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COMPLETED

NCT06080477

Enhancing Mental Health Outcomes for Patients With Psychosis in Malawi Through Community-based Rehabilitation

Sponsor: University of North Carolina, Chapel Hill

View on ClinicalTrials.gov

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 for community-dwelling individuals living with psychosis in Blantyre, Malawi using a pilot randomized controlled trial.

Official title: Enhancing Post-acute Mental Health Outcomes for Patients With Psychosis in Malawi Through Nurse-delivered Community-based Rehabilitation: The ENHANCE Pilot Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

178

Start Date

2023-12-04

Completion Date

2025-08-31

Last Updated

2026-09-24

Healthy Volunteers

Yes

Conditions

Psychosis

Interventions

BEHAVIORAL

Enhanced Usual Care

Participants randomized to usual care will continue to receive their standard clinical care at Queen Elizabeth Central Hospital (QECH) as previously. The clinical team will be provided a summary of the results of the eligibility assessment, specifically an interpretation of the scores on the symptomatology and disability scales with any relevant clinical recommendations. These individuals will receive no home-based services.

BEHAVIORAL

Adapted ENHANCE Intervention

Participants randomized to the intervention arm will receive community-based rehabilitation (CBR) delivered by the Queen Elizabeth Central Hospital (QECH) clinical team of psychiatric nurses. The ENHANCE CBR intervention will consist of nurse-delivered home visits over approximately a 12-month period with decreasing intensity, with approximately weekly visits for an initial phase of 2-4 months; biweekly visits for an intermediate phase of 4-6 months; and monthly for a final transition phase of 3-4 months. The exact schedule and duration of each phase will be individualized by the nurse to the participant based on the participant's initial presentation and their response during the intervention. The intervention team will deliver intervention content with the participant and/or family members and caregivers as appropriate to the module.

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

Locations (1)

Queen Elizabeth Central Hosptial

Blantyre, Malawi