Support Centre
21 October 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

New application
Updating record

governing board
data set
letter of agreement
request information
guidance notes

[ Print-friendly version ]
Clinical and cost effectiveness of cognitive behaviour therapy for depressed older people in primary care
DOI 10.1186/ISRCTN18271323
ClinicalTrials.gov identifier
EudraCT number
Public title Clinical and cost effectiveness of cognitive behaviour therapy for depressed older people in primary care
Scientific title
Acronym N/A
Serial number at source N/A
Study hypothesis To determine the clinical and cost effectiveness of Cognitive Behaviour Therapy (CBT)
Primary hypothesis: CBT plus Treatment As Usual (TAU) is more clinically and cost effective than TAU
Secondary hypothesis: AC plus TAU is more clinically and cost effective than TAU
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Depressive disorder
Participants - inclusion criteria 1. Diagnosis of depressive disorder according to the Geriatric Mental State and History and Aetiology Schedule (GMS-HAS) to confirm a primary diagnosis of depression. This uses a computer-based, semi-structured interview, which has been well validated in the community and used in international comparisons of depression.
2. Severity of depression score on the Beck Depression Inventory (BDI) of 14 or more than 25; this threshold is to include people with the less severe levels of mixed anxiety and depression frequently seen in primary care which may respond to CBT
3. Sufficient command of English to use CBT techniques
4. If taking an antidepressant, this must have been at a stable dose for at least 8 weeks prior to randomisation
Participants - exclusion criteria 1. Intense suicidal intent requiring in-patient admission
2. A GMS-HAS diagnosis of alcohol misuse or drug dependence
3. History of bipolar affective disorder
4. Presence of hallucinations or delusions
5. Cognitive deficits judged by a score of less than 24 on the Mini-Mental State Examination (MMSE), which means that the participant may have difficulty with cognitive techniques
6. People who have received cognitive therapy within the last year
7. Having received Electro-Convulsive Therapy (ECT) within the last 6 months as this may have a residual effect on cognition (it also implies recent, severe disorder)
Anticipated start date 01/04/2004
Anticipated end date 31/03/2007
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 198
Interventions 1. CBT plus TAU: up to twelve 50-minute sessions of CBT will be offered
2. AC plus TAU: up to twelve 50-minute sessions of non-specific talking to control for attention will be offered - this is to match the time spent face to face in the CBT group
3. TAU only: general practitioners will provide usual treatment but will be asked not to refer patients for CBT or other brief talking therapies
Primary outcome measure(s) Beck Depression Inventory
Secondary outcome measure(s) Patient completes:
1. EuroQuol (EQ-5D)
2. Social functioning questionnaire
3. Patient satisfaction with treatment
4. Credibility of treatments

Researcher completes:
1. Practice record data
2. Resource use and costs - the trial will measure all the costs of participants in the trial regardless of why costs were incurred, starting prior to randomisation and continuing for the duration of follow-up. Data on services used will be collected using a modified version of the Client Service Receipt Inventory (CSRI) developed specifically for the study from pilot work. Questions will be retrospective, covering the previous 6 months. This will include examination of the general practitioners’ records for consultation rates (at home or the practice) and other treatments received throughout the trial.
3. Rate of non-attendance to therapy sessions
4. Therapists’ expectation of outcome
5. Assessment of blindness by rater
Sources of funding Not provided at time of registration
Trial website
Publications 2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19996038
2011 cost-effectiveness results in: http://www.ncbi.nlm.nih.gov/pubmed/21314920
Contact name Dr  Marc  Serfaty
  Address Department of Mental Health Sciences
Royal Free and University College Medical School
Rowland Hill street
  City/town London
  Zip/Postcode NW3 2PF
  Country United Kingdom
Sponsor Health Foundation (UK)
  Address 90 Long Acre
  City/town London
  Zip/Postcode WC2E 9RA
  Country United Kingdom
  Sponsor website: http://www.health.org.uk
Date applied 14/09/2005
Last edited 13/06/2014
Date ISRCTN assigned 09/02/2006
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.