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Completed

NCT Number: NCT05863572

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

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.

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Key information

Conditions

Psychosis Mental Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

YouBelong Uganda

Kampala, 99999, Uganda

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Primary care health worker training

Other

Training primary care workers to detect and treat psychosis.

Community Health Workers Training

Other

training community health workers in detection and referral

Home visits

Other

home visits conducted by people with lived experience of psychosis

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. World Health Organization Quality of Life-Brief Scale

    Time frame: immediately after enrollment

    Brief quality of life scale, minimum = 0, maximum = 100, Higher score refers to better quality of life

  2. World Health Organization Quality of Life-Brief Scale

    Time frame: 4 months post enrollment

    Brief quality of life scale, minimum = 0, maximum = 100, Higher score refers to better quality of life

  3. World Health Organization Quality of Life-Brief Scale

    Time frame: 8 months post enrollment

    Brief quality of life scale, minimum = 0, maximum = 100, Higher score refers to better quality of life

  4. Service user collaboration checklist

    Time frame: immediately after enrollment

    Benefits and challenges of service users' collaboration, minimum = 12, maximum = 48, higher number refers to strong collaboration experience

  5. Service user collaboration checklist

    Time frame: 4 months post enrollment

    Benefits and challenges of service users' collaboration, minimum = 12, maximum = 48, higher number refers to strong collaboration experience

  6. Service user collaboration checklist

    Time frame: 8 months post enrollment

    Benefits and challenges of service users' collaboration, minimum = 12, maximum = 48, higher number refers to strong collaboration experience

  7. EuroQuality of Life 5-Dimension 5-Level

    Time frame: immediately after enrollment

    Quality of Life (for health economics analyses), minimum = 5, maximum=25, higher score is worse

  8. EuroQuality of Life 5-Dimension 5-Level

    Time frame: 4 months post enrollment

    Quality of Life (for health economics analyses), minimum = 5, maximum=25, higher score is worse

  9. EuroQuality of Life 5-Dimension 5-Level

    Time frame: 8 months post enrollment

    Quality of Life (for health economics analyses), minimum = 5, maximum=25, higher score is worse

  10. Discrimination and Stigma Scale-Brief version

    Time frame: immediately after enrollment

    Stigma experienced by persons living with mental illness, minimum = 0, maximum = 33, Higher score refers to higher experience of stigma

  11. Discrimination and Stigma Scale-Brief version

    Time frame: 4 months post enrollment

    Stigma experienced by persons living with mental illness, minimum = 0, maximum = 33, Higher score refers to higher experience of stigma

  12. Discrimination and Stigma Scale-Brief version

    Time frame: 8 months post enrollment

    Stigma experienced by persons living with mental illness, minimum = 0, maximum = 33, Higher score refers to higher experience of stigma

  13. Social Inclusion Scale

    Time frame: immediately after enrollment

    Social Inclusion of service users, minimum = 10, maximum = 50, Higher score refers to better experience of social inclusion

  14. Social Inclusion Scale

    Time frame: 4 months post enrollment

    Social Inclusion of service users, minimum = 10, maximum = 50, Higher score refers to better experience of social inclusion

  15. Social Inclusion Scale

    Time frame: 8 months post enrollment

    Social Inclusion of service users, minimum = 10, maximum = 50, Higher score refers to better experience of social inclusion

  16. Hospitalization Record

    Time frame: immediately after enrollment

    no minimum or maximum, score is total number of days patient was hospitalized during study period

  17. Hospitalization Record

    Time frame: 4 months post-enrollment

    no minimum or maximum, score is total number of days patient was hospitalized during study period

  18. Hospitalization Record

    Time frame: 8 months post enrollment

    no minimum or maximum, score is total number of days patient was hospitalized during study period

  19. Client Service Receipt Inventory

    Time frame: immediately after enrollment

    Costs of care to patients, there is no maximum or minimum score, the outcome is total cost for patient to get healthcare

  20. Client Service Receipt Inventory

    Time frame: 4 months post enrollment

    Costs of care to patients, there is no maximum or minimum score, the outcome is total cost for patient to get healthcare

