Condition category
Mental and Behavioural Disorders
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
29/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Stephen Barton

ORCID ID

Contact details

University of Newcastle
Ridley Building
Newcastle upon Tyne
NE1 7RU
United Kingdom
+44 (0)191 222 7523
s.b.barton@ncl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0573188386

Study information

Scientific title

Cognitive-behavioural therapy for treatment-resistant depression: early intervention study

Acronym

Study hypothesis

Is cognitive-behavioural therapy (CBT) more effective than treatment-as-usual (TAU) for depression that has been resistant to anti-depressants and other primary care interventions?

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

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Depression

Intervention

Patients are randomised to:
1. CBT
2. Treatment-as-usual

Face to face interviews and video recording will also take place.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. CORE
2. Hamilton Depression Scale (HAM-D)
3. Beck Depression Inventory (BDI)
4. Beck Hopelessness Scale (BHS)

Secondary outcome measures

1. Quality of Life and Social Functioning: to be determined through discussion with Psychological Therapies Research Network
2. Mediating Variables: Dysfunctional Attitudes Scale (DAS), Automatic Thoughts Questionnaire (ATQ), Sentence Completion Test for Depression (SCD), Roles and Goals Questionnaire (RAG).

Overall trial start date

01/05/2006

Overall trial end date

01/05/2009

Reason abandoned

Lack of staff/facilities/resources

Eligibility

Participant inclusion criteria

24 depressed NHS patients, aged 18 - 65 years, will be recruited from routine referrals to the Newcastle CBT Centre (NCBTC) and secondary care mental health services within the 3Ns Trust. Inclusion criteria:
1. Adults aged 18 - 65 years
2. Major depressive episode as the primary diagnosis, first or second major episode, lasting at least 12 months duration
3. Moderate or severe depression symptoms
4. Treatment-resistance to at least one course of anti-depressant previously administered at an adequate dose for adequate period, treatment resistance to other primary care interventions

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

24

Participant exclusion criteria

1. Previous individual or group CBT following a recognised protocol within secondary care services
2. Three or more major episodes of depression
3. People with bi-polar disorder, psychosis, learning disability, borderline personality disorder, alcohol or addiction problems

Recruitment start date

01/05/2006

Recruitment end date

01/05/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Newcastle
Newcastle upon Tyne
NE1 7RU
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2007 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Northumberland, Tyne and Wear NHS Trust (UK)

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

Publication citations

Additional files

Editorial Notes

29/04/2016: The trial was not completed due to staff changes and shortages.