Improving mental health for people with psychosis in Malawi through community support

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the feasibility, acceptability, fidelity, and preliminary effectiveness of a nurse-led, community-based rehabilitation model for individuals living with psychosis in Blantyre, Malawi. It focuses on providing long-term outpatient treatment and support to address the chronic nature of psychotic disorders, which are prevalent in low- and middle-income countries. The study will involve a pilot randomized controlled trial to assess the impact of enhanced usual care and an adapted intervention on patient outcomes. By addressing community factors that contribute to relapse, the study seeks to improve overall mental health outcomes for patients.

Why it matters

Who can join: the full rules

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

Where it's running

• Queen Elizabeth Central Hosptial
  Blantyre, Malawi Recruiting

Study contacts

• Principal investigator: Brian Pence, PhD, MPH — University of North Carolina, Chapel Hill
• Study coordinator: Brian Pence, PhD, MPH
• Email: bpence@unc.edu
• Phone: 1-919-966-7446

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.