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
Scientific
Department of Mental Health Sciences
Royal Free and University College Medical School
Rowland Hill street
London
NW3 2PF
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/04/2004 |
| Completion date | 31/03/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Department of Mental Health Sciences
London
NW3 2PF
United Kingdom
NW3 2PF
United Kingdom
Sponsor information
Health Foundation (UK)
Charity
Charity
90 Long Acre
London
WC2E 9RA
United Kingdom
| Website | http://www.health.org.uk |
|---|---|
"ROR" |
https://ror.org/02bzj4420 |
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
