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

BackgroundComputerised 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.ObjectivesTo 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.DesignA 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.SettingPrimary care in England.ParticipantsAdults with depression who scored ≥ 10 on the Patient Health Questionnaire-9 (PHQ-9).InterventionsParticipants 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.Main outcome measuresThe 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.ResultsClinical 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.ConclusionsThe 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.Trial registrationThis trial is registered as ISRCTN91947481.FundingThis project was funded by the National Institute for Health Research Health Technology Assessment programme.

Clinical effectiveness, cost-effectiveness and acceptability of low-intensity interventions in the management of obsessive–compulsive disorder: the Obsessive–Compulsive Treatment Efficacy randomised controlled Trial (OCTET)

“…Similar methods (large-scale screening of existing lists of potentially eligible patients) have underpinned a number of our successful large multicentre mental health trials [e.g. the Randomised Evaluation of the Effectiveness and Acceptability of Computerised Therapy (REEACT trial), 36 cost-effectiveness of collaborative care for depression in UK primary care trial (CADET) 37 ].…”

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

“…with minimal professional support). 12 The REEACT-2 trial specifically tests the hypothesis that increasing the level of professional support offered alongside cCBT leads to a greater level of engagement with the computer technology and in turn leads to improved outcomes. The need for the REEACT-2 trial was highlighted by the negative results of the REEACT trial and the emergence of indirect evidence from systematic reviews which showed that meta-analyses of professionally supported cCBT demonstrated larger effect sizes than minimally supported cCBT.…”

“…12 The design of the REEACT trial was to compare the clinical effectiveness and cost-effectiveness of commercially developed cCBT (Beating the Blues; Ultrasis, London, UK) versus free-to-use cCBT (MoodGYM) versus usual GP care. The trial was pragmatic in design and recruited 691 participants in UK primary care.…”

“…Second, we have shown in the REEACT trial that MoodGYM is not inferior to commercially developed cCBT products. 12 Third, the technology can be accessed at no direct cost to patients in the UK NHS and it had received cautious support in earlier technology appraisals. 6 The results of the REEACT-2 trial are therefore of relevance to decision-makers as investment or commissioning of the use of cCBT will not require purchase of commercially developed products.…”

An evidence-based approach to the use of telehealth in long-term health conditions: development of an intervention and evaluation through pragmatic randomised controlled trials in patients with depression or raised cardiovascular risk

“…85 Although at the time that we planned this study NICE recommended computerised CBT packages for depression, 27,39,266 Kaltenthaler et al 85 have highlighted that all of the research published at the time of her review had been conducted on highly selected populations and more recent research based on the findings of the REEACT trial has questioned the efficacy of computerised CBT. 409 A qualitative study has highlighted the barriers to the use of computerised CBT experienced by many potentially suitable participants. 81 With regards to participants at raised CVD risk, earlier research had demonstrated the effectiveness of telehealth interventions for specific risk factors such as hypertension 150 and smoking cessation, 385,386 but our systematic review of trials of telehealth interventions aimed at reducing multiple risk factors to reduce overall CVD risk found no evidence of effectiveness.…”