PsychosisSCAPE-UNCT05863572
Strengthening Care in Collaboration With People With Lived Experience of Psychosis in Uganda
A study testing Primary care health worker training, Community Health Workers Training and Home visits in people with Psychosis, run by George Washington University at 1 site in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychosis
- What is being tested?
- Primary care health worker training, Community Health Workers Training and Home visits
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 1 siteUganda
- Study dates
- 16 Jan 2024to 13 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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)
- Persons diagnosed with psychosis at a primary health care facility in Kampala/Wakiso District; For this study, a diagnosis of psychosis will include the following diagnoses according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5):schizophrenia spectrum and other psychotic disorders [brief psychotic disorder, schizophreniform disorder, schizoaffective disorder, schizophrenia, and organic psychosis (i.e., psychosis secondary to a medical condition such as HIV or an alcohol- or substance-use disorder)];bipolar affective disorder and related disorders;
- Ability of the patient or responsible surrogate to consent to study enrolment and procedures;
- Persons eligible for outpatient management of psychosis
- Family members a. Family member or caregiver of the patients above.
Who cannot join
- Facilitators of the implementation strategy:
- Inability to provide informed consent.
- Primary care providers:
- None
- Community health workers:
- None
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The aim of the current study is to conduct a pilot cluster randomized controlled trial to determine feasibility and acceptability of people with lived experience of psychosis collaborating in training primary care and community health care workers and co-delivering services in the home. This pilot study will consist of two trial arms: - Training- As- Usual vs the experimental arm. It will be implemented across three-tiers - in primary health care, community, and home settings. The pilot will also determine the parameters needed for appropriate design and implementation of a fully-power future cluster randomized controlled trial.
Objective 1 - To assess the feasibility and acceptability of the implementation strategy from the perspective of people with lived experience of psychosis, family members and primary and community care providers.
Objective 2 - To demonstrate proof-of-concept for the benefit of the implementation strategy for service users (i.e., patients with psychosis receiving primary care services) and their families, including changes in psychosis symptoms, quality of life, frequency of hospitalization and the potential impacts on family members.
Objective 3 - To evaluate changes in health systems outcomes in terms of primary care provider knowledge, attitudes, competency in psychosis diagnosis and management, accuracy of diagnosis and fidelity to treatment guidelines in actual care settings as well as trial procedures.
Objective 4: To evaluate costing, recruitment and retention, and data collection procedures and protocols to determine the optimal design for a future fully powered cluster Randomized Controlled Trial.
Objective 5: To establish and demonstrate ethics and safety in collaborating with service users.
- Conditions
- Psychosis
- Being tested
- Primary care health worker training, Community Health Workers Training, Home visits
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary care health worker trainingOther
Training primary care workers to detect and treat psychosis.
