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.

Using e-diaries to investigate ADHD - State-of-the-art and the promising feature of just-in-time-adaptive interventions.

Attention-deficit/hyperactive disorder (ADHD) is characterized by symptoms which are dynamic in nature: states of hyperactivity, inattention and impulsivity as core symptoms, and emotion dysregulation as associated feature. Although tremendous work has been done to investigate between-subject differences (how patients with ADHD differ from healthy controls or patients with other disorders), little is known about the relationship between symptoms with triggers and contexts, that may allow us to better understand their causes and consequences. Understanding the temporal associations between symptoms and environmental triggers in an ecologically valid manner may be the basis to developing just-in-time adaptive interventions. Fortunately, recent years have seen advances in methodology, hardware and innovative statistical approaches to study dynamic processes in daily life. In this narrative review, we provide a description of the methodology (ambulatory assessment), summarize the existing literature in ADHD, and discuss future prospects for these methods, namely mobile sensing to assess contextual information, real-time analyses and just-in-time adaptive interventions.

Comparable emotional dynamics in women with ADHD and borderline personality disorder.

BACKGROUND: Emotional dysregulation (ED) is a core diagnostic symptom in borderline personality disorder (BPD) and an associated feature of attention-deficit/hyperactivity disorder (ADHD). We aimed to investigate differences in dynamical indices of ED in daily life in ADHD and BPD. METHODS: We used experience sampling method (ESM) and multilevel modelling to assess momentary changes in reports of affective symptoms, and retrospective questionnaire measures of ED in a sample of 98 adult females with ADHD, BPD, comorbid ADHD+BPD and healthy controls. RESULTS: We found marked differences between the clinical groups and healthy controls. However, the ESM assessments did not show differences in the intensity of feeling angry and irritable, and the instability of feeling sad, irritable and angry, findings paralleled by data from retrospective questionnaires. The heightened intensity in negative emotions in the clinical groups compared to controls was only partially explained by bad events at the time of reporting negative emotions, suggesting both reactive and endogenous influences on ED in both ADHD and BPD. CONCLUSIONS: This study supports the view that ED is a valuable trans-diagnostic aspect of psychopathology in both ADHD and BPD, with similar levels of intensity and instability. These findings suggest that the presence or severity of ED should not be used in clinical practice to distinguish between the two disorders.

Wandering minds in attention-deficit/hyperactivity disorder and borderline personality disorder.

Attention-deficit/hyperactivity Disorder (ADHD) and borderline personality disorder (BPD) have overlapping symptoms. We proposed that excessive spontaneous mind wandering (MW-S) might reflect a component of psychopathology that distinguishes ADHD from BPD. Using a questionnaire measure of MW-S and an experience sampling method, we investigated MW-S in daily life, in 28 ADHD, 19 BPD, 22 comorbid ADHD+BPD, and 29 control females. The clinical groups reported heightened frequency and intensity of MW-S compared to controls, but no differences from each other. When controlling for depression and anxiety, significant differences only persisted between controls and ADHD, who also showed elevated intensity of MW-S compared to BPD and comorbid ADHD+BPD. We found no MW-S instability differences amongst clinical cases as well as cases versus controls. Negative content of MW-S was higher in BPD and comorbid ADHD+BPD compared to controls, with no differences between ADHD and controls. When controlling for depression/anxiety, the differences between BPD and comorbid ADHD+BPD and controls dissipated. MW-S is a trans-diagnostic process present in both ADHD and BPD. Yet, the underlying mechanisms of this experience may be driven by anxiety/depression in BPD but reflect a core process in ADHD.

Emotion dysregulation in attention-deficit/hyperactivity disorder and borderline personality disorder.

There is ongoing debate on the overlap between Attention-Deficit/Hyperactivity Disorder (ADHD) and Borderline Personality Disorder (BPD), particularly regarding emotion dysregulation (ED). In this paper, we present a narrative review of the available evidence on the association of these two disorders from several standpoints. First, we discuss the unique and shared diagnostic criteria for ADHD and BPD, focusing particularly on ED. We consider the methodology of ecological momentary assessment and discuss why this approach could be an alternative and more accurate way to qualitatively distinguish between ADHD and BPD. We summarise key findings on the genetic and environmental risk factors for ADHD and BPD and the extent to which there are shared or unique aetiological and neurobiological risk factors. Finally, we discuss the clinical relevance of considering both disorders in the assessment of patients presenting with trait-like behavioural syndromes, distinguishing the two conditions and implications for treatment.