  21. Client Service Receipt Inventory

    Time frame: 8 months post enrollment

    Costs of care to patients, there is no maximum or minimum score, the outcome is total cost for patient to get healthcare

  22. Family Interview Schedule-Impact on Caregivers

    Time frame: immediately after enrollment

    Impact on family members and caregivers of people with mental illness, minimum = 0, maximum = 48, higher score means higher burden on the families

  23. Family Interview Schedule-Impact on Caregivers

    Time frame: 4 months post enrollment

    Impact on family members and caregivers of people with mental illness, minimum = 0, maximum = 48, higher score means higher burden on the families

  24. Family Interview Schedule-Impact on Caregivers

    Time frame: 8 months post enrollment

    Impact on family members and caregivers of people with mental illness, minimum = 0, maximum = 48, higher score means higher burden on the families

  25. Community Health Workers: Social Distance Scale

    Time frame: pre training

    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

  26. Community Health Workers: Social Distance Scale

    Time frame: immediately after training

    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

  27. Community Health Workers: Assessment tool

    Time frame: monthly throughout the study period : average of 8 months, However accuracy check during SCID diagnosis check

    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

  28. Community Health Workers: Village health team referral

    Time frame: monthly throughout the study period (average of 8 months), starts immediately after training

    no maximum or minimum, outcome is the number of patients referred by community health workers to the health post

  29. Community Health Workers: Village health team referral with psychosis

    Time frame: monthly throughout the study period (average of 8 months), starts immediately after training

    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

  30. Primary care workers: Social Distance Scale

    Time frame: pre training

    12-item scale of willingness to interact with persons with mental illness, minimum = 0, maximum = 72, higher score is worse outcome

  31. Primary care workers: Social Distance Scale

    Time frame: immediately after training

    12-item scale of willingness to interact with persons with mental illness, minimum = 0, maximum = 72, higher score is worse outcome

  32. Primary care workers: Social Distance Scale

    Time frame: final supervision: 8 months post training

    12-item scale of willingness to interact with persons with mental illness, minimum = 0, maximum = 72, higher score is worse outcome

  33. Primary care workers: Mental health Gap Action Program Knowledge

    Time frame: pre training

    Multiple-choice assessment from mental health Gap Action Programme training materials; minimum = 0, maximum = 100, higher is better outcome

  34. Primary care workers: Mental health Gap Action Program Knowledge

    Time frame: immediately after training

    Multiple-choice assessment from mental health Gap Action Programme training materials; minimum = 0, maximum = 100, higher is better outcome

  35. Primary care workers: Mental health Gap Action Program Knowledge

    Time frame: final supervision: 8 months post training

    Multiple-choice assessment from mental health Gap Action Programme training materials; minimum = 0, maximum = 100, higher is better outcome

  36. Primary care workers: Enhancing Assessment of Common Therapeutic factors for Psychosis

    Time frame: pre training

    Observed structured clinical evaluation using a standardized role play, minimum score = 0, maximum = 100, higher scores are better

  37. Primary care workers: Enhancing Assessment of Common Therapeutic factors for Psychosis

    Time frame: immediately after training

    Observed structured clinical evaluation using a standardized role play, minimum score = 0, maximum = 100, higher scores are better

  38. Primary care workers: Enhancing Assessment of Common Therapeutic factors for Psychosis

    Time frame: final supervision - 8 months post training

    Observed structured clinical evaluation using a standardized role play, minimum score = 0, maximum = 100, higher scores are better

  39. Health Facility Record

    Time frame: pre training

    no minimum or maximum, score is the total number of patient diagnosed with psychosis : clinical records reviewed by Research Assistants

  40. Health Facility Record

    Time frame: immediately after training

    no minimum or maximum, score is the total number of patient diagnosed with psychosis : clinical records reviewed by Research Assistants

  41. Health Facility Record

    Time frame: final supervision - 8 months post training

    no minimum or maximum, score is the total number of patient diagnosed with psychosis : clinical records reviewed by Research Assistants

  42. Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders 5

    Time frame: 3 months post patient enrollment

    Accuracy of patient diagnosis by study mental health specialist

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Collaborators

  • Butabika National Referral Hospital
  • YouBelong Uganda

Registry information

Acronym: SCAPE-U

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 18, 2023
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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