Improving mental health for people with psychosis in Malawi through community support
Enhancing Post-acute Mental Health Outcomes for Patients With Psychosis in Malawi Through Nurse-delivered Community-based Rehabilitation: The ENHANCE Pilot Trial
This study is testing a new community support program led by nurses to see if it can help people with psychosis in Malawi feel better and manage their condition more effectively.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Blantyre) |
| Trial ID | NCT06080477 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of schizophrenia spectrum disorder or significant psychotic symptoms, currently receiving outpatient care in Blantyre.
Not a fit: Patients who are not currently residing in Blantyre or those who do not have a primary caregiver willing to participate may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the quality of life and functional outcomes for patients with psychosis in Malawi.
How similar studies have performed: Other studies have shown promise in community-based interventions for mental health, suggesting that this approach could be effective, although it may be novel in the specific context of Malawi.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Blantyre
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.