COllaborative Shared Care to IMprove Psychosis Outcome

• Register: ClinicalTrials.gov
• Last refreshed on: 8 January 2018
• Main ID: NCT02895269
• Date of registration: 30/07/2016
• Prospective Registration: Yes
• Primary sponsor: University of Ibadan
• Public title: COllaborative Shared Care to IMprove Psychosis Outcome COSIMPO
• Scientific title: Partnership for Mental Health Development in Sub-Saharan Africa: COllaborative Shared Care to IMprove Psychosis Outcome
• Date of first enrolment: September 2016
• Target sample size: 307
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02895269
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Ghana, Nigeria

Contacts

• Name: Oye Gureje, DSc
• Affiliation: University of Ibadan, Ibadan, Nigeria

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Patients aged 18 and over and who speak the study language of Yoruba (Nigeria) or Kwi
(Ghana). Only patients who speak the languages of the study will be included.

2. All patients presenting to the CAPs in the selected clusters with a confirmed
diagnosis of non-organic psychosis as assessed by research interviewers using the
Structured Clinical Interview for DSM (SCID).

3. Patients must be on admission at the CAP facility and must be symptomatic at the time
of recruitment as indicated by a minimum total PANSS score of 60.

4. Patients must have a caregiver who is willing to give consent to participate in the
study.

Exclusion Criteria:

1. Those with serious physical illness in need of urgent medical attention (this could be
a serious infection, injury, etc.).

2. Serious cognitive impairment that may interfere with assessment by the research team.

3. Those who will not be in the study area for at least six month following recruitment.

4. Women who are pregnant or will attempt to become pregnant during the study period.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Psychosis

Intervention(s)

Behavioral: Collaborative shared care

Primary Outcome(s)

Reduction in symptoms of psychosis [Time Frame: 6 months]

Secondary Outcome(s)

Stigma [Time Frame: 3,and 6 months]

Victimisation [Time Frame: 3, and 6 months]

Disability [Time Frame: 3, and 6 months]

Harmful treatment practices [Time Frame: 3,and 6 months]

Secondary ID(s)

1U19MH098718-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors