Systems Analysis and Improvement Approach to Optimize the Task-shared Mental Health Treatment Cascade (SAIA-MH)

NCT05103033 | Active Not Recruiting

• 2 other identifiers: STUDY000125271R01MH123682-01A1
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 16

Brief Summary

The purpose of this study is to test the effectiveness of a multicomponent implementation strategy entitled the Systems Analysis and Improvement Approach for mental health (SAIA-M) using a cluster randomized trial at the health facility level. SAIA-MH focuses on improving the mental health treatment cascade in primary outpatient mental healthcare. The mental health treatment cascade is a model that outlines the sequential, linked treatment steps that people with mental illness must navigate, from initial diagnosis to symptom/function improvement. This study will also assess the potential mechanisms by which the SAIA-MH implementation strategy works, or does not work, along with the cost and effectiveness of scaling-up SAIA-MH in Mozambique.

Conditions

Mental Health Disorder

Keywords

Outpatient primary care

Outcome Measures

Primary Outcomes (1)

• Patient Function Improvement

  Patient function improvement is evaluated for all patients diagnosed with a mental disorder, prescribed a medication, given a follow-up date, and who return at least once. All patients diagnosed with a mental disorder in target clinics will have function improvement measured by the WHODAS 2.0 at each clinic visit. Improvement will be determined as patients with at least 1 follow-up visits who score less than 10 on the WHODAS 2.0 or have a 50% reduction in their baseline WHODAS 2.0 score.

  data collection will occur over 6 months baseline, 24-month intervention and 12-month sustainment period

Secondary Outcomes (2)

• Patient Retention

  data collection will occur over 6 months baseline, 24-month intervention and 12-month sustainment period

• Patient Medication Adherence

  data collection will occur over 6 months baseline, 24-month intervention and 12-month sustainment period

Study Arms (2)

Systems Analysis and Improvement Approach (SAIA) for mental health

EXPERIMENTAL

Those receiving SAIA-MH will attend a 1-week in-person training for facility learning collaboratives. Following the 1-week in-person training, SAIA-MH standard operating procedures will be implemented, including: (1) structured internal/external facilitation following tablet-based guides used in pilot study (1x per week first month; 2x per week for next two months; 1x per month for remainder); (2) facilitation in the 5-step SAIA-MH improvement process.

Behavioral: Systems Analysis and Improvement Approach for Mental Health (SAIA-MH)

Attentional Placebo Control

OTHER

Control facilities will mimic activities of the intervention group in time and contacts, but without the "active ingredient" of the SAIA-MH implementation strategy

Behavioral: Attentional Placebo Control

Interventions

Attentional Placebo Control BEHAVIORAL

Facilities randomized to attentional placebo control will attend a 1-week in-person training which will include the same minimum staff above for SAIA-MH. This training will focus on reviewing data collection tools, ethics, mental health stigma and burnout for mental health professionals. Following the 1-week in person training, attentional placebo control facilities will receive regular supervision following the same schedule as SAIA-MH focused on reviewing data collection tools.

Attentional Placebo Control

Systems Analysis and Improvement Approach for Mental Health (SAIA-MH) BEHAVIORAL

The 5 steps of SAIA-MH include: (1) cascade analysis to visualize treatment cascade drop-offs and prioritize areas for system improvements; (2) process mapping to identify modifiable facility-level bottlenecks; (3) identification and implementation of modifications to improve system performance; (4) assessment of modification effects on the cascade; and (5) repeated analysis and improvement cycles.

Systems Analysis and Improvement Approach (SAIA) for mental health

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patient diagnosed with a mental health condition in outpatient primary care, prescribed a medication, and given a follow-up date.

