Cognitive Behavioural Case Management (CBCM) in First-Episode Schizophrenia and Related Psychotic Disorders - a pilot study

ISRCTN	ISRCTN65536352
DOI	https://doi.org/10.1186/ISRCTN65536352
Protocol serial number	N0038161724
Sponsor	Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funder	Avon and Wiltshire Mental Health Partnership NHS Trust (UK) NHS R&D Support Funding

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Prof Glynn Harrison
Scientific

University of Bristol
Division of Psychiatry
Cottham House
Cotham Hill
Bristol
BS6 6JL
United Kingdom

Phone	+44 (0)117 954 6665
Email	G.Harrison@Bristol.ac.uk

Primary study design	Interventional
Study design	Pilot randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Cognitive Behavioural Case Management (CBCM) in First-Episode Schizophrenia and Related Psychotic Disorders - a pilot study
Study objectives	Will a group of participants with first episode psychosis (FEP) receiving CBCM report lower levels of psychopathology, better psychosocial functioning and quality of life, greater service satisfaction and be more engaged with treatment than a group of participants with FEP receiving treatment-as-usual at the end of a 12 month intervention and at an 18 month follow-up?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Mental and Behavioural Disorders: Schizophrenia
Intervention	[A] Cognitive Behavioural Case Management [B] Treatment-as-usual
Intervention type	Other
Primary outcome measure(s)	Quality of Life Survey
Key secondary outcome measure(s)	1. Brief psychiatric rating scale (expanded version) 2. Montgomery-Asberg Depression Rating Scale 3. WHOQOL-BREF 4. Social and Occupational Functioning Assessment Scale 5. Addition Severity Scale 6. Illness Duration Interview 7. Pathways to care item (from CORS) 8. Premorbid Adjustment Scale 9. Verona Service Satisfaction Scale 10. An engagement measure 11. Socio-demographic & Service Receipt Inventory 12. SCID-P 13. OCPRIT
Completion date	07/03/2006

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	15
Key inclusion criteria	12-15 patients with first-episode psychosis, recruited from Bath & North East Somerset and North Somerset localities in the Avon & Wiltshire Mental Health Partnership NHS Trust.
Key exclusion criteria	1. Presence of organic mental disorder 2. Mental retardation 3. Inadequate command of language
Date of first enrolment	08/03/2005
Date of final enrolment	07/03/2006

University of Bristol

Bristol
BS6 6JL
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

12/08/2016: No publications found in PubMed, verifying study status with principal investigator.