The Acceptability and Usability of Digital Health Interventions for Adults With Depression, Anxiety, and Somatoform Disorders: Qualitative Systematic Review and Meta-Synthesis

The prevalence of mental health disorders continues to rise, with almost 4% of the world population having an anxiety disorder and almost 3.5% having depression in 2017. Despite the high prevalence, only one-third of people with depression or anxiety receive treatment. Over the last decade, the use of digital health interventions (DHIs) has risen rapidly as a means of accessing mental health care and continues to increase. Although there is evidence supporting the effectiveness of DHIs for the treatment of mental health conditions, little is known about what aspects are valued by users and how they might be improved. This systematic review aimed to identify, appraise, and synthesize the qualitative literature available on service users' views and experiences regarding the acceptability and usability of DHIs for depression, anxiety, and somatoform disorders. A systematic search strategy was developed, and searches were run in 7 electronic databases. Qualitative and mixed methods studies published in English were included. A meta-synthesis was used to interpret and synthesize the findings from the included studies. A total of 24 studies were included in the meta-synthesis, and 3 key themes emerged with descriptive subthemes. The 3 key themes were initial motivations and approaches to DHIs, personalization of treatment, and the value of receiving personal support in DHIs. The meta-synthesis suggests that participants' initial beliefs about DHIs can have an important effect on their engagement with these types of interventions. Personal support was valued very highly as a major component of the success of DHIs. The main reason for this was the way it enabled individual personalization of care. Findings from the systematic review have implications for the design of future DHIs to improve uptake, retention, and outcomes in DHIs for depression, anxiety, and somatoform disorders. DHIs need to be personalized to the specific needs of the individual. Future research should explore whether the findings could be generalized to other health conditions. [Abstract copyright: ©Shireen Patel, Athfah Akhtar, Sam Malins, Nicola Wright, Emma Rowley, Emma Young, Stephanie Sampson, Richard Morriss. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 06.07.2020.

Cognitive behaviour therapy for long-term frequent attenders in primary care: a feasibility case series and treatment development study

Background: Most frequent attendance in primary care is temporary. Long-term frequent attendance may be suitable for psychological intervention to address health management and service use. Aim: To explore the feasibility and acceptability of cognitive-behaviour therapy (CBT) for long-term frequent attendance in primary care and obtain preliminary evidence regarding clinical and cost-effectiveness. Design and Setting: A CBT case series was carried out in five GP practices. Method: Frequent attenders (FAs) were identified from case notes and invited by their practice for assessment, then offered CBT. Feasibility and acceptability were assessed by CBT session attendance and thematic analysis of semi-structured questionnaires. Clinical and cost effectiveness was assessed by primary care use and clinically important change on a range of health and quality of life instruments. Results: Of 462 FAs invited to interview, 87 (19%) consented to assessment. Thirty-two (7%) undertook CBT over median three months. Twenty-four (75%) attended > 6 sessions. Eighteen FAs (86%, n=21) reported overall satisfaction with treatment. Patients reported valuing listening without judgement alongside support to develop coping strategies. Thirteen (55%, n=24) achieved clinically important improvement on the SF-36 Mental-Component Scale at six month follow-up and improved quality of life, but no improvement on other outcomes. Primary care use reduced from median eight contacts in three months at baseline (n=32) to three contacts in three months at one year (n=18). Conclusion: CBT appears feasible and acceptable to a sub-set of long-term FAs in primary care who halved their primary care use. With improved recruitment strategies, this approach might contribute to decreasing GP workload and merits larger-scale evaluation

Clinical characteristics of persistent frequent attenders in primary care: case–control study

