Randomised controlled trial of the clinical and cost effectiveness of a specialist team for managing refractory unipolar depressive disorder.
BACKGROUND
Around 40 per cent of patients with unipolar depressive disorder who are treated in secondary care mental health services do not respond to first or second line treatments for depression. Such patients have 20 times the suicide rate of the general population and treatment response becomes harder to achieve and sustain the longer they remain depressed. Despite this there are no randomised controlled trials of community based service delivery interventions delivering both algorithm based pharmacotherapy and psychotherapy for patients with chronic depressive disorder in secondary care mental health services who remain moderately or severely depressed after six months treatment. Without such trials evidence based guidelines on services for such patients cannot be derived.


METHODS
Single blind individually randomised controlled trial of a specialist depression disorder team (psychiatrist and psychotherapist jointly assessing and providing algorithm based drug and psychological treatment) versus usual secondary care treatment. We will recruit 174 patients with unipolar depressive disorder in secondary mental health services with a Hamilton Depression Rating Scale (HDRS) score ≥ 16 and global assessment of function (GAF) ≤ 60 after ≥ 6 months treatment. The primary outcome measures will be the HDRS and GAF supplemented by economic analysis including the EQ5 D and analysis of barriers to care, implementation and the process of care. Audits to benchmark both treatment arms against national standards of care will aid the interpretation of the results of the study.


CONCLUSIONS
This trial will be the first to assess the effectiveness and implementation of a community based specialist depression disorder team. The study has been specially designed as part of the CLAHRC Nottinghamshire, Derbyshire and Lincolnshire joint collaboration between university, health and social care organisations to provide information of direct relevance to decisions on commissioning, service provision and implementation.
School of Community Health Sciences, Division of Psychiatry and Institute of Mental Health, University of Nottingham, Triumph Road, Nottingham, UK. richard.morriss@nottingham.ac.uk
Richard
R
Morriss
Sarah
S
Marttunnen
Anne
A
Garland
Neil
N
Nixon
Ruth
R
McDonald
Tim
T
Sweeney
Heather
H
Flambert
Richard
R
Fox
Catherine
C
Kaylor-Hughes
Marilyn
M
James
Min
M
Yang
D000928:Antidepressive Agents / Q000191:economics / Q000627:therapeutic use*; D015928:Cognitive Behavioral Therapy / Q000191:economics* / Q000379:methods*; D003131:Combined Modality Therapy; D003156:Community Mental Health Services / Q000379:methods; D003362:Cost-Benefit Analysis; D003866:Depressive Disorder / Q000175:diagnosis / Q000191:economics / Q000628:therapy*; D017048:Health Care Costs / Q000706:statistics & numerical data; D006801:Humans; D008137:Longitudinal Studies; D010348:Patient Care Team / Q000191:economics / Q000458:organization & administration*; D011569:Psychiatric Status Rating Scales / Q000706:statistics & numerical data; D011570:Psychiatry / Q000191:economics / Q000379:methods; D011613:Psychotherapy / Q000191:economics / Q000379:methods; D012107:Research Design; D016037:Single-Blind Method; D013038:Specialization / Q000191:economics / Q000592:standards; D059039:Standard of Care; D016896:Treatment Outcome
D000928:Antidepressive Agents