Community Health Workers TrainingOther
training community health workers in detection and referral
Home visitsOther
home visits conducted by people with lived experience of psychosis
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual | Active comparator | Training primary care workers in diagnosis and treatment; training community health workers in detection and referral. Receives: 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. Receives: Other: Primary care health worker training; Other: Community Health Workers Training; Other: Home visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Symptoms of Schizophrenia (PANSS) scale
Symptoms of Psychosis, minimum = 0, maximum = 56, higher score is worse
Measured: baseline - immediately after enrollment
Positive and Negative Symptoms of Schizophrenia (PANSS) scale
Symptoms of Psychosis, minimum = 0, maximum = 56, higher score is worse
Measured: 4 months post enrollment
Positive and Negative Symptoms of Schizophrenia (PANSS) scale
Symptoms of Psychosis, minimum = 0, maximum = 56, higher score is worse
Measured: 8 months post enrollment
Secondary outcomes (42)
World Health Organization Quality of Life-Brief Scale
Brief quality of life scale, minimum = 0, maximum = 100, Higher score refers to better quality of life
Measured: immediately after enrollment
World Health Organization Quality of Life-Brief Scale
Brief quality of life scale, minimum = 0, maximum = 100, Higher score refers to better quality of life
Measured: 4 months post enrollment
World Health Organization Quality of Life-Brief Scale
Brief quality of life scale, minimum = 0, maximum = 100, Higher score refers to better quality of life
Measured: 8 months post enrollment
Service user collaboration checklist
Benefits and challenges of service users' collaboration, minimum = 12, maximum = 48, higher number refers to strong collaboration experience
Measured: immediately after enrollment
Service user collaboration checklist
Benefits and challenges of service users' collaboration, minimum = 12, maximum = 48, higher number refers to strong collaboration experience
Measured: 4 months post enrollment
Service user collaboration checklist
Benefits and challenges of service users' collaboration, minimum = 12, maximum = 48, higher number refers to strong collaboration experience
Measured: 8 months post enrollment
EuroQuality of Life 5-Dimension 5-Level
Quality of Life (for health economics analyses), minimum = 5, maximum=25, higher score is worse
Measured: immediately after enrollment
EuroQuality of Life 5-Dimension 5-Level
Quality of Life (for health economics analyses), minimum = 5, maximum=25, higher score is worse
Measured: 4 months post enrollment
EuroQuality of Life 5-Dimension 5-Level
Quality of Life (for health economics analyses), minimum = 5, maximum=25, higher score is worse
Measured: 8 months post enrollment
Discrimination and Stigma Scale-Brief version
Stigma experienced by persons living with mental illness, minimum = 0, maximum = 33, Higher score refers to higher experience of stigma
Measured: immediately after enrollment
Discrimination and Stigma Scale-Brief version
Stigma experienced by persons living with mental illness, minimum = 0, maximum = 33, Higher score refers to higher experience of stigma
Measured: 4 months post enrollment
Discrimination and Stigma Scale-Brief version
Stigma experienced by persons living with mental illness, minimum = 0, maximum = 33, Higher score refers to higher experience of stigma
Measured: 8 months post enrollment
Social Inclusion Scale
Social Inclusion of service users, minimum = 10, maximum = 50, Higher score refers to better experience of social inclusion
Measured: immediately after enrollment
Social Inclusion Scale
Social Inclusion of service users, minimum = 10, maximum = 50, Higher score refers to better experience of social inclusion
Measured: 4 months post enrollment
Social Inclusion Scale
Social Inclusion of service users, minimum = 10, maximum = 50, Higher score refers to better experience of social inclusion
Measured: 8 months post enrollment
Hospitalization Record
no minimum or maximum, score is total number of days patient was hospitalized during study period
Measured: immediately after enrollment
Hospitalization Record
no minimum or maximum, score is total number of days patient was hospitalized during study period
Measured: 4 months post-enrollment
Hospitalization Record
no minimum or maximum, score is total number of days patient was hospitalized during study period
Measured: 8 months post enrollment
Client Service Receipt Inventory
Costs of care to patients, there is no maximum or minimum score, the outcome is total cost for patient to get healthcare
Measured: immediately after enrollment
Client Service Receipt Inventory
Costs of care to patients, there is no maximum or minimum score, the outcome is total cost for patient to get healthcare
Measured: 4 months post enrollment
Client Service Receipt Inventory
Costs of care to patients, there is no maximum or minimum score, the outcome is total cost for patient to get healthcare
Measured: 8 months post enrollment
Family Interview Schedule-Impact on Caregivers
Impact on family members and caregivers of people with mental illness, minimum = 0, maximum = 48, higher score means higher burden on the families
Measured: immediately after enrollment
Family Interview Schedule-Impact on Caregivers
Impact on family members and caregivers of people with mental illness, minimum = 0, maximum = 48, higher score means higher burden on the families
Measured: 4 months post enrollment
Family Interview Schedule-Impact on Caregivers
Impact on family members and caregivers of people with mental illness, minimum = 0, maximum = 48, higher score means higher burden on the families
Measured: 8 months post enrollment
Community Health Workers: Social Distance Scale
Attitudes of community health workers towards people with psychosis, 12-item scale of willingness to interact with persons with mental illness, minimum = 0, maximum = 72, higher score is worse outcome
Measured: pre training
Community Health Workers: Social Distance Scale
Attitudes of community health workers towards people with psychosis, 12-item scale of willingness to interact with persons with mental illness, minimum = 0, maximum = 72, higher score is worse outcome
Measured: immediately after training
Community Health Workers: Assessment tool
Accuracy of detection, no score - will check if their detection matches with the gold standard - Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders 5
Measured: monthly throughout the study period : average of 8 months, However accuracy check during SCID diagnosis check
Community Health Workers: Village health team referral
no maximum or minimum, outcome is the number of patients referred by community health workers to the health post
Measured: monthly throughout the study period (average of 8 months), starts immediately after training
Community Health Workers: Village health team referral with psychosis
no maximum or minimum, outcome is the number of patients diagnosed with psychosis by PCP and referred by community health workers to the health post
Measured: monthly throughout the study period (average of 8 months), starts immediately after training
Primary care workers: Social Distance Scale
12-item scale of willingness to interact with persons with mental illness, minimum = 0, maximum = 72, higher score is worse outcome
Measured: pre training
Primary care workers: Social Distance Scale
12-item scale of willingness to interact with persons with mental illness, minimum = 0, maximum = 72, higher score is worse outcome
Measured: immediately after training
Primary care workers: Social Distance Scale
12-item scale of willingness to interact with persons with mental illness, minimum = 0, maximum = 72, higher score is worse outcome
Measured: final supervision: 8 months post training
Primary care workers: Mental health Gap Action Program Knowledge
Multiple-choice assessment from mental health Gap Action Programme training materials; minimum = 0, maximum = 100, higher is better outcome
Measured: pre training
Primary care workers: Mental health Gap Action Program Knowledge
Multiple-choice assessment from mental health Gap Action Programme training materials; minimum = 0, maximum = 100, higher is better outcome
Measured: immediately after training
Primary care workers: Mental health Gap Action Program Knowledge
Multiple-choice assessment from mental health Gap Action Programme training materials; minimum = 0, maximum = 100, higher is better outcome
Measured: final supervision: 8 months post training
Primary care workers: Enhancing Assessment of Common Therapeutic factors for Psychosis
Observed structured clinical evaluation using a standardized role play, minimum score = 0, maximum = 100, higher scores are better
Measured: pre training
Primary care workers: Enhancing Assessment of Common Therapeutic factors for Psychosis
Observed structured clinical evaluation using a standardized role play, minimum score = 0, maximum = 100, higher scores are better
Measured: immediately after training
Primary care workers: Enhancing Assessment of Common Therapeutic factors for Psychosis
Observed structured clinical evaluation using a standardized role play, minimum score = 0, maximum = 100, higher scores are better
Measured: final supervision - 8 months post training
Health Facility Record
no minimum or maximum, score is the total number of patient diagnosed with psychosis : clinical records reviewed by Research Assistants
Measured: pre training
Health Facility Record
no minimum or maximum, score is the total number of patient diagnosed with psychosis : clinical records reviewed by Research Assistants
Measured: immediately after training
Health Facility Record
no minimum or maximum, score is the total number of patient diagnosed with psychosis : clinical records reviewed by Research Assistants
Measured: final supervision - 8 months post training
Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders 5
Accuracy of patient diagnosis by study mental health specialist
Measured: 3 months post patient enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start16 Jan 2024
- Primary completion13 Jan 2026
- Study completion13 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Collaborators
- YouBelong Uganda, Butabika National Referral Hospital
- Responsible party
- Principal investigator, Brandon A Kohrt, MD, PhD, George Washington University
- Investigators
- Brandon Kohrt, MD, PhD, Principal investigator, George Washington UniversityByamah Mutamba, MD, PhD, Principal investigator, YouBelong Uganda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05863572
- Sponsor's protocol ID
- HS2327ES
- Acronym
- SCAPE-U
- Status last verified
- May 2026
- First submitted
- 12 Apr 2023
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available. No plan for feasibility study.
