Bridging the gap from medical to psychological safety assessment: consensus study in a digital mental health context.

BACKGROUND: Digital Mental Health Interventions (DMHIs) that meet the definition of a medical device are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. The MHRA uses procedures that were originally developed for pharmaceuticals to assess the safety of DMHIs. There is recognition that this may not be ideal, as is evident by an ongoing consultation for reform led by the MHRA and the National Institute for Health and Care Excellence. AIMS: The aim of this study was to generate an experts' consensus on how the medical regulatory method used for assessing safety could best be adapted for DMHIs. METHOD: An online Delphi study containing three rounds was conducted with an international panel of 20 experts with experience/knowledge in the field of UK digital mental health. RESULTS: Sixty-four items were generated, of which 41 achieved consensus (64%). Consensus emerged around ten recommendations, falling into five main themes: Enhancing the quality of adverse events data in DMHIs; Re-defining serious adverse events for DMHIs; Reassessing short-term symptom deterioration in psychological interventions as a therapeutic risk; Maximising the benefit of the Yellow Card Scheme; and Developing a harmonised approach for assessing the safety of psychological interventions in general. CONCLUSION: The implementation of the recommendations provided by this consensus could improve the assessment of safety of DMHIs, making them more effective in detecting and mitigating risk.

Successful remote treatment of a client with Hikikomori using internet-delivered cognitive therapy for social anxiety disorder: a case report.

Hikikomori (prolonged social withdrawal) has been discussed as a hidden worldwide epidemic and a significant social and healthcare issue. Social anxiety disorder is the most common psychiatric disorder preceding the onset of Hikikomori. Although studies exist suggesting the effectiveness of family-support interventions, little is known about psychotherapeutic approaches for Hikikomori individuals. Here, we present a case of Hikikomori wherein an internet-delivered cognitive therapy for social anxiety disorder (iCT-SAD) worked effectively in improving the client's social anxiety symptoms and social interaction behaviors. This case study demonstrates the principle that evidence-based psychological interventions focusing on social anxiety can be effective for clients with Hikikomori. Furthermore, the online mode of treatment delivery, along with a variety of relevant modules, may facilitate clients' engagement with treatment at home. The findings suggest that iCT-SAD might be a promising option for Hikikomori clients who have social anxiety problems, within the recommended stepped-intervention approach.

Acknowledging religion in cognitive behavioural therapy: The effect on alliance, treatment expectations and credibility in a video-vignette study.

OBJECTIVES: Developing mental health services which are accessible and acceptable to those from minority backgrounds continues to be a priority. In the United Kingdom, individuals who identify with a religion are underrepresented in Talking Therapies services as compared to those with no religion. This necessitates an understanding of how therapy is perceived. This online study explored the impact of explicitly acknowledging religion on anticipated alliance, treatment credibility and expectations of therapy in a non-clinical sample of British Muslims. METHODS: A video-vignette experimental design was used in which participants who self-reported as either high or low in religiosity were randomly allocated to receiving information about cognitive behavioural therapy either with or without an explicit mention of religion as a value in the therapeutic process. RESULTS: One hundred twenty-nine British Muslim adults aged 18-70+ years from various ethnic backgrounds participated in the study. Between-subjects ANOVAs showed that scores on the perceived credibility of therapy and treatment expectations were significantly higher when religion was explicitly mentioned by the 'therapist', but that acknowledging religion did not impact upon anticipated alliance. CONCLUSIONS: These findings suggest that mentioning religion as a value to be considered in therapy has some positive impacts upon how therapy is perceived by British Muslims. Although video vignettes do not provide insight into the complexity of actual therapeutic encounters, acknowledging religion in mental health services more broadly remains an important consideration for improving equity of access and may bear relevance to other minoritized groups.

The addition of employment support alongside psychological therapy enhances the chance of recovery for clients most at risk of poor clinical outcomes.

