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Telephone-supported computerised cognitive–behavioural therapy: REEACT-2 large-scale pragmatic randomised controlled trial.Gilbody, Simon; Brabyn, Sally; Lovell, Karina; Kessler, David; Devlin, Thomas; Smith, Lucy; Araya, Ricardo; Barkham, Michael; Bower, Peter; Cooper, Cindy; et al. (Cambridge University Press, 2018-01-02)Background Computerised cognitive–behavioural therapy (cCBT) for depression has the potential to be efficient therapy but engagement is poor in primary care trials. Aims We tested the benefits of adding telephone support to cCBT. Method We compared telephone-facilitated cCBT (MoodGYM) ( n = 187) to minimally supported cCBT (MoodGYM) ( n = 182) in a pragmatic randomised trial (trial registration: ISRCTN55310481). Outcomes were depression severity (Patient Health Questionnaire (PHQ)-9), anxiety (Generalized Anxiety Disorder Questionnaire (GAD)-7) and somatoform complaints (PHQ-15) at 4 and 12 months. Results Use of cCBT increased by a factor of between 1.5 and 2 with telephone facilitation. At 4 months PHQ-9 scores were 1.9 points lower (95% CI 0.5–3.3) for telephone-supported cCBT. At 12 months, the results were no longer statistically significant (0.9 PHQ-9 points, 95% CI –0.5 to 2.3). There was improvement in anxiety scores and for somatic complaints. Conclusions Telephone facilitation of cCBT improves engagement and expedites depression improvement. The effect was small to moderate and comparable with other low-intensity psychological interventions.
The use of unequal randomisation in clinical trials — An update.Peckham, Emily; Brabyn, Sally; Cook, Liz; Devlin, Thomas; Dumville, Jo; Torgerson, David J.; University of York; University of Manchester (Elsevier, 2015-11)Objective To update a 2005 review of the reasons researchers have given for the use of unequal randomisation in randomised controlled trials (RCTs). Main measures Intervention being tested; type of study; number of participants; randomisation ratio; sample size calculation and reason given for using unequal randomisation. Methods Review of trials using unequal randomisation. Databases and sources Cochrane library, Medline and CINAHL. Results A total of 86 trials were identified. Of these 82 trials (95%) recruited patients in favour of the experimental group. Various reasons for the use of unequal randomisation were given including: gaining treatment experience; identification of adverse events; ethical; logistic and enhancing recruitment. No trial reported explicitly used it for cost-effectiveness. Most of the papers (i.e. 47, 55%) did not state why they had used unequal randomisation and only 38 trials (44%) appeared to have taken the unequal randomisation into account in their sample size calculation. Conclusion Most studies did not mention the rationale for unequal allocation, and a significant proportion did not appear to account for it in the sample size calculations. Unlike the previous review economic considerations were not stated as a rationale for its use. A number of trials used it to enhance recruitment, although this has not been tested.