Cognitive-behavioural therapy for treatment-resistant depression: early intervention study
ISRCTN | ISRCTN53305823 |
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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
Scientific
University of Newcastle
Ridley Building
Newcastle upon Tyne
NE1 7RU
United Kingdom
Phone | +44 (0)191 222 7523 |
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s.b.barton@ncl.ac.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/05/2006 |
Completion date | 01/05/2009 |
Reason abandoned (if study stopped) | Lack of staff/facilities/resources |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Upper age limit | 65 Years |
Sex | Both |
Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Newcastle
Newcastle upon Tyne
NE1 7RU
United Kingdom
NE1 7RU
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Editorial Notes
29/04/2016: The trial was not completed due to staff changes and shortages.