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

Completed
Conditions
Depressive disorder
Mental and Behavioural Disorders
Registration Number
ISRCTN18271323
Lead Sponsor
Health Foundation (UK)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
198
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

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)

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Beck Depression Inventory
Secondary Outcome Measures
NameTimeMethod
Patient completes: <br>1. EuroQuol (EQ-5D) <br>2. Social functioning questionnaire<br>3. Patient satisfaction with treatment<br>4. Credibility of treatments<br><br>Researcher completes:<br>1. Practice record data<br>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.<br>3. Rate of non-attendance to therapy sessions<br>4. Therapists? expectation of outcome<br>5. Assessment of blindness by rater
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