Improving mental health treatment in Mozambique

Systems Analysis and Improvement Approach to Optimize the Task-shared Mental Health Treatment Cascade (SAIA-MH): A Cluster Randomized Trial

This study is testing a new approach to improve mental health treatment in Mozambique to see if it helps patients stick with their care and take their medications as prescribed.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 155 (estimated)
• Sex: All
• Sponsor: University of Washington (Academic / other)
• Locations: 16 sites (Catandica, Manica and 15 other locations)
• Trial ID: NCT05103033 on ClinicalTrials.gov

What this trial studies

This study tests the effectiveness of the Systems Analysis and Improvement Approach for mental health (SAIA-MH) to enhance the mental health treatment cascade in primary outpatient care settings in Mozambique. It employs a cluster randomized trial design at health facilities to assess how well this multicomponent implementation strategy works in improving patient outcomes, including retention in care and medication adherence. The study also aims to understand the mechanisms behind the implementation strategy's effectiveness and evaluate the costs associated with scaling it up in low-resource settings.

Who should consider this trial

Good fit: Ideal candidates include patients diagnosed with a mental health condition in outpatient primary care who have been prescribed medication and given a follow-up date.

Not a fit: Patients not enrolled in the targeted mental health facilities or those not prescribed medication will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve access to quality mental health care and patient outcomes in low-resource settings.

How similar studies have performed: While task-sharing approaches have been explored, this specific implementation strategy targeting the mental health treatment cascade in low-resource settings is novel and has not been previously tested.

Eligibility criteria

Inclusion Criteria for Primary and Secondary Outcomes:

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

Exclusion Criteria for Primary and Secondary Outcomes:

1. Patient enrolled in treatment outside of targeted mental health systems analysis and improvement approach (SAIA-MH) facilities.
2. Patients not prescribed a medication.
3. Patients not given a follow-up date.

Inclusion Criteria for Qualitative Interviews:

1. Mental health workers currently working and collaborating on the treatment of outpatient mental health patients in target clinics in Sofala or Manica provinces, Mozambique.
2. Mental health workers must be employed by Ministry of Health.
3. 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.

Exclusion Criteria for Qualitative Interviews:

1. Health worker not involved in outpatient mental healthcare delivery. Health worker not employed by the Ministry of Health.

Where this trial is running

Catandica, Manica and 15 other locations

• District Hospital Catandica — Catandica, Manica, Mozambique (Recruiting)
• Urban Health Center Nhamaonha — Chimoio, Manica, Mozambique (Recruiting)
• Urban Health Center Vila Nova — Chimoio, Manica, Mozambique (Recruiting)
• District Hospital Gondola — Gondola, Manica, Mozambique (Recruiting)
• Rural Health Center Macate — Macate, Manica, Mozambique (Recruiting)
• Rural Health Center Sussundenga Sede — Sussundenga, Manica, Mozambique (Recruiting)
• Rural Health Center Vanduzi — Vanduzi, Manica, Mozambique (Recruiting)
• Urban Health Center Chingussura — Beira, Sofala, Mozambique (Recruiting)
• Urban Health Center Inhamizua — Beira, Sofala, Mozambique (Recruiting)
• Urban Health Center Macurungo — Beira, Sofala, Mozambique (Recruiting)
• Urban Health Center Mascarenhas — Beira, Sofala, Mozambique (Recruiting)
• Hospital Muxúngue — Chibabava, Sofala, Mozambique (Recruiting)
• Rural Health Center Mafambisse — Dondo, Sofala, Mozambique (Recruiting)
• Urban Health Center Dondo Sede — Dondo, Sofala, Mozambique (Recruiting)
• Rural Hospital Nhamatanda — Nhamatanda, Sofala, Mozambique (Recruiting)
• District Hospital Manica — Manica, Mozambique (Recruiting)

Study contacts

• Principal investigator: Bradley Wagenaar, MPH, PhD — University of Washington
• Study coordinator: Morgan Turner, LICSW, MAS

Conditions Mental Health Disorder; Outpatient primary care