PMID- 27498098
OWN - NLM
STAT- MEDLINE
DCOM- 20171109
LR  - 20220316
IS  - 2215-0374 (Electronic)
IS  - 2215-0366 (Linking)
VI  - 3
IP  - 9
DP  - 2016 Sep
TI  - Efficacy and cost-effectiveness of a specialist depression service versus usual 
      specialist mental health care to manage persistent depression: a randomised 
      controlled trial.
PG  - 821-31
LID - S2215-0366(16)30143-2 [pii]
LID - 10.1016/S2215-0366(16)30143-2 [doi]
AB  - BACKGROUND: Persistent moderate or severe unipolar depression is common and 
      expensive to treat. Clinical guidelines recommend combined pharmacotherapy and 
      psychotherapy. Such treatments can take up to 1 year to show an effect, but no 
      trials of suitable duration have been done. We investigated the efficacy and 
      cost-effectiveness of outpatient-based, specialist depression services (SDS) 
      versus treatment as usual (TAU) on depression symptoms and function. METHODS: We 
      did a multicentre, single-blind, patient-level, parallel, randomised controlled 
      trial (RCT), as part of the National Institute for Health Research (NIHR) 
      Collaboration for Leadership in Applied Health Research and Care (CLAHRC) study, 
      in three mental health outpatient settings in England. Eligible participants were 
      in secondary care, were older than 18 years, had unipolar depression (with a 
      current major depressive episode, a 17-item Hamilton Depression Rating Scale 
      [HDRS17] score of >/=16, and a Global Assessment of Function [GAF] score of </=60), 
      and had not responded to 6 months or more of treatment for depression. 
      Randomisation was stratified by site with allocation conveyed to a trial 
      administrator, with research assessors masked to outcome. Patients were 
      randomised (1:1) using a computer-generated pseudo-random code with random 
      permuted blocks of varying sizes of two, four, or six to either SDS 
      (collaborative care approach between psychiatrists and cognitive behavioural 
      therapists for 12 months, followed by graduated transfer of care up to 15 months) 
      or to the TAU group. Intention-to-treat primary outcome measures were changes in 
      HDRS17 and GAF scores between baseline and 6, 12, and 18 months' follow-up. We 
      will separately publish follow-up outcomes for months 24 and 36. Clinical 
      efficacy and cost-effectiveness were examined from health and social care persp 
      ectives at 18 months, as recommended by the National Institute for Health and 
      Care Excellence. This trial is registered at ClinicalTrials.gov (NCT01047124) and 
      the ISRCTN registry (ISRCTN10963342); the trial has ended. FINDINGS: 307 patients 
      were assessed for eligibility between Dec 21, 2009, and Oct 31, 2012. 94 patients 
      were assigned to TAU and 93 patients to SDS, and were included in 
      intention-to-treat analyses. The changes from baseline to 6 months in HDRS17 and 
      GAF scores did not significantly differ between treatment groups (mean change 
      difference in HDRS17 score -1.01 [95% CI -3.30 to 1.28], p=0.385; and in GAF 
      score 1.33 [-2.92 to 5.57], p=0.538). Primary outcome data were available for 134 
      (72%) patients at 12 months. We noted no differences at 12 months' follow-up 
      between SDS and TAU for mean HDRS17 score (14.8 [SD 7.9] in the SDS group vs 17.2 
      [7.3] in the TAU group, p=0.056) or GAF score (60.4 [11.7] vs 55.8 [12.7], 
      p=0.064), and the changes from baseline to 12 months in HDRS17 and GAF scores did 
      not significantly differ between treatment groups (mean change difference in 
      HDRS17 score -2.45 [95% CI -5.04 to 0.14], p=0.064; and in GAF score 4.12 [-0.11 
      to 8.35], p=0.056). The mean change in HDRS17 score from baseline to 18 months 
      was significantly improved in the SDS group compared with the TAU group (13.6 [SD 
      8.8] in the SDS group vs 16.1 [6.6] in the TAU group; mean change difference 
      -2.96 [95% CI -5.33 to -0.59], p=0.015), but the GAF scores showed no significant 
      differences between the groups (61.2 [SD 13.0] vs 57.7 [11.9]; mean change 
      difference 3.82 [-9.3 to 8.57], p=0.113). We reported no deaths, but one (1%) 
      patient was admitted to hospital for myocardial infarction, and three episodes of 
      self-harm were reported in three (2%) patients (two receiving TAU, one receiving 
      SDS care). The incremental cost-effectiveness ratio of SDS versus TAU was  pound43 603 
      per quality-adjusted life-year. INTERPRETATION: Compared with usual specialist 
      mental health secondary care, SDS might improve depression symptoms for patients 
      with persistent moderate to severe depression, but functional outcomes and 
      economic benefits are equivocal. FUNDING: National Institute for Health Research 
      Collaboration for Leadership in Applied Health Research and Care, UK Medical 
      Research Council, Nottinghamshire Healthcare NHS Foundation Trust, Derbyshire 
      Healthcare NHS Foundation Trust, Cambridgeshire and Peterborough NHS Foundation 
      Trust, University of Nottingham.