BACKGROUND: Many people achieve positive outcomes from psychological therapies for anxiety and depression. However, not everyone benefits and some may require additional support. Previous studies have examined the demographic and clinical characteristics of people starting treatment and identified a patient profile that is associated with poor clinical outcomes. AIMS: To examine whether the addition of employment-related support alongside psychological therapy was associated with a greater chance of recovery for clients belonging to this patient profile. METHOD: We analysed 302 clients across three services, who were offered employment-related support alongside psychological therapy. The rate of clinical recovery (falling below clinical thresholds on measures of both anxiety and depression) was compared between individuals who accepted the offer and those who declined, while adjusting for potential confounders. RESULTS: Logistic regression showed that receiving employment support was significantly associated with clinical recovery after controlling for baseline anxiety and depression scores, the number of psychological treatment sessions, and other clinical and demographic variables. The odds of recovery were 2.54 times greater if clients received employment support; 47% of clients who received employment support alongside psychological therapy were classified as recovered, compared with 27% of those receiving psychological therapy only. CONCLUSIONS: Providing employment support alongside therapy may be particularly helpful for clients belonging to this patient profile, who represent approximately 10% of referrals to NHS Talking Therapies for Anxiety and Depression services. Services could consider how to increase the provision and uptake of employment-focused support to enhance clients' clinical outcomes.

Therapist-assisted online psychological therapies differing in trauma focus for post-traumatic stress disorder (STOP-PTSD): a UK-based, single-blind, randomised controlled trial.

BACKGROUND: Many patients are currently unable to access psychological treatments for post-traumatic stress disorder (PTSD), and it is unclear which types of therapist-assisted internet-based treatments work best. We aimed to investigate whether a novel internet-delivered cognitive therapy for PTSD (iCT-PTSD), which implements all procedures of a first-line, trauma-focused intervention recommended by the UK National Institute for Health and Care Excellence (NICE) for PTSD, is superior to internet-delivered stress management therapy for PTSD (iStress-PTSD), a comprehensive cognitive behavioural treatment programme focusing on a wide range of coping skills. METHODS: We did a single-blind, randomised controlled trial in three locations in the UK. Participants (≥18 years) were recruited from UK National Health Service (NHS) Improving Access to Psychological Therapies (IAPT) services or by self-referral and met DSM-5 criteria for PTSD to single or multiple events. Participants were randomly allocated by a computer programme (3:3:1) to iCT-PTSD, iStress-PTSD, or a 3-month waiting list with usual NHS care, after which patients who still met PTSD criteria were randomly allocated (1:1) to iCT-PTSD or iStress-PTSD. Randomisation was stratified by location, duration of PTSD (<18 months or ≥18 months), and severity of PTSD symptoms (high vs low). iCT-PTSD and iStress-PTSD were delivered online with therapist support by messages and short weekly phone calls over the first 12 weeks (weekly treatment phase), and three phone calls over the next 3 months (booster phase). The primary outcome was the severity of PTSD symptoms at 13 weeks after random assignment, measured by self-report on the PTSD Checklist for DSM-5 (PCL-5), and analysed by intention-to-treat. Safety was assessed in all participants who started treatment. Process analyses investigated acceptability and compliance with treatment, and candidate moderators and mediators of outcome. The trial was prospectively registered with the ISRCTN registry, ISRCTN16806208. FINDINGS: Of the 217 participants, 158 (73%) self-reported as female, 57 (26%) as male, and two (1%) as other; 170 (78%) were White British, 20 (9%) were other White, six (3%) were Asian, ten (5%) were Black, eight (4%) had a mixed ethnic background, and three (1%) had other ethnic backgrounds. Mean age was 36·36 years (SD 12·11; range 18-71 years). 52 (24%) participants met self-reported criteria for ICD-11 complex PTSD. Fewer than 10% of participants dropped out of each treatment group. iCT-PTSD was superior to iStress-PTSD in reducing PTSD symptoms, showing an adjusted difference on the PCL-5 of -4·92 (95% CI -8·92 to -0·92; p=0·016; standardised effect size d=0·38 [0·07 to 0·69]) for immediate allocations and -5·82 (-9·59 to -2·04; p=0·0027; d=0·44 [0·15 to 0·72]) for all treatment allocations. Both treatments were superior to the waiting list for PCL-5 at 13 weeks (d=1·67 [1·23 to 2·10] for iCT-PTSD and 1·29 [0·85 to 1·72] for iStress-PTSD). The advantages in outcome for iCT-PTSD were greater for participants with high dissociation or complex PTSD symptoms, and mediation analyses showed both treatments worked by changing negative meanings of the trauma, unhelpful coping, and flashback memories. No serious adverse events were reported. INTERPRETATION: Trauma-focused iCT-PTSD is effective and acceptable to patients with PTSD, and superior to a non-trauma-focused cognitive behavioural stress management therapy, suggesting that iCT-PTSD is an effective way of delivering the contents of CT-PTSD, one of the NICE-recommended first-line treatments for PTSD, while reducing therapist time compared with face-to-face therapy. FUNDING: Wellcome Trust, UK National Institute for Health and Care Research Oxford Health Biomedical Research Centre.