Background. Most frequent attendance in primary care is temporary, but persistent frequent attendance is expensive and may be suitable for psychological intervention. To plan appropriate intervention and service delivery, there is a need for research involving standardized psychiatric interviews with assessment of physical health and health status. Objective. To compare the mental and physical health characteristics and health status of persistent frequent attenders (FAs) in primary care, currently and over the preceding 2 years, with normal attenders (NAs) matched by age, gender and general practice. Methods. Case–control study of 71 FAs (30 or more GP or practice nurse consultations in 2 years) and 71 NAs, drawn from five primary care practices, employing standardized psychiatric interview, quality of life, health anxiety and primary care electronic record review over the preceding 2 years. Results. Compared to NAs, FAs were more likely to report a lower quality of life (P < 0.001), be unmarried (P = 0.03) and have no educational qualifications (P = 0.009) but did not differ in employment status. FAs experienced greater health anxiety (P < 0.001), morbid obesity (P = 0.02), pain (P < 0.001) and long-term pathological and ill-defined physical conditions (P < 0.001). FAs had more depression including dysthymia, anxiety and somatoform disorders (all P < 0.001). Conclusions. Persistent frequent attendance in primary care was associated with poor quality of life and high clinical complexity characterized by diverse and often persistent physical and mental multimorbidity. A brokerage model with GPs working in close liaison with skilled psychological therapists is required to manage such persistent complexity

Preventing Relapse with Personalised Smart-Messaging After Cognitive Behavioral Therapy: A Proof of Concept Evaluation

Objective. Current Cognitive Behavioral Therapy (CBT) relapse prevention methods are often resource intensive. The paper investigates a personalized means of reducing relapse using smart-messaging in two settings; research and routine care. Methods. Fifteen of 56 CBT completers who participated in a trial for the treatment of health anxiety wrote advice they would want if in future they were doing well, experiencing early warning signs of relapse, or experiencing full relapse. Following CBT, participants received weekly text-message requests to rate their wellbeing. Dependent upon their response, participants received tailored advice they had written, appropriate to the wellbeing level reported after recovery from health anxiety. Smart-messaging was also trialed in a routine practice sample of 14 CBT completers with anxiety and depression. Results. Across a 12-month follow-up, participants receiving smart-messaging showed greater health improvements than those who did not. Wellbeing scores showed stability between CBT completion and six-month follow-up among routine care patients. Conclusion. These findings suggest that a low-intensity, personalized relapse prevention method can have a clinical benefit following CBT for common mental health problems

Protocol investigating the clinical outcomes and cost-effectiveness of cognitive–behavioural therapy delivered remotely for unscheduled care users with health anxiety: randomised controlled trial

Background Health anxiety and medically unexplained symptoms cost the National Health Service (NHS) an estimated £3 billion per year in unnecessary costs with little evidence of patient benefit. Effective treatment is rarely taken up due to issues such as stigma or previous negative experiences with mental health services. An approach to overcome this might be to offer remotely delivered psychological therapy, which can be just as effective as face-to-face therapy and may be more accessible and suitable. Aims To investigate the clinical outcomes and cost-effectiveness of remotely delivered cognitive–behavioural therapy (CBT) to people with high health anxiety repeatedly accessing unscheduled care (trial registration: NCT02298036). Method A multicentre randomised controlled trial (RCT) will be undertaken in primary and secondary care providers of unscheduled care across the East Midlands. One hundred and forty-four eligible participants will be equally randomised to receive either remote CBT (6–12 sessions) or treatment as usual (TAU). Two doctoral research studies will investigate the barriers and facilitators to delivering the intervention and the factors contributing to the optimisation of therapeutic outcome. Results This trial will be the first to test the clinical outcomes and costeffectiveness of remotely delivered CBT for the treatment of high health anxiety. Conclusions The findings will enable an understanding as to how this intervention might fit into a wider care pathway to enhance patient experience of care

Evaluating the clinical effectiveness of the NHS Health Check programme: a prospective analysis in the Genetics and Vascular Health Check (GENVASC) study

OBJECTIVE: The aim of the study was to assess the clinical effectiveness of the national cardiovascular disease (CVD) prevention programme-National Health Service Health Check (NHSHC) in reduction of CVD risk. DESIGN: Prospective cohort study. SETTING: 147 primary care practices in Leicestershire and Northamptonshire in England, UK. PARTICIPANTS: 27 888 individuals undergoing NHSHC with a minimum of 18 months of follow-up data. OUTCOME MEASURES: The primary outcomes were NHSHC attributed detection of CVD risk factors, prescription of medications, changes in values of individual risk factors and frequency of follow-up. RESULTS: At recruitment, 18% of participants had high CVD risk (10%-20% 10-year risk) and 4% very high CVD risk (>20% 10-year risk). New diagnoses or hypertension (HTN) was made in 2.3% participants, hypercholesterolaemia in 0.25% and diabetes mellitus in 0.9%. New prescription of stains and antihypertensive medications was observed in 5.4% and 5.4% of participants, respectively. Total cholesterol was decreased on average by 0.38 mmol/L (95% CI -0.34 to -0.41) and 1.71 mmol/L (-1.48 to -1.94) in patients with initial cholesterol >5 mmol/L and >7.5 mmol/L, respectively. Systolic blood pressure was decreased on average by 2.9 mm Hg (-2.3 to -3.7), 15.7 mm Hg (-14.1 to -17.5) and 33.4 mm Hg (-29.4 to -37.7), in patients with grade 1, 2 and 3 HTN, respectively. About one out of three patients with increased CVD risk had no record of follow-up or treatment. CONCLUSIONS: Majority of patients identified with increased CVD risk through the NHSHC were followed up and received effective clinical interventions. However, one-third of high CVD risk patients had no follow-up and therefore did not receive any treatment. Our study highlights areas of focus which could improve the effectiveness of the programme. TRIAL REGISTRATION NUMBER: NCT04417387

A randomised controlled trial investigating the clinical and cost-effectiveness of Alpha-Stim AID cranial electrotherapy stimulation (CES) in patients seeking treatment for moderate severity depression in primary care (Alpha-Stim-D Trial)

Background: Major depression is the second leading cause of years lost to disability worldwide and is a leading contributor to suicide. However, first-line antidepressants are only fully effective for 33%, and only 40% of those offered psychological treatment attend for two sessions or more. Views gained from patients and primary care professionals are that greater treatment uptake might be achieved if people with depression could be offered alternative and more accessible treatment options. Although there is evidence that the Alpha-Stim Anxiety Insomnia and Depression (AID) device is safe and effective for anxiety and depression symptoms in people with anxiety disorders, there is much less evidence of efficacy in major depression without anxiety. This study investigates the effectiveness of the Alpha-Stim AID device, a cranial electrotherapy stimulation (CES) treatment that people can safely use independently at home. The device provides CES which has been shown to increase alpha oscillatory brain activity, associated with relaxation. Methods: The aim of this study is to investigate the clinical and cost-effectiveness of Alpha-Stim AID in treatment-seeking patients (aged 16 years upwards) with moderate to moderately severe depressive symptoms in primary care. The study is a multi-centre parallel-group, double-blind, non-commercial, randomised controlled superiority trial. The primary objective of the study is to examine the clinical efficacy of active daily use of 8 weeks of Alpha-Stim AID versus sham Alpha-Stim AID on depression symptoms at 16 weeks (8 weeks after the end of treatment) in people with moderate severity depression. The primary outcome is the 17-item Hamilton Depression Rating Scale at 16 weeks. All trial and treatment procedures are carried out remotely using videoconferencing, telephone and postal delivery considering the COVID-19 pandemic restrictions. Discussion: This study is investigating whether participants using the Alpha-Stim AID device display a reduction in depressive symptoms that can be maintained over 8 weeks post-treatment. The findings will help to determine whether Alpha-Stim AID should be recommended, including being made available in the NHS for patients with depressive symptoms. Trial registration: ISRTCN ISRCTN11853110. Registered on 14 August 202

Clinical effectiveness of active Alpha-Stim AID versus sham Alpha-Stim AID in major depression in primary care in England (Alpha-Stim-D): a multicentre, parallel group, double-blind, randomised controlled trial

