Condition category
Mental and Behavioural Disorders
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
18/04/2012
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

Dr Hannah Patrick

ORCID ID

Contact details

Bexley Care Trust
221 Erith Road
Bexleyheath
DA7 6HZ
United Kingdom
+44 020 8298 6210

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0560180008

Study information

Scientific title

Acronym

Study hypothesis

To implement and compare the impact of three cognitive behavioural therapies: Beating the Blues, workbook and internet based.

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

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Mental and Behavioural Disorders: Depression

Intervention

A co-ordinator will establish proactive links with GPs in the area, organize data collection for the research, assess the need for an interpreter to facilitate sessions, and oversee the use of computers by clients GPs will refer patients if they meet certain criteria. Interested individuals will be asked to give signed consent and then complete a baseline CORE assessment before being randomly allocated to one of the three self-help tools.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Differences in the following indicators of mental health and use of services: total antidepressants dispensed during the 6 months following the diagnosis
2. Use of counselling or other secondary mental health services in the 6 months following the diagnosis
3. Programme completed or interrupted
4. Consultations with primary care staff over the 6 months follow up period
5. Consultations with secondary care over the 6 months follow up period
5. CORE assessment scores at 6 weeks.

Secondary outcome measures

At six months the following data items will be recorded for all patients:
1. Consultations with primary care staff over the 6 months follow up period
2. Total antidepressants dispensed during the 6 months following the diagnosis (information gathered from the GP's computer)
3. Use of counselling or other secondary mental health services in the 6 months following the diagnosis and referral to the service (information gathered from the local counseling service and Oxleas mental health Trust)
4. Programme completed or interrupted



CORE assessment scores at 8 weeks

Overall trial start date

01/06/2006

Overall trial end date

01/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients aged 18+ years old
2. Suffering from depression, mixed anxiety and depression or anxiety disorder
3. Not receiving any form of psychological treatment or counselling

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

180 referrals to the research although not all have completed the treatment and followup protocol.

Participant exclusion criteria

1. Active suicidal ideas
2. A current or lifetime diagnosis of psychosis, personality disorder or organic mental disorder
3. Alcohol and/or drug dependence
4. Have taken medication for anxiety and /or depression continuously for 6 months or more immediately prior to entry

Recruitment start date

01/06/2006

Recruitment end date

01/12/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bexley Care Trust
Bexleyheath
DA7 6HZ
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2007 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Bexley Care Trust

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

1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/22477905

Publication citations

  1. Results

    Pittaway S, Cupitt C, Palmer D, Arowobusoye N, Milne R, Holttum S, Pezet R, Patrick H, Comparative, clinical feasibility study of three tools for delivery of cognitive behavioural therapy for mild to moderate depression and anxiety provided on a self-help basis., Ment Health Fam Med, 2009, 6, 3, 145-154.

Additional files

Editorial Notes