Condition category
Mental and Behavioural Disorders
Date applied
14/09/2005
Date assigned
09/02/2006
Last edited
13/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Marc Serfaty

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

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

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/04/2004

Overall trial end date

31/03/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

198

Participant 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)

Recruitment start date

01/04/2004

Recruitment end date

31/03/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Mental Health Sciences
London
NW3 2PF
United Kingdom

Sponsor information

Organisation

Health Foundation (UK)

Sponsor details

90 Long Acre
London
WC2E 9RA
United Kingdom

Sponsor type

Charity

Website

http://www.health.org.uk

Funders

Funder type

Not defined

Funder name

Not provided at time of registration

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19996038
2011 cost-effectiveness results in: http://www.ncbi.nlm.nih.gov/pubmed/21314920

Publication citations

  1. Results

    Serfaty MA, Haworth D, Blanchard M, Buszewicz M, Murad S, King M, Clinical effectiveness of individual cognitive behavioral therapy for depressed older people in primary care: a randomized controlled trial., Arch. Gen. Psychiatry, 2009, 66, 12, 1332-1340, doi: 10.1001/archgenpsychiatry.2009.165.

  2. Holman AJ, Serfaty MA, Leurent BE, King MB, Cost-effectiveness of cognitive behaviour therapy versus talking and usual care for depressed older people in primary care., BMC Health Serv Res, 2011, 11, 33, doi: 10.1186/1472-6963-11-33.

Additional files

Editorial Notes