BackgroundRandomised sham-controlled trials of cranial electrostimulation with the Alpha-Stim Anxiety Insomnia and Depression (AID) device have reported improved anxiety and depression symptoms; however, no adequately powered sham-controlled trials in major depression are available. We investigated whether active Alpha-Stim AID is superior to sham Alpha-Stim AID in terms of clinical effectiveness for depression symptoms in major depression.MethodsThe Alpha-Stim-D trial was a multicentre, parallel group, double-blind, randomised controlled trial, recruiting participants from 25 primary care centres in two regions in England, UK. Eligible participants were aged 16 years or older with a current diagnosis of primary major depression, a score of 10–19 on the nine-item Patient Health Questionnaire, and had been offered or prescribed and reported taking antidepressant medication for at least 6 weeks in the previous 3 months. Main exclusion criteria were contraindications to Alpha-Stim AID device use, having persistent suicidal ideation or self-harm, neurological conditions, a substance use disorder or dependence, an eating disorder, bipolar disorder, or non-affective psychosis, or receiving psychological treatment in the past 3 months. Eligible participants were randomly assigned (1:1, minimised by region, anxiety disorder, and antidepressant use) to 1 h daily use of active (100 μA) or sham Alpha-Stim AID treatment for 8 weeks. Randomisation was via an independent web-based system, with participants, outcome assessors, and data analyst masked to treatment assignment. The primary outcome was change from baseline in score on the 17-item Hamilton Depression Rating Scale (HDRS-17, GRID version) at 16 weeks after randomisation, with participants analysed by intention to treat (ITT; all randomly assigned participants). Safety was assessed in all randomly assigned participants. The trial is registered with the ISRCTN registry (ISRCTN11853110); status completed.FindingsBetween Sept 8, 2020, and Jan 14, 2022, 236 eligible participants were randomly assigned to active or sham Alpha-Stim AID (n=118 each). 156 (66%) participants were women, 77 (33%) were men, and three (1%) self-reported as other gender; 200 (85%) were White British or Irish; and the mean age was 38·0 years (SD 15·3; range 16–83). 102 (86%) participants in the active Alpha-Stim AID group and 98 (83%) in the sham group were followed up 16 weeks after randomisation. In the ITT population, mean change in GRID-HDRS-17 at 16 weeks was –5·9 (95% CI –7·1 to –4·8) in the active Alpha-Stim AID group and –6·5 (–7·7 to –5·4) in the sham group (mean change difference –0·6 [95% CI –1·0 to 2·2], p=0·46). Among the 236 participants, 17 adverse events were reported in 17 (7%) participants (nine [8%] participants in the active Alpha-Stim AID group; and eight [7%] participants in the sham group). One serious adverse event of suicidal ideation leading to hospitalisation was reported in the sham group, which was judged to be unrelated to the device.InterpretationActive Alpha-Stim AID was safe and acceptable, but no more clinically effective than sham Alpha-Stim AID in major depression

Clinical and economic outcomes of remotely delivered cognitive behaviour therapy versus treatment as usual for repeat unscheduled care users with severe health anxiety: a multi-centre randomised controlled trial

Background: Repeat users of unscheduled health care with severe health anxiety are challenging to engage in psychological help and incur high service costs. We investigated whether clinical and economic outcomes were improved by offering remote cognitive behaviour therapy using videoconferencing or telephone (RCBT) compared to treatment as usual (TAU). Methods: A single-blind, parallel group, multi-centre randomised controlled trial (RCT) was undertaken in primary and general hospital care. Participants were aged >18 years with >2 unscheduled healthcare contacts within 12 months, health anxiety > 18 on the Health Anxiety Inventory (HAI). Randomisation to RCBT or TAU was stratified by site, with allocation conveyed to a trial administrator, research assessors masked to outcome. Data were collected at baseline, 3, 6, 9 and 12 months. Primary outcome was change in HAI from baseline to six months on an intention-to-treat basis. Secondary outcomes were generalised anxiety, depression, physical symptoms, function and overall health. Health economic analysis was conducted from a health service and societal perspective.Results: 524 patients were referred and assessed for trial eligibility. Of these 470 were eligible and 156 (33%) were recruited; 78 were randomised to TAU and 78 to RCBT. Compared to TAU, RCBT significantly reduced health anxiety at 6 months maintained to 9 and 12 months (mean change difference HAI -2.81; 95% CI -5.11, -0.50; p=0.017) with significant improvements in generalised anxiety, depression and overall health at 12 months but no significant change in physical symptoms or function. RCBT was strictly dominant with a net monetary benefit of £3,164 per participant at willingness to pay threshold of £30,000. No treatment-related adverse events were reported in either group. Conclusions: RCBT may reduce health anxiety, general anxiety and depression and improve overall health with considerable reductions in health and informal care costs in repeat users of unscheduled care with severe health anxiety who have previously been difficult to engage in psychological treatment. RCBT may be an easy to implement intervention to improve clinical outcome and save costs in one group of repeat users of unscheduled care

