Training Providers to Conduct PRIDES-sSA (PRIDE-sSA)
Primary Purpose
Common Mental Disorders, Severe Mental Disorder
Status
Recruiting
Phase
Not Applicable
Locations
Mozambique
Study Type
Interventional
Intervention
psychiatric medications and evidence-based psychotherapies
Sponsored by
About this trial
This is an interventional health services research trial for Common Mental Disorders focused on measuring Community Mental Health Care, Task-shifting
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Other clinic staff besides clinic directors, trainers, supervisors, providers of participating clinics: Community Health Workers; Nurses; and Medicine, Preventive Medicine andPsychiatric Technicians.
Sites / Locations
- MIHER: Mozambique Institute for Health Education and ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Specialty Care
Integrated Care
Community Clinic Stepped Care
Arm Description
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.
Psychiatric medications and evidence-based psychotherapies to be provided by primary care providers.
Psychiatric medications and evidence-based psychotherapies to be provided by primary care providers and community health workers, respectively.
Outcomes
Primary Outcome Measures
Change in Reach (implementation)
Number of people who access mental health care from those who need care
Cost
Cost of Implementing each arm through the Stages of Implementation Completion (SIC) measure together with the Cost of Implementing New Strategies (COINS) method
Secondary Outcome Measures
Change in Retention (implementation)
Number of people who receive mental health care from those who need care
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
Full Information
NCT ID
NCT03610750
First Posted
March 13, 2018
Last Updated
January 20, 2023
Sponsor
New York State Psychiatric Institute
Collaborators
Columbia University, University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT03610750
Brief Title
Training Providers to Conduct PRIDES-sSA
Acronym
PRIDE-sSA
Official Title
PRIDE SSA - Partnerships in Research to Implement and Disseminate Sustainable and Scalable Evidence Based Practices in Sub-Saharan Africa
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
Columbia University, University of Pennsylvania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Mental Disorders, Severe Mental Disorder
Keywords
Community Mental Health Care, Task-shifting
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Effectiveness-Implementation Hybrid 1 Trial
Masking
Investigator
Masking Description
De-identified aggregate clinic will be collected
Allocation
Randomized
Enrollment
901 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Specialty Care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Integrated Care
Arm Type
Experimental
Arm Description
Psychiatric medications and evidence-based psychotherapies to be provided by primary care providers.
Arm Title
Community Clinic Stepped Care
Arm Type
Experimental
Arm Description
Psychiatric medications and evidence-based psychotherapies to be provided by primary care providers and community health workers, respectively.
Intervention Type
Other
Intervention Name(s)
psychiatric medications and evidence-based psychotherapies
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Reach (implementation)
Description
Number of people who access mental health care from those who need care
Time Frame
Change from Baseline in Reach at 12 months
Title
Cost
Description
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
Secondary Outcome Measure Information:
Title
Change in Retention (implementation)
Description
Number of people who receive mental health care from those who need care
Time Frame
Change from Baseline in Retention at 12 months
Title
Change in Clinical symptoms
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Other clinic staff besides clinic directors, trainers, supervisors, providers of participating clinics: Community Health Workers; Nurses; and Medicine, Preventive Medicine andPsychiatric Technicians.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Milton L WAINBERG, MD
Phone
6467746430
Email
mlw35@cumc.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Milton L Wainberg, MD
Organizational Affiliation
NYSPI
Official's Role
Principal Investigator
Facility Information:
Facility Name
MIHER: Mozambique Institute for Health Education and Research
City
Maputo
ZIP/Postal Code
1101
Country
Mozambique
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alcido Nguenha
Phone
+254213180
Email
info@miher.org
12. IPD Sharing Statement
Citations:
PubMed Identifier
28425023
Citation
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.
Results Reference
result
PubMed Identifier
26734070
Citation
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.
Results Reference
result
PubMed Identifier
33334157
Citation
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.
Results Reference
derived
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Training Providers to Conduct PRIDES-sSA
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