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

ISRCTN	ISRCTN53305823
DOI	https://doi.org/10.1186/ISRCTN53305823
Protocol serial number	N0573188386
Sponsor	Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Funder	Northumberland, Tyne and Wear NHS Trust (UK)

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

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Cognitive-behavioural therapy for treatment-resistant depression: early intervention study
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	1. CORE 2. Hamilton Depression Scale (HAM-D) 3. Beck Depression Inventory (BDI) 4. Beck Hopelessness Scale (BHS)
Key secondary outcome measure(s)	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).
Completion date	01/05/2009
Reason abandoned (if study stopped)	Lack of staff/facilities/resources

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	24
Key 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
Key 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
Date of first enrolment	01/05/2006
Date of final enrolment	01/05/2009

University of Newcastle

Newcastle upon Tyne
NE1 7RU
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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