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.

Feasibility and preliminary efficacy of app-based audio tools to improve sleep health in working adults experiencing poor sleep: a multi-arm randomized pilot trial.

STUDY OBJECTIVES: Many adults without a diagnosed sleep disorder report poor sleep. Recently, there has been a dramatic increase in the use of app-based audio tools to aid sleep by the general public, yet there is a paucity of evidence on whether such tools are efficacious. This study evaluated the feasibility and preliminary efficacy of two categories of audio tools, comprising music and narrated stories, featured on the Unmind app. METHODS: We conducted an online, parallel, multi-arm, external pilot randomized controlled trial, with two intervention arms and a waitlist (WL) control group. Participants were working adults who were screened for poor sleep. Feasibility was assessed via objective and self-report measures. Preliminary efficacy was evaluated via self-report measures of sleep disturbance, work productivity, and other mental health outcomes, captured at baseline (t0) and following a 4-week intervention period (t1), and analyzed using mixed effects models with intention-to-treat principles. RESULTS: Three hundred participants were randomized, and 92% were retained at t1. 90.5% of participants completed at least one intervention session. 82.1% reported being "satisfied" or "very satisfied" with their intervention, and 84.3% rated their intervention as "good" or "excellent." The between-group Hedges' g effect size for sleep disturbance was 0.92 [0.63-1.22] and 1.09 [0.80-1.39] for the two interventions compared to the WL group. CONCLUSIONS: Both interventions are feasible and acceptable. Preliminary efficacy findings suggest that audio tools designed to aid sleep could have widespread financial and public health implications, and should be investigated in a definitive trial. CLINICAL TRIAL: International Standard Randomized Controlled Trial Number (ISRCTN), 12614821, http://www.isrctn.com/ISRCTN12614821.

Validating the Unmind Index as a measure of mental health and wellbeing among adults in USA, Australia, and New Zealand.

BACKGROUND: The Unmind Index is a 26-item, 7-subscale measure of mental health and wellbeing designed for use on the Unmind digital workplace mental health platform. The Unmind Index was developed and validated in the UK but is used internationally. This paper reports further psychometric validation of this measure for use in USA, Australia, and New Zealand (ANZ). METHODS: Participants in four countries completed the Unmind Index and a battery of existing measures. In Study 1 (N = 770), we validated the Unmind Index separately in USA and in ANZ. In Study 2 (N = 600), we used multiple group confirmatory factor analysis to test the measurement invariance of the Unmind Index across the UK, USA, and ANZ. RESULTS: Study 1 establishes the factor structure, reliability, convergent and discriminant validity, and measurement invariance by age and gender of the Unmind Index separately for USA and for ANZ. Study 2 further demonstrates measurement invariance across locations, and establishes benchmark scores by location, age, and gender. CONCLUSIONS: We conclude that the Unmind Index is valid and reliable as a measure of mental health and wellbeing in these locations.

Feasibility and Preliminary Efficacy of Digital Interventions for Depressive Symptoms in Working Adults: Multiarm Randomized Controlled Trial.

