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.

BACKGROUND: Randomised 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. METHODS: The 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. FINDINGS: Between 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. INTERPRETATION: Active Alpha-Stim AID was safe and acceptable, but no more clinically effective than sham Alpha-Stim AID in major depression. FUNDING: National Institute for Health Research Applied Research Collaboration East Midlands and Electromedical Products International.

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 2020.

Impact of autoencoder based compact representation on emotion detection from audio.

Emotion recognition from speech has its fair share of applications and consequently extensive research has been done over the past few years in this interesting field. However, many of the existing solutions aren't yet ready for real time applications. In this work, we propose a compact representation of audio using conventional autoencoders for dimensionality reduction, and test the approach on two benchmark publicly available datasets. Such compact and simple classification systems where the computing cost is low and memory is managed efficiently may be more useful for real time application. System is evaluated on the Ryerson Audio-Visual Database of Emotional Speech and Song (RAVDESS) and the Toronto Emotional Speech Set (TESS). Three classifiers, namely, support vector machines (SVM), decision tree classifier, and convolutional neural networks (CNN) have been implemented to judge the impact of the approach. The results obtained by attempting classification with Alexnet and Resnet50 are also reported. Observations proved that this introduction of autoencoders indeed can improve the classification accuracy of the emotion in the input audio files. It can be concluded that in emotion recognition from speech, the choice and application of dimensionality reduction of audio features impacts the results that are achieved and therefore, by working on this aspect of the general speech emotion recognition model, it may be possible to make great improvements in the future.

Long-term effect of gender-affirming hormone treatment on depression and anxiety symptoms in transgender people: A prospective cohort study.

BACKGROUND: Cross-sectional studies show that transgender people are more likely than cisgender people to experience depression and anxiety before gender-affirming hormone treatment (GAHT). However, the effect of GAHT on mental health in transgender people, and the role of other factors that may have a predictive effect, is poorly explored. OBJECTIVES: Using a longitudinal methodology, this study investigated the effect of 18-month GAHT on depression and anxiety symptomatology and the predictors on mental health outcomes in a large population of transgender people. MATERIALS AND METHODS: Participants (n = 178) completed a socio-demographic questionnaire, the Hospital Anxiety and Depression Scale (HADS), the Multidimensional Scale of Perceived Social Support (MSPSS) and the Autism Spectrum Quotient-Short Version (AQ-Short) at pre-assessment (T0) and at 18 months after initiation of GAHT (T1). RESULTS: From T0 to T1, symptomatology was significantly decreased for depression (P < .001) and non-significantly reduced for anxiety (P = .37). Scores on the MSPSS predicted reduction in depression, while scores on the AQ-Short predicted reduction in anxiety. DISCUSSION: GAHT reduces symptoms of depression which are predicted by having higher levels of social support. Although anxiety symptoms also reduce, the changes are not significant and high levels of anxiety still remain post-GAHT. CONCLUSIONS: These results highlight the important mental health benefits of GAHT. Support services (professional, third sector or peer support) aiming at increasing social support for transgender individuals should be made available.

Systematic review and meta-analysis of augmented reality in medicine, retail, and games.

This paper presents a detailed review of the applications of augmented reality (AR) in three important fields where AR use is currently increasing. The objective of this study is to highlight how AR improves and enhances the user experience in entertainment, medicine, and retail. The authors briefly introduce the topic of AR and discuss its differences from virtual reality. They also explain the software and hardware technologies required for implementing an AR system and the different types of displays required for enhancing the user experience. The growth of AR in markets is also briefly discussed. In the three sections of the paper, the applications of AR are discussed. The use of AR in multiplayer gaming, computer games, broadcasting, and multimedia videos, as an aspect of entertainment and gaming is highlighted. AR in medicine involves the use of AR in medical healing, medical training, medical teaching, surgery, and post-medical treatment. AR in retail was discussed in terms of its uses in advertisement, marketing, fashion retail, and online shopping. The authors concluded the paper by detailing the future use of AR and its advantages and disadvantages in the current scenario.

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

BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Preventing relapse with personalized smart-messaging after cognitive behavioural therapy: A proof-of-concept evaluation.

