Sally Brabyn

Background Economic evaluations provide evidence on whether or not digital interventions offer value for money, based on their costs and outcomes relative to the costs and outcomes of alternatives. Objectives (1) Evaluate and summarise published economic studies about digital interventions across different technologies, therapies, comparators and mental health conditions; (2) synthesise clinical evidence about digital interventions for an exemplar mental health condition; (3) construct an economic model for the same exemplar mental health condition using the previously synthesised clinical evidence; and (4) consult with stakeholders about how they understand and assess the value of digital interventions. Methods We completed four work packages: (1) a systematic review and quality assessment of economic studies about digital interventions; (2) a systematic review and network meta-analysis of randomised controlled trials on digital interventions for generalised anxiety disorder; (3) a...

Aims To determine whether age, gender and marital status are associated with prognosis for adults with depression who sought treatment in primary care. Methods Medline, Embase, PsycINFO and Cochrane Central were searched from inception to 1st December 2020 for randomised controlled trials (RCTs) of adults seeking treatment for depression from their general practitioners, that used the Revised Clinical Interview Schedule so that there was uniformity in the measurement of clinical prognostic factors, and that reported on age, gender and marital status. Individual participant data were gathered from all nine eligible RCTs (N = 4864). Two-stage random-effects meta-analyses were conducted to ascertain the independent association between: (i) age, (ii) gender and (iii) marital status, and depressive symptoms at 3–4, 6–8, and 9–12 months post-baseline and remission at 3–4 months. Risk of bias was evaluated using QUIPS and quality was assessed using GRADE. PROSPERO registration: CRD42019129...

BackgroundComputerized cognitive–behavioural therapy (cCBT) forms a core component of stepped psychological care for depression. Existing evidence for cCBT has been informed by developer-led trials. This is the first study based on a large independent pragmatic trial to assess the cost-effectiveness of cCBT as an adjunct to usual general practitioner (GP) care compared with usual GP care alone and to establish the differential cost-effectiveness of a free-to-use cCBT programme (MoodGYM) in comparison with a commercial programme (Beating the Blues) in primary care.MethodCosts were estimated from a healthcare perspective and outcomes measured using quality-adjusted life years (QALYs) over 2 years. The incremental cost-effectiveness of each cCBT programme was compared with usual GP care. Uncertainty was estimated using probabilistic sensitivity analysis and scenario analyses were performed to assess the robustness of results.ResultsNeither cCBT programme was found to be cost-effective ...

Background Cognitive behavioural therapy (CBT) is an effective treatment for depression. Self-directed online CBT interventions have made CBT more accessible at a lower cost. However, adherence is often poor and, in the absence of therapist support, effects are modest and short-term. Delivering CBT online using instant messaging is clinically and cost-effective; however, most existing platforms are limited to instant messaging sessions, without the support of between-session “homework” activities. The INTERACT intervention integrates online CBT materials and ‘high-intensity’ therapist-led CBT, delivered remotely in real-time. The INTERACT trial will evaluate this novel integration in terms of clinical and cost-effectiveness, and acceptability to therapists and clients. Methods Pragmatic, two parallel-group multi-centre individually randomised controlled trial, with 434 patients recruited from primary care practices in Bristol, London and York. Participants with depression will be id...

BACKGROUND Treatment of established depression is the dominant approach to care of older adults, but prevention holds much promise. Self-help interventions are a feasible preventive approach, since they are scalable and low cost. There are few trials in this area. Behavioral Activation (BA) is a credible candidate psychological approach, which has been shown to work in therapist led care but not been trialled in a self-help form. AIM To test the effectiveness of an unguided self-help intervention based on BA for older adults. METHODS We compared a self-help intervention based on BA for older people (n = 172) to usual care (n = 160) in a pragmatic randomized controlled trial. Outcomes were depression status and severity (PHQ9) and health related quality of life (SF12). The primary timepoint of the primary outcome was depression at 4 months, with longer term follow up at 12 months to test sustained impact of the primary outcome. RESULTS At 4 months adjusted PHQ-9 scores for BA self-help were 0.79 lower (95% CI: -1.70 to 0.13; p = 0.09) and the proportion of participants with case-level depression was significantly reduced (BA 31/137 (22.6%) versus usual care 41/141 (29.1%); Odds Ratio 0.48; 95% CI: 0.26-0.92; p = 0.03). There was no PHQ-9 difference at 12 months or for health related quality of life at any point (4 or 12 months). DISCUSSION Self-help using BA for older people at risk of depression is a feasible and scalable intervention with potential short-term benefits in preventing depression.

