementation tool-kit for low-cost, feasible, and sustainable system-wide implementation of the most effective WHO Mental Health Gap Action Programme (mhGAP) delivery pathway in Sub-Saharan Africa (sSA) with collaboration of Members of the PRIDES sSA Five-Country Council, External Advisory Board and the WHO.
1,740 studies on the registry are indexed under Mental Disorders; 348 are open to participants now.
This study's enrollment of 901 is above the median of 100 across 1,301 interventional studies indexed under Mental Disorders.
Browse Mental Disorders studies →New York State Psychiatric Institute is the lead sponsor of 435 studies on the registry; 27 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 45 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Psychiatric medications and evidence-based psychotherapies to be provided at a specialty mental clinic facilitated by psychiatric technicians, the mental health specialty workforce already in place in Mozambique.
Other: psychiatric medications and evidence-based psychotherapies
Psychiatric medications and evidence-based psychotherapies to be provided by primary care providers.
Other: psychiatric medications and evidence-based psychotherapies
Psychiatric medications and evidence-based psychotherapies to be provided by primary care providers and community health workers, respectively.
Other: psychiatric medications and evidence-based psychotherapies
Patients who screen positive with any psychiatric condition are referred for evaluation and treatment according to the treatment arm. This may combine psychiatric medications or evidence based psychotherapies according to treatment.
Change in Reach (implementation)
Number of people who access mental health care from those who need care
Time frame: Change from Baseline in Reach at 12 months
Cost
Cost of Implementing each arm through the Stages of Implementation Completion (SIC) measure together with the Cost of Implementing New Strategies (COINS) method
Time frame: Cost of implementing each arm will be calculated through study completion, an average of 2 years
Change in Retention (implementation)
Number of people who receive mental health care from those who need care
Time frame: Change from Baseline in Retention at 12 months
Change in Clinical symptoms
Symptom reduction using a newly validated tool - the Comprehensive Mental Health Tool (CmhTool) to monitor symptoms of common and severe mental disorders as well as substance use disorders
Time frame: Change from Baseline CmhTool at 12 months
Ran from Dec 2018 to primary completion in Aug 2025, 80 months.
Of 666 non-industry interventional studies with no phase under Mental Disorders, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 45. This study's 80 months is above that.
Counting every sponsor, half of 680 studies reached it within 29 months; a quarter within 13 and three quarters within 45.
Mental Disorders covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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