You may not qualify if:

• Patient enrolled in treatment outside of targeted mental health systems analysis and improvement approach (SAIA-MH) facilities.
• Patients not prescribed a medication.
• Patients not given a follow-up date.
• Mental health workers currently working and collaborating on the treatment of outpatient mental health patients in target clinics in Sofala or Manica provinces, Mozambique.
• Mental health workers must be employed by Ministry of Health.
• Mental health managers or directors currently supervising mental health workers who are leading treatment of outpatient mental health patients in target clinics in Sofala or Manica provinces, Mozambique. Must be employed by the Ministry of Health.
• \. Health worker not involved in outpatient mental healthcare delivery. Health worker not employed by the Ministry of Health.

Sponsors & Collaborators

• Comité para a Saúde de Moçambique: collaborator
• Ministry of Health, Mozambique: collaborator
• University of Washington: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (16)

District Hospital Catandica

Catandica, Manica Province, Mozambique

Location

Urban Health Center Nhamaonha

Chimoio, Manica Province, Mozambique

Location

Urban Health Center Vila Nova

Chimoio, Manica Province, Mozambique

Location

District Hospital Gondola

Gondola, Manica Province, Mozambique

Location

Rural Health Center Macate

Macate, Manica Province, Mozambique

Location

Rural Health Center Sussundenga Sede

Sussundenga, Manica Province, Mozambique

Location

Rural Health Center Vanduzi

Vanduzi, Manica Province, Mozambique

Location

Urban Health Center Chingussura

Beira, Sofala, Mozambique

Location

Urban Health Center Inhamizua

Beira, Sofala, Mozambique

Location

Urban Health Center Macurungo

Beira, Sofala, Mozambique

Location

Urban Health Center Mascarenhas

Beira, Sofala, Mozambique

Location

Hospital Muxúngue

Chibabava, Sofala, Mozambique

Location

Rural Health Center Mafambisse

Dondo, Sofala, Mozambique

Location

Urban Health Center Dondo Sede

Dondo, Sofala, Mozambique

Location

Rural Hospital Nhamatanda

Nhamatanda, Sofala, Mozambique

Location

District Hospital Manica

Manica, Mozambique

Location

Related Publications (3)

• Cumbe VFJ, Muanido A, Turner M, Jala JN Jr, Armando EE, Faduque F, Xerinda ER, Sherr K, Flaherty BP, Sharma M, Wagenaar BH. Effectiveness of the Systems Analysis and Improvement Approach to optimise outpatient mental, neurological, and substance-use disorder treatment cascades in Mozambique: a cluster-randomised trial. Lancet Psychiatry. 2026 Apr;13(4):316-326. doi: 10.1016/S2215-0366(26)00034-9.

  PMID: 41862257 DERIVED

• Turner M, Muanido A, Cumbe V, Jala JN Jr, Armando EE, Mambuque E Jr, Faduque F, Xerinda ER, Sherr K, Weiner BJ, Flaherty BP, Sharma M, Wagenaar BH. Mental health care cascade performance and associated factors: longitudinal analyses of routine Ministry of Health services in Mozambique. BMJ Public Health. 2025 Mar 13;3(1):e001024. doi: 10.1136/bmjph-2024-001024. eCollection 2025.

  PMID: 40099137 DERIVED

• Cumbe VFJ, Muanido AG, Turner M, Ramiro I, Sherr K, Weiner BJ, Flaherty BP, Sharma M, Faduque F, Xerinda ER, Wagenaar BH. Systems analysis and improvement approach to optimize outpatient mental health treatment cascades in Mozambique (SAIA-MH): study protocol for a cluster randomized trial. Implement Sci. 2022 Jun 6;17(1):37. doi: 10.1186/s13012-022-01213-8.

  PMID: 35668423 DERIVED

MeSH Terms

Conditions

Mental Disorders

Interventions

Mental Health

Intervention Hierarchy (Ancestors)

Health; Population Characteristics

Study Officials

• Bradley Wagenaar, MPH, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Public Health: Global Health

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: November 2, 2021
• Study Start: March 14, 2022
• Primary Completion: October 14, 2024
• Study Completion: January 30, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

MO (16)