title: A pragmatic randomised controlled trial assessing the non-inferiority of counselling for depression versus cognitive-behaviour therapy for patients in primary care meeting a diagnosis of moderate or severe depression (PRaCTICED): Study protocol for a randomised controlled trial.
abstract: NICE guidelines state cognitive behavioural therapy (CBT) is a front-line psychological treatment for people presenting with depression in primary care. Counselling for Depression (CfD), a form of Person-Centred Experiential therapy, is also offered within Improving Access to Psychological Therapies (IAPT) services for moderate depression but its effectiveness for severe depression has not been investigated. A full-scale randomised controlled trial to determine the efficacy and cost-effectiveness of CfD is required.
  
  
  
  PRaCTICED is a two-arm, parallel group, non-inferiority randomised controlled trial comparing CfD against CBT. It is embedded within the local IAPT service using a stepped care service delivery model where CBT and CfD are routinely offered at step 3. Trial inclusion criteria comprise patients aged 18 years or over, wishing to work on their depression, judged to require a step 3 intervention, and meeting an ICD-10 diagnosis of moderate or severe depression. Patients are randomised using a centralised, web-based system to CfD or CBT with each treatment being delivered up to a maximum 20 sessions. Both interventions are manualised with treatment fidelity tested via supervision and random sampling of sessions using adherence/competency scales. The primary outcome measure is the Patient Health Questionnaire-9 collected at baseline, 6 and 12 months. Secondary outcome measures tap depression, generic psychological distress, anxiety, functioning and quality of life. Cost-effectiveness is determined by a patient service receipt questionnaire. Exit interviews are conducted with patients by research assessors blind to treatment allocation. The trial requires 500 patients (250 per arm) to test the non-inferiority hypothesis of -2 PHQ-9 points at the one-sided, 2.5% significance level with 90% power, assuming no underlying difference and a standard deviation of 6.9. The primary analysis will be undertaken on all patients randomised (intent to treat) alongside per-protocol and complier-average causal effect analyses as recommended by the extension to the CONSORT statement for non-inferiority trials.
  
  
  
  This large-scale trial utilises routinely collected outcome data as well as specific trial data to provide evidence of the comparative efficacy and cost-effectiveness of Counselling for Depression compared with Cognitive Behaviour Therapy as delivered within the UK government's Improving Access to Psychological Therapies initiative.
  
  
  