BACKGROUND: Depressive symptoms are highly prevalent and have broad-ranging negative implications. Digital interventions are increasingly available in the workplace context, but supporting evidence is limited. OBJECTIVE: This study aimed to evaluate the feasibility, acceptability, and preliminary efficacy of 3 digital interventions for depressive symptoms in a sample of UK-based working adults experiencing mild to moderate symptoms. METHODS: This was a parallel, multiarm, pilot randomized controlled trial. Participants were allocated to 1 of 3 digital interventions or a waitlist control group and had 3 weeks to complete 6 to 8 short self-guided sessions. The 3 interventions are available on the Unmind mental health app for working adults and draw on behavioral activation, cognitive behavioral therapy, and acceptance and commitment therapy. Web-based assessments were conducted at baseline, postintervention (week 3), and at 1-month follow-up (week 7). Participants were recruited via Prolific, a web-based recruitment platform, and the study was conducted entirely on the web. Feasibility and acceptability were assessed using objective engagement data and self-reported feedback. Efficacy outcomes were assessed using validated self-report measures of mental health and functioning and linear mixed models with intention-to-treat principles. RESULTS: In total, 2003 individuals were screened for participation, of which 20.22% (405/2003) were randomized. A total of 92% (373/405) of the participants were retained in the study, 97.4% (295/303) initiated their allocated intervention, and 66.3% (201/303) completed all sessions. Moreover, 80.6% (229/284) of the participants rated the quality of their allocated intervention as excellent or good, and 79.6% (226/284) of the participants were satisfied or very satisfied with their intervention. All active groups showed improvements in well-being, functioning, and depressive and anxiety symptoms compared with the control group, which were maintained at 4 weeks. Hedges g effect sizes for depressive symptoms ranged from -0.53 (95% CI -0.25 to -0.81) to -0.74 (95% CI -0.45 to -1.03). CONCLUSIONS: All interventions were feasible and acceptable, and the preliminary efficacy findings indicated that their use may improve depressive symptoms, well-being, and functioning. The predefined criteria for a definitive trial were met. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number (ISRCTN) ISRCTN13067492; https://www.isrctn.com/ISRCTN13067492.

Feasibility and Preliminary Efficacy of Web-Based and Mobile Interventions for Common Mental Health Problems in Working Adults: Multi-Arm Randomized Pilot Trial.

BACKGROUND: There is growing interest in digital platforms as a means of implementing scalable, accessible, and cost-effective mental health interventions in the workplace. However, little is known about the efficacy of such interventions when delivered to employee groups. OBJECTIVE: This study aims to evaluate the feasibility and preliminary efficacy of a digital mental health platform for the workplace, which incorporates evidence-based practices such as cognitive behavioral therapy and acceptance and commitment therapy. A total of 3 brief, unguided interventions designed to address stress, anxiety, and resilience, respectively, are evaluated. The primary aim is to determine the feasibility of the study methods and interventions in preparation for a definitive randomized controlled trial. METHODS: The study used a fully remote, parallel, multi-arm, external pilot randomized controlled trial, with 3 intervention arms and a no-intervention control group. Participants were working adults representative of the general UK population with respect to age, sex, and ethnicity who were recruited from a web-based participant platform. Primary outcomes included objective and self-report measures of feasibility, acceptability, engagement, transferability, relevance, and negative effects. Secondary outcomes included 4 self-report measures of mental health and well-being, completed at baseline (time point 0 [t0]), postintervention (time point 1 [t1]), and the 1-month follow-up (time point 2 [t2]). Secondary outcomes were analyzed via linear mixed-effects models using intention-to-treat principles. Preregistered criteria for progression to a definitive trial were evaluated. RESULTS: Data were collected between January and March of 2021. A total of 383 working adult participants meeting trial eligibility were randomized, of whom 356 (93%) were retained at t2. Objective engagement data showed that 67.8% (196/289) of participants randomized to an intervention arm completed their intervention. Overall, 87.1% (203/233) of participants reported being satisfied or very satisfied with their intervention and rated the quality of their intervention as good or excellent. All intervention groups reported significantly greater improvements than the control group on at least one secondary outcome at t1, with between-group Hedges g effect sizes for the pooled interventions ranging from 0.25 (95% CI 0.05-0.46) to 0.43 (95% CI 0.23-0.64). All the improvements were maintained at t2. CONCLUSIONS: The study methods were feasible, and all preregistered criteria for progression to a definitive trial were met. Several minor protocol amendments were noted. Preliminary efficacy findings suggest that the study interventions may result in improved mental health outcomes when offered to working adults. TRIAL REGISTRATION: ISRCTN Registry 80309011; http://www.isrctn.com/ISRCTN80309011.

A New Digital Assessment of Mental Health and Well-being in the Workplace: Development and Validation of the Unmind Index.

BACKGROUND: Unmind is a workplace, digital, mental health platform with tools to help users track, maintain, and improve their mