Trial of the Clinical and Cost Effectiveness of a Specialist Expert Mood Disorder Team for Refractory Unipolar Depressive Disorder
NCT ID: NCT01047124
Last Updated: 2015-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
219 participants
INTERVENTIONAL
2009-09-30
2016-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intervention
Specialist mood disorders team: treatment plan according to need
Specialist Mood Disorders Team
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.
Treatment as usual
No interventions assigned to this group
Interventions
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Specialist Mood Disorders Team
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Does not speak fluent English.
* Is pregnant
18 Years
ALL
No
Sponsors
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National Institute for Health Research, United Kingdom
OTHER_GOV
University of Nottingham
OTHER
Responsible Party
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Principal Investigators
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Richard Morriss
Role: PRINCIPAL_INVESTIGATOR
University of Nottingham
Locations
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Derbyshire Mental Health NHS Trust
Derby, Derbyshire, United Kingdom
Lincolnshire Partnership Trust
Lincoln, Lincolnshire, United Kingdom
Nottinghamshire Healthcare NHS Trust
Nottingham, Nottinghamshire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Marttunen
Role: primary
Marttunen
Role: primary
Marttunen
Role: primary
References
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Anderson IM, Ferrier IN, Baldwin RC, Cowen PJ, Howard L, Lewis G, Matthews K, McAllister-Williams RH, Peveler RC, Scott J, Tylee A. Evidence-based guidelines for treating depressive disorders with antidepressants: a revision of the 2000 British Association for Psychopharmacology guidelines. J Psychopharmacol. 2008 Jun;22(4):343-96. doi: 10.1177/0269881107088441. Epub 2008 Apr 15.
Baker R, Reddish S, Robertson N, Hearnshaw H, Jones B. Randomised controlled trial of tailored strategies to implement guidelines for the management of patients with depression in general practice. Br J Gen Pract. 2001 Sep;51(470):737-41.
Gilbody S, Bower P, Fletcher J, Richards D, Sutton AJ. Collaborative care for depression: a cumulative meta-analysis and review of longer-term outcomes. Arch Intern Med. 2006 Nov 27;166(21):2314-21. doi: 10.1001/archinte.166.21.2314.
Greden JF. The burden of disease for treatment-resistant depression. J Clin Psychiatry. 2001;62 Suppl 16:26-31.
Parker GB, Malhi GS, Crawford JG, Thase ME. Identifying "paradigm failures" contributing to treatment-resistant depression. J Affect Disord. 2005 Aug;87(2-3):185-91. doi: 10.1016/j.jad.2005.02.015.
Rush AJ, Trivedi MH, Wisniewski SR, Nierenberg AA, Stewart JW, Warden D, Niederehe G, Thase ME, Lavori PW, Lebowitz BD, McGrath PJ, Rosenbaum JF, Sackeim HA, Kupfer DJ, Luther J, Fava M. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry. 2006 Nov;163(11):1905-17. doi: 10.1176/ajp.2006.163.11.1905.
Warden D, Rush AJ, Trivedi MH, Fava M, Wisniewski SR. The STAR*D Project results: a comprehensive review of findings. Curr Psychiatry Rep. 2007 Dec;9(6):449-59. doi: 10.1007/s11920-007-0061-3.
Sartorius N. The economic and social burden of depression. J Clin Psychiatry. 2001;62 Suppl 15:8-11.
Schramm E, Schneider D, Zobel I, van Calker D, Dykierek P, Kech S, Harter M, Berger M. Efficacy of Interpersonal Psychotherapy plus pharmacotherapy in chronically depressed inpatients. J Affect Disord. 2008 Jul;109(1-2):65-73. doi: 10.1016/j.jad.2007.10.013. Epub 2007 Dec 11.
Sheldon TA, Cullum N, Dawson D, Lankshear A, Lowson K, Watt I, West P, Wright D, Wright J. What's the evidence that NICE guidance has been implemented? Results from a national evaluation using time series analysis, audit of patients' notes, and interviews. BMJ. 2004 Oct 30;329(7473):999. doi: 10.1136/bmj.329.7473.999.
Nixon N, Guo B, Kaylor-Hughes C, Simpson S, Garland A, Dalgleish T, Morriss R. Specialist treatment for persistent depression in secondary care: Sustained effects from a multicentre UK study at 24 and 36 months. J Affect Disord. 2024 Jan 15;345:70-77. doi: 10.1016/j.jad.2023.10.105. Epub 2023 Oct 19.
Thomson L, Barker M, Kaylor-Hughes C, Garland A, Ramana R, Morriss R, Hammond E, Hopkins G, Simpson S. How is a specialist depression service effective for persistent moderate to severe depressive disorder?: a qualitative study of service user experience. BMC Psychiatry. 2018 Jun 15;18(1):194. doi: 10.1186/s12888-018-1708-9.
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.
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.
Other Identifiers
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09044
Identifier Type: -
Identifier Source: org_study_id