OBJECTIVES: Cognitive behavioural therapy (CBT) can improve symptoms of anxiety and depression, but also reduces the risk of future relapse after therapy completion. However, current CBT relapse prevention methods are resource-intensive and can be limited in clinical practice. This paper investigates a personalized means of reducing relapse using smart-messaging in two settings: research and routine care. DESIGN: Study 1 presents a cohort study comparing a cohort of smart-messaging users versus non-users. Study 2 presents time series follow-up data from a case series of smart-messaging users from clinical practice. 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 well-being. Dependent upon their response, participants received tailored advice they had written, appropriate to the well-being level reported after recovery from health anxiety. Smart-messaging was also trialled 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. Well-being scores showed stability between CBT completion and 6-month follow-up among routine care patients. CONCLUSIONS: These findings suggest that a low-intensity, personalized relapse prevention method can have a clinical benefit following CBT for common mental health problems. PRACTITIONER POINTS: Post-treatment outcomes may be improved using personalized smart-messaging to prevent relapse following cognitive behavioural therapy (CBT) for health anxiety. In clinical practice, post-treatment smart-messaging can be well-used by patients and may help maintain stable well-being in the 6 months after CBT ends. This evidence supports the clinical utility of a brief tailored digital intervention, which can be integrated within routine clinical practice with minimal therapist input. Overall, longer-term post-CBT outcomes may be improved by integrating a smart-messaging intervention at the end of therapy.

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

BACKGROUND: It is challenging to engage repeat users of unscheduled healthcare with severe health anxiety in psychological help and high service costs are incurred. We investigated whether clinical and economic outcomes were improved by offering remote cognitive behaviour therapy (RCBT) using videoconferencing or telephone compared to treatment as usual (TAU). METHODS: A single-blind, parallel group, multicentre randomised controlled trial was undertaken in primary and general hospital care. Participants were aged ≥18 years with ≥2 unscheduled healthcare contacts within 12 months and scored >18 on the Health Anxiety Inventory. 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. The primary outcome was change in HAI score from baseline to six months on an intention-to-treat basis. Secondary outcomes were generalised anxiety, depression, physical symptoms, function and overall health. Health economics analysis was conducted from a health service and societal perspective. RESULTS: Of the 524 patients who were referred and assessed for trial eligibility, 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 six months, maintained to 9 and 12 months (mean change difference HAI -2.81; 95% CI -5.11 to -0.50; P = 0.017). Generalised anxiety, depression and overall health was significantly improved at 12 months, but there was no significant change in physical symptoms or function. RCBT was strictly dominant with a net monetary benefit of £3,164 per participant at a 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. TRIAL REGISTRATION: The trial was registered at ClinicalTrials.gov on 19 Nov 2014 with reference number NCT02298036.

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 cost-effectiveness 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. DECLARATION OF INTEREST: None. COPYRIGHT AND USAGE: © The Royal College of Psychiatrists 2016. This is an open access article distributed under the terms of the Creative Commons Non-commercial, No Derivatives (CC BY-NC-ND) licence.

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 in the East Midlands. 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 a median of 3 months. Twenty-four (75%) attended at least six sessions. Eighteen FAs (86%, n = 21) reported overall satisfaction with treatment. Patients reported valuing listening without judgement alongside support to develop coping strategies. Thirteen (54%, n = 24), achieved clinically important improvement on the SF-36 Mental-Component Scale at 6-month follow-up and improved quality of life, but no improvement on other outcomes. Primary care use reduced from a median of eight contacts in 3 months at baseline (n = 32) to three contacts in 3 months at 1 year (n = 18). CONCLUSION: CBT appears feasible and acceptable to a subset of long-term FAs in primary care who halved their primary care use. With improved recruitment strategies, this approach could 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.

Persistent frequent attenders in primary care: costs, reasons for attendance, organisation of care and potential for cognitive behavioural therapeutic intervention.

BACKGROUND: The top 3% of frequent attendance in primary care is associated with 15% of all appointments in primary care, a fivefold increase in hospital expenditure, and more mental disorder and functional somatic symptoms compared to normal attendance. Although often temporary if these rates of attendance last more than two years, they may become persistent (persistent frequent or regular attendance). However, there is no long-term study of the economic impact or clinical characteristics of regular attendance in primary care. Cognitive behaviour formulation and treatment (CBT) for regular attendance as a motivated behaviour may offer an understanding of the development, maintenance and treatment of regular attendance in the context of their health problems, cognitive processes and social context. METHODS/DESIGN: A case control design will compare the clinical characteristics, patterns of health care use and economic costs over the last 10 years of 100 regular attenders (≥30 appointments with general practitioner [GP] over 2 years) with 100 normal attenders (6-22 appointments with GP over 2 years), from purposefully selected primary care practices with differing organisation of care and patient demographics. Qualitative interviews with regular attending patients and practice staff will explore patient barriers, drivers and experiences of consultation, and organisation of care by practices with its challenges. Cognitive behaviour formulation analysed thematically will explore the development, maintenance and therapeutic opportunities for management in regular attenders. The feasibility, acceptability and utility of CBT for regular attendance will be examined. DISCUSSION: The health care costs, clinical needs, patient motivation for consultation and organisation of care for persistent frequent or regular attendance in primary care will be explored to develop training and policies for service providers. CBT for regular attendance will be piloted with a view to developing this approach as part of a multifaceted intervention.