MRC Multicentre randomised controlled trial of cognitive behaviour therapy in bipolar affective disorder

ISRCTN	ISRCTN99884475
DOI	https://doi.org/10.1186/ISRCTN99884475
Protocol serial number	G9721149
Sponsor	Medical Research Council (MRC) (UK)
Funder	Medical Research Council (MRC) (UK)

Submission date: 23/10/2000
Registration date: 23/10/2000
Last edited: 05/12/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Michaela Rodger
Scientific

Study Co-ordinator Academic Centre
Gartnavel Royal Hospital
1055 Great Western Road
Glasgow
G12 OXH
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	MRC Multicentre randomised controlled trial of cognitive behaviour therapy in bipolar affective disorder
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/04/2003

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	220
Key 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
Key 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
Date of first enrolment	01/07/1999
Date of final enrolment	30/04/2003

Locations

Countries of recruitment

United Kingdom

Study participating centre

Study Co-ordinator Academic Centre

Glasgow
G12 OXH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results of preliminary investigation	01/06/2003	Yes	No
Results article	results	01/05/2006	Yes	No
Results article	results	01/02/2007	Yes	No
Protocol article	protocol	01/06/2005	Yes	No

Editorial Notes

05/12/2017: internal review.