Common Mental DisordersPRIDE-sSANCT03610750
Training Providers to Conduct PRIDES-sSA
A study testing psychiatric medications and evidence-based psychotherapies in people with Common Mental Disorders and Severe Mental Disorder, run by New York State Psychiatric Institute at 1 site in Mozambique.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Common Mental Disorders, Severe Mental Disorder
- What is being tested?
- psychiatric medications and evidence-based psychotherapies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 901 participants
- Where
- 1 siteMozambique
- Study dates
- 1 Dec 2018to 30 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Staff in one of the 36 clinics - Clinic directors, trainers, supervisors, providers of participating clinics: Community Health Workers; Nurses; and Medicine, Preventive Medicine andPsychiatric Technicians.
Who cannot join
- Other clinic staff besides clinic directors, trainers, supervisors, providers of participating clinics: Community Health Workers; Nurses; and Medicine, Preventive Medicine andPsychiatric Technicians.
Trial locations and contacts
1 site in 1 country.
Mozambique1 site
MIHER: Mozambique Institute for Health Education and Research
Maputo, Cidade de Maputo, 1101
About this study
Official title: PRIDE SSA - Partnerships in Research to Implement and Disseminate Sustainable and Scalable Evidence Based Practices in Sub-Saharan Africa
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.
Read the detailed description
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.
- Conditions
- Common Mental Disorders, Severe Mental Disorder
- Being tested
- psychiatric medications and evidence-based psychotherapies
- Keywords
- Community Mental Health Care, Task-shifting
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychiatric medications and evidence-based psychotherapiesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Specialty Care | Active comparator | 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. Receives: Other: psychiatric medications and evidence-based psychotherapies |
| Integrated Care | Experimental | Psychiatric medications and evidence-based psychotherapies to be provided by primary care providers. Receives: Other: psychiatric medications and evidence-based psychotherapies |
| Community Clinic Stepped Care | Experimental | Psychiatric medications and evidence-based psychotherapies to be provided by primary care providers and community health workers, respectively. Receives: Other: psychiatric medications and evidence-based psychotherapies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Reach (implementation)
Number of people who access mental health care from those who need care
Measured: 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
Measured: Cost of implementing each arm will be calculated through study completion, an average of 2 years
Secondary outcomes (2)
Change in Retention (implementation)
Number of people who receive mental health care from those who need care
Measured: 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
Measured: Change from Baseline CmhTool at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start1 Dec 2018
- Primary completion30 Aug 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Common Mental DisordersStudies of the same condition, open and under way.
- 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
- Model description
- Effectiveness-Implementation Hybrid 1 Trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 901 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University, University of Pennsylvania
- Responsible party
- Principal investigator, Milton L. Wainberg, MD, New York State Psychiatric Institute
- Investigators
- Milton L Wainberg, MD, Principal investigator, NYSPI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03610750
- Sponsor's protocol ID
- 7485
- Acronym
- PRIDE-sSA
- Status last verified
- Sep 2025
- First submitted
- 13 Mar 2018
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wainberg ML, Scorza P, Shultz JM, Helpman L, Mootz JJ, Johnson KA, Neria Y, Bradford JE, Oquendo MA, Arbuckle MR. Challenges and Opportunities in Global Mental Health: a Research-to-Practice Perspective. Curr Psychiatry Rep. 2017 May;19(5):28. doi: 10.1007/s11920-017-0780-z.
PubMed 28425023Dos Santos PF, Wainberg ML, Caldas-de-Almeida JM, Saraceno B, Mari Jde J. Overview of the mental health system in Mozambique: addressing the treatment gap with a task-shifting strategy in primary care. Int J Ment Health Syst. 2016 Jan 4;10:1. doi: 10.1186/s13033-015-0032-8. eCollection 2016.
PubMed 26734070Wainberg ML, Lovero KL, Duarte CS, Fiks Salem A, Mello M, Bezuidenhout C, Mootz J, Feliciano P, Suleman A, Fortunato Dos Santos P, Weissman MM, Cournos F, Marques AH, Fumo W, Mabunda D, Alves-Bradford JE, Mello M, Mari JJ, Ngwepe P, Cidav Z, Mocumbi AO, Medina-Marino A, Wall M, Gouveia L, Oquendo MA. Partnerships in Research to Implement and Disseminate Sustainable and Scalable Evidence-Based Practices (PRIDE) in Mozambique. Psychiatr Serv. 2021 Jul 1;72(7):802-811. doi: 10.1176/appi.ps.202000090. Epub 2020 Dec 18.