Antimicrobial resistance among migrants in Europe: a systematic review and meta-analysis

BACKGROUND: Rates of antimicrobial resistance (AMR) are rising globally and there is concern that increased migration is contributing to the burden of antibiotic resistance in Europe. However, the effect of migration on the burden of AMR in Europe has not yet been comprehensively examined. Therefore, we did a systematic review and meta-analysis to identify and synthesise data for AMR carriage or infection in migrants to Europe to examine differences in patterns of AMR across migrant groups and in different settings. METHODS: For this systematic review and meta-analysis, we searched MEDLINE, Embase, PubMed, and Scopus with no language restrictions from Jan 1, 2000, to Jan 18, 2017, for primary data from observational studies reporting antibacterial resistance in common bacterial pathogens among migrants to 21 European Union-15 and European Economic Area countries. To be eligible for inclusion, studies had to report data on carriage or infection with laboratory-confirmed antibiotic-resistant organisms in migrant populations. We extracted data from eligible studies and assessed quality using piloted, standardised forms. We did not examine drug resistance in tuberculosis and excluded articles solely reporting on this parameter. We also excluded articles in which migrant status was determined by ethnicity, country of birth of participants' parents, or was not defined, and articles in which data were not disaggregated by migrant status. Outcomes were carriage of or infection with antibiotic-resistant organisms. We used random-effects models to calculate the pooled prevalence of each outcome. The study protocol is registered with PROSPERO, number CRD42016043681. FINDINGS: We identified 2274 articles, of which 23 observational studies reporting on antibiotic resistance in 2319 migrants were included. The pooled prevalence of any AMR carriage or AMR infection in migrants was 25·4% (95% CI 19·1-31·8; I2 =98%), including meticillin-resistant Staphylococcus aureus (7·8%, 4·8-10·7; I2 =92%) and antibiotic-resistant Gram-negative bacteria (27·2%, 17·6-36·8; I2 =94%). The pooled prevalence of any AMR carriage or infection was higher in refugees and asylum seekers (33·0%, 18·3-47·6; I2 =98%) than in other migrant groups (6·6%, 1·8-11·3; I2 =92%). The pooled prevalence of antibiotic-resistant organisms was slightly higher in high-migrant community settings (33·1%, 11·1-55·1; I2 =96%) than in migrants in hospitals (24·3%, 16·1-32·6; I2 =98%). We did not find evidence of high rates of transmission of AMR from migrant to host populations. INTERPRETATION: Migrants are exposed to conditions favouring the emergence of drug resistance during transit and in host countries in Europe. Increased antibiotic resistance among refugees and asylum seekers and in high-migrant community settings (such as refugee camps and detention facilities) highlights the need for improved living conditions, access to health care, and initiatives to facilitate detection of and appropriate high-quality treatment for antibiotic-resistant infections during transit and in host countries. Protocols for the prevention and control of infection and for antibiotic surveillance need to be integrated in all aspects of health care, which should be accessible for all migrant groups, and should target determinants of AMR before, during, and after migration. FUNDING: UK National Institute for Health Research Imperial Biomedical Research Centre, Imperial College Healthcare Charity, the Wellcome Trust, and UK National Institute for Health Research Health Protection Research Unit in Healthcare-associated Infections and Antimictobial Resistance at Imperial College London