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
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
-
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.