Clinical trial NCT06080477: Enhancing Mental Health Outcomes for Patients With Psychosis in Malawi Through Community-based Rehabilitation
Official title: Enhancing Post-acute Mental Health Outcomes for Patients With Psychosis in Malawi Through Nurse-delivered Community-based Rehabilitation: The ENHANCE Pilot Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychosis
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-10-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm individually randomized trial
Primary purpose: TREATMENT

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.

Detailed description: Psychosis exacts a heavy morbidity and mortality toll worldwide, but especially in low- and middle-income countries (LMICs). Psychotic disorders are one of the most common presenting complaints for individuals admitted to specialty mental health services in many LMICs. Psychotic disorders typically have onset in early adulthood and a chronic course, meaning patients suffer from many years of poor functionality, disability, and lost productivity. Indeed, psychotic disorders remain among the 15 leading causes of disability globally. The chronicity and severity of psychotic disorders exert a heavy burden on family as relatives frequently have to assume caregiver roles in LMIC where access to formal mental health care is limited.

Despite the significant toll of psychosis in LMICs, treatment options are extremely limited and focus heavily on acute, time-limited inpatient stabilization. This focus fails to consider the demonstrated need for long-term post-acute outpatient treatment and community-based rehabilitation to improve outcomes and prevent relapse. Contextual community factors such as reliable continued access to mental health care, stigma and its negative impact on medication adherence, inadequate support, and family conflict are key risk factors for subsequent relapse upon discharge into the community. Research has recommended the need for community interventions to minimize medication non-adherence and limit relapse and readmission.

Community-based rehabilitation (CBR) directly addresses the need for a concerted approach to post-acute community-based care for people with psychosis in low-resource settings. CBR is a general evidence-based approach for the long-term treatment and support of individuals with a broad range of disabilities in resource-constrained settings that is particularly well suited to address the needs of those with psychosis. CBR aims to improve the quality of life of individuals living with disability by supporting medical care engagement, addressing functional goals, and encouraging social inclusion within their families and communities. CBR is amenable to delivery by a range of personnel and involves collaboration between caregivers, community members, and available public sector services to facilitate the rehabilitation of patients.

Accordingly, in this protocol the investigators will pilot-test an adaptation of the evidence-based Community-Based Rehabilitation (CBR) treatment model specifically to address the needs of community-dwelling individuals with psychosis in Malawi. Specifically, investigators will complete a pilot randomized controlled trial to evaluate the feasibility, acceptability, fidelity, and preliminary effectiveness of the adapted CBR treatment model. This work will provide a critical advance in establishing the evidence base for community-based treatment models for people living with psychosis outside of the context of acute inpatient stabilization so as to enhance rehabilitation, functioning, and quality of life.

Eligibility 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

Primary outcomes:
measure: Recruitment Rate (Recruitment Feasibility)
timeFrame: Baseline
measure: Proportion of participants retained in the study (Retention Feasibility)
timeFrame: 12 months
measure: Number of Participants Who Were Either Very Satisfied or Somewhat Satisfied with the Intervention (Intervention Acceptability)
timeFrame: Conclusion of study
measure: Proportion of Completed Intervention Sessions (Intervention Attendance Fidelity)
timeFrame: 12 months
Secondary outcomes:
measure: Overall Functioning
timeFrame: 12 months
measure: Quality of Life based on Short-Form 8 measure
timeFrame: 12 months
measure: Change in psychosis symptoms from baseline
timeFrame: Baseline,12 months
measure: Psychosis Symptom Response
timeFrame: 12 months
measure: Psychosis Symptom Remission
timeFrame: 12 months
measure: Clinical Improvement
timeFrame: 12 months
measure: Internalized stigma
timeFrame: 12 months
Other outcomes:
Locations:
city: Blantyre
country: Malawi
facility: Queen Elizabeth Central Hosptial
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Brian Pence, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: