Supporting self-management of low back pain with an internet intervention with and without telephone support in primary care (SupportBack 2): a randomised controlled trial of clinical and cost-effectiveness.

BACKGROUND: Low back pain is prevalent and a leading cause of disability. We aimed to determine the clinical and cost-effectiveness of an accessible, scalable internet intervention for supporting behavioural self-management (SupportBack). METHODS: Participants in UK primary care with low back pain without serious spinal pathology were randomly assigned 1:1:1 using computer algorithms stratified by disability level and telephone-support centre to usual care, usual care and SupportBack, or usual care and SupportBack with physiotherapist telephone-support (three brief calls). The primary outcome was low back pain-related disability (Roland Morris Disability Questionnaire [RMDQ] score) at 6 weeks, 3 months, 6 months, and 12 months using a repeated measures model, analysed by intention to treat using 97·5% CIs. A parallel economic evaluation from a health services perspective was used to estimate cost-effectiveness. People with lived experience of low back pain were involved in this trial from the outset. This completed trial was registered with ISRCTN, ISRCTN14736486. FINDINGS: Between Nov 29, 2018, and Jan 12, 2021, 825 participants were randomly assigned (274 to usual care, 275 to SupportBack only, 276 to SupportBack with telephone-support). Participants had a mean age of 54 (SD 15), 479 (58%) of 821 were women and 342 (42%) were men, and 591 (92%) of 641 were White. Follow-up rates were 687 (83%) at 6 weeks, 598 (73%) at 3 months, 589 (72%) at 6 months, and 652 (79%) at 12 months. For the primary analysis, 736 participants were analysed (249 usual care, 245 SupportBack, and 242 SupportBack with telephone support). At a significance level of 0·025, there was no difference in RMDQ over 12 months with SupportBack versus usual care (adjusted mean difference -0·5 [97·5% CI -1·2 to 0·2]; p=0·085) or SupportBack with telephone-support versus usual care (-0·6 [-1·2 to 0·1]; p=0·048). There were no treatment-related serious adverse events. The economic evaluation showed that the SupportBack group dominated usual care, being both more effective and less costly. Both interventions were likely to be cost-effective at a threshold of £20 000 per quality adjusted life year compared with usual care. INTERPRETATION: The SupportBack internet interventions did not significantly reduce low back pain-related disability over 12 months compared with usual care. They were likely to be cost-effective and safe. Clinical effectiveness, cost-effectiveness, and safety should be considered together when determining whether to apply these interventions in clinical practice. FUNDING: National Institute for Health and Care Research Health Technology Assessment (16/111/78).

Determining the clinical and cost-effectiveness of nasal sprays and a physical activity and stress management intervention to reduce respiratory tract infections in primary care: A protocol for the 'Immune Defence' randomised controlled trial.

BACKGROUND: Most adults in the UK experience at least one viral respiratory tract infection (RTI) per year. Individuals with comorbidities and those with recurrent RTIs are at higher risk of infections. This can lead to more severe illness, worse quality of life and more days off work. There is promising evidence that using common nasal sprays or improving immune function through increasing physical activity and managing stress, may reduce the incidence and severity of RTIs. METHODS AND DESIGN: Immune Defence is an open, parallel group, randomised controlled trial. Up to 15000 adults from UK general practices, with a comorbidity or risk factor for infection and/or recurrent infections (3 or more infections per year) will be randomly allocated to i) a gel-based nasal spray designed to inhibit viral respiratory infections; ii) a saline nasal spray, iii) a digital intervention promoting physical activity and stress management, or iv) usual care with brief advice for managing infections, for 12 months. Participants will complete monthly questionnaires online. The primary outcome is the total number of days of illness due to RTIs over 6 months. Key secondary outcomes include: days with symptoms moderately bad or worse; days where work/normal activities were impaired; incidence of RTI; incidence of COVID-19; health service contacts; antibiotic usage; beliefs about antibiotics; intention to consult; number of days of illness in total due to respiratory tract infections over 12 months. Economic evaluation from an NHS perspective will compare the interventions, expressed as incremental cost effectiveness ratios. A nested mixed methods process evaluation will examine uptake and engagement with the interventions and trial procedures. TRIAL STATUS: Recruitment commenced in December 2020 and the last participant is expected to complete the trial in April 2024. DISCUSSION: Common nasal sprays and digital interventions to promote physical activity and stress management are low cost, accessible interventions applicable to primary care. If effective, they have the potential to reduce the individual and societal impact of RTIs. TRIAL REGISTRATION: Prospectively registered with ISRCTN registry (17936080) on 30/10/2020. SPONSOR: This RCT is sponsored by University of Southampton. The sponsors had no role in the study design, decision to publish, or preparation of the manuscript.

A Digital Intervention for Primary Care Practitioners to Support Antidepressant Discontinuation (Advisor for Health Professionals): Development Study.

BACKGROUND: The number of people receiving antidepressants has increased in the past 3 decades, mainly because of people staying on them longer. However, in many cases long-term treatment is not evidence based and risks increasing side effects. Additionally, prompting general practitioners (GPs) to review medication does not improve the rate of appropriate discontinuation. Therefore, GPs and other health professionals may need help to support patients discontinuing antidepressants in primary care. OBJECTIVE: This study aims to develop a digital intervention to support practitioners in helping patients discontinue inappropriate long-term antidepressants (as part of a wider intervention package including a patient digital intervention and patient telephone support). METHODS: A prototype digital intervention called Advisor for Health Professionals (ADvisor HP) was planned and developed using theory, evidence, and a person-based approach. The following elements informed development: a literature review and qualitative synthesis, an in-depth qualitative study, the development of guiding principles for design elements, and theoretical behavioral analyses. The intervention was then optimized through think-aloud qualitative interviews with health professionals while they were using the prototype intervention. RESULTS: Think-aloud qualitative interviews with 19 health professionals suggested that the digital intervention contained useful information and was readily accessible to practitioners. The development work highlighted a need for further guidance on drug tapering schedules for practitioners and clarity about who is responsible for broaching the subject of discontinuation. Practitioners highlighted the need to have information in easily and quickly accessible formats because of time constraints in day-to-day practice. Some GPs felt that some information was already known to them but understood why this was included. Practitioners differed in their ideas about how they would use ADvisor HP in practice, with some preferring to read the resource in its entirety and others wanting to dip in and out as needed. Changes were made to the wording and structure of the intervention in response to the feedback provided. CONCLUSIONS: ADvisor HP is a digital intervention that has been developed using theory, evidence, and a person-based approach. The optimization work suggests that practitioners may find this tool to be useful in supporting the reduction of long-term antidepressant use. Further quantitative and qualitative evaluation through a randomized controlled trial is needed to examine the feasibility, effectiveness, and cost-effectiveness of the intervention.

Supporting self-management of low back pain with an internet intervention in primary care: a protocol for a randomised controlled trial of clinical and cost-effectiveness (SupportBack 2).

INTRODUCTION: Self-management and remaining physically active are first-line recommendations for the care of patients with low back pain (LBP). With a lifetime prevalence of up to 85%, novel approaches to support behavioural self-management are needed. Internet interventions may provide accessible support for self-management of LBP in primary care. The aim of this randomised controlled trial is to determine the clinical and cost-effectiveness of the 'SupportBack' internet intervention, with or without physiotherapist telephone support in reducing LBP-related disability in primary care patients. METHODS AND ANALYSIS: A three-parallel arm, multicentre randomised controlled trial will compare three arms: (1) usual primary care for LBP; (2) usual primary care for LBP and an internet intervention; (3) usual primary care for LBP and an internet intervention with additional physiotherapist telephone support. Patients with current LBP and no indicators of serious spinal pathology are identified and invited via general practice list searches and mailouts or opportunistic recruitment following LBP consultations. Participants undergo a secondary screen for possible serious spinal pathology and are then asked to complete baseline measures online after which they are randomised to an intervention arm. Follow-ups occur at 6 weeks, 3, 6 and 12 months. The primary outcome is physical function (using the Roland and Morris Disability Questionnaire) over 12 months (repeated measures design). Secondary outcomes include pain intensity, troublesome days in pain over the last month, pain self-efficacy, catastrophising, kinesophobia, health-related quality of life and cost-related measures for a full health economic analysis. A full mixed-methods process evaluation will be conducted. ETHICS AND DISSEMINATION: This trial has been approved by a National Health Service Research Ethics Committee (REC Ref: 18/SC/0388). Results will be disseminated through peer-reviewed journals, conferences, communication with practices and patient groups. Patient representatives will support the implementation of our full dissemination strategy. TRIAL REGISTRATION NUMBER: ISRCTN14736486.

REDUCE (Reviewing long-term antidepressant use by careful monitoring in everyday practice) internet and telephone support to people coming off long-term antidepressants: protocol for a randomised controlled trial.

BACKGROUND: Around one in ten adults take antidepressants for depression in England, and their long-term use is increasing. Some need them to prevent relapse, but 30-50% could possibly stop them without relapsing and avoid adverse effects and complications of long-term use. However, stopping is not always easy due to withdrawal symptoms and a fear of relapse of depression. When general practitioners review patients on long-term antidepressants and recommend to those who are suitable to stop the medication, only 6-8% are able to stop. The Reviewing long-term antidepressant use by careful monitoring in everyday practice (REDUCE) research programme aims to identify safe and cost-effective ways of helping patients taking long-term antidepressants taper off treatment when appropriate. METHODS: Design: REDUCE is a two-arm, 1:1 parallel group randomised controlled trial, with randomisation clustered by participating family practices. SETTING: England and north Wales. POPULATION: patients taking antidepressants for longer than 1 year for a first episode of depression or longer than 2 years for repeated episodes of depression who are no longer depressed and want to try to taper off their antidepressant use. INTERVENTION: provision of 'ADvisor' internet programmes to general practitioners or nurse practitioners and to patients designed to support antidepressant withdrawal, plus three patient telephone calls from a psychological wellbeing practitioner. The control arm receives usual care. Blinding of patients, practitioners and researchers is not possible in an open pragmatic trial, but statistical and health economic data analysts will remain blind to allocation. OUTCOME MEASURES: the primary outcome is self-reported nine-item Patient Health Questionnaire at 6 months for depressive symptoms. SECONDARY OUTCOMES: depressive symptoms at other follow-up time points, anxiety, discontinuation of antidepressants, social functioning, wellbeing, enablement, quality of life, satisfaction, and use of health services for costs. SAMPLE SIZE: 402 patients (201 intervention and 201 controls) from 134 general practices recruited over 15-18 months, and followed-up at 3, 6, 9 and 12 months. A qualitative process evaluation will be conducted through interviews with 15-20 patients and 15-20 practitioners in each arm to explore why the interventions were effective or not, depending on the results. DISCUSSION: Helping patients reduce and stop antidepressants is often challenging for practitioners and time-consuming for very busy primary care practices. If REDUCE provides evidence showing that access to internet and telephone support enables more patients to stop treatment without increasing depression we will try to implement the intervention throughout the National Health Service, publishing practical guidance for professionals and advice for patients to follow, publicised through patient support groups. TRIAL REGISTRATION: ISRCTN:12417565. Registered on 7 October 2019.

Patient-reported outcome measures for monitoring primary care patients with depression (PROMDEP): study protocol for a randomised controlled trial.

BACKGROUND: Benefits to patients from reduced depression have been shown from monitoring progress with patient-reported outcome measures (PROMs) in psychological therapy and mental health settings. This approach has not yet been researched in the United Kingdom for primary care, which is where most people with depression are treated in the United Kingdom. METHODS: This is a parallel-group cluster randomised trial with 1:1 allocation to intervention and control. Patients who are age 18+ years, with a new episode of depressive disorder/symptoms, meet the inclusion criteria. Patients with current depression treatment, comorbid dementia/psychosis/substance misuse/suicidal ideas are excluded. The intervention includes the Administration of Patient Health Questionnaire (PHQ-9) as a PROM within 2 weeks of diagnosis and at follow-up 4 weeks later. General practitioners are trained in interpreting scores and asked to take them into account in their treatment decisions. Patients are given written feedback on scores and suggested treatments. The primary outcome measure is Depression on the Beck Depression Inventory BDI-II at 12 weeks. Secondary outcomes include BDI-II at 26 weeks, changes in drug treatments and referrals, social functioning (Work & Social Adjustment Scale) and quality of life (EQ-5D) at 12 and 26 weeks, service use over 26 weeks (modified Client Services Receipt Inventory) to calculate NHS costs, and patient satisfaction at 26 weeks (Medical Informant Satisfaction Scale). The sample includes 676 total participants from 113 practices across three centres. Randomisation is achieved by computerised sequence generation. Blinding is impossible given the nature of the intervention (self-report outcome measures prevent rating bias). Differences at 12 and 26 weeks between intervention and controls in depression, social functioning and quality of life are analysed using linear mixed models, adjusted for socio-demographics, baseline depression, anxiety, and clustering, while including practice as a random effect. Patient satisfaction, quality of life (QALYs) and costs over 26 weeks will be compared between arms. Qualitative process analysis includes interviews with 15-20 GP/NPs and 15-20 patients per arm to reflect trial results and implementation issues, using Normalization Process Theory as a theoretical framework. DISCUSSION: If PROMs are helpful in improving patient outcomes for depression even to a small extent, then they are likely to be good value for money, given their low cost. The benefits could be considerable, given that depression is common, disabling, and costly. TRIAL REGISTRATION: ISRCTN no: 17299295. Registered 1st October 2018.

