1. Randomised controlled trial of the clinical and cost effectiveness of a specialist team for managing refractory unipolar depressive disorder
- Author
-
Ruth McDonald, Richard Fox, Min Yang, Sarah Marttunnen, Neil Nixon, Anne Garland, Catherine Kaylor-Hughes, Heather Flambert, Richard Morriss, Tim Sweeney, and Marilyn James
- Subjects
medicine.medical_specialty ,Cost effectiveness ,lcsh:RC435-571 ,medicine.medical_treatment ,Cost-Benefit Analysis ,Population ,Psychological intervention ,Collaborative Care ,Poison control ,law.invention ,Study Protocol ,Randomized controlled trial ,law ,lcsh:Psychiatry ,Medicine ,Humans ,Single-Blind Method ,Longitudinal Studies ,education ,Psychiatry ,Patient Care Team ,Psychiatric Status Rating Scales ,education.field_of_study ,Depressive Disorder ,Cognitive Behavioral Therapy ,business.industry ,Standard of Care ,Health Care Costs ,Mental health ,Combined Modality Therapy ,Antidepressive Agents ,Community Mental Health Services ,Cognitive behavioral therapy ,Psychotherapy ,Psychiatry and Mental health ,Treatment Outcome ,Research Design ,Physical therapy ,business ,Specialization - Abstract
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/design 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 incuding 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. Discussion 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. Trial registration Clinical trials.gov identifier NCT01047124
- Published
- 2010