Enhancing Mental Health Outcomes for Patients With Psychosis in Malawi Through Community-based Re… (NCT06080477) | Clinical Trial Compass
CompletedNot Applicable
Enhancing Mental Health Outcomes for Patients With Psychosis in Malawi Through Community-based Rehabilitation
Malawi60 participantsStarted 2023-12-04
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 prima…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recruitment Rate (Recruitment Feasibility)
Timeframe: Baseline
2
Proportion of participants retained in the study (Retention Feasibility)
Timeframe: 12 months
3
Number of Participants Who Were Either Very Satisfied or Somewhat Satisfied with the Intervention (Intervention Acceptability)
Timeframe: Conclusion of study
4
Proportion of Completed Intervention Sessions (Intervention Attendance Fidelity)