Condition category
Mental and Behavioural Disorders
Date applied
23/10/2000
Date assigned
23/10/2000
Last edited
04/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Michaela Rodger

ORCID ID

Contact details

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

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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Additional files

Editorial Notes