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 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
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