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

ISRCTN ISRCTN18271323
DOI https://doi.org/10.1186/ISRCTN18271323
Secondary identifying numbers N/A
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

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectivesTo 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) studiedDepressive disorder
Intervention1. 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 typeOther
Primary outcome measureBeck Depression Inventory
Secondary outcome measuresPatient 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 study start date01/04/2004
Completion date31/03/2007

Eligibility

Participant type(s)Patient
Age groupSenior
SexAll
Target number of participants198
Key inclusion criteria1. 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 criteria1. 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 enrolment01/04/2004
Date of final enrolment31/03/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Mental Health Sciences
London
NW3 2PF
United Kingdom

Sponsor information

Funders

Funder type

Not defined

Not provided at time of registration

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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
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