title: The second Randomised Evaluation of the Effectiveness, cost-effectiveness and Acceptability of Computerised Therapy (REEACT-2) trial: does the provision of telephone support enhance the effectiveness of computer-delivered cognitive behaviour therapy? A randomised controlled trial.
abstract: Computerised cognitive behaviour therapy (cCBT) is an efficient form of therapy potentially improving access to psychological care. Indirect evidence suggests that the uptake and effectiveness of cCBT can be increased if facilitated by telephone, but this is not routinely offered in the NHS.
  
  
  
  To compare the clinical effectiveness and cost-effectiveness of telephone-facilitated free-to-use cCBT [e.g. MoodGYM (National Institute for Mental Health Research, Australian National University, Canberra, ACT, Australia)] with minimally supported cCBT.
  
  
  
  This study was a multisite, pragmatic, open, two-arm, parallel-group randomised controlled trial with a concurrent economic evaluation.
  
  
  
  Participants were recruited from GP practices in Bristol, Manchester, Sheffield, Hull and the north-east of England.
  
  
  
  Potential participants were eligible to participate in the trial if they were adults with depression scoring ≥ 10 on the Patient Health Questionnaire-9 (PHQ-9).
  
  
  
  Participants were randomised using a computer-generated random number sequence to receive minimally supported cCBT or telephone-facilitated cCBT. Participants continued with usual general practitioner care.
  
  
  
  The primary outcome was self-reported symptoms of depression, as assessed by the PHQ-9 at 4 months post randomisation.
  
  
  
  Secondary outcomes were depression at 12 months and anxiety, somatoform complaints, health utility (as assessed by the European Quality of Life-5 Dimensions questionnaire) and resource use at 4 and 12 months.
  
  
  
  Clinical effectiveness: 182 participants were randomised to minimally supported cCBT and 187 participants to telephone-facilitated cCBT. There was a difference in the severity of depression at 4 and 12 months, with lower levels in the telephone-facilitated group. The odds of no longer being depressed (defined as a PHQ-9 score of < 10) at 4 months were twice as high in the telephone-facilitated cCBT group [odds ratio (OR) 2.05, 95% confidence interval (CI) 1.23 to 3.42]. The benefit of telephone-facilitated cCBT was no longer significant at 12 months (OR 1.63, 95% CI 0.98 to 2.71). At 4 months the between-group difference in PHQ-9 scores was 1.9 (95% CI 0.5 to 3.3). At 12 months the results still favoured telephone-facilitated cCBT but were no longer statistically significant, with a difference in PHQ-9 score of 0.9 (95% CI -0.5 to 2.3). When considering the whole follow-up period, telephone-facilitated cCBT was asssociated with significantly lower PHQ-9 scores than minimally supported cCBT (mean difference -1.41, 95% CI -2.63 to -0.17;p= 0.025). There was a significant improvement in anxiety scores over the trial period (between-group difference 1.1, 95% CI 0.1 to 2.3;p= 0.037). In the case of somatic complaints (assessed using the Patient Health Questionnaire-15), there was a borderline statistically significant difference over the trial period (between-group difference 1.1, 95% CI 0.0 to 1.8;p= 0.051). There were gains in quality-adjusted life-years at reduced cost when telephone facilitation was added to MoodGYM. However, the results were subject to uncertainty.
  
  
  
  The results showed short-term benefits from the addition of telephone facilitation to cCBT. The effect was small to moderate and comparable with that of other primary care psychological interventions. Telephone facilitation should be considered when offering cCBT for depression.
  
  
  
  Participants' depression was assessed with the PHQ-9, cCBT use was quite low and there was a slightly greater than anticipated loss to follow-up.
  
  
  
  Improve the acceptability of cCBT and its capacity to address coexisting disorders. Large-scale pragmatic trials of cCBT with bibliotherapy and telephone-based interventions are required.
  
  
  
  Current Controlled Trials ISRCTN55310481.
  
  
  
  This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 89. See the NIHR Journals Library website for further project information.
authors.affiliation: Department of Health Sciences, University of York, York, UK.
authors.forename: Sally
authors.initials: S
authors.lastname: Brabyn
authors.affiliation: Department of Population Health, Centre of Global Mental 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: Centre for Primary Care, University of Manchester, Manchester, UK.
authors.forename: Peter
authors.initials: P
authors.lastname: Bower
authors.affiliation: School of Health and Related Research, University of Sheffield, Sheffield, UK.
authors.forename: Cindy
authors.initials: C
authors.lastname: Cooper
authors.affiliation: Centre for Health Economics, University of York, York, UK.
authors.forename: Ana
authors.initials: A
authors.lastname: Duarte
authors.affiliation: Academic Unit of Primary Health Care, University of Bristol, Bristol, UK.
authors.forename: David
authors.initials: D
authors.lastname: Kessler
authors.affiliation: Centre for Primary Care, University of Manchester, Manchester, UK.
authors.forename: Sarah
authors.initials: S
authors.lastname: Knowles
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: Department of Health Sciences, University of York, York, UK.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Littlewood
authors.affiliation: Department of Health Sciences, University of York, York, UK.|Centre for Health Economics, University of York, York, UK.
authors.forename: Richard
authors.initials: R
authors.lastname: Mattock
authors.affiliation: Centre for Health Economics, University of York, York, UK.
authors.forename: Stephen
authors.initials: S
authors.lastname: Palmer
authors.affiliation: Department of Health Sciences, University of York, York, UK.
authors.forename: Jodi
authors.initials: J
authors.lastname: Pervin
authors.affiliation: University of Exeter Medical School, University of Exeter, Exeter, UK.
authors.forename: David
authors.initials: D
authors.lastname: Richards
authors.affiliation: School of Social and Community Medicine, University of Bristol, Bristol, UK.
authors.forename: Debbie
authors.initials: D
authors.lastname: Tallon
authors.affiliation: Clinical Trials Research Unit, University of Sheffield, Sheffield, UK.
authors.forename: David
authors.initials: D
authors.lastname: White
authors.affiliation: Centre for Health Economics, University of York, York, UK.
authors.forename: Simon
authors.initials: S
authors.lastname: Walker
authors.affiliation: York Trials Unit, University of York, York, UK.
authors.forename: Gillian
authors.initials: G
authors.lastname: Worthy
authors.affiliation: Department of Health Sciences, University of York, York, UK.
authors.forename: Simon
authors.initials: S
authors.lastname: Gilbody
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001007:Anxiety / Q000453:epidemiology / Q000628:therapy; D015928:Cognitive Behavioral Therapy / Q000191:economics* / Q000379:methods*; D003362:Cost-Benefit Analysis; D003863:Depression / Q000453:epidemiology / Q000628:therapy*; D005260:Female; D006801:Humans; D020407:Internet; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D019057:Quality-Adjusted Life Years; D013001:Somatoform Disorders / Q000453:epidemiology / Q000628:therapy; D013222:State Medicine; D017216:Telemedicine / Q000191:economics* / Q000379:methods*; D013689:Telephone; D006113:United Kingdom; D055815:Young Adult