title: A randomised controlled trial of computerised cognitive behaviour therapy for the treatment of depression in primary care: the Randomised Evaluation of the Effectiveness and Acceptability of Computerised Therapy (REEACT) trial.
abstract: BACKGROUND
  Computerised cognitive behaviour therapy (cCBT) has been developed as an efficient form of therapy delivery with the potential to enhance access to psychological care. Independent research is needed which examines both the clinical effectiveness and cost-effectiveness of cCBT over the short and longer term.
  
  
  OBJECTIVE
  To compare the clinical effectiveness and cost-effectiveness of cCBT as an adjunct to usual general practitioner (GP) care against usual GP care alone, for a free-to-use cCBT program (MoodGYM; National Institute for Mental Health Research, Australian National University, Canberra, Australia) and a commercial pay-to-use cCBT program (Beating the Blues(®); Ultrasis, London, UK) for adults with depression, and to determine the acceptability of cCBT and the experiences of users.
  
  
  METHODS
  A pragmatic, multicentre, three-armed, parallel, randomised controlled trial (RCT) with concurrent economic and qualitative evaluations. Simple randomisation was used. Participants and researchers were not blind to treatment allocation.
  
  
  METHODS
  Primary care in England.
  
  
  METHODS
  Adults with depression who scored ≥ 10 on the Patient Health Questionnaire-9 (PHQ-9).
  
  
  METHODS
  Participants who were randomised to either of the two intervention groups received cCBT (Beating the Blues or MoodGYM) in addition to usual GP care. Participants who were randomised to the control group were offered usual GP care.
  
  
  METHODS
  The primary outcome was depression at 4 months (PHQ-9). Secondary outcomes were depression at 12 and 24 months; measures of mental health and health-related quality of life at 4, 12 and 24 months; treatment preference; and the acceptability of cCBT and experiences of users.
  
  
  RESULTS
  Clinical effectiveness: 210 patients were randomised to Beating the Blues, 242 patients were randomised to MoodGYM and 239 patients were randomised to usual GP care (total 691). There was no difference in the primary outcome (depression measured at 4 months) either between Beating the Blues and usual GP care [odds ratio (OR) 1.19, 95% confidence interval (CI) 0.75 to 1.88] or between MoodGYM and usual GP care (OR 0.98, 95% CI 0.62 to 1.56). There was no overall difference across all time points for either intervention compared with usual GP care in a mixed model (Beating the Blues versus usual GP care, p = 0.96; and MoodGYM versus usual GP care, p = 0.11). However, a small but statistically significant difference between MoodGYM and usual GP care at 12 months was found (OR 0.56, 95% CI 0.34 to 0.93). Free-to-use cCBT (MoodGYM) was not inferior to pay-to-use cCBT (Beating the Blues) (OR 0.91, 90% CI 0.62 to 1.34; p = 0.69). There were no consistent benefits of either intervention when secondary outcomes were examined. There were no serious adverse events thought likely to be related to the trial intervention. Despite the provision of regular technical telephone support, there was low uptake of the cCBT programs. Cost-effectiveness: cost-effectiveness analyses suggest that neither Beating the Blues nor MoodGYM appeared cost-effective compared with usual GP care alone. Qualitative evaluation: participants were often demotivated to access the computer programs, by reason of depression. Some expressed the view that a greater level of therapeutic input would be needed to promote engagement.
  
  
  CONCLUSIONS
  The benefits that have previously been observed in developer-led trials were not found in this large pragmatic RCT. The benefits of cCBT when added to routine primary care were minimal, and uptake of this mode of therapy was relatively low. There remains a clinical and economic need for effective low-intensity psychological treatments for depression with improved patient engagement.
  
  
  BACKGROUND
  This trial is registered as ISRCTN91947481.
  
