Training Providers to Conduct PRIDES-sSA

NCT03610750 | Completed DMC

• 1 other identifier: 7485
• Study Type: interventional
• Target: 901
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Common Mental Disorders; Severe Mental Disorder

Keywords

Community Mental Health Care; Task-shifting

Outcome Measures

Primary Outcomes (2)

• Change in Reach (implementation)

  Number of people who access mental health care from those who need care

  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

  Cost of implementing each arm will be calculated through study completion, an average of 2 years

Secondary Outcomes (2)

• Change in Retention (implementation)

  Change from Baseline in Retention at 12 months

• Change in Clinical symptoms

  Change from Baseline CmhTool at 12 months

Study Arms (3)

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.

Other: psychiatric medications and evidence-based psychotherapies

Integrated Care

EXPERIMENTAL

Psychiatric medications and evidence-based psychotherapies to be provided by primary care providers.

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.

Other: psychiatric medications and evidence-based psychotherapies

Interventions

psychiatric medications and evidence-based psychotherapies OTHER

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.

Community Clinic Stepped Care; Integrated Care; Specialty Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Other clinic staff besides clinic directors, trainers, supervisors, providers of participating clinics: Community Health Workers; Nurses; and Medicine, Preventive Medicine andPsychiatric Technicians.

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• Columbia University: collaborator
• University of Pennsylvania: collaborator

Study Sites (1)

MIHER: Mozambique Institute for Health Education and Research

Maputo, Cidade de Maputo, 1101, Mozambique

Location

Related Publications (3)

• 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.

  PMID: 28425023 BACKGROUND

• Dos 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.

  PMID: 26734070 BACKGROUND

• Wainberg 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.

  PMID: 33334157 DERIVED

MeSH Terms

Conditions

Mental Disorders

Study Officials

• Milton L Wainberg, MD

  NYSPI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: De-identified aggregate clinic will be collected
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Psychiatrist

Model Details: Effectiveness-Implementation Hybrid 1 Trial

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: August 1, 2018
• Study Start: December 1, 2018
• Primary Completion: August 30, 2025
• Study Completion: August 30, 2025
• Last Updated: October 6, 2025

Record last verified: 2025-09

Locations

MO (1)