Chronic Unipolar Depressive Disorder Clinical Trial
Official title:
Randomised Control Trial of the Clinical and Cost Effectiveness of a Specialist Expert Mood Disorder Team for Refractory Unipolar Depressive Disorder
The purpose of this study is determine whether a specialised mood disorder service, which offers tailored psychological and pharmacological treatment, is more effective in the treatment of chronic unipolar depressive disorder then treatment as usual.
A pragmatic randomised controlled trial of a specialist mood disorder intervention versus
treatment as usual will be conducted. Patients will be individually randomised with
stratification by mental health trust to either treatment by a specialist team offering
tailored psychological and pharmacological treatment or treatment as usual.
The specialist mood disorders team will include a psychiatrist and health professionals
providing cognitive behaviour therapy. Together the team will assess participants and then
provide a co-ordinated and supervised combination of pharmacological and psychological
treatment according to guidelines developed by NICE and the British Association of
Psychopharmacology. Each participant will receive a treatment plan that is tailored to
his/her specific needs. The participants in the treatment as usual team will have their
usual access to the same treatments. The outcome in terms of improvement in depressive
symptoms, function and costs will be examined after one year in service users with chronic
depression.
Eligible patients will be followed for 12 months and the primary outcomes will be observer
rated depressive symptoms and cost effectiveness from a health and social care perspective.
Along side the RCT, implementation analysis and audit of the standard care and specialised
care for depression will be carried out.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment