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
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