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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.

BackgroundThis study consisted of a qualitative exploration of stakeholder experience regarding the implementation of internet-delivered cognitive behavioral therapy (iCBT) as part of routine service provision within the UK's Improving Access to Psychological Therapies program.MethodsStakeholder groups included service providers (n = 6), commercial iCBT representatives (n = 6) and patients who received a course of iCBT as part of treatment at the service (n = 7). Participants took part in a semi-structured interview over the telephone, and subsequent data were qualitatively analyzed using the descriptive-interpretive approach.ResultsService providers highlighted the importance of effective leadership and management, training initiatives, the provision of feedback to commercial iCBT representatives and creating work structures around iCBT to facilitate iCBT supporting staff in their use of it. Commercial iCBT representatives similarly reported the importance of training clinicians in iCBT use, identifying the appropriate individuals at all levels of the service to drive iCBT implementation, and the importance of being responsive to any problems or needs that arise from the service. Patients reported an overall positive experience of receiving iCBT but highlighted a need for more information from their supporter and the intervention to better structure their usage. Contextual factors, in terms of barriers and facilitators, were also highlighted by service provider and commercial participants; citing negative clinician attitudes and technological issues/bugs as barriers to implementation, and the exposure to iCBT created by COVID-19 and perseverance in using iCBT over time as facilitators.DiscussionThe findings contribute to a growing field of literature that seeks to understand the experience of relevant stakeholders who are involved with and contribute to iCBT implementation, including commercial iCBT representatives who, to our knowledge, have not been accounted for as part of published research to date.

Abstract Background Research has shown that internet-based cognitive behavioural therapy (iCBT) can be a very promising solution to increase access to and the dissemination of evidence-based treatments to all of the population in need. However, iCBT is still underutilized in clinical contexts, such as primary care. In order to achieve the effective implementation of these protocols, more studies in ecological settings are needed. The Unified Protocol (UP) is a transdiagnostic CBT protocol for the treatment of emotional disorders, which includes depression, anxiety and related disorders, that has shown its efficacy across different contexts and populations. An internet-based UP (iUP) programme has recently been developed as an emerging internet-based treatment for emotional disorders. However, the internet-delivered version of the UP (iUP) has not yet been examined empirically. The current project seeks to analyse the effectiveness of the iUP as a treatment for depression, anxiety and related emotional disorders in a primary care public health setting. Methods The current study will employ a parallel-group, randomized controlled trial design. Participants will be randomly assigned to (a) the internet-based Unified Protocol (iUP), or (b) enhanced waiting list control (eWLC). Randomization will follow a 2:1 allocation ratio, with sample size calculations suggesting a required sample of 120 (iUP=80; eWLC=40). The Mini-International Neuropsychiatric Interview (M.I.N.I.) will be used for assessing potential participants. The Overall Anxiety Severity and Impairment Scale (OASIS) and the Overall Depression Severity and Impairment Scale (ODSIS) as well as other standardized questionnaires will be used for assessments at baseline, 4 weeks, 8 weeks and 12 weeks from baseline and for the iUP condition during the follow-up. Discussion Combining the advantages of a transdiagnostic treatment with an online delivery format may have the potential to significantly lower the burden of emotional disorders in public health primary care setting. Anxiety and depression, often comorbid, are the most prevalent psychological disorders in primary care. Because the iUP allows for the treatment of different disorders and comorbidity, this treatment could represent an adequate choice for patients that demand mental health care in a primary care setting. Trial registration ISRCTN18056450 https://doi.org/10.1186/ISRCTN18056450 .