Preliminary Evaluation of Translated and Culturally Adapted Internet-Delivered Cognitive Therapy for Social Anxiety Disorder: Multicenter, Single-Arm Trial in Japan.

BACKGROUND: Internet-delivered cognitive therapy for social anxiety disorder (iCT-SAD), which is a therapist-guided modular web-based treatment, has shown strong efficacy and acceptability in English-language randomized controlled trials in the United Kingdom and Hong Kong. However, it is not yet known whether iCT-SAD can retain its efficacy following linguistic translation and cultural adaptation of treatment contents and implementation in other countries such as Japan. OBJECTIVE: This study aimed to examine the preliminary efficacy and acceptability of the translated and culturally adapted iCT-SAD in Japanese clinical settings. METHODS: This multicenter, single-arm trial recruited 15 participants with social anxiety disorder. At the time of recruitment, participants were receiving usual psychiatric care but had not shown improvement in their social anxiety and required additional treatment. iCT-SAD was provided in combination with usual psychiatric care for 14 weeks (treatment phase) and for a subsequent 3-month follow-up phase that included up to 3 booster sessions. The primary outcome measure was the self-report version of the Liebowitz Social Anxiety Scale. The secondary outcome measures examined social anxiety-related psychological processes, taijin kyofusho (the fear of offending others), depression, generalized anxiety, and general functioning. The assessment points for the outcome measures were baseline (week 0), midtreatment (week 8), posttreatment (week 15; primary assessment point), and follow-up (week 26). Acceptability was measured using the dropout rate from the treatment, the level of engagement with the program (the rate of module completion), and participants' feedback about their experience with the iCT-SAD. RESULTS: Evaluation of the outcome measures data showed that iCT-SAD led to significant improvements in social anxiety symptoms during the treatment phase (P<.001; Cohen d=3.66), and these improvements were maintained during the follow-up phase. Similar results were observed for the secondary outcome measures. At the end of the treatment phase, 80% (12/15) of participants demonstrated reliable improvement, and 60% (9/15) of participants demonstrated remission from social anxiety. Moreover, 7% (1/15) of participants dropped out during treatment, and 7% (1/15) of participants declined to undergo the follow-up phase after completing the treatment. No serious adverse events occurred. On average, participants completed 94% of the modules released to them. Participant feedback was positive and highlighted areas of strength in treatment, and it included further suggestions to improve suitability for Japanese settings. CONCLUSIONS: Translated and culturally adapted iCT-SAD demonstrated promising initial efficacy and acceptability for Japanese clients with social anxiety disorder. A randomized controlled trial is required to examine this more robustly.

Sudden gains in face-to-face and internet-based cognitive therapy for social anxiety disorder.

