Strengthening Care in Collaboration With People With Lived Experience of Psychosis in Uganda

NCT05863572 | Recruiting DMC

• 1 other identifier: HS2327ES
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Mental health services are most effective and equitable when designed, delivered, and evaluated in collaboration with people with lived experience of mental health conditions. Unfortunately, people with lived experience are rarely involved in health systems strengthening or are limited to specific components (e.g., peer helpers) rather than multi-tiered collaboration in the continuum of health services (e.g., ranging from home- to community- to clinic-based services). Moreover, programs that do involve people with lived experience, typically involve people with a history of a substance use conditions or common mental disorders. In contrast, the collaboration of people with lived experience of psychosis is especially rare. A pilot cluster randomized controlled trial will be conducted in urban and peri-urban areas around Kampala, Uganda, to evaluate the benefits of an implementation strategy for mental health services with engagement of people with lived experience of psychosis throughout the home-to-community-to-clinic care continuum, this is a hybrid type-III implementation-effectiveness pilot focusing on the differences in implementation strategy. This implementation strategy, entitled "Strengthening CAre in collaboration with People with lived Experience of psychosis in Uganda", will include training people with lived experience of psychosis using PhotoVoice and other methods to participate at three levels: in-home services, community engagement, and primary health care facilities. The investigators will compare a standard task-sharing implementation arm using training by mental health specialists with an experimental implementation arm that includes collaboration with people with lived experience. The primary objective is to evaluate the feasibility and acceptability of this strategy in the context of assuring safety and wellbeing of people with lived experience of psychosis who collaborate in health systems strengthening. By collaborating on health systems strengthening across these multiple levels, we foresee a more in-depth contribution that can lead to rethinking how best to design and deliver care for people with lived experience of psychosis. Successful completion of this pilot will be the foundation for a fully powered trial to evaluate the benefits of multi-level collaboration with people with lived experience of psychosis.

Conditions

Psychosis

Outcome Measures

Primary Outcomes (3)

• Positive and Negative Symptoms of Schizophrenia (PANSS) scale

  Symptoms of Psychosis, minimum = 0, maximum = 56, higher score is worse

  baseline - immediately after enrollment

• Positive and Negative Symptoms of Schizophrenia (PANSS) scale

  Symptoms of Psychosis, minimum = 0, maximum = 56, higher score is worse

  4 months post enrollment

• Positive and Negative Symptoms of Schizophrenia (PANSS) scale

  Symptoms of Psychosis, minimum = 0, maximum = 56, higher score is worse

  8 months post enrollment

Secondary Outcomes (42)

• World Health Organization Quality of Life-Brief Scale

  immediately after enrollment

• World Health Organization Quality of Life-Brief Scale

  4 months post enrollment

• World Health Organization Quality of Life-Brief Scale

  8 months post enrollment

• Service user collaboration checklist

  immediately after enrollment

• Service user collaboration checklist

  4 months post enrollment

Study Arms (2)

Treatment as usual

ACTIVE COMPARATOR

Training primary care workers in diagnosis and treatment; training community health workers in detection and referral.

Other: Primary care health worker training; Other: Community Health Workers Training

Strengthening care in collaboration with people with lived experience of psychosis in Uganda

EXPERIMENTAL

Trainings done in collaboration with people with lived experience of psychosis; as well as additional home visits conducted by people with lived experience of psychosis.

Other: Primary care health worker training; Other: Community Health Workers Training; Other: Home visits

Interventions

Primary care health worker training OTHER

Training primary care workers to detect and treat psychosis.

Strengthening care in collaboration with people with lived experience of psychosis in Uganda; Treatment as usual

Community Health Workers Training OTHER

training community health workers in detection and referral

Strengthening care in collaboration with people with lived experience of psychosis in Uganda; Treatment as usual

Home visits OTHER

home visits conducted by people with lived experience of psychosis

Strengthening care in collaboration with people with lived experience of psychosis in Uganda

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Facilitators of the implementation strategy:
• At least 18 years of age
• Confirmed diagnosis of a primary psychotic disorder (e.g., schizophrenia) by a psychiatrist or psychiatric clinical officer
• Completion of the YouBelongHOME (YBH) program
• Provision of informed consent,
• Fluency in the local language (Luganda)
• Good functioning with respect to performance of daily chores,engagement with family members, comprehension and community participation as assessed by the YBH team
• A supportive family member.
• Primary care providers:
• Provides primary care in health facility of Kampala/Wakiso District
• Selected by facility in-charge
• Community health workers
• Provides community based health service in health facility where primary care providers are trained (from Kampala/Wakiso district)
• Selected by facility in-charge
• Patients (Primary beneficiaries)

You may not qualify if:

• Facilitators of the implementation strategy:
• a. Inability to provide informed consent.
• Primary care providers:
• None
• Community health workers:
• None
• Patients
• Persons diagnosed with psychosis requiring inpatient management/services; and
• Persons for whom consent for participation in the study cannot be obtained.
• Patients found to be severely ill beyond the capacity of the health facility to treat.
• Family members a. Family members who doesn't provide consent for participation

Sponsors & Collaborators

• George Washington University: lead
• YouBelong Uganda: collaborator
• Butabika National Referral Hospital: collaborator

Study Sites (1)

YouBelong Uganda

Kampala, 99999, Uganda

RECRUITING

Related Publications (1)

• Mutamba BB, Rai S, Semakula L, Cappo D, Asher L, Gwaikolo W, Kohrt BA. Strengthening care in collaboration with people with lived experience of psychosis in Uganda (SCAPE-U): A protocol for a cluster randomized controlled feasibility trial. Pilot Feasibility Stud. 2025 Jul 21;11(1):103. doi: 10.1186/s40814-025-01684-8.

  PMID: 40691846 DERIVED

MeSH Terms

Conditions

Psychotic Disorders

Interventions

House Calls

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Brandon Kohrt, MD, PhD

  George Washington University

  PRINCIPAL INVESTIGATOR

• Byamah Mutamba, MD, PhD

  YouBelong Uganda

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brandon A Kohrt, MD, PhD

CONTACT

2027412860; bkohrt@gwu.edu

Sauharda Rai, MA,PhD

CONTACT

2027412860; sauharda@gwu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors are masked to study arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Cluster randomized controlled trial

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: May 18, 2023
• Study Start: September 5, 2023
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)