Publications
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.
PubMed 40691846
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening Care in Collaboration With People With Lived Experience of Psychosis in Uganda
- ClinicalTrials.gov ID
- NCT05863572
- Acronym / sponsor ID
- SCAPE-U / HS2327ES
- Conditions
- Psychosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Collaborators
- YouBelong Uganda, Butabika National Referral Hospital
- Study start
- 16 Jan 2024 (actual)
- Primary completion
- 13 Jan 2026 (actual)
- Study completion
- 13 Jan 2026 (actual)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The aim of the current study is to conduct a pilot cluster randomized controlled trial to determine feasibility and acceptability of people with lived experience of psychosis collaborating in training primary care and community health care workers and co-delivering services in the home. This pilot study will consist of two trial arms: - Training- As- Usual vs the experimental arm. It will be implemented across three-tiers - in primary health care, community, and home settings. The pilot will also determine the parameters needed for appropriate design and implementation of a fully-power future cluster randomized controlled trial.
Objective 1 - To assess the feasibility and acceptability of the implementation strategy from the perspective of people with lived experience of psychosis, family members and primary and community care providers.
Objective 2 - To demonstrate proof-of-concept for the benefit of the implementation strategy for service users (i.e., patients with psychosis receiving primary care services) and their families, including changes in psychosis symptoms, quality of life, frequency of hospitalization and the potential impacts on family members.
Objective 3 - To evaluate changes in health systems outcomes in terms of primary care provider knowledge, attitudes, competency in psychosis diagnosis and management, accuracy of diagnosis and fidelity to treatment guidelines in actual care settings as well as trial procedures.
Objective 4: To evaluate costing, recruitment and retention, and data collection procedures and protocols to determine the optimal design for a future fully powered cluster Randomized Controlled Trial.
Objective 5: To establish and demonstrate ethics and safety in collaborating with service users.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | Active comparator | Other: Primary care health worker training, Other: Community Health Workers TrainingTraining primary care workers in diagnosis and treatment; training community health workers in detection and referral. |
| Strengthening care in collaboration with people with lived experience of psychosis in Uganda | Experimental | Other: Primary care health worker training, Other: Community Health Workers Training, Other: Home visitsTrainings done in collaboration with people with lived experience of psychosis; as well as additional home visits conducted by people with lived experience of psychosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Facilitators of the implementation strategy:
- Primary care providers:
- Community health workers
- Patients (Primary beneficiaries)
- Family members a. Family member or caregiver of the patients above.
