Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
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
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
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Depressive disorder
Intervention
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
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Beck Depression Inventory
Secondary outcome measures
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 practitionersÂ’ 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. TherapistsÂ’ expectation of outcome
5. Assessment of blindness by rater
Overall trial start date
01/04/2004
Overall trial end date
31/03/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
198
Participant 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)
Recruitment start date
01/04/2004
Recruitment end date
31/03/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Mental Health Sciences
London
NW3 2PF
United Kingdom
Sponsor information
Organisation
Health Foundation (UK)
Sponsor details
90 Long Acre
London
WC2E 9RA
United Kingdom
Sponsor type
Charity
Website
Funders
Funder type
Not defined
Funder name
Not provided at time of registration
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
2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19996038
2011 cost-effectiveness results in: http://www.ncbi.nlm.nih.gov/pubmed/21314920
Publication citations
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Results
Serfaty MA, Haworth D, Blanchard M, Buszewicz M, Murad S, King M, Clinical effectiveness of individual cognitive behavioral therapy for depressed older people in primary care: a randomized controlled trial., Arch. Gen. Psychiatry, 2009, 66, 12, 1332-1340, doi: 10.1001/archgenpsychiatry.2009.165.
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Holman AJ, Serfaty MA, Leurent BE, King MB, Cost-effectiveness of cognitive behaviour therapy versus talking and usual care for depressed older people in primary care., BMC Health Serv Res, 2011, 11, 33, doi: 10.1186/1472-6963-11-33.