NCT06080477Completed
Enhancing Mental Health Outcomes for Patients With Psychosis in Malawi Through Community-based Rehabilitation
Enhancing Post-acute Mental Health Outcomes for Patients With Psychosis in Malawi Through Nurse-delivered Community-based Rehabilitation: The ENHANCE Pilot Trial
Source: ClinicalTrials.gov · Last updated 24 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 178 (actual)
- First submitted
- 6 Oct 2023
- Start date
- Dec 2023
- Primary completion date
- Aug 2025
- Lead sponsor
- University of North Carolina, Chapel Hill
- Diseases
- Schizophrenia
- NCT number
- NCT06080477
What you commit to
- Study type: Interventional
- Participants enrolled: 178
- From Dec 2023 to the primary completion date, Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Age
- Not Age 18 or older
- Not Age 18 or older
Other
- Not a current outpatient at Queen Elizabeth Central Hospital psychiatry clinic
- 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)
- Is not a current caregiver for an eligible and consenting patient participant.
- Not a resident in Blantyre District
- Planning to relocate out of Blantyre District in next 12 months
Who the study is looking for
- 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)
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Queen Elizabeth Central Hosptial Coordinator of this site? Confirm its status | Blantyre | Malawi | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.