  
  BACKGROUND
  This project was funded by the National Institute for Health Research Health Technology Assessment programme.
authors.affiliation: Department of Health Sciences, University of York, York, UK.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Littlewood
authors.affiliation: Centre for Health Economics, University of York, York, UK.
authors.forename: Ana
authors.initials: A
authors.lastname: Duarte
authors.affiliation: York Trials Unit, Department of Health Sciences, University of York, York, UK.
authors.forename: Catherine
authors.initials: C
authors.lastname: Hewitt
authors.affiliation: Centre for Primary Care, Institute of Population Health, University of Manchester, Manchester, UK.|National Institute for Health Research (NIHR) School for Primary Care Research, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK (previously National Primary Care Research and Development Centre, University of Manchester, Manchester, UK).
authors.forename: Sarah
authors.initials: S
authors.lastname: Knowles
authors.affiliation: Centre for Health Economics, University of York, York, UK.
authors.forename: Stephen
authors.initials: S
authors.lastname: Palmer
authors.affiliation: Centre for Health Economics, University of York, York, UK.
authors.forename: Simon
authors.initials: S
authors.lastname: Walker
authors.affiliation: Department of Health Sciences, University of York, York, UK.
authors.forename: Phil
authors.initials: P
authors.lastname: Andersen
authors.affiliation: Academic Unit of Psychiatry, University of Bristol, Bristol, UK.|Department of Population Health, London School of Hygiene and Tropical Medicine, London, UK.
authors.forename: Ricardo
authors.initials: R
authors.lastname: Araya
authors.affiliation: Centre for Psychological Services Research, University of Sheffield, Sheffield, UK.
authors.forename: Michael
authors.initials: M
authors.lastname: Barkham
authors.affiliation: National Institute for Health Research (NIHR) School for Primary Care Research, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK (previously National Primary Care Research and Development Centre, University of Manchester, Manchester, UK).
authors.forename: Peter
authors.initials: P
authors.lastname: Bower
authors.affiliation: Department of Health Sciences, University of York, York, UK.
authors.forename: Sally
authors.initials: S
authors.lastname: Brabyn
authors.affiliation: Department of Health Sciences, University of York, York, UK.|Medical Research Council (MRC) Epidemiology Unit, University of Cambridge School of Clinical Medicine, Cambridge, UK.
authors.forename: Gwen
authors.initials: G
authors.lastname: Brierley
authors.affiliation: Clinical Trials Research Unit, School of Health and Related Research, University of Sheffield, Sheffield, UK.
authors.forename: Cindy
authors.initials: C
authors.lastname: Cooper
authors.affiliation: National Institute for Health Research (NIHR) School for Primary Care Research, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK (previously National Primary Care Research and Development Centre, University of Manchester, Manchester, UK).
authors.forename: Linda
authors.initials: L
authors.lastname: Gask
authors.affiliation: Academic Unit of Primary Health Care, University of Bristol, Bristol, UK.
authors.forename: David
authors.initials: D
authors.lastname: Kessler
authors.affiliation: National Institute for Health Research (NIHR) School for Primary Care Research, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK (previously National Primary Care Research and Development Centre, University of Manchester, Manchester, UK).|Primary Care Clinical Sciences, University of Birmingham, Birmingham, UK.
authors.forename: Helen
authors.initials: H
authors.lastname: Lester
authors.affiliation: School of Nursing, Midwifery and Social Work, University of Manchester, Manchester, UK.
authors.forename: Karina
authors.initials: K
authors.lastname: Lovell
authors.affiliation: York Trials Unit, Department of Health Sciences, University of York, York, UK.
authors.forename: Usman
authors.initials: U
authors.lastname: Muhammad
authors.affiliation: Clinical Trials Research Unit, School of Health and Related Research, University of Sheffield, Sheffield, UK.
authors.forename: Glenys
authors.initials: G
authors.lastname: Parry
authors.affiliation: Department of Health Sciences, University of York, York, UK.|University of Exeter Medical School, University of Exeter, Exeter, UK.
authors.forename: David A
authors.initials: DA
authors.lastname: Richards
authors.affiliation: Department of Health Sciences, University of York, York, UK.
authors.forename: Rachel
authors.initials: R
authors.lastname: Richardson
authors.affiliation: School of Social & Community Medicine, University of Bristol, Bristol, UK.
authors.forename: Debbie
authors.initials: D
authors.lastname: Tallon
authors.affiliation: York Trials Unit, Department of Health Sciences, University of York, York, UK.
authors.forename: Puvan
authors.initials: P
authors.lastname: Tharmanathan
authors.affiliation: Clinical Trials Research Unit, School of Health and Related Research, University of Sheffield, Sheffield, UK.
authors.forename: David
authors.initials: D
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authors.affiliation: Department of Health Sciences, University of York, York, UK.
authors.forename: Simon
authors.initials: S
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mesh_terms: D000328:Adult; D015928:Cognitive Behavioral Therapy / Q000191:economics / Q000379:methods*; D003362:Cost-Benefit Analysis; D003865:Major Depressive Disorder / Q000523:psychology / Q000628:therapy*; D005260:Female; D006801:Humans; D020407:Internet; D007407:Interviews as Topic; D008297:Male; D008875:Middle Aged; D011320:Primary Health Care; D011788:Quality of Life; D013673:Technology Assessment, Biomedical; D013689:Telephone; D013813:Therapy, Computer-Assisted / Q000379:methods; D016896:Treatment Outcome; D006113:United Kingdom