Comparison of three forms of self help cognitive behavioural therapy

ISRCTN	ISRCTN66542253
DOI	https://doi.org/10.1186/ISRCTN66542253
Secondary identifying numbers	N0560180008

Submission date: 28/09/2007
Registration date: 28/09/2007
Last edited: 18/04/2012

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

Dr Hannah Patrick
Scientific

Bexley Care Trust
221 Erith Road
Bexleyheath
DA7 6HZ
United Kingdom

Phone	+44 020 8298 6210

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	To implement and compare the impact of three cognitive behavioural therapies: Beating the Blues, workbook and internet based.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/06/2006
Completion date	01/12/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	180 referrals to the research although not all have completed the treatment and followup protocol.
Key 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
Key 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
Date of first enrolment	01/06/2006
Date of final enrolment	01/12/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Bexley Care Trust

Bexleyheath
DA7 6HZ
United Kingdom

Sponsor information

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

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Bexley Care Trust

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2009		Yes	No