PubMed 33334157
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRIDE SSA - Partnerships in Research to Implement and Disseminate Sustainable and Scalable Evidence Based Practices in Sub-Saharan Africa
- ClinicalTrials.gov ID
- NCT03610750
- Acronym / sponsor ID
- PRIDE-sSA / 7485
- Conditions
- Common Mental Disorders, Severe Mental Disorder
- Keywords
- Community Mental Health Care, Task-shifting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 901 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- Columbia University, University of Pennsylvania
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 1 Aug 2018 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- Effectiveness-Implementation Hybrid 1 Trial
| Arm | Type | Receives |
|---|---|---|
| Specialty Care | Active comparator | Other: psychiatric medications and evidence-based psychotherapiesPsychiatric 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. |
| Integrated Care | Experimental | Other: psychiatric medications and evidence-based psychotherapiesPsychiatric medications and evidence-based psychotherapies to be provided by primary care providers. |
| Community Clinic Stepped Care | Experimental | Other: psychiatric medications and evidence-based psychotherapiesPsychiatric medications and evidence-based psychotherapies to be provided by primary care providers and community health workers, respectively. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Staff in one of the 36 clinics - Clinic directors, trainers, supervisors, providers of participating clinics: Community Health Workers; Nurses; and Medicine, Preventive Medicine andPsychiatric Technicians.
Key exclusion criteria (1 listed)
- Other clinic staff besides clinic directors, trainers, supervisors, providers of participating clinics: Community Health Workers; Nurses; and Medicine, Preventive Medicine andPsychiatric Technicians.
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 |
|---|---|---|
| psychiatric medications and evidence-based psychotherapiesPatients 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. | Other | Community Clinic Stepped Care, Integrated Care, Specialty Care |
Primary outcome
Change in Reach (implementation)
Time frame: Change from Baseline in Reach at 12 months
Number of people who access mental health care from those who need care
Cost
Time frame: Cost of implementing each arm will be calculated through study completion, an average of 2 years
Cost of Implementing each arm through the Stages of Implementation Completion (SIC) measure together with the Cost of Implementing New Strategies (COINS) method
2 secondary outcomes
Change in Retention (implementation)
Time frame: Change from Baseline in Retention at 12 months
Change in Clinical symptoms
Time frame: Change from Baseline CmhTool at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Results publication: PubMed 28425023Wainberg ML, Scorza P, Shultz JM, Helpman L, Mootz JJ, Johnson KA, Neria Y, Bradford JE, Oquendo MA, Arbuckle MR. Challenges and Opportunities in Global Mental Health: a Research-to-Practice Perspective. Curr Psychiatry Rep. 2017 May;19(5):28. doi: 10.1007/s11920-017-0780-z.
- Results publication: PubMed 26734070Dos Santos PF, Wainberg ML, Caldas-de-Almeida JM, Saraceno B, Mari Jde J. Overview of the mental health system in Mozambique: addressing the treatment gap with a task-shifting strategy in primary care. Int J Ment Health Syst. 2016 Jan 4;10:1. doi: 10.1186/s13033-015-0032-8. eCollection 2016.
- Derived from this study: PubMed 33334157Wainberg ML, Lovero KL, Duarte CS, Fiks Salem A, Mello M, Bezuidenhout C, Mootz J, Feliciano P, Suleman A, Fortunato Dos Santos P, Weissman MM, Cournos F, Marques AH, Fumo W, Mabunda D, Alves-Bradford JE, Mello M, Mari JJ, Ngwepe P, Cidav Z, Mocumbi AO, Medina-Marino A, Wall M, Gouveia L, Oquendo MA. Partnerships in Research to Implement and Disseminate Sustainable and Scalable Evidence-Based Practices (PRIDE) in Mozambique. Psychiatr Serv. 2021 Jul 1;72(7):802-811. doi: 10.1176/appi.ps.202000090. Epub 2020 Dec 18.
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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. This study is not recruiting at the moment.
Milton L Wainberg, MD principal investigator
NYSPI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psychiatric medications and evidence-based psychotherapies in people with Common Mental Disorders and Severe Mental Disorder, run by New York State Psychiatric Institute at 1 site in Mozambique.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mozambique. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Reach (implementation) (time frame: Change from Baseline in Reach at 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03610750, which also lists 3 linked publications.
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 6 Oct 2025.