Background: There is evidence that depressive symptom severity is associated with prognosis but existing studies have usually been for people on a single treatment so we lack evidence for this effect independent of treatment. There are other factors that we will call ‘disorder severity’ such as duration and comorbidity that have been reported as associated with prognosis, but current evidence does not indicate if these associations are independent of treatment and symptom severity. Methods: Medline, Embase, PsycINFO and Cochrane Central were searched from inception to 20th March 2019 for randomised controlled trials (RCTs) of adults seeking treatment for depression from their general practitioners, that used the Revised Clinical Interview Schedule (CIS-R) so that there was uniformity in the measurement of disorder severity factors. Individual participant data were gathered from 12 RCTs. Two-stage random-effects meta-analyses were undertaken calculating effect estimates within each study and then pooling across these to ascertain the independent association between each potential prognostic factor and depressive symptoms at 3-4 months post-baseline, remission and depressive symptoms at 6-8 months post-baseline. Risk of bias was calculated using QUIPS and quality was assessed using GRADE. Findings: Baseline depressive symptom severity was strongly associated with prognosis independent of treatment; there was a 27∙5%(95%CI: 25∙0 to 30∙1) difference in depressive symptoms at 3-4 months per one standard deviation increase in baseline score, equivalent to about eight Beck Depression Inventory points or five PHQ-9 points. The duration of anxiety, duration of depression, comorbid panic disorder, and a history of antidepressant treatment were also associated with prognosis independent of depressive symptom severity, though the association with antidepressant treatment was less robust. For participants with all four of these factors, there was a difference of 39∙9%(95%CI: 12∙6 to 74∙0) in their score at 3-4 months. Risk of bias was low in all studies, quality was high and heterogeneity was within acceptable limits for all but two prognostic indicators. A number of sensitivity analyses did not alter our conclusions. Interpretation: Depressive symptom severity had a strong association with prognosis independent of treatment. The duration of depressive symptoms, duration of anxiety symptoms, panic disorder and past antidepressant use were all associated with prognosis independent of depressive symptom severity and treatment. Consideration of these prognostic indicators could be clinically important for determining prognosis and inform patients and clinicians about likely outcomes in the clinical management of depression. Funding Statement: This work was supported by the Wellcome Trust through a Clinical Research Fellowship to JB (201292/Z/16/Z), Medical Research Council (Programme for IW: MC_UU_12023/21), MQ Foundation (for ZC: MQDS16/72), the Higher Education Funding Council for England, the National Institute of Health Research (NIHR), NIHR University College London Hospitals Biomedical Research Centre (RS, KC, PB, and SP), University College London (GA, GL), University of Pennsylvania (RDR), Vanderbilt University (SDH), University of Southampton (TK), University of Exeter (EW), and University of York (SG). Declaration of Interests: All authors declare no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; and no other relationships or activities that could appear to have influenced the submitted work. Ethics Approval Statement: PROSPERO registration: CRD42019129512.

