Condition category
Mental and Behavioural Disorders
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
31/03/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Mariajose Gutierrez

ORCID ID

Contact details

Co-ordinated Psychological Treatments Service (CPTS)
The Ladywell Unit
University Hospital Lewisham
Lewisham High street
London
SE13 6LH
United Kingdom
+44
mjgros@yahoo.co.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0534139816

Study information

Scientific title

Acronym

Study hypothesis

To determine if a psycho-educational intervention is associated with significant clinical improvements

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Mental and Behavioural Disorders: Bipolar disorders

Intervention

Brief psycho-educational programme vs standard care plus biblio-therapy

Added 21 July 2008: trial discontinued in 2005

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Time to first relapse as assessed by independent blind reviewer.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/02/2004

Overall trial end date

31/10/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Subjects with bipolar disorder in contact with 3CMHT in Lewisham catchment area, inpatient units at Ladywell or by direct recruitment by GPs.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

60

Participant exclusion criteria

1. Subjects with co-morbid schizophrenia, schizo-affective disorder and psychosis
2. Subjects with severe borderline or antisocial personality disorder
3. Subjects with primary substance abuse disorder
4. Subjects suffering from an organic brain syndrome
5. Participants who currently meet DSM-IV criteria for mania, hypomania or mixed state (plus B-R> 15, &/or HRSD> 17). These patients could be admitted to the study in a later stage once they are euthymic, or mildly depressed or hypomaniac.
6. Subjects unable to read or write English
7. Subjects unable to give informed consent

Recruitment start date

01/02/2004

Recruitment end date

31/10/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Co-ordinated Psychological Treatments Service (CPTS)
London
SE13 6LH
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

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

Lambeth, Southwark and Lewisham Primary Care Trusts (UK)

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