Sudden gains are large and stable decreases in clinical symptoms between consecutive therapy sessions. This work examined the frequency and possible determinants of sudden gains in Cognitive Therapy for Social Anxiety Disorder, comparing face-to-face (CT) and internet-based (iCT) formats of treatment delivery. Data from 99 participants from a randomised controlled trial were analysed. The frequency of sudden gains was high: 64% and 51% of participants experienced a sudden gain in CT and iCT respectively. Having a sudden gain was associated with lower social anxiety symptoms at posttreatment and follow-up. There was evidence of reductions in negative social cognitions and self-focused attention immediately prior to the sudden gain, contrasting with no prior reductions in depression symptoms. Ratings of session videotapes in CT showed that clients' statements indicated greater generalised learning in sessions immediately prior to gains, compared to control sessions. This may suggest a role for generalised learning in facilitating these large symptom reductions. There were no significant differences in results between the CT and iCT treatment formats, suggesting that the therapy content appears to play a more important role in determining participants' large symptom improvements than the medium of treatment delivery.

Video feedback to update negative self-perceptions in social anxiety disorder: A comparison of internet-delivered vs face-to-face cognitive therapy formats.

BACKGROUND: Video feedback is a technique used in cognitive therapy for social anxiety disorder (CT-SAD) to update patients' negative self-perceptions of how they appear to others. Clients are supported to watch video of themselves engaging in social interactions. While typically undertaken in session with a therapist, this study aimed to investigate the effectiveness of remotely delivered video feedback embedded within an Internet-based cognitive therapy program (iCT-SAD). METHODS: We examined patients' self-perceptions and social anxiety symptoms before and after video feedback in two randomised controlled trials. Study 1 compared 49 iCT-SAD participants with 47 from face-to-face CT-SAD. Study 2 was a replication using data from 38 iCT-SAD participants from Hong Kong. RESULTS: In Study 1, ratings of self-perceptions and social anxiety showed significant reductions following video feedback, in both treatment formats. 92 % of participants in iCT-SAD, and 96 % in CT-SAD thought they looked less anxious compared to their predictions after viewing the videos. The change in self-perception ratings was larger in CT-SAD compared to iCT-SAD, but there was no evidence that the impact of video feedback on social anxiety symptoms around a week later differed between the two treatments. Study 2 replicated the iCT-SAD findings of Study 1. LIMITATIONS: The level of therapist support in iCT-SAD videofeedback varied with clinical need and was not measured. CONCLUSIONS: The findings indicate that video feedback can be delivered effectively online, and that its impact on social anxiety is not significantly different from in-person treatment delivery.

Early intervention in post-traumatic stress disorder without exposure to trauma memories using internet-delivered cognitive therapy: A pilot case series.

OBJECTIVES: Trauma-focussed psychological interventions are the treatments of choice for post-traumatic stress disorder (PTSD). As many clinical services receive high demand for PTSD interventions, strategies to improve treatment efficiency are needed. Some people seek help in the early phase post-trauma, including as soon as the first few months. It is unclear whether all components of trauma-focussed CBT are needed in this initial stage. Providing brief intervention in this early phase without work on trauma memories may be feasible and effective. This service evaluation study describes a case series of five participants experiencing PTSD following recent traumas. METHODS: Participants completed a shortened 6-week form of Internet-delivered Cognitive Therapy for PTSD (iCT-PTSD), which used fewer treatment modules and focussed primarily on psychoeducation about PTSD, and two key treatment components, 'reclaiming your life' and trigger discrimination. Unlike the full course of iCT-PTSD, this format did not include working directly with trauma memories. RESULTS: The intervention was associated with large reductions in symptoms of PTSD, depression and anxiety at the 6-week timepoint, which were maintained at 3-month follow-up. Scores on the composite PTSD measure showed an average reduction of 91% between baseline and end of follow-up. One client required an extension to the weekly phase of treatment and received further treatment modules. All were discharged after follow-up and did not require further treatment. CONCLUSIONS: The findings provide preliminary evidence that this briefer format of iCT-PTSD was of benefit for those seeking support following recent traumas. Further examination in a larger controlled study is required.

More than doubling the clinical benefit of each hour of therapist time: a randomised controlled trial of internet cognitive therapy for social anxiety disorder.