Distinguishing between emotional distress and psychiatric disorder in primary care attenders: A cross sectional study of the four-dimensional symptom questionnaire (4DSQ).

BACKGROUND: Detection of psychiatric disorder in primary care is a complex issue. Distinctions between 'normal' emotional distress and psychiatric disorder depend on how disorder is conceptualized. Our aim was to explore two different conceptualizations by examining patients' scores on one-dimensional depression measures and scores on the Four Dimensional Symptom Questionnaire (4DSQ), a measure that uniquely has separate dimensions for general distress and depressive disorder. METHODS: This was a cross sectional study of 487 primary care patients attending general clinics in Hampshire, UK. Patients completed the 4DSQ, Patient Health Questionnaire-9 (PHQ-9), General Health Questionnaire-12 (GHQ-12) and the Hospital Anxiety and Depression Scale (HADS) whilst in the waiting room. RESULTS: The 4DSQ classified 26% (126/485) of patients as having heightened distress levels and 8% (38/468) as possible cases of depressive disorder. Casesness was consistently higher across the one-dimensional measures (PHQ-9: 16%, GHQ-12: 28%, HADS-D: 13%). Of those patients deemed possible cases by the PHQ-9 (≥ 10), the 4DSQ classified 91% (71/78) as having heightened distress and 44% (32/72) as possible cases of depressive disorder. LIMITATIONS: The sample was predominately older and white, which may limit generalizability of the findings to more diverse patient groups. There are limits to self-report measures in the assessment of complex diagnostic issues. CONCLUSIONS: Inclusion of a distinct general distress dimension alongside a dimension focusing on specific depression symptomatology lowered the number of primary care patients classified as possible cases of disorder. This view of symptoms may have implications for the targeting of existing treatments, and may be useful in guiding the development of novel self-management interventions.

Changes in rates of recorded depression in English primary care 2003-2013: Time trend analyses of effects of the economic recession, and the GP contract quality outcomes framework (QOF).

BACKGROUND: Depression may be increasing, particularly since the economic recession. Introduction of quality outcomes framework (QOF) performance indicators may have altered GP recording of depression. METHODS: Time trend analyses of GP recording of depression before and after the recession (from April 2008), and the QOF (from April 2006) were conducted on anonymised consultation data from 142 English practices contributing to the Clinical Practice Research Datalink, April 2003-March 2013. RESULTS: 293,596 patients had computer codes for depressive diagnoses or symptoms in the 10 years. Prevalence of depression codes fell from 44.6 (95% CI 44.2, 45.0) per 1000 person years at risk (PYAR) in 2003/2004 to 38.0 (37.7, 38.3) in 2008/2009, rising to 39.5 (39.2, 39.9) in 2012/2013. Incidence of first-ever depression codes fell from 11.9 (95% CI 11.7, 12.1) per 1000 PYAR in 2003/2004 to 9.5 (9.3, 9.7) in 2008/2009, rising to 10.0 (9.8, 10.2) in 2012/1203. Prevalence increased in men but not women following the recession, associated with increased unemployment. Following introduction of the QOF, GPs used more non-QOF-qualifying symptom or other codes than QOF-qualifying diagnostic codes for new episodes. LIMITATIONS: Clinical data recording is probably incomplete. Participating practices were relatively large and not representative across English regions. CONCLUSIONS: Rates of recorded depression in English general practices were falling prior to the economic recession but increased again subsequently, among men, associated with increased unemployment. GPs responded to the QOF by switching from diagnostic to symptom codes, removing most depressed patients from the denominator for measuring GP performance in assessing depression.

Internet-based vestibular rehabilitation for adults aged 50 years and over: a protocol for a randomised controlled trial.

