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Could nurse home visits help psychosis patients in malawi?

NCT ID NCT06080477

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 01, 2026 · Updated 3 times

Summary

This pilot study tested whether a nurse-led community-based rehabilitation program is feasible and acceptable for people with psychosis in Blantyre, Malawi. Sixty adults with psychosis were randomly assigned to either usual care or the home-based program. The study focused on recruitment, retention, satisfaction, and session attendance, not on whether the program improves symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nurse-delivered community-based rehabilitation (behavioral intervention)
What this could lead to
If successful, this could point toward a scalable, low-cost way to improve mental health outcomes for people with psychosis in low-resource settings.
What could go wrong
This is a small pilot study (60 participants) testing feasibility, not effectiveness. Results may not generalize to other regions or populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

178 people

The number who actually took part.

Started

Dec 2023

Finished

Aug 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Queen Elizabeth Central Hosptial

    Blantyre, Malawi

More trials for these conditions

Other studies related to the condition(s) this trial covers.