BACKGROUND: Cognitive therapy for social anxiety disorder (CT-SAD) is recommended by NICE (2013) as a first-line intervention. Take up in routine services is limited by the need for up to 14 ninety-min face-to-face sessions, some of which are out of the office. An internet-based version of the treatment (iCT-SAD) with remote therapist support may achieve similar outcomes with less therapist time. METHODS: 102 patients with social anxiety disorder were randomised to iCT-SAD, CT-SAD, or waitlist (WAIT) control, each for 14 weeks. WAIT patients were randomised to the treatments after wait. Assessments were at pre-treatment/wait, midtreatment/wait, posttreatment/wait, and follow-ups 3 & 12 months after treatment. The pre-registered (ISRCTN 95 458 747) primary outcome was the social anxiety disorder composite, which combines 6 independent assessor and patient self-report scales of social anxiety. Secondary outcomes included disability, general anxiety, depression and a behaviour test. RESULTS: CT-SAD and iCT-SAD were both superior to WAIT on all measures. iCT-SAD did not differ from CT-SAD on the primary outcome at post-treatment or follow-up. Total therapist time in iCT-SAD was 6.45 h. CT-SAD required 15.8 h for the same reduction in social anxiety. Mediation analysis indicated that change in process variables specified in cognitive models accounted for 60% of the improvements associated with either treatment. Unlike the primary outcome, there was a significant but small difference in favour of CT-SAD on the behaviour test. CONCLUSIONS: When compared to conventional face-to-face therapy, iCT-SAD can more than double the amount of symptom change associated with each therapist hour.

Advances in digital CBT: where are we now, and where next?

Digital CBT refers to the use of digital tools, platforms or devices to deliver or enhance cognitive behavioural therapy assessment, formulation, treatment, training and supervision. The 'Advances in Digital CBT' special issue aimed to document examples of innovative digital CBT practice in this rapidly developing field. In this paper, we have briefly summarised and synthesised the advances demonstrated in this group of articles. These include developments in our understanding of mental health apps, the use of digital tools as an adjunct to therapy, the effectiveness of remotely delivered CBT in routine clinical practice, our understanding of user experiences and involvement, and in digital CBT research methods. We consider the extent of current knowledge in these areas and identify where gaps in evidence lie and how the field could be taken forward to address these. Lastly, we reflect on the broader digital CBT picture and offer our suggestions of six key directions for future research: using robust study designs to evaluate and optimise digital tools; translating and culturally adapting digital tools and practices; understanding and addressing digital exclusion; exploring, reporting and addressing possible negative effects; improving user involvement in design and evaluation; and addressing the implementation gap for digital tools. We suggest that further advances in these areas would be of particular benefit to the digital CBT field.

lcsm: An R package and tutorial on latent change score modelling.

Latent change score models (LCSMs) are used across disciplines in behavioural sciences to study how constructs change over time. LCSMs can be used to estimate the trajectory of one construct (univariate) and allow the investigation of how changes between two constructs (bivariate) are associated with each other over time. This paper introduces the R package lcsm, a tool that aims to help users understand, analyse, and visualise different latent change score models. The lcsm package provides functions to generate model syntax for basic univariate and bivariate latent change score models with different model specifications. It is also possible to visualise different model specifications in simplified path diagrams. An interactive application illustrates the main functions of the package and demonstrates how the model syntax and path diagrams change based on different model specifications. This R package aims to increase the transparency of reporting analyses and to provide an additional resource to learn latent change score modelling.

Internet-delivered cognitive therapy for social anxiety disorder in Hong Kong: A randomized controlled trial.

Background: Research is needed to determine the extent to which internet-delivered psychological therapies are effective when delivered in countries and cultures outside of where they were developed. Objective: This waitlist-controlled study evaluated the efficacy of a UK-developed, therapist-guided internet Cognitive Therapy programme for Social Anxiety Disorder (iCT-SAD) when delivered in Hong Kong by local therapists. Methods: Patients were randomized to iCT-SAD (n = 22) or a waitlist control group (n = 22). Assessments took place at weeks 0, 8, and 15 (posttreatment/postwait), with a further 3-month follow-up assessment for the iCT-SAD group. The primary outcome measure was the Liebowitz Social Anxiety Scale (self-report), and posttreatment/postwait diagnostic assessments were completed by independent assessors blind to condition. Trial Registration: ISRCTN11357117. Results: Compared with the waitlist group, iCT-SAD significantly reduced social anxiety symptoms (adjusted difference at posttreatment 55.36, 95%CI 44.32 to 66.39, p < 0.001; d Cohen 2.41). The treatment was also superior to waitlist on all secondary outcome measures. 86% of the iCT-SAD group demonstrated remission from SAD based on the LSAS, compared to 5% of the waitlist group. 73% no longer met diagnostic criteria at posttreatment, compared to 9% of the waitlist group. The gains made by the iCT-SAD group were maintained at three-month follow-up. Conclusions: iCT-SAD showed strong efficacy for the treatment of SAD in Hong Kong. As the clinical outcomes were similar to UK studies, this suggests the dissemination of the treatment into a different cultural setting did not result in a substantial loss of efficacy.

'I'm unlikeable, boring, weird, foolish, inferior, inadequate': how to address the persistent negative self-evaluations that are central to social anxiety disorder with cognitive therapy.

Patients with social anxiety disorder (SAD) have a range of negative thoughts and beliefs about how they think they come across to others. These include specific fears about doing or saying something that will be judged negatively (e.g. 'I'll babble', 'I'll have nothing to say', 'I'll blush', 'I'll sweat', 'I'll shake', etc.) and more persistent negative self-evaluative beliefs such as 'I am unlikeable', 'I am foolish', 'I am inadequate', 'I am inferior', 'I am weird/different' and 'I am boring'. Some therapists may take the presence of such persistent negative self-evaluations as being a separate problem of 'low self-esteem', rather than seeing them as a core feature of SAD. This may lead to a delay in addressing the persistent negative self-evaluations until the last stages of treatment, as might be typically done in cognitive therapy for depression. It might also prompt therapist drift from the core interventions of NICE recommended cognitive therapy for social anxiety disorder (CT-SAD). Therapists may be tempted to devote considerable time to interventions for 'low self-esteem'. Our experience from almost 30 years of treating SAD within the framework of the Clark and Wells (1995) model is that when these digressions are at the cost of core CT-SAD techniques, they have limited value. This article clarifies the role of persistent negative self-evaluations in SAD and shows how these beliefs can be more helpfully addressed from the start, and throughout the course of CT-SAD, using a range of experiential techniques. Key learning aims: To recognise persistent negative self-evaluations as a key feature of SAD.To understand that persistent negative self-evaluations are central in the Clark and Wells (1995) cognitive model and how to formulate these as part of SAD.To be able to use all the experiential interventions in cognitive therapy for SAD to address these beliefs.

Belief in Protecting Others and Social Perceptions of Face Mask Wearing Were Associated With Frequent Mask Use in the Early Stages of the COVID Pandemic in the UK.

Face masks are now seen as a key tool in the world's recovery from the COVID-19 pandemic. However, during the early stages of the outbreak, face mask use in the United Kingdom (UK) was significantly lower than that of countries equally impacted by the virus. We were interested to explore whether social cognitions played a role in levels of mask wearing. A cross-sectional online survey of UK adults (n=908) was conducted in July 2020. Estimated face mask use and thoughts about wearing face masks were assessed using measures developed for this study. Participants also answered questions about their general mood, social anxiety and basic demographic data. Multiple regression was used to examine factors associated with mask wearing. Participants' estimated mask wearing was low when in public spaces, such as the park (17%) or walking on the high street (36%). However, broadly fitting with UK guidance at the time, rates were considerably higher when in situations of closer proximity to others, such as on public transport (94%), in a shop or café (62%), when speaking to somebody in an enclosed public space (67%) or in a busy area when social distancing was not possible (79%). When looking at estimated mask wearing when in proximity to others, positive social cognitions (e.g., I'll look confident and competent wearing a mask) were associated with more wearing, whereas negative social cognitions (e.g., I'll look anxious, I'll look foolish) were associated with less wearing. These results remained after controlling for factors that have indicated increased risk from COVID-19 (age, gender, ethnicity, presence of a health condition or pregnancy), belief about the health benefit for others and levels of depression and social anxiety. The largest predictors of mask wearing were the amount of people believed wearing a mask would keep others safe and the presence of an underlying health condition. The study findings indicate that future public health campaigns would benefit from a focus on strengthening beliefs about the protective benefits of masks, but also promoting positive social messages about wearing in public (e.g., mask wearing means you are confident and competent).

