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ISRCTN
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ISRCTN99884475
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DOI
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10.1186/ISRCTN99884475
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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MRC Multicentre randomised controlled trial of cognitive behaviour therapy in bipolar affective disorder
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Scientific title
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Acronym
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N/A
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Serial number at source
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G9721149
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Study hypothesis
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To show:
1. That Cognitive Behaviour Therapy (CBT) added to usual treatment is more efficacious than usual treatment alone in reducing relapse rates and symptom levels and improving quality of life and functioning
2. That the additional costs of CBT will be offset by reductions in direct health care costs, direct non-treatment costs and indirect costs, when compared with usual treatment alone
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Bipolar affective disorder
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Participants - inclusion criteria
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1. Aged 18 years or more
2. Two or more episodes
3. Last episode in previous 12 months
4. Currently/last six months in contact with mental health
5. Currently asymptomatic, depression, hypomania
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Participants - exclusion criteria
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1. Cannot engage/ rapid cycling bipolar disorder (more than or equal to four episodes per year)
2. Bipolar disorder secondary to organic cause
3. Mental disorder primarily alcohol or drug related
4. Severe borderline personality disorder
5. Receiving systematic psychological treatment for bipolar disorder
6. Unable to read/write English
7. Unable to give informed consent
8. If the patients referred to the study knew the therapist when the therapist worked in a previous capacity, (e.g. as a community psychiatric nurse in a community mental health team looking after the patient), the patient would not be entered into the study
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Anticipated start date
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01/07/1999
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Anticipated end date
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30/04/2003
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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220
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Interventions
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1. One group receiving cognitive behaviour therapy as well as treatment as usual
2. One group receiving only treatment as usual
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Primary outcome measure(s)
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1. Recurrence of an episode of illness of sufficient severity to reach the Diagnostic and Statistical Manual of mental disorders fourth edition (DSM-IV) criteria for major depressive episode, manic episode or mixed episode, based on the Structured Clinical Interview (SCID)instrument
2. A longitudinal severity rating of overall symptom levels for each week since last interview (two months) based on the Longitudinal Interval Follow-up Evaluation (LIFE-II)
3. Total costs - data on all services received will be obtained using the Client/Service Receipt Inventory (CSRI; Beecham and Knapp 1992) to cover first the year prior to study entry and then every six months until the end of the follow-up period
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Medical Research Council (MRC) (UK)
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Trial website
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Publications
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1. 2005 protocol in http://www.ncbi.nlm.nih.gov/pubmed/15826737
2. 2003 results of preliminary investigation in http://www.ncbi.nlm.nih.gov/pubmed/12777347
3. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16648539
4. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17391350
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Contact name
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Ms
Michaela
Rodger
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Address
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Study Co-ordinator Academic Centre
Gartnavel Royal Hospital
1055 Great Western Road
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City/town
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Glasgow
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Zip/Postcode
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G12 OXH
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Country
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United Kingdom
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Email
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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23/10/2000
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Last edited
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04/09/2009
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Date ISRCTN assigned
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23/10/2000
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