CI  - Copyright (c) 2016 Elsevier Ltd. All rights reserved.
FAU - Morriss, Richard
AU  - Morriss R
AD  - Department of Psychiatry and Applied Psychology, Institute of Mental Health, 
      University of Nottingham, Nottingham, UK. Electronic address: 
      richard.morriss@nottingham.ac.uk.
FAU - Garland, Anne
AU  - Garland A
AD  - Adult Mental Health Directorate, Nottinghamshire Healthcare Trust, Nottingham, 
      UK.
FAU - Nixon, Neil
AU  - Nixon N
AD  - Adult Mental Health Directorate, Nottinghamshire Healthcare Trust, Nottingham, 
      UK.
FAU - Guo, Boliang
AU  - Guo B
AD  - Department of Psychiatry and Applied Psychology, Institute of Mental Health, 
      University of Nottingham, Nottingham, UK.
FAU - James, Marilyn
AU  - James M
AD  - Division of Rehabilitation and Ageing, School of Medicine, University of 
      Nottingham, Nottingham, UK.
FAU - Kaylor-Hughes, Catherine
AU  - Kaylor-Hughes C
AD  - Department of Psychiatry and Applied Psychology, Institute of Mental Health, 
      University of Nottingham, Nottingham, UK.
FAU - Moore, Richard
AU  - Moore R
AD  - Independent Practitioner, Cambridge, UK.
FAU - Ramana, Rajini
AU  - Ramana R
AD  - Cambridge and Peterborough Partnership NHS Foundation Trust, Cambridge, UK.
FAU - Sampson, Christopher
AU  - Sampson C
AD  - Division of Rehabilitation and Ageing, School of Medicine, University of 
      Nottingham, Nottingham, UK.
FAU - Sweeney, Timothy
AU  - Sweeney T
AD  - Adult Mental Health Directorate, Nottinghamshire Healthcare Trust, Nottingham, 
      UK.
FAU - Dalgleish, Tim
AU  - Dalgleish T
AD  - Medical Research Council Cognition and Brain Sciences Unit, Cambridge, UK.
CN  - NIHR CLAHRC Specialist Mood Disorder Study Group
LA  - eng
SI  - ClinicalTrials.gov/NCT01047124
GR  - MC_U105579215/MRC_/Medical Research Council/United Kingdom
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20160803
PL  - England
TA  - Lancet Psychiatry
JT  - The lancet. Psychiatry
JID - 101638123
SB  - IM
CIN - Lancet Psychiatry. 2016 Sep;3(9):792-3. PMID: 27498097
MH  - Adult
MH  - Ambulatory Care/*economics/*methods
MH  - Cost-Benefit Analysis
MH  - Depressive Disorder, Major/*therapy
MH  - Female
MH  - Humans
MH  - Male
MH  - Mental Health Services/*economics
MH  - Middle Aged
MH  - Single-Blind Method
MH  - Specialization/*economics
MH  - Treatment Outcome
EDAT- 2016/08/09 06:00
MHDA- 2017/11/10 06:00
CRDT- 2016/08/08 06:00
PHST- 2016/03/14 00:00 [received]
PHST- 2016/06/08 00:00 [revised]
PHST- 2016/06/13 00:00 [accepted]
PHST- 2016/08/08 06:00 [entrez]
PHST- 2016/08/09 06:00 [pubmed]
PHST- 2017/11/10 06:00 [medline]
AID - S2215-0366(16)30143-2 [pii]
AID - 10.1016/S2215-0366(16)30143-2 [doi]
PST - ppublish
SO  - Lancet Psychiatry. 2016 Sep;3(9):821-31. doi: 10.1016/S2215-0366(16)30143-2. Epub 
      2016 Aug 3.