Evaluating the effectiveness of a group-based resilience intervention versus psychoeducation for emergency responders in England: A randomised controlled trial.

BACKGROUND: Emergency responders are routinely exposed to traumatic critical incidents and other occupational stressors that place them at higher risk of mental ill health compared to the general population. There is some evidence to suggest that resilience training may improve emergency responders' wellbeing and related health outcomes. The aim of this study was to evaluate the effectiveness of a tertiary service resilience intervention compared to psychoeducation for improving psychological outcomes among emergency workers. METHODS: We conducted a multicentre, parallel-group, randomised controlled trial. Minim software was used to randomly allocate police, ambulance, fire, and search and rescue services personnel, who were not suffering from depression or post-traumatic stress disorder, to Mind's group intervention or to online psychoeducation on a 3:1 basis. The resilience intervention was group-based and included stress management and mindfulness tools for reducing stress. It was delivered by trained staff at nine centres across England in six sessions, one per week for six weeks. The comparison intervention was psychoeducation about stress and mental health delivered online, one module per week for six weeks. Primary outcomes were assessed by self-report and included wellbeing, resilience, self-efficacy, problem-solving, social capital, confidence in managing mental health, and number of days off work due to illness. Follow-up was conducted at three months. Blinding of participants, researchers and outcome assessment was not possible due to the type of interventions. RESULTS: A total of 430 participants (resilience intervention N = 317; psychoeducation N = 113) were randomised and included in intent-to-treat analyses. Linear Mixed-Effects Models did not show a significant difference between the interventions, at either the post-intervention or follow-up time points, on any outcome measure. CONCLUSIONS: The limited success of this intervention is consistent with the wider literature. Future refinements to the intervention may benefit from targeting predictors of resilience and mental ill health. TRIAL REGISTRATION: ISRCTN registry, ISRCTN79407277.

Treating posttraumatic stress disorder remotely with cognitive therapy for PTSD.

Delivering trauma-focused cognitive behavioural therapy to patients with PTSD during the COVID-19 pandemic poses challenges. The therapist cannot meet with the patient in person to guide them through trauma-focused work and other treatment components, and patients are restricted in carrying out treatment-related activities and behavioural experiments that involve contact with other people. Whilst online trauma-focused CBT treatments for PTSD have been developed, which overcome some of these barriers in that they can be delivered remotely, they are not yet routinely available in clinical services in countries, such as the UK. Cognitive therapy for PTSD (CT-PTSD) is a trauma-focused cognitive behavioural therapy that is acceptable to patients, leads to high rates of recovery and is recommended as a first-line treatment for the disorder by international clinical practice guidelines. Here we describe how to deliver CT-PTSD remotely so that patients presenting with PTSD during the COVID-19 pandemic can still benefit from this evidence-based treatment.

