Depression
Depression is the most common mental health disorder in community settings and is estimated to become the second largest cause of global disability by 2020.1 It is one of the most common reasons for consulting with a general practitioner (GP) and its associated personal and economic burden is considerable.2
Psychological therapy for depression
Although antidepressants remain an important treatment option, many patients and health-care professionals would like access to psychological therapy as an alternative or adjunct to drug therapy.3 Cognitive behaviour therapy (CBT) has emerged as the leading evidence-supported form of brief psychological therapy for people with depression.4,5 However, demand for CBT cannot be met from existing therapist resources.6 One promising alternative to therapist-delivered CBT is the use of self-help interventions including the provision of therapy via a computer.7 In recent years a number of interactive computer programs have been developed that enable CBT to be delivered by a computer. The National Institute for Health and Care Excellence (NICE) guidelines for depression recommend the provision of computerised CBT (cCBT) as an initial, lower-intensity treatment for depression as part of a ‘stepped care’ approach in primary care.5 If effective, such programmes have the potential to expand the provision of psychological therapy in primary care and may represent an efficient and effective form of care for depression.8
For those who decide to use (or commission the provision of) cCBT there are a number of interactive internet-based products, some commercially produced and others free to use.7 In the first category, a number of commercial products have been marketed to bodies such as the NHS. Free-to-use products comprise a range of programs that have been developed by the public sector or by research institutes. These can be accessed at no direct purchase cost to health-care providers. An example of a free-to-use cCBT program is MoodGYM (National Institute for Mental Health Research, Australian National University, Canberra, ACT, Australia), which was developed in Australia and can be accessed by patients with depression, either directly or at the suggestion of their health-care provider.
Evidence for computerised cognitive behaviour therapy
Computerised CBT represents an alternative form of therapy delivery that has the potential to enhance access to psychological care. A number of systematic reviews have been conducted studying the effectiveness of cCBT. An overall beneficial effect of cCBT has been found within trials, although there is a high level of variability in effect size between studies. An early health technology assessment review by Kaltenthaler et al.,6 published in 2006, noted preliminary evidence of clinical effectiveness and cost-effectiveness. The authors noted the existence of internet-based free-to-use packages, such as MoodGYM, which had been evaluated in randomised trials, but also noted that a major limitation of the existing literature was that the trials had been conducted by the package developers.8 Since this review there have been few independent evaluations of cCBT packages and the randomised literature remains dominated by developer-led studies.
Later systematic reviews have also highlighted the potential for cCBT to be effective, but have also further demonstrated variable effect sizes and substantial between-study heterogeneity.9,10 One important source of between-study heterogeneity is the level of support that is made available to people who are offered treatment with cCBT. cCBT involves replacing the therapist with a computer, and requires the person with depression to engage with a self-help computer-based technology. Research by Waller and Gilbody11 has shown that people with depression often do not engage with cCBT, and only a minority actually complete all of the planned sessions of the computer package. This observation is consistent with a broader body of research into the uptake and effectiveness across the range of self-help interventions for depression, including bibliotherapy (self-treatment using written materials). Research in the area of self-help treatments for depression has demonstrated that entirely self-guided materials (with no professional support) are likely to be less effective than self-help technologies for which there is a level of guidance and professional support (‘guided self-help’). Unsupported self-help treatment (including unsupported computer-delivered self-help) has been shown in systematic reviews to have minimal or relatively small effect sizes. In contrast, more intensively and professionally supported treatments have generally been found in efficacy trials to have moderate effect sizes claimed to be comparable to those achieved with face-to-face therapy. To our knowledge the comparative effectiveness of minimally supported cCBT versus more intensively supported cCBT has not been directly tested in large-scale, independently conducted, head-to-head effectiveness trials. Based on indirect estimates drawn from systematic reviews of trials of cCBT the effect is therefore potentially enhanced through the provision of professional support. The magnitude of benefit associated with supported cCBT in groups of patients is, on average, larger than that with unsupported/minimally supported cCBT [pooled effect size for professionally supported therapy, Cohen’s d = 0.61, 95% confidence interval (CI) 0.45 to 0.77 vs. unsupported therapy, Cohen’s d = 0.25, 95% CI 0.14 to 0.35].9
Existing Health Technology Assessment programme-funded research into computerised cognitive behaviour therapy for depression: the results of the REEACT trial and the need for further research on the effectiveness of supported computerised cognitive behaviour therapy
On the basis of a UK technology appraisal by Kaltenthaler et al.6 and the identified need for independent (non-developer-led) research into cCBT, the Randomised Evaluation of the Effectiveness and Acceptability of Computerised Therapy (REEACT) trial was commissioned in 2008, recruited in 2010–12 and reported in 2015.12 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. The level of support that was offered to both cCBT packages was designed to replicate current practice in NHS primary care in which professional facilitation is not routinely offered. In view of the findings of systematic reviews, and evidence of lower uptake of packages in entirely self-directed/unsupported therapies, the REEACT trial included technical telephone support. Participants were proactively offered technical support and weekly encouragement to use the computer packages, but we purposely did not augment psychological therapy over the telephone. Telephone support in the REEACT trial did not involve explanations of CBT and did not involve a review of homework or between-session tasks. The cCBT was therefore a form of supported self-help, but was not one that was guided by a clinician. The REEACT trial is, at the time of writing, the largest publicly funded, independently conducted primary care trial of cCBT.
The main finding of the REEACT trial was that for the primary outcome of depression severity at 4 months, there was no significant benefit when participants were offered technically supported cCBT in addition to usual GP care. This negative finding was true for both a free-to-use package (MoodGYM) and commercially produced cCBT (Beating the Blues). The most likely explanatory mechanism of lack of effect was poor uptake and use of computer packages by trial participants. For both cCBT packages (MoodGYM and Beating the Blues) the median number of actual computer therapy sessions that were completed by participants was between 1 and 2. The conclusion of the REEACT trial was that technically supported cCBT was clinically ineffective when added to usual GP care, and that this treatment should not routinely be offered in this form to patients with depression.
Preliminary findings from a concurrent qualitative evaluation in REEACT, and anecdotal evidence from recruiting researchers, indicated that participants were demotivated as a consequence of depression and struggled to engage with computer sessions despite appreciating the offer of technical support. Participants expressed an interest in computer packages, but identified a preference for guidance. We postulated on the basis of these findings and on the basis of emerging trial-based evidence summarised in systematic reviews (e.g. Andersson and Cuijpers9) that cCBT might show an effect but only if offered alongside a greater level of facilitation and support and designed the REEACT-2 study to run alongside, but independently of, REEACT and test this hypothesis. The REEACT-2 trial represents a follow-on trial from the REEACT trial to answer this related question, and most of the fundamental aspects of trial design (primary care setting, recruitment process and inclusion criteria) are replicated in the two trials.
Research objectives
This was a fully randomised patient trial to examine the additional benefits of telephone facilitation alongside a free-to-use computer-delivered CBT package (MoodGYM). The comparator was a minimally supported mode of delivery of the same cCBT package that replicated the mode of delivery of cCBT as offered in primary care in the NHS. The REEACT-2 study included a concurrent economic evaluation to meet the following specific aims:
to establish the clinical effectiveness of a telephone-facilitated cCBT package compared with minimally supported cCBT over a 1-year trial follow-up period
to establish the cost-effectiveness of a telephone-facilitated cCBT package compared with minimally supported cCBT over a 1-year trial follow-up period.
