Condition category
Mental and Behavioural Disorders
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
12/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Glynn Harrison

ORCID ID

Contact details

University of Bristol
Division of Psychiatry
Cottham House
Cotham Hill
Bristol
BS6 6JL
United Kingdom
+44 (0)117 954 6665
G.Harrison@Bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0038161724

Study information

Scientific title

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

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Pilot randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Mental and Behavioural Disorders: Schizophrenia

Intervention

[A] Cognitive Behavioural Case Management
[B] Treatment-as-usual

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Quality of Life Survey

Secondary outcome measures

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

Overall trial start date

08/03/2005

Overall trial end date

07/03/2006

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

15

Participant exclusion criteria

1. Presence of organic mental disorder
2. Mental retardation
3. Inadequate command of language

Recruitment start date

08/03/2005

Recruitment end date

07/03/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Bristol
Bristol
BS6 6JL
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Avon and Wiltshire Mental Health Partnership NHS Trust (UK) NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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