Brindar terapia cognitivo conductual (TCC) centrada en el trauma a pacientes con Trastorno de Estrés Postraumático (TEPT) durante la pandemia de COVID-19 plantea desafíos. El terapeuta no puede reunirse con el paciente en persona para guiarlo a través del trabajo centrado en el trauma y apoyarlo con otros componentes del tratamiento; y por otra parte, los pacientes tienen restricciones para llevar a cabo las actividades relacionadas con el tratamiento y los experimentos de comportamiento que impliquen contacto con otras personas. Si bien se han desarrollado tratamientos de TCC centrados en el trauma en línea para el TEPT, que superan algunas de estas barreras en el sentido de que pueden administrarse de forma remota, todavía no están disponibles de forma rutinaria en los servicios clínicos de los países, como en el Reino Unido. La terapia cognitiva para el TEPT (TC-TEPT) es una terapia cognitiva conductual centrada en el trauma que es aceptable para los pacientes, conduce a altas tasas de recuperación y se recomienda como tratamiento de primera línea para el trastorno según las pautas internacionales de práctica clínica (APA, 2017; International Society of Traumatic Stress Studies, 2019; National Institute of Health and Clinical Excellence, 2018). Aquí describimos cómo administrar TC-TEPT de forma remota para que los pacientes que se presentan con TEPT durante la pandemia de COVID-19 aún puedan beneficiarse de este tratamiento basado en la evidencia.

suddengains: An R package to identify sudden gains in longitudinal data.

Sudden gains are large and stable improvements in an outcome variable between consecutive measurements, for example during a psychological intervention with multiple assessments. Researching these occurrences could help understand individual change processes in longitudinal data. Three criteria are generally used to identify sudden gains in psychological interventions. However, applying these criteria can be time consuming and prone to errors if not fully automated. Adaptations to these criteria and methodological decisions such as how multiple gains are handled vary across studies and are reported with different levels of detail. These problems limit the comparability of individual studies and make it hard to understand or replicate the exact methods used. The R package suddengains provides a set of tools to facilitate sudden gains research. This article illustrates how to use the package to identify sudden gains or sudden losses and how to extract descriptive statistics as well as exportable data files for further analysis. It also outlines how these analyses can be customised to apply adaptations of the standard criteria. The suddengains package therefore offers significant scope to improve the efficiency, reporting, and reproducibility of sudden gains research.

Treating social anxiety disorder remotely with cognitive therapy.

Remote delivery of evidence-based psychological therapies via video conference has become particularly relevant following the COVID-19 pandemic, and is likely to be an on-going method of treatment delivery post-COVID. Remotely delivered therapy could be of particular benefit for people with social anxiety disorder (SAD), who tend to avoid or delay seeking face-to-face therapy, often due to anxiety about travelling to appointments and meeting mental health professionals in person. Individual cognitive therapy for SAD (CT-SAD), based on the Clark and Wells (1995) model, is a highly effective treatment that is recommended as a first-line intervention in NICE guidance (NICE, 2013). All of the key features of face-to-face CT-SAD (including video feedback, attention training, behavioural experiments and memory-focused techniques) can be adapted for remote delivery. In this paper, we provide guidance for clinicians on how to deliver CT-SAD remotely, and suggest novel ways for therapists and patients to overcome the challenges of carrying out a range of behavioural experiments during remote treatment delivery. KEY LEARNING AIMS: To learn how to deliver all of the core interventions of CT-SAD remotely.To learn novel ways of carrying out behavioural experiments remotely when some in-person social situations might not be possible.

IAPT and the internet: the current and future role of therapist-guided internet interventions within routine care settings.

Compared with the traditional face-to-face format, therapist-guided internet interventions offer a different approach to supporting clients in learning skills to manage and overcome mental health difficulties. Such interventions are already in use within IAPT (Improving Access to Psychological Therapies) and other routine care settings, but given their potential to deliver treatment more efficiently and therefore increase availability and access to evidence-based interventions, their use is likely to increase significantly over the coming years. This article outlines what is meant by therapist-guided internet interventions and why an online format is thought to be advantageous for clients, therapists, services, and communities more broadly. It reviews the current evidence in the context of common therapist beliefs about internet-based treatment. It aims to identify gaps where further research is required, particularly in relation to the broader implementation of these treatments in IAPT and other routine clinical services. Specifically, it emphasises the importance of choosing the right programmes, providing adequate therapist training in their use, and considering practical and organisational issues, all of which are likely to determine the success of implementation efforts. KEY LEARNING AIMS: To understand what therapist-guided internet interventions are and their potential advantages.To understand the current evidence base for these interventions.To learn where further research is needed with regard to both the interventions themselves, and to their broader implementation in IAPT.