Clinical and cost effectiveness of cognitive behaviour therapy for depressed older people in primary care

ISRCTN	ISRCTN18271323
DOI	https://doi.org/10.1186/ISRCTN18271323
Protocol serial number	N/A
Sponsor	Health Foundation (UK)
Funder	Not provided at time of registration

Submission date: 14/09/2005
Registration date: 09/02/2006
Last edited: 13/06/2014

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 Marc Serfaty
Scientific

Department of Mental Health Sciences
Royal Free and University College Medical School
Rowland Hill street
London
NW3 2PF
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Beck Depression Inventory
Key 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
Completion date	31/03/2007

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	198
Key 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
Key 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)
Date of first enrolment	01/04/2004
Date of final enrolment	31/03/2007

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Department of Mental Health Sciences

London
NW3 2PF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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	01/12/2009		Yes	No
Results article	cost-effectiveness results	11/02/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes