Status:
COMPLETED
Enhancing Mental Health Outcomes for Patients With Psychosis in Malawi Through Community-based Rehabilitation
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Psychosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The overall aim of the proposed study is to determine the feasibility, acceptability, fidelity, and preliminary effectiveness of the adapted nurse-led, community-based rehabilitation treatment model f...
Detailed Description
Psychosis exacts a heavy morbidity and mortality toll worldwide, but especially in low- and middle-income countries (LMICs). Psychotic disorders are one of the most common presenting complaints for in...
Eligibility Criteria
Inclusion
- Inclusion Criteria for PWLE:
- Current outpatient at Queen Elizabeth Central Hospital psychiatry clinic
- Age 18 or older
- Diagnosis of schizophrenia spectrum disorder or clinical presentation of symptoms of hallucinations, delusions or thought disorder that persisted for longer than one month and are accompanied by significant functional impairment
- Resident in Blantyre District
- Not planning to relocate out of Blantyre District in next 12 months
- Has a primary caregiver willing to participate in the study
- Has current elevated symptoms or poor functioning as demonstrated by one or more of:
- Positive and Negative Symptoms Scale score ≥58
- WHO Disability Assessment Schedule 2.0 score ≥35
- Clinical Global Impression Severity score ≥2 (at least mildly ill)
- Inclusion Criteria for Caregivers:
- Is a current caregiver for an eligible and consenting patient participant.
- Age 18 or older
- Resident in Blantyre District
- Not planning to relocate out of Blantyre District in next 12 months
- Exclusion Criteria for PWLE:
- Not a current outpatient at Queen Elizabeth Central Hospital psychiatry clinic
- Not Age 18 or older
- No diagnosis of schizophrenia spectrum disorder or clinical presentation of symptoms of hallucinations, delusions or thought disorder that persisted for longer than one month and are accompanied by significant functional impairment
- Not a resident in Blantyre District
- Planning to relocate out of Blantyre District in next 12 months
- Does not have a primary caregiver willing to participate in the study
- Does not have current elevated symptoms or poor functioning as demonstrated by one or more of:
- Positive and Negative Symptoms Scale score ≥58
- WHO Disability Assessment Schedule 2.0 score ≥35
- Clinical Global Impression Severity score ≥2 (at least mildly ill)
- Exclusion Criteria for Caregivers:
- Is not a current caregiver for an eligible and consenting patient participant.
- Not Age 18 or older
- Not a resident in Blantyre District
- Planning to relocate out of Blantyre District in next 12 months
Exclusion
Key Trial Info
Start Date :
December 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06080477
Start Date
December 4 2023
End Date
August 31 2025
Last Update
September 22 2025
Active Locations (1)
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1
Queen Elizabeth Central Hosptial
Blantyre, Malawi