NCT02895269

Brief Summary

COSIMPO is a randomised controlled trial in which a collaborative shared care for psychosis implemented by complementary alternative providers (traditional and faith healers) and conventional primary health care providers (PHCP) is compared with care as usual in which no formal collaboration takes place between the two groups of health providers. COSIMPO is therefore a test of a complex task sharing approach for the care of patients with severe mental disorders.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
307

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 9, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

December 12, 2017

Status Verified

December 1, 2017

Enrollment Period

1.1 years

First QC Date

July 30, 2016

Last Update Submit

December 11, 2017

Conditions

Psychosis

Keywords

Complementary Alternative ProvidersCollaborative Shared CarePrimary Health Care ProvidersPsychosis

Outcome Measures

Primary Outcomes (1)

  • Reduction in symptoms of psychosis

    The primary outcome will be improvement of psychosis as determined by a 7-point difference on the PANSS total scores between the two groups at 6 months after study entry, controlling for baseline scores.

    6 months

Secondary Outcomes (4)

  • Disability

    3, and 6 months

  • Stigma

    3,and 6 months

  • Harmful treatment practices

    3,and 6 months

  • Victimisation

    3, and 6 months

Study Arms (2)

Collaborative shared care

EXPERIMENTAL

Conventional primary health care providers (PHCP) are trained to collaborate with and support traditional and faith healers (complementary alternative providers, CAPs) in the care of patients with psychosis. The PHCP are purposively trained to deliver evidence-based treatment for psychosis and to conduct scheduled and on-request visits to the facilities of the CAPs to collaborate in the treatment of patients with psychosis through joint decision making and clinical management. The overall care of the patients remains the responsibility of the healers. The role of the PHCP is to support the healers deliver safe and acceptable care to patients, including the promotion of and respect for human rights and avoidance of harmful practices in the care of patients.

Behavioral: Collaborative shared care

Usual care

ACTIVE COMPARATOR

Complementary alternative providers deliver intervention for patients with psychosis without active or formal collaboration with conventional primary health care providers. The primary health care providers in this arm nevertheless receive training on evidence-based treatment of psychosis.

Behavioral: Collaborative shared care

Interventions

Collaborative shared careBEHAVIORAL

Collaboration between complementary alternative health providers and primary health care providers in the care of persons with psychosis.

Collaborative shared careUsual care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Those with serious physical illness in need of urgent medical attention (this could be a serious infection, injury, etc.).
  • Serious cognitive impairment that may interfere with assessment by the research team.
  • Those who will not be in the study area for at least six month following recruitment.
  • Women who are pregnant or will attempt to become pregnant during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ghanian Site

Kumasi, Ghana

Location

Nigerian site

Ibadan, Oyo State, Nigeria

Location

Related Publications (6)

  • Osrin D, Azad K, Fernandez A, Manandhar DS, Mwansambo CW, Tripathy P, Costello AM. Ethical challenges in cluster randomized controlled trials: experiences from public health interventions in Africa and Asia. Bull World Health Organ. 2009 Oct;87(10):772-9. doi: 10.2471/blt.08.051060.

    PMID: 19876544BACKGROUND

  • Awuah-Nyamekye, Samuel, and Paul Sarfo-Mensah. Mining or our heritage? Indigenous local people's views on industrial waste of mines in Ghana. INTECH Open Access Publisher, 2012.

    BACKGROUND

  • Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76. doi: 10.1093/schbul/13.2.261.

    PMID: 3616518BACKGROUND

  • Campbell MK, Elbourne DR, Altman DG; CONSORT group. CONSORT statement: extension to cluster randomised trials. BMJ. 2004 Mar 20;328(7441):702-8. doi: 10.1136/bmj.328.7441.702. No abstract available.

    PMID: 15031246BACKGROUND

  • Gureje O, Appiah-Poku J, Bello T, Kola L, Araya R, Chisholm D, Esan O, Harris B, Makanjuola V, Othieno C, Price L, Seedat S. Effect of collaborative care between traditional and faith healers and primary health-care workers on psychosis outcomes in Nigeria and Ghana (COSIMPO): a cluster randomised controlled trial. Lancet. 2020 Aug 29;396(10251):612-622. doi: 10.1016/S0140-6736(20)30634-6.

    PMID: 32861306DERIVED

  • Gureje O, Makanjuola V, Kola L, Yusuf B, Price L, Esan O, Oladeji BD, Appiah-Poku J, Haris B, Othieno C, Seedat S. COllaborative Shared care to IMprove Psychosis Outcome (COSIMPO): study protocol for a randomized controlled trial. Trials. 2017 Oct 10;18(1):462. doi: 10.1186/s13063-017-2187-x.

    PMID: 29017605DERIVED

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Oye Gureje, DSc

    University of Ibadan, Ibadan, Nigeria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry

Study Record Dates

First Submitted

July 30, 2016

First Posted

September 9, 2016

Study Start

September 1, 2016

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

December 12, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

NG(1)GH(1)