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

Rewards to stimulate safety belt use : an overview of research findings.

A multitude of psychological theories - generally in the field of learning and motivation reserve an important place for the principle of reward. In theories varying from those postulated by Skinner and Banduras modern stimulus response theories to theories with a more cognitive orientation, such as Festingers cognitive dissonance theory, goal-setting and expectancy theory, rewards are explicitly regarded as powerful influences on behaviour, even though the principles and presumed mechanisms of effect of the individual theories can vary greatly (see for an overview Lindzey and Aronson, 1985, for example). No matter how different these theories may be, the effect of reward is generally considered greater than that of punishment. Nevertheless, it has been traditional practice in the (Dutch) traffic system for desirable behaviour to be stimulated by rules and laws, resulting in the punishment of offences. The possible role of reward in influencing safe behaviour in traffic is hardly recognised. In recent years, however, this concept is also beginning to reach this field of application. This paper gives an overview of the research that has been performed to determine the effect of rewards (incentives) on safety belt use. In particular the effect of offering material rewards is considered. The greatest proportion of research was performed in the United States: in the Netherlands, only a few studies have been done in this field

Current sleep interventions for shift workers : a mini review to shape a new preventative, multicomponent sleep management programme

Introduction. Shift work can lead to sleep disturbances and insomnia during the sleeping period, as well as excessive sleepiness and fatigue during the waking period. While Cognitive Behavioral Therapy (CBT-i) is recommended as the first line of treatment for insomnia, key elements of CBT-i, such as maintaining a consistent sleep schedule, can be challenging for shift workers, highlighting the need for tailored sleep interventions. This mini review provides a narrative synthesis of nonpharmacological sleep interventions for shift workers and informs the development of a preventative, multicomponent sleep management programme. Method. An informal review was conducted in line with Phase 1 of the Framework for the Development and Evaluation of Complex Interventions. Results. A variety of strategies have been employed to help manage the impacts of shift work on sleep, including: CBT-i, adjusting shift schedules, controlled light exposure, sleep hygiene education, planned napping, caffeine consumption, and mind-body interventions (e.g., yogic relaxation).Discussion. Recommendations, limitations, and directions for future research are discussed; notably, the role of the family, the commute to and from the workplace, and the eating behaviors of employees appear to have been overlooked in current intervention efforts. Digital CBT-i platforms could help to provide an effective, scalable, and low-cost method of reducing insomnia in shift workers

Table_1_Current sleep interventions for shift workers: a mini review to shape a new preventative, multicomponent sleep management programme.docx

IntroductionShift work can lead to sleep disturbances and insomnia during the sleeping period, as well as excessive sleepiness and fatigue during the waking period. While Cognitive Behavioral Therapy (CBT-i) is recommended as the first line of treatment for insomnia, key elements of CBT-i, such as maintaining a consistent sleep schedule, can be challenging for shift workers, highlighting the need for tailored sleep interventions. This mini review provides a narrative synthesis of non-pharmacological sleep interventions for shift workers and informs the development of a preventative, multicomponent sleep management programme.MethodAn informal review was conducted in line with Phase 1 of the Framework for the Development and Evaluation of Complex Interventions.ResultsA variety of strategies have been employed to help manage the impacts of shift work on sleep, including: CBT-i, adjusting shift schedules, controlled light exposure, sleep hygiene education, planned napping, caffeine consumption, and mind-body interventions (e.g., yogic relaxation).DiscussionRecommendations, limitations, and directions for future research are discussed; notably, the role of the family, the commute to and from the workplace, and the eating behaviors of employees appear to have been overlooked in current intervention efforts. Digital CBT-i platforms could help to provide an effective, scalable, and low-cost method of reducing insomnia in shift workers.</p

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

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. 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. 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. 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. 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

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.</p

Bridging the gap from medical to psychological safety assessment : a 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