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

ISRCTN ISRCTN53305823
DOI https://doi.org/10.1186/ISRCTN53305823
Secondary identifying numbers N0573188386
Submission date
28/09/2007
Registration date
28/09/2007
Last edited
29/04/2016
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Stephen Barton
Scientific

University of Newcastle
Ridley Building
Newcastle upon Tyne
NE1 7RU
United Kingdom

Phone +44 (0)191 222 7523
Email s.b.barton@ncl.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleCognitive-behavioural therapy for treatment-resistant depression: early intervention study
Study objectivesIs 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedDepression
InterventionPatients are randomised to:
1. CBT
2. Treatment-as-usual

Face to face interviews and video recording will also take place.
Intervention typeOther
Primary outcome measure1. CORE
2. Hamilton Depression Scale (HAM-D)
3. Beck Depression Inventory (BDI)
4. Beck Hopelessness Scale (BHS)
Secondary outcome measures1. 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 study start date01/05/2006
Completion date01/05/2009
Reason abandoned (if study stopped)Lack of staff/facilities/resources

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexBoth
Target number of participants24
Key inclusion criteria24 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
Key exclusion criteria1. 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
Date of first enrolment01/05/2006
Date of final enrolment01/05/2009

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of Newcastle
Newcastle upon Tyne
NE1 7RU
United Kingdom

Sponsor information

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

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Northumberland, Tyne and Wear NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

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