Key exclusion criteria (11 listed)
- Facilitators of the implementation strategy:
- Primary care providers:
- None
- Community health workers:
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary care health worker trainingTraining primary care workers to detect and treat psychosis. | Other | Strengthening care in collaboration with people with lived experience of psychosis in Uganda, Treatment as usual |
| Community Health Workers Trainingtraining community health workers in detection and referral | Other | Strengthening care in collaboration with people with lived experience of psychosis in Uganda, Treatment as usual |
| Home visitshome visits conducted by people with lived experience of psychosis | Other | Strengthening care in collaboration with people with lived experience of psychosis in Uganda |
Primary outcome
Positive and Negative Symptoms of Schizophrenia (PANSS) scale
Time frame: baseline - immediately after enrollment
Symptoms of Psychosis, minimum = 0, maximum = 56, higher score is worse
Positive and Negative Symptoms of Schizophrenia (PANSS) scale
Time frame: 4 months post enrollment
Symptoms of Psychosis, minimum = 0, maximum = 56, higher score is worse
Positive and Negative Symptoms of Schizophrenia (PANSS) scale
Time frame: 8 months post enrollment
Symptoms of Psychosis, minimum = 0, maximum = 56, higher score is worse
42 secondary outcomes
World Health Organization Quality of Life-Brief Scale
Time frame: immediately after enrollment
World Health Organization Quality of Life-Brief Scale
Time frame: 4 months post enrollment
World Health Organization Quality of Life-Brief Scale
Time frame: 8 months post enrollment
Service user collaboration checklist
Time frame: immediately after enrollment
Service user collaboration checklist
Time frame: 4 months post enrollment
Service user collaboration checklist
Time frame: 8 months post enrollment
EuroQuality of Life 5-Dimension 5-Level
Time frame: immediately after enrollment
EuroQuality of Life 5-Dimension 5-Level
Time frame: 4 months post enrollment
EuroQuality of Life 5-Dimension 5-Level
Time frame: 8 months post enrollment
Discrimination and Stigma Scale-Brief version
Time frame: immediately after enrollment
Discrimination and Stigma Scale-Brief version
Time frame: 4 months post enrollment
Discrimination and Stigma Scale-Brief version
Time frame: 8 months post enrollment
Social Inclusion Scale
Time frame: immediately after enrollment
Social Inclusion Scale
Time frame: 4 months post enrollment
Social Inclusion Scale
Time frame: 8 months post enrollment
Hospitalization Record
Time frame: immediately after enrollment
Hospitalization Record
Time frame: 4 months post-enrollment
Hospitalization Record
Time frame: 8 months post enrollment
Client Service Receipt Inventory
Time frame: immediately after enrollment
Client Service Receipt Inventory
Time frame: 4 months post enrollment
Client Service Receipt Inventory
Time frame: 8 months post enrollment
Family Interview Schedule-Impact on Caregivers
Time frame: immediately after enrollment
Family Interview Schedule-Impact on Caregivers
Time frame: 4 months post enrollment
Family Interview Schedule-Impact on Caregivers
Time frame: 8 months post enrollment
Community Health Workers: Social Distance Scale
Time frame: pre training
Community Health Workers: Social Distance Scale
Time frame: immediately after training
Community Health Workers: Assessment tool
Time frame: monthly throughout the study period : average of 8 months, However accuracy check during SCID diagnosis check
Community Health Workers: Village health team referral
Time frame: monthly throughout the study period (average of 8 months), starts immediately after training
Community Health Workers: Village health team referral with psychosis
Time frame: monthly throughout the study period (average of 8 months), starts immediately after training
Primary care workers: Social Distance Scale
Time frame: pre training
Primary care workers: Social Distance Scale
Time frame: immediately after training
Primary care workers: Social Distance Scale
Time frame: final supervision: 8 months post training
Primary care workers: Mental health Gap Action Program Knowledge
Time frame: pre training
Primary care workers: Mental health Gap Action Program Knowledge
Time frame: immediately after training
Primary care workers: Mental health Gap Action Program Knowledge
Time frame: final supervision: 8 months post training
Primary care workers: Enhancing Assessment of Common Therapeutic factors for Psychosis
Time frame: pre training
Primary care workers: Enhancing Assessment of Common Therapeutic factors for Psychosis
Time frame: immediately after training
Primary care workers: Enhancing Assessment of Common Therapeutic factors for Psychosis
Time frame: final supervision - 8 months post training
Health Facility Record
Time frame: pre training
Health Facility Record
Time frame: immediately after training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Derived from this study: PubMed 40691846Mutamba 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.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available. No plan for feasibility study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brandon Kohrt, MD, PhD principal investigator
George Washington University
Byamah Mutamba, MD, PhD principal investigator
YouBelong Uganda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary care health worker training, Community Health Workers Training and Home visits in people with Psychosis, run by George Washington University at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and Negative Symptoms of Schizophrenia (PANSS) scale (time frame: baseline - immediately after enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05863572, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.