INTRODUCTION: Dizziness is highly prevalent in older adults and can lead to falls, fear of falling, loss of confidence, anxiety and depression. Vestibular rehabilitation (VR) exercises are effective in reducing dizziness due to vestibular dysfunction, but access to trained therapists is limited. Providing dizzy patients with booklets teaching them how to carry out VR exercises has been shown to be a cost-effective way of managing dizziness in primary care. Internet-based intervention delivery has many advantages over paper-based methods, including the provision of video instructions, automated tailoring and symptom-related feedback. This trial will examine whether an internet-based VR intervention is (1) effective in reducing dizziness and (2) a cost-effective primary care treatment option. METHODS/ANALYSIS: This will be a single blind, randomised controlled trial carried out in UK primary care. A stand-alone internet-based VR intervention will be compared with routine care in 262 dizzy patients aged 50 years and over. Measures will be taken at baseline, 3 and 6 months. Our primary outcome measure will be the effectiveness of the intervention in reducing dizziness symptoms compared with routine care at 6 months. Cost-effectiveness will be examined along with the effect of the intervention on dizziness-related disability and symptoms of depression and anxiety. Psychological process variables including expectancy, self-efficacy and acceptance will be explored in relation to adherence and symptom reduction. ETHICS/DISSEMINATION: This trial has undergone ethical scrutiny and been approved by an NHS Research Ethics Committee, Southampton A REC Reference: 13/SC/0119. The findings of this trial will be disseminated to the scientific community through presentations at national and international conferences, and by publishing in peer review journals. Findings will be disseminated to the public through targeted press releases. This trial will provide valuable information on the role of internet interventions in facilitating self-management in older adults. TRIAL REGISTRATION NUMBER ISRCTN: 86912968.

Understanding attrition from international Internet health interventions: a step towards global eHealth.

Worldwide automated Internet health interventions have the potential to greatly reduce health disparities. High attrition from automated Internet interventions is ubiquitous, and presents a challenge in the evaluation of their effectiveness. Our objective was to evaluate variables hypothesized to be related to attrition, by modeling predictors of attrition in a secondary data analysis of two cohorts of an international, dual language (English and Spanish) Internet smoking cessation intervention. The two cohorts were identical except for the approach to follow-up (FU): one cohort employed only fully automated FU (n = 16 430), while the other cohort also used 'live' contact conditional upon initial non-response (n = 1000). Attrition rates were 48.1 and 10.8% for the automated FU and live FU cohorts, respectively. Significant attrition predictors in the automated FU cohort included higher levels of nicotine dependency, lower education, lower quitting confidence and receiving more contact emails. Participants' younger age was the sole predictor of attrition in the live FU cohort. While research on large-scale deployment of Internet interventions is at an early stage, this study demonstrates that differences in attrition from trials on this scale are (i) systematic and predictable and (ii) can largely be eliminated by live FU efforts. In fully automated trials, targeting the predictors we identify may reduce attrition, a necessary precursor to effective behavioral Internet interventions that can be accessed globally.

A pilot study of StopAdvisor: a theory-based interactive internet-based smoking cessation intervention aimed across the social spectrum.

BACKGROUND: This article reports a pilot study of a new smoking cessation website ('StopAdvisor'), which has been developed on the basis of PRIME theory, evidence, web-design expertise and user-testing. The aims were to i) evaluate whether cessation, website usage and satisfaction were sufficiently high to warrant a randomised controlled trial (RCT) and ii) assess whether outcomes were affected by socio-economic status. METHODS: This was an uncontrolled pilot study. Two hundred and four adult daily smokers willing to make a serious quit attempt were included. All participants received support from 'StopAdvisor', which recommends a structured quit plan and a variety of evidence-based behaviour change techniques for smoking cessation. A series of tunnelled sessions and a variety of interactive menus provide tailored support for up to a month before quitting through until one-month post-quit (http://www.lifeguideonline.org/player/play/stopadvisordemonstration). The primary outcome was self-report of at least 1month of continuous abstinence collected at 2months post-enrolment and verified by saliva cotinine or anabasine. Usage was indexed by log-ins and page views. Satisfaction was assessed by dichotomous ratings of helpfulness, personal relevance, likelihood of recommendation and future use, which were collected using an online questionnaire at 2months post-enrolment. Outcomes according to socio-economic status were assessed. RESULTS: At 8weeks post-enrolment, 19.6% (40/204) of participants were abstinent according to the primary outcome criteria (95% C.I.=14.1% to 25.1%). Participants viewed a mean of 133.5 pages (median=71.5) during 6.4 log-ins (median=3). A majority of respondents rated the website positively on each of the four satisfaction `ratings (range=66.7% to 75.3%). There was no evidence of an effect of socio-economic status on abstinence (OR=1.01, C.I.=0.50-2.07), usage (page-views, t(202)=0.11, p=.91; log-ins, t(202)=0.21, p=.83), or satisfaction (helpfulness, OR=1.09, C.I.=0.41-2.88; personal relevance, OR=0.55, C.I.=0.20-1.56; recommendation, OR=0.98, C.I.=0.34-2.81; use in future, OR=1.45, C.I.=0.49-4.27). CONCLUSIONS: The systematic application of theory, evidence, web-design expertise, and user-testing has resulted in a website that shows sufficiently promising efficacy and usability to warrant evaluation in a RCT. The website appears to be similarly effective and acceptable to users across the social spectrum.