title: Cognitive behavioural therapy as an adjunct to pharmacotherapy for primary care based patients with treatment resistant depression: results of the CoBalT randomised controlled trial.
abstract: BACKGROUND
  Only a third of patients with depression respond fully to antidepressant medication but little evidence exists regarding the best next-step treatment for those whose symptoms are treatment resistant. The CoBalT trial aimed to examine the effectiveness of cognitive behavioural therapy (CBT) as an adjunct to usual care (including pharmacotherapy) for primary care patients with treatment resistant depression compared with usual care alone.
  
  
  METHODS
  This two parallel-group multicentre randomised controlled trial recruited 469 patients aged 18-75 years with treatment resistant depression (on antidepressants for ≥6 weeks, Beck depression inventory [BDI] score ≥14 and international classification of diseases [ICD]-10 criteria for depression) from 73 UK general practices. Participants were randomised, with a computer generated code (stratified by centre and minimised according to baseline BDI score, whether the general practice had a counsellor, previous treatment with antidepressants, and duration of present episode of depression) to one of two groups: usual care or CBT in addition to usual care, and were followed up for 12 months. Because of the nature of the intervention it was not possible to mask participants, general practitioners, CBT therapists, or researchers to the treatment allocation. Analyses were by intention to treat. The primary outcome was response, defined as at least 50% reduction in depressive symptoms (BDI score) at 6 months compared with baseline. This trial is registered, ISRCTN38231611.
  
  
  RESULTS
  Between Nov 4, 2008, and Sept 30, 2010, we assigned 235 patients to usual care, and 234 to CBT plus usual care. 422 participants (90%) were followed up at 6 months and 396 (84%) at 12 months, finishing on Oct 31, 2011. 95 participants (46%) in the intervention group met criteria for response at 6 months compared with 46 (22%) in the usual care group (odds ratio 3·26, 95% CI 2·10-5·06, p<0·001).
  
  
  CONCLUSIONS
  Before this study, no evidence from large-scale randomised controlled trials was available for the effectiveness of augmentation of antidepressant medication with CBT as a next-step for patients whose depression has not responded to pharmacotherapy. Our study has provided robust evidence that CBT as an adjunct to usual care that includes antidepressants is an effective treatment, reducing depressive symptoms in this population.
  
  
  BACKGROUND
  National Institute for Health Research Health Technology Assessment.
authors.affiliation: Centre for Mental Health, Addiction and Suicide Research, School of Social and Community Medicine, University of Bristol, Bristol, UK. nicola.wiles@bristol.ac.uk
authors.forename: Nicola
authors.initials: N
authors.lastname: Wiles
authors.forename: Laura
authors.initials: L
authors.lastname: Thomas
authors.forename: Anna
authors.initials: A
authors.lastname: Abel
authors.forename: Nicola
authors.initials: N
authors.lastname: Ridgway
authors.forename: Nicholas
authors.initials: N
authors.lastname: Turner
authors.forename: John
authors.initials: J
authors.lastname: Campbell
authors.forename: Anne
authors.initials: A
authors.lastname: Garland
authors.forename: Sandra
authors.initials: S
authors.lastname: Hollinghurst
authors.forename: Bill
authors.initials: B
authors.lastname: Jerrom
authors.forename: David
authors.initials: D
authors.lastname: Kessler
authors.forename: Willem
authors.initials: W
authors.lastname: Kuyken
authors.forename: Jill
authors.initials: J
authors.lastname: Morrison
authors.forename: Katrina
authors.initials: K
authors.lastname: Turner
authors.forename: Chris
authors.initials: C
authors.lastname: Williams
authors.forename: Tim
authors.initials: T
authors.lastname: Peters
authors.forename: Glyn
authors.initials: G
authors.lastname: Lewis
mesh_terms: D000328:Adult; D000928:Antidepressive Agents / Q000627:therapeutic use*; D015928:Cognitive Behavioral Therapy; D003131:Combined Modality Therapy; D061218:Depressive Disorder, Treatment-Resistant / Q000175:diagnosis / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011320:Primary Health Care; D016896:Treatment Outcome
chemical_list: D000928:Antidepressive Agents