Clinical trial NCT01047124: Trial of the Clinical and Cost Effectiveness of a Specialist Expert Mood Disorder Team for Refractory Unipolar Depressive Disorder
Official title: Randomised Control Trial of the Clinical and Cost Effectiveness of a Specialist Expert Mood Disorder Team for Refractory Unipolar Depressive Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Unipolar Depressive Disorder
Keywords: Depression
Collaborative Care
Cognitive Behaviour Therapy
Mental Health Services
Antidepressants
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2010-01-12
Enrollment: 219
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* The responsible medical officer or care coordinator leading care considers the patient to be suffering from a primary unipolar depressive disorder which is not a consequence of having another axis 1 or 2 psychiatric disorder.
* Age over 18 years.
* Able and willing to give oral and written informed consent to participation in the study.
* From the date of first assessment by a health professional working for the index mental health trust, they have been offered or received direct care from one or more health professionals from the Trust three or more occasions for 6 months.
* Meet NICE criteria for moderate depression, namely the presence of five out of nine symptoms of (NICE, 2004), have a Hamilton Depression Rating Scale of at least 20, and score 60 or less on the Global Assessment of Functioning Scale (American Psychiatric Association, 1994).

Exclusion Criteria:

* Is receiving emergency care for suicide risk, risk of severe neglect or homicide risk and requires it; however, patients will not be excluded because of such risk provided the risk is adequately contained with their current care setting and the primary medical responsibility for care remains with the referring team.
* Does not speak fluent English.
* Is pregnant

Primary outcomes:
measure: Hamilton Depression Rating Scale - Grid version
timeFrame: 6 months
Secondary outcomes:
measure: Change in self rated depression measures: Beck Depression Inventory version 1; Personal Health Questionnaire; Quick Inventory of Depressive Symptomology
timeFrame: 3 months
measure: Cost utility or cost effectiveness using the Euroqol 5D as a measure of quality of life and costs from health and social care and society perspectives.
timeFrame: 6 months
measure: Change in social adjustment (Cooper, Osborn, Gath & Feggetter, 1982), an assessment of social and occupational functioning.
timeFrame: 6 months
measure: Patient satisfaction and patient/doctor relationship
timeFrame: 6 months
Other outcomes:
Locations:
city: Derby
country: United Kingdom
facility: Derbyshire Mental Health NHS Trust
state: Derbyshire
city: Lincoln
country: United Kingdom
facility: Lincolnshire Partnership Trust
state: Lincolnshire
city: Nottingham
country: United Kingdom
facility: Nottinghamshire Healthcare NHS Trust
state: Nottinghamshire
Study officials:
affiliation: University of Nottingham
name: Richard Morriss
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Morriss R, Garland A, Nixon N, Guo B, James M, Kaylor-Hughes C, Moore R, Ramana R, Sampson C, Sweeney T, Dalgleish T; NIHR CLAHRC Specialist Mood Disorder Study Group. Efficacy and cost-effectiveness of a specialist depression service versus usual specialist mental health care to manage persistent depression: a randomised controlled trial. Lancet Psychiatry. 2016 Sep;3(9):821-31. doi: 10.1016/S2215-0366(16)30143-2. Epub 2016 Aug 3.
citation: Morriss R, Marttunnen S, Garland A, Nixon N, McDonald R, Sweeney T, Flambert H, Fox R, Kaylor-Hughes C, James M, Yang M. Randomised controlled trial of the clinical and cost effectiveness of a specialist team for managing refractory unipolar depressive disorder. BMC Psychiatry. 2010 Nov 29;10:100. doi: 10.1186/1471-244X-10-100.