Enhancing Mental Health Outcomes for Patients With Psychosis in Malawi Through Community-based Rehabilitation

NCT06080477 | Completed

• 2 other identifiers: 23-1665R34MH131234
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psychosis

Outcome Measures

Primary Outcomes (4)

• Recruitment Rate (Recruitment Feasibility)

  This measure is the ability to successfully enroll people with lived experience (PWLE) in the pilot intervention. Feasibility will be evaluated by measuring the recruitment rate (number of patients approached in order to accrue the final sample).

  Baseline

• Proportion of participants retained in the study (Retention Feasibility)

  Feasibility will be evaluated by measuring the proportion of participants retained in the study (number of patients enrolled at baseline who are still enrolled in the trial through 12 months).

  12 months

• Number of Participants Who Were Either Very Satisfied or Somewhat Satisfied with the Intervention (Intervention Acceptability)

  The number of patients who were either very satisfied or somewhat satisfied with the intervention among all participants who received the intervention. Satisfaction will be measured on a 4-point Likert scale where 1 indicates high satisfaction and 4 indicates high dissatisfaction.

  Conclusion of study

• Proportion of Completed Intervention Sessions (Intervention Attendance Fidelity)

  The total number of intervention sessions completed, out of the number of sessions expected to be completed.

  12 months

Secondary Outcomes (7)

• Overall Functioning

  12 months

• Quality of Life based on Short-Form 8 measure

  12 months

• Change in psychosis symptoms from baseline

  Baseline,12 months

• Psychosis Symptom Response

  12 months

• Psychosis Symptom Remission

  12 months

Study Arms (2)

Adapted ENHANCE Intervention

EXPERIMENTAL

Nurse-delivered community-based treatment model for people living with psychosis in the community, coordinated with the usual outpatient care

Behavioral: Adapted ENHANCE Intervention

Enhanced usual care

ACTIVE COMPARATOR

Continue with usual outpatient care, enhanced with additional feedback and clinical recommendations to the outpatient treatment team

Behavioral: Enhanced Usual Care

Interventions

Enhanced Usual Care BEHAVIORAL

Participants randomized to usual care will continue to receive their standard clinical care at Queen Elizabeth Central Hospital (QECH) as previously. The clinical team will be provided a summary of the results of the eligibility assessment, specifically an interpretation of the scores on the symptomatology and disability scales with any relevant clinical recommendations. These individuals will receive no home-based services.

Enhanced usual care

Adapted ENHANCE Intervention BEHAVIORAL

Participants randomized to the intervention arm will receive community-based rehabilitation (CBR) delivered by the Queen Elizabeth Central Hospital (QECH) clinical team of psychiatric nurses. The ENHANCE CBR intervention will consist of nurse-delivered home visits over approximately a 12-month period with decreasing intensity, with approximately weekly visits for an initial phase of 2-4 months; biweekly visits for an intermediate phase of 4-6 months; and monthly for a final transition phase of 3-4 months. The exact schedule and duration of each phase will be individualized by the nurse to the participant based on the participant's initial presentation and their response during the intervention. The intervention team will deliver intervention content with the participant and/or family members and caregivers as appropriate to the module.

Adapted ENHANCE Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Queen Elizabeth Central Hosptial

Blantyre, Malawi

Location

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Brian Pence, PhD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-arm individually randomized trial

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 12, 2023
• Study Start: December 4, 2023
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: 9 to 36 months following publication
• Access Criteria: The investigator who proposes to use the data has approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC.

Locations

MA (1)