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| [ Print-friendly version ] |
| Clinical and cost effectiveness of cognitive behaviour therapy for depressed older people in primary care |
| ISRCTN | ISRCTN18271323 |
| ClinicalTrials.gov identifier | |
| 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 | |
| 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 eight 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 six 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 | |
| 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 pratitioners 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 six months. This will include examination of the general pratitioners’ 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 | N/A |
| Trial website | |
| Publications | 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19996038 |
| 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 | 10/12/2009 |
| Date ISRCTN assigned | 09/02/2006 |
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| © 2012 ISRCTN unless otherwise stated. | |
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