  Controlled Trials ISRCTN Registry, ISRCTN06461651 . Registered on 14 September 2014.
authors.affiliation: Health Services Research, Centre for Psychological Services Research, School of Health and Related Research, University of Sheffield, 30 Regent St, Sheffield, S1 2DA, UK.
authors.forename: David
authors.initials: D
authors.lastname: Saxon
authors.affiliation: Health Services Research, Centre for Psychological Services Research, School of Health and Related Research, University of Sheffield, 30 Regent St, Sheffield, S1 2DA, UK.|Sheffield IAPT (Sheffield Health & Social Care NHS Foundation Trust), St George's Community Health Centre, Winter Street, Sheffield, S3 7ND, UK.
authors.forename: Kate
authors.initials: K
authors.lastname: Ashley
authors.affiliation: Health Services Research, Centre for Psychological Services Research, School of Health and Related Research, University of Sheffield, 30 Regent St, Sheffield, S1 2DA, UK.
authors.forename: Lindsey
authors.initials: L
authors.lastname: Bishop-Edwards
authors.affiliation: Health Services Research, Centre for Psychological Services Research, School of Health and Related Research, University of Sheffield, 30 Regent St, Sheffield, S1 2DA, UK.
authors.forename: Janice
authors.initials: J
authors.lastname: Connell
authors.affiliation: Clinical Psychology Unit, Centre for Psychological Services Research, University of Sheffield, Sheffield, S10 2TN, UK.|Department of Psychology, University of Sheffield, Sheffield, S10 2TN, UK.
authors.forename: Phillippa
authors.initials: P
authors.lastname: Harrison
authors.affiliation: Health Services Research, School of Health and Related Research, University of Sheffield, 30 Regent St, Sheffield, S1 4DA, UK.
authors.forename: Sally
authors.initials: S
authors.lastname: Ohlsen
authors.affiliation: Clinical Psychology Unit, Centre for Psychological Services Research, University of Sheffield, Sheffield, S10 2TN, UK.|Department of Psychology, University of Sheffield, Sheffield, S10 2TN, UK.
authors.forename: Gillian E
authors.initials: GE
authors.lastname: Hardy
authors.affiliation: Clinical Psychology Unit, Centre for Psychological Services Research, University of Sheffield, Sheffield, S10 2TN, UK.|Department of Psychology, University of Sheffield, Sheffield, S10 2TN, UK.|Sheffield IAPT (Sheffield Health & Social Care NHS Foundation Trust), St George's Community Health Centre, Winter Street, Sheffield, S3 7ND, UK.
authors.forename: Stephen
authors.initials: S
authors.lastname: Kellett
authors.affiliation: Health Economics and Decision Science, School of Health and Related Research, University of Sheffield, 30 Regent St, Sheffield, S1 2DA, UK.
authors.forename: Clara
authors.initials: C
authors.lastname: Mukuria
authors.affiliation: Sheffield IAPT (Sheffield Health & Social Care NHS Foundation Trust), St George's Community Health Centre, Winter Street, Sheffield, S3 7ND, UK.
authors.forename: Toni
authors.initials: T
authors.lastname: Mank
authors.affiliation: NIHR School for Primary Care Research, University of Manchester, Manchester, M13 9PL, UK.
authors.forename: Peter
authors.initials: P
authors.lastname: Bower
authors.affiliation: Clinical Trial Research Unit, School of Health and Related Research, University of Sheffield, 30 Regent St, Sheffield, S1 2DA, UK.
authors.forename: Mike
authors.initials: M
authors.lastname: Bradburn
authors.affiliation: Health Economics and Decision Science, School of Health and Related Research, University of Sheffield, 30 Regent St, Sheffield, S1 2DA, UK.
authors.forename: John
authors.initials: J
authors.lastname: Brazier
authors.affiliation: Counselling Unit, School of Psychological Sciences and Health, University of Strathclyde, Room 507, Graham Hills Building, 40 George Street, Glasgow, G1 1QE, UK.
authors.forename: Robert
authors.initials: R
authors.lastname: Elliott
authors.affiliation: School of Psychological and Social Sciences, York St John University, Lord Mayor's Walk, York, YO31 7EX, UK.
authors.forename: Lynne
authors.initials: L
authors.lastname: Gabriel
authors.affiliation: Division of Psychiatry, Faculty of Brain Sciences, University College London, Sixth Floor, Maple House, 149 Tottenham Court Rd, London, W1T 7NF, UK.
authors.forename: Michael
authors.initials: M
authors.lastname: King
authors.affiliation: Research Department of Clinical Health and Educational Psychology, University College London, 1-19 Torrington Place, London, WC1E 7HB, UK.
authors.forename: Stephen
authors.initials: S
authors.lastname: Pilling
authors.affiliation: c/o Mental Health Group, Health Services Research, School of Health and Related Research, University of Sheffield, 30 Regent St, Sheffield, S1 2DA, UK.
authors.forename: Sue
authors.initials: S
authors.lastname: Shaw
authors.affiliation: Department of Psychology, University of Sheffield, Sheffield, S10 2TN, UK.|Department of Psychology, Clinical Psychology Unit, University of Sheffield, Sheffield, S10 2TN, UK.
authors.forename: Glenn
authors.initials: G
authors.lastname: Waller
authors.affiliation: Clinical Psychology Unit, Centre for Psychological Services Research, University of Sheffield, Sheffield, S10 2TN, UK. m.barkham@sheffield.ac.uk.|Department of Psychology, University of Sheffield, Sheffield, S10 2TN, UK. m.barkham@sheffield.ac.uk.
authors.forename: Michael
authors.identifier: 0000-0003-1687-6376
authors.initials: M
authors.lastname: Barkham
mesh_terms: D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy / Q000191:economics; D057186:Comparative Effectiveness Research; D003362:Cost-Benefit Analysis; D003376:Counseling / Q000191:economics; D003863:Depression / Q000175:diagnosis / Q000191:economics / Q000523:psychology / Q000628:therapy*; D004739:England; D017048:Health Care Costs; D006801:Humans; D057194:Intention to Treat Analysis; D011320:Primary Health Care / Q000191:economics; D011569:Psychiatric Status Rating Scales; D012107:Research Design; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
keywords: Cognitive behaviour therapy; Counselling for depression; Depression; Non-inferiority trial