title: Cognitive behavioural therapy as an adjunct to pharmacotherapy for treatment resistant depression in primary care: the CoBalT randomised controlled trial protocol.
abstract: BACKGROUND
  Antidepressants are often the first-line treatment for depression but only one third of patients respond fully to pharmacotherapy. This paper describes the protocol for a randomised controlled trial (RCT) designed to evaluate the clinical and cost effectiveness of cognitive behavioural therapy (CBT) as an adjunct to pharmacotherapy for patients with treatment resistant depression in primary care.
  
  
  METHODS
  CoBalT is a two parallel group multi-centre pragmatic RCT. Eligible participants were those who: (i) were aged 18-75years; (ii) were currently taking antidepressant medication (for at least 6weeks at an adequate dose); (iii) scored ≥14 on the Beck Depression Inventory (BDI-II); (iv) had adhered to their medication; and (v) met ICD-10 criteria for depression (assessed using the Clinical Interview Schedule - revised version). Those who gave written informed consent were randomised to one of two treatment groups: usual care or usual care plus CBT. The primary outcome is depressive symptoms assessed using the BDI-II at 6months post-randomisation. Secondary outcomes measured at 6 and 12months include quality of life, antidepressant use and health care utilisation. Outcomes will be analysed on an intention-to-treat basis.
  
  
  CONCLUSIONS
  The CoBalT trial will provide evidence on the clinical and cost effectiveness of CBT as an adjunct to antidepressant medication in the treatment of depression that has not responded to pharmacotherapy. Given the move to widen access to 'talking therapies', the results of this study will be timely.
authors.affiliation: School of Social and Community Medicine, University of Bristol, Oakfield House, Oakfield Road, Bristol, BS8 2BN, UK. L.J.Bridges@bristol.ac.uk
authors.forename: Laura J
authors.initials: LJ
authors.lastname: Thomas
authors.forename: Anna
authors.initials: A
authors.lastname: Abel
authors.forename: Nicola
authors.initials: N
authors.lastname: Ridgway
authors.forename: Tim
authors.initials: T
authors.lastname: Peters
authors.forename: David
authors.initials: D
authors.lastname: Kessler
authors.forename: Sandra
authors.initials: S
authors.lastname: Hollinghurst
authors.forename: Katrina
authors.initials: K
authors.lastname: Turner
authors.forename: Anne
authors.initials: A
authors.lastname: Garland
authors.forename: Bill
authors.initials: B
authors.lastname: Jerrom
authors.forename: Jill
authors.initials: J
authors.lastname: Morrison
authors.forename: Chris
authors.initials: C
authors.lastname: Williams
authors.forename: John
authors.initials: J
authors.lastname: Campbell
authors.forename: Willem
authors.initials: W
authors.lastname: Kuyken
authors.forename: Glyn
authors.initials: G
authors.lastname: Lewis
authors.forename: Nicola
authors.initials: N
authors.lastname: Wiles
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000928:Antidepressive Agents / Q000627:therapeutic use*; D015928:Cognitive Behavioral Therapy / Q000191:economics / Q000379:methods*; D003362:Cost-Benefit Analysis; D061218:Depressive Disorder, Treatment-Resistant / Q000191:economics / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D011320:Primary Health Care / Q000379:methods*; D012189:Retrospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000928:Antidepressive Agents