Abstract Background The Counselling in Primary Care service (CIPC) is the first and only nationally available public counselling service in the Republic of Ireland. This study provides initial data for the effectiveness of short-term psychotherapy delivered in a primary care setting in Ireland for the first time. Method A practice-based observational research approach was employed to examine outcome data from 2806 clients receiving therapy from 130 therapists spread over 150 primary care locations throughout Ireland. Pre-post outcomes were assessed using the CORE-OM and reliable and clinically significant change proportions. Binary logistic regression examined the effect of pre therapy symptom severity on the log odds of recovering. Six and 12 month follow up data from a subsample of 276 clients were also analysed using growth curve analysis. Results Of 14,156 referred clients, 5356 presented for assessment and 52.3% (N = 2806) consented to participate. Between assessment and post-therapy a large reduction in severity of symptoms was observed- Cohen’s d = 0.98. Furthermore, 47% of clients achieved recovery,a further 15.5% reliably improved, 2.7% reliably deteriorated and34.7% showed no reliable improvement. Higher initial severity was associated with less chance of recovering at post-therapy. Significant gains were maintained between assessment and12 months after therapy- Cohen’s d = 0.50. Conclusions Outcomes for clients in the CIPC service compared favourably with large scale counselling and psychotherapy services in jurisdictions in the U.K., the U.S.A., Norway and Sweden. This study expands the international primary care psychotherapy research base to include the entire Republic of Ireland jurisdiction.

Abstract Utilization of internet-delivered cognitive behavioural therapy (iCBT) for treating depression and anxiety disorders in stepped-care models, such as the UK’s Improving Access to Psychological Therapies (IAPT), is a potential solution for addressing the treatment gap in mental health. We investigated the effectiveness and cost-effectiveness of iCBT when fully integrated within IAPT stepped-care settings. We conducted an 8-week pragmatic randomized controlled trial with a 2:1 (iCBT intervention: waiting-list) allocation, for participants referred to an IAPT Step 2 service with depression and anxiety symptoms (Trial registration: ISRCTN91967124). The primary outcomes measures were PHQ-9 (depressive symptoms) and GAD-7 (anxiety symptoms) and WSAS (functional impairment) as a secondary outcome. The cost-effectiveness analysis was based on EQ-5D-5L (preference-based health status) to elicit the quality-adjust life year (QALY) and a modified-Client Service Receipt Inventory (care resource-use). Diagnostic interviews were administered at baseline and 3 months. Three-hundred and sixty-one participants were randomized (iCBT, 241; waiting-list, 120). Intention-to-treat analyses showed significant interaction effects for the PHQ-9 (b = −2.75, 95% CI −4.00, −1.50) and GAD-7 (b = −2.79, 95% CI −4.00, −1.58) in favour of iCBT at 8-week and further improvements observed up to 12-months. Over 8-weeks the probability of cost-effectiveness was 46.6% if decision makers are willing to pay £30,000 per QALY, increasing to 91.2% when the control-arm’s outcomes and costs were extrapolated over 12-months. Results indicate that iCBT for depression and anxiety is effective and potentially cost-effective in the long-term within IAPT. Upscaling the use of iCBT as part of stepped care could help to enhance IAPT outcomes. The pragmatic trial design supports the ecological validity of the findings.

BackgroundTreatment dropout continues to be reported from internet-delivered cognitive behavioral therapy (iCBT) interventions, and lower completion rates are generally associated with lower treatment effect sizes. However, evidence is emerging to suggest that completion of a predefined number of modules is not always necessary for clinical benefit or consideration of the needs of each individual patient. ObjectiveThe aim of this study is to perform a qualitative analysis of patients’ experiences with an iCBT intervention in a routine care setting to achieve a deeper insight into the phenomenon of dropout. MethodsA total of 15 purposively sampled participants (female: 8/15, 53%) from a larger parent randomized controlled trial were interviewed via telephone using a semistructured interview schedule that was developed based on the existing literature and research on dropout in iCBT. Data were analyzed using a descriptive-interpretive approach. ResultsThe experience of treatment leading to dropout can be understood in terms of 10 domains: relationship to technology, motivation to start, background knowledge and attitudes toward iCBT, perceived change in motivation, usage of the program, changes due to the intervention, engagement with content, experience interacting with the supporter, experience of web-based communication, and termination of the supported period. ConclusionsPatients who drop out of treatment can be distinguished in terms of their change in motivation: those who felt ready to leave treatment early and those who had negative reasons for dropping out. These 2 groups of participants have different treatment experiences, revealing the potential attributes and nonattributes of dropout. The reported between-group differences should be examined further to consider those attributes that are strongly descriptive of the experience and regarded less important than those that have become loosely affiliated.

Background: Culturally adapted psychotherapy (CAP) studies are limited and until now there are few published examples that illustrate the process of cultural adaptation with internet-delivered treatments. Aim: This paper aims to illustrate an integrative approach to the cultural adaptation of an evidence-based internet-delivered cognitive-behavioural therapy intervention for depression (Space from Depression programme). Method: Mixed method approach utilising quantitative and qualitative methods to assist in the cultural adaptation of the Space from Depression programme was used. The adaptation involved a framework for cultural sensitivity (CSF), alongside an ecological validity framework (EVF) and principles from cross-cultural assessment research. The method included the development of a theory-informed measure, the Cultural Relevance Questionnaire (CRQ), designed specifically for this research. Results: The adaptation included an establishment of CSF, which included the incorporation of Colombian cultural expressions. College students' (n = 5) and experts' (n = 7) evaluated the EVF based on cross-cultural assessment principles of a preliminary adapted version through the CRQ, showing reliability in the sample (Cronbach's Alpha 0.744). Qualitative analysis supported the culturally sensitive changes or incorporations made to the programme, such as: personal stories and textual translations from English and these were considered ecologically valid and representative. Conclusions: The research provided support for the idea that CAP can be conducted systematically for internet-delivered interventions. Keywords: Culturally adapted psychotherapy, Internet-delivered treatment, Cultural sensitivity framework, Ecological validity framework, Cultural equivalence, Depression

Background: Depression, anxiety and related disorders, including obsessive-compulsive disorders and trauma/stressor related disorders, have high prevalence, chronic courses and cause significant impairment. These disorders are also highly co-morbid, and appear to share etiology and maintenance factors. Recent developments have seen the emergence of transdiagnostic approaches that systematically address the common/shared features of these disorders. A key advantage of transdiagnostic approaches is that they can reduce the pressure on mental health professionals to be proficient in a plethora of single-disorder focused treatments. Currently almost all transdiagnostic approaches come from cognitive-behavioural therapy (CBT). However, not all clients prefer or benefit from CBT. Emotion-focused therapy (EFT) represents an evidence-based alternative to CBT. This study aims to examine a transdiagnostic adaptation of EFT (EFT-T) as a treatment for depression, anxiety and related disorders. Method: The current study is a randomised controlled trial that aims to establish the efficacy of EFT-T vs. wait-list control in the treatment of depression, anxiety and related disorders. Up to 40 clients presenting in a psychology/counselling service will be randomly assigned to two conditions: EFT-T (n=20) and wait-list control, with delayed intervention (n=20). Primary outcome measures will be the Overall Anxiety Severity and Impairment Symptoms, the Overall Depression Severity and Impairment Symptoms, and the Clinical Outcome in Routine Evaluation – Outcome Measure. Disorder specific self-report measures will also be used to assess the main symptomatology of respective primary diagnoses. Clients will be assessed prior to therapy, at week 16, at end of therapy, and at 6 months follow-up. Discussion: This study aims to provide an initial test of EFT-T as a transdiagnostic treatment for depression, anxiety and related disorders. It will provide estimates of effects sizes that can inform power calculations for a comparative trial, comparing EFT-T to a standard transdiagnostic treatment, CBT. Registration: ISRCTN11430110; registered on 07 January 2019.

Abstract Background Generalised anxiety disorder (GAD) is a chronic and debilitating condition characterised by high co-morbidity. Alongside pharmacological treatment, cognitive behavioural therapy (CBT) is an established psychological therapy for GAD. Its effectiveness is limited, however, with only an estimated 50% of clients presenting in the non-clinical range after a course of treatment. Furthermore, not all clients prefer CBT as a psychological therapy. Recently, emotion-focused therapy (EFT) was developed for GAD and was tested in an open trial with promising results. Methods/design The present research project is a feasibility testing randomised controlled trial (RCT) that compares the efficacy of EFT with an established treatment for GAD, CBT. Sixty clients presenting in a primary care psychology/counselling service will be randomly assigned to one of two conditions: EFT or CBT. Outcomes will be assessed using several measures (Generalised Anxiety Disorder-7, Generalised Anxiety Disorder Severity Scale, Patient Health Questionnaire-9, and Clinical Outcome in Routine Evaluation – Outcome Measure). Clients will be assessed prior to and at the end of therapy, as well as at 6-month follow-up. On the basis of findings from the initial open EFT trial with regard to the optimal length of therapy, it is proposed that therapy last between 16 and 20 sessions. Discussion This study aims to test the feasibility of a full comparison RCT. It will test subject recruitment, therapist adherence to manualised treatment, and client retention rates. It will also provide estimates of comparative outcomes that can inform power calculations for a definitive trial. Trial registration ISRCTN Registry, ISRCTN52689081. Registered on 24 October 2017.

Abstract Background Depression and anxiety are common mental health disorders worldwide. The UK’s Improving Access to Psychological Therapies (IAPT) programme is part of the National Health Service (NHS) designed to provide a stepped care approach to treating people with anxiety and depressive disorders. Cognitive Behavioural Therapy (CBT) is widely used, with computerised and internet-delivered cognitive behavioural therapy (cCBT and iCBT, respectively) being a suitable IAPT approved treatment alternative for step 2, low- intensity treatment. iCBT has accumulated a large empirical base for treating depression and anxiety disorders. However, the cost-effectiveness and impact of these interventions in the longer-term is not routinely assessed by IAPT services. The current study aims to evaluate the clinical and cost-effectiveness of internet-delivered interventions for symptoms of depression and anxiety disorders in IAPT. Methods The study is a parallel-groups, randomised controlled trial examining the effectiveness and cost-effectiveness of iCBT interventions for depression and anxiety disorders, against a waitlist control group. The iCBT treatments are of 8 weeks duration and will be supported by regular post-session feedback by Psychological Wellbeing Practitioners. Assessments will be conducted at baseline, during, and at the end of the 8-week treatment and at 3, 6, 9, and 12-month follow-up. A diagnostic interview will be employed at baseline and 3-month follow-up. Participants in the waitlist control group will complete measures at baseline and week 8, at which point they will receive access to the treatment. All adult users of the Berkshire NHS Trust IAPT Talking Therapies Step 2 services will be approached to participate and measured against set eligibility criteria. Primary outcome measures will assess anxiety and depressive symptoms using the GAD-7 and PHQ-9, respectively. Secondary outcome measures will allow for the evaluation of long-term outcomes, mediators and moderators of outcome, and cost-effectiveness of treatment. Analysis will be conducted on a per protocol and intention-to-treat basis. Discussion This study seeks to evaluate the immediate and longer-term impact, as well as the cost effectiveness of internet-delivered interventions for depression and anxiety. This study will contribute to the already established literature on internet-delivered interventions worldwide. The study has the potential to show how iCBT can enhance service provision, and the findings will likely be generalisable to other health services. Trial registration Current Controlled Trials ISRCTN ISRCTN91967124. DOI: https://doi.org/10.1186/ISRCTN91967124. Web: http://www.isrctn.com/ISRCTN91967124. Clinicaltrials.gov: NCT03188575. Trial registration date: June 8, 2017 (prospectively registered).

Abstract Background Depression is the principal cause of disability in the world. High prevalence rates of depression in general populations and college students have been found worldwide and in various cultural groups. Low-intensity cognitive behavioural internet-delivered treatment has demonstrated efficacy in high-income-countries (HICs). However little is known of their potential for adaptation and efficacy in low and middle-income countries. Methods Study (1) involves the cultural adaptation of the Space from Depression cognitive-behaviour internet-delivered programme with an asynchronous support for depressive symptoms. This includes initial researcher/clinician adaptation and the integration of cultural assessment feedback of the programme by a panel of experts and users through the theoretically-based Cultural Relevance Questionnaire (CRQ). Study (2) describes the implementation of the culturally adapted intervention using a randomised controlled trial methodology. The efficacy trial will include an active treatment group and a waiting-list control group of participants meeting eligibility criteria (mild to moderate depression symptoms). The active condition will consist of 7 weekly modules of internet-delivered cognitive behavioural therapy (iCBT) Space from Depression, with post-session feedback support. The primary outcome will be the Patient Health Questionnaire (PHQ-9). The study also involves collection of client reported significant events and client satisfaction with the internet-delivered treatment. Data will be collected at baseline and at post-treatment (week 7), and at follow-up (week 20/3 months). Analysis will be conducted on the intention-to-treat basis. Discussion The study seeks to establish a theoretically robust methodology for culturally adapting internet-delivered interventions for mental health disorders and to evaluate the efficacy of a culturally adapted internet-delivered treatment for depression in Colombia, with support. The study will be a first contribution to a method for culturally adapting internet-delivered interventions and also a first to examine the efficacy of such an adapted intervention in Latin America. Trial registration Clinical trials NCT03062215. Retrospectively registered 14th February 2017.

Background: There are clear advantages to internet-delivered interventions for depression. Users' perspectives on the acceptability, satisfaction, and efficacy of an internet-delivered treatment for depression can inform future developments in the area. Methods: Respondents (n = 281) were participants in an 8 week supported internet-delivered Cognitive Behaviour Therapy treatment for depressive symptoms. Self-report online questionnaires gathered quantitative and qualitative data on the user experience. Principle findings: Most respondents were satisfied with the programme (n = 191), felt supported (n = 203), reported positive gains and impact resulting from use of the programme, and perceived these to be likely to be lasting effects (n = 149). Flexibility and accessibility were the most liked aspects. A small number of respondents felt their needs were not met by the intervention (n = 64); for this group suggestions for improvements centred on the programme's structure and how supporter feedback is delivered. Conclusion: Results will deepen the understanding of users' experience and inform the development and implementation of evidence-based internet-delivered interventions.

Antecedentes/Objetivo : La depresión es uno de los trastornos de salud mental más co - munes y un incipiente problema de salud pública. Pocos estudios han investigado la prevalencia y factores predictivos de su gravedad en el contexto irlandés. El objetivo del estudio fue investigar los factores de riesgo que predicen la gravedad de la depresión en una muestra de adultos en Irlanda en búsqueda de tratamiento. Método : Los participan - tes auto-referidos accedieron a una intervención en línea para la depresión. Los partici - pantes ( N = 641) completaron cuestionarios, incluyendo el BDI-II, e información asociada con predictores comunes de la depresión. Resultados : Se encontraron varios factores que predijeron la gravedad de la depresión: el sexo, ser mujer, ser joven, situación laboral, estar soltero o con pareja pero no casado, diagnóstico previo de depresión y experiencias de estrés recientes. Conclusiones : El estudio contribuye a la elaboración de perfiles de incidencia y factores predictivos en la gravedad de la depresión. Los resultados confir - man algunos de los factores de riesgo conocidos y ponen en relieve la necesidad de nue - vas investigaciones que lleven a cabo la detección de la depresión así como un mayor acceso a las intervenciones.

An amendment to this paper has been published and can be accessed via a link at the top of the paper.

Generalized Anxiety Disorder (GAD) is typically considered a chronic condition characterized by excessive worry. Lifetime prevalence is 4.3–5.9%, yet only a small percentage seeks treatment. GAD is treatable and in recent years internet-delivered treatment interventions have shown promise. This paper aims to systematically search for literature on internet-delivered psychological interventions for the treatment of GAD and conduct a meta-analysis to examine their efficacy. The purpose of the paper is to inform the community of researchers, program developers and practitioners in internet delivered interventions of the current state-of-the-art and research gaps that require attention. A systematic search of the literature was conducted to find all studies of internet-delivered treatments for GAD (N = 20). Using Review Manager 5 all Randomized Controlled Trials (RCTs; n = 11) that met our established eligibility criteria were included into a meta-analysis that calculated effect sizes via the standardized mean difference. Compared to the waiting-list controls, the results demonstrate positive outcomes for GAD symptoms (d = −0.91) and its central construct of pathological worry (d = −0.74). The meta-analysis supports the efficacy of internet-delivered treatments for GAD including the use of disorder-specific (4 studies) and transdiagnostic treatment protocols (7 studies). Caution is advised regarding the results as the data is limited and highly heterogeneous, but revealing of what future research might be needed.