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Trial record 32 of 138 for:    Mental Disorders | Recruiting, Not yet recruiting, Available Studies | "Mental Health"

Training Providers to Conduct PRIDES-sSA (PRIDE-sSA)

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ClinicalTrials.gov Identifier: NCT03610750
Recruitment Status : Not yet recruiting
First Posted : August 1, 2018
Last Update Posted : August 1, 2018
Sponsor:
Collaborators:
Columbia University
University of Pennsylvania
Information provided by (Responsible Party):
Milton L. Wainberg, New York State Psychiatric Institute

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.

Condition or disease Intervention/treatment Phase
Common Mental Disorders Severe Mental Disorder Other: psychiatric medications and evidence-based psychotherapies Phase 4

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 901 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Effectiveness-Implementation Hybrid 1 Trial
Masking: Single (Investigator)
Masking Description: De-identified aggregate clinic will be collected
Primary Purpose: Health Services Research
Official Title: PRIDE SSA - Partnerships in Research to Implement and Disseminate Sustainable and Scalable Evidence Based Practices in Sub-Saharan Africa
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Specialty Care
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
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.

Experimental: Integrated Care
Psychiatric medications and evidence-based psychotherapies to be provided by primary care providers.
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.

Experimental: Community Clinic Stepped Care
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.




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Change in Retention (implementation) [ Time Frame: Change from Baseline in Retention at 12 months ]
    Number of people who receive mental health care from those who need care

  2. Change in Clinical symptoms [ Time Frame: Change from Baseline CmhTool at 12 months ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03610750


Contacts
Contact: Milton L WAINBERG, MD 6467746430 mlw35@cumc.columbia.edu

Locations
Mozambique
MIHER: Mozambique Institute for Health Education and Research Not yet recruiting
Maputo, Mozambique, 1101
Contact: Alcido Nguenha    +254213180    info@miher.org   
Sponsors and Collaborators
New York State Psychiatric Institute
Columbia University
University of Pennsylvania
Investigators
Principal Investigator: Milton L Wainberg, MD NYSPI

Publications of Results:
Responsible Party: Milton L. Wainberg, Professor of Clinical Psychiatrist, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT03610750     History of Changes
Other Study ID Numbers: 7485
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Milton L. Wainberg, New York State Psychiatric Institute:
Community Mental Health Care
Task-shifting

Additional relevant MeSH terms:
Disease
Mental Disorders
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders