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.

Integration of a smartwatch within an internet-delivered intervention for depression: Protocol for a feasibility randomized controlled trial on acceptance.

BACKGROUND: Mood tracking is commonly employed within a range of mental health interventions. Physical activity and sleep are also important for contextualizing mood data but can be difficult to track manually and rely on retrospective recall. Smartwatches could enhance self-monitoring by addressing difficulties in recall of sleep and physical activity and reducing the burden on patients in terms of remembering to track and the effort of tracking. This feasibility study will explore the acceptance of a smartwatch app for self-monitoring of mood, sleep, and physical activity, in an internet-based cognitive-behavioral therapy (iCBT) for depression offered in a routine care setting. METHODS: Seventy participants will be randomly allocated to (i) iCBT intervention plus smartwatch app or (ii) iCBT intervention alone. Patient acceptance will be measured longitudinally using a theory-based acceptance questionnaire to understand and compare the evolution of acceptance of the technology-delivered self-report in the two groups. A post-treatment interview will explore participants subjective experience of using the smartwatch. Engagement with the intervention, including self-report, and clinical outcomes, will be measured across both groups to assess for any differences. IMPLICATIONS: This is the first study investigating the evolution of patient acceptance of smartwatch self-report in an iCBT delivered intervention in a clinical sample. Through an engaging and convenient means of capturing ecologically valid mood data, the study has the potential to show that smartwatches are an acceptable means for patient self-monitoring within iCBT interventions for depression and support potential use-cases for smartwatches in the context of mental health interventions in general. Prospectively registered at ClinicalTrials.gov (NCT04568317).

Predictors of depression severity in a treatment-seeking sample / Predictores de la gravedad de la depresión en personas adultas que buscan tratamiento

Background/Objective: Depression is a common mental health disorder and an emerging public health concern. Few studies have investigated prevalence and predictors of depression severity in the Irish context. To investigate the relative contribution of known risk factors that predicts depression severity in a treatment-seeking sample of adults in Ireland. Method: As part of a randomised controlled trial of an internet-delivered intervention for depression participants (N=641) completed online screening questionnaires including BDI-II and information associated with common predictors of depression. Results: The mean score on the BDI-II was 24.13 (SD=11.20). Several factors were shown to predict greater severity of depression in the sample including female gender, younger age, unemployment, being single or partnered as opposed to married, previous diagnosis of depression, recent experience of life stressors. Alcohol use, recent losses, knowing a suicide completer, education level, type of employment and income level were not found to be significant. Conclusions: The study contributes to the profiling of the incidence and predictors of severity of depression in an Irish context. The results confirm some of the known risk factors and highlight the need for further research to be carried out on screening for depression and increasing access to interventions (AU)

Antecedentes/Objetivo: La depresión es uno de los trastornos de salud mental más comunes 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 participantes auto-referidos accedieron a una intervención en línea para la depresión. Los participantes (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: ser mujer, ser joven, estar desempleado, estar soltero o con pareja pero no casado, tener diagnóstico previo de depresión y experiencia reciente con factores vitales estresantes. Conclusiones: El estudio contribuye a la elaboración de perfiles de incidencia y factores predictivos en la gravedad de la depresión. Los resultados confirman algunos de los factores de riesgo conocidos y ponen de relieve la necesidad de nuevas investigaciones que lleven a cabo la detección de la depresión así como un mayor acceso a las intervenciones (AU)

Acceptability, satisfaction and perceived efficacy of "Space from Depression" an internet-delivered treatment for depression.

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.

Predictors of depression severity in a treatment-seeking sample.

Background/Objective: Depression is a common mental health disorder and an emerging public health concern. Few studies have investigated prevalence and predictors of depression severity in the Irish context. To investigate the relative contribution of known risk factors that predicts depression severity in a treatment-seeking sample of adults in Ireland. Method: As part of a randomised controlled trial of an internet-delivered intervention for depression participants (N = 641) completed online screening questionnaires including BDI-II and information associated with common predictors of depression. Results: The mean score on the BDI-II was 24.13 (SD = 11.20). Several factors were shown to predict greater severity of depression in the sample including female gender, younger age, unemployment, being single or partnered as opposed to married, previous diagnosis of depression, recent experience of life stressors. Alcohol use, recent losses, knowing a suicide completer, education level, type of employment and income level were not found to be significant. Conclusions: The study contributes to the profiling of the incidence and predictors of severity of depression in an Irish context. The results confirm some of the known risk factors and highlight the need for further research to be carried out on screening for depression and increasing access to interventions.

Antecedentes/Objetivo:La depresión es uno de los trastornos de salud mental más comunes 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 participantes auto-referidos accedieron a una intervención en línea para la depresión. Los participantes (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: ser mujer, ser joven, estar desempleado, estar soltero o con pareja pero no casado, tener diagnóstico previo de depresión y experiencia reciente con factores vitales estresantes. Conclusiones: El estudio contribuye a la elaboración de perfiles de incidencia y factores predictivos en la gravedad de la depresión. Los resultados confirman algunos de los factores de riesgo conocidos y ponen de relieve la necesidad de nuevas investigaciones que lleven a cabo la detección de la depresión así como un mayor acceso a las intervenciones.

Online counseling: a narrative and critical review of the literature.

OBJECTIVE: This article aimed to critically review the literature on online counseling. METHOD: Database and hand-searches were made using search terms and eligibility criteria, yielding a total of 123 studies. RESULTS: The review begins with what characterizes online counseling. Outcome and process research in online counseling is reviewed. Features and cyberbehaviors of online counseling such as anonymity and disinhibition, convenience, time-delay, the loss of social signaling, and writing behavior in cyberspace are discussed. Ethical behavior, professional training, client suitability, and clients' and therapists' attitudes and experiences of online counseling are reviewed. CONCLUSION: A growing body of knowledge to date is positive in showing that online counseling can have a similar impact and is capable of replicating the facilitative conditions as face-to-face encounters. A need remains for stronger empirical evidence to establish efficacy and effectiveness and to understand better the unique mediating and facilitative variables.