Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G9721149
Study information
Scientific title
Acronym
Study hypothesis
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
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
Bipolar affective disorder
Intervention
1. One group receiving cognitive behaviour therapy as well as treatment as usual
2. One group receiving only treatment as usual
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/07/1999
Overall trial end date
30/04/2003
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
220
Participant exclusion criteria
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
Recruitment start date
01/07/1999
Recruitment end date
30/04/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Study Co-ordinator Academic Centre
Glasgow
G12 OXH
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
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
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
Publication citations
-
Protocol
Scott J, Colom F, Psychosocial treatments for bipolar disorders., Psychiatr. Clin. North Am., 2005, 28, 2, 371-384, doi: 10.1016/j.psc.2005.01.002.
-
Results of preliminary investigation
Hammersley P, Dias A, Todd G, Bowen-Jones K, Reilly B, Bentall RP, Childhood trauma and hallucinations in bipolar affective disorder: preliminary investigation., Br J Psychiatry, 2003, 182, 543-547.
-
Results
Scott J, Paykel E, Morriss R, Bentall R, Kinderman P, Johnson T, Abbott R, Hayhurst H, Cognitive-behavioural therapy for bipolar disorder., Br J Psychiatry, 2006, 188, 488-489, doi: 10.1192/bjp.188.5.488.
-
Results
Morriss R, Scott J, Paykel E, Bentall R, Hayhurst H, Johnson T, Social adjustment based on reported behaviour in bipolar affective disorder., Bipolar Disord, 9, 1-2, 53-62, doi: 10.1111/j.1399-5618.2007.00343.x.