BackgroundQuality-adjusted life years (QALYs) are widely used to measure the impact of various diseases on both the quality and quantity of life and in their economic valuations. It will be clinically important and informative if we can estimate QALYs based on measurements of depression severity.ObjectiveTo construct a conversion table from the Patient Health Questionnaire-9 (PHQ-9), the most frequently used depression scale in recent years, to the Euro-Qol Five Dimensions Three Levels (EQ-5D-3L), one of the most commonly used instruments to assess QALYs.MethodsWe obtained individual participant data of randomised controlled trials of internet cognitive-behavioural therapy which had administered depression severity scales and the EQ-5D-3L at baseline and at end of treatment. Scores from depression scales were all converted into the PHQ-9 according to the validated algorithms. We used equipercentile linking to establish correspondences between the PHQ-9 and the EQ-5D-3L.FindingsIndiv...

BackgroundDespite a growing number of prescriptions for antidepressants (over 70 million in 2018), there is uncertainty about when people with depression might benefit from antidepressant medication and concern that antidepressants are prescribed unnecessarily.ObjectivesThe main objective of the PANDA (What are the indications for Prescribing ANtiDepressAnts that will lead to a clinical benefit?) research programme was to provide more guidance about when antidepressants are likely to benefit people with depression. We aimed to estimate the minimal clinically important difference for commonly used self-administered scales for depression and anxiety, and to understand more about how patients respond to such assessments. We carried out an observational study of patients with depressive symptoms and a placebo-controlled randomised controlled trial of sertraline versus placebo to estimate the treatment effect in UK primary care. The hypothesis was that the severity and duration of sympto...

Accessible summary People with severe mental ill health are up to three times more likely to smoke than other members of the general population. Life expectancy in this client group is reduced by up to 30 years, and smoking is the single most important cause of premature death. The aim of this study was to explore why people with severe mental ill health smoked and why they might want to stop smoking or cut down on the amount of cigarettes that they smoked. The study found that people with severe mental ill health are motivated to cut down or stop smoking, and this is mainly due to concerns about their own health. The reasons people gave for smoking were to relieve stress, to help relax and for something to do when they are bored. Health professionals should offer evidence supported smoking cessation therapy to people with severe mental ill health. In addition to standard National Health Service smoking cessation treatments such as pharmacotherapy and behavioural support. Practition...

To update a 2005 review of the reasons researchers have given for the use of unequal randomisation in randomised controlled trials (RCTs). Intervention being tested; type of study; number of participants; randomisation ratio; sample size calculation and reason given for using unequal randomisation. Review of trials using unequal randomisation. Cochrane library, Medline and CINAHL. 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. 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.

Irritable bowel syndrome (IBS) is a common, chronic disorder that leads to decreased health-related quality of life and work productivity. Evidence-based treatment guidelines have not been able to give guidance on the effects of homeopathic treatment for IBS because no systematic reviews have been carried out to assess the effectiveness of homeopathic treatment for IBS. Two types of homeopathic treatment were evaluated in this systematic review. In clinical homeopathy a specific remedy is prescribed for a specific condition. This differs from individualised homeopathic treatment, where a homeopathic remedy based on a person's individual symptoms is prescribed after a detailed consultation. To assess the effectiveness and safety of homeopathic treatment for treating IBS. We searched MEDLINE, the Cochrane Central Register of Controlled Trials, EMBASE, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Allied and Complementary Medicine Database (AMED), Cochr...

BACKGROUND There has been a steady increase in the number of primary care patients receiving long-term maintenance antidepressant treatment, despite limited evidence of a benefit of this treatment beyond 8 months. OBJECTIVE The ANTidepressants to prevent reLapse in dEpRession (ANTLER) trial investigated the clinical effectiveness and cost-effectiveness of antidepressant medication in preventing relapse in UK primary care. DESIGN This was a Phase IV, double-blind, pragmatic, multisite, individually randomised parallel-group controlled trial, with follow-up at 6, 12, 26, 39 and 52 weeks. Participants were randomised using minimisation on centre, type of antidepressant and baseline depressive symptom score above or below the median using Clinical Interview Schedule - Revised (two categories). Statisticians were blind to allocation for the outcome analyses. SETTING General practices in London, Bristol, Southampton and York. PARTICIPANTS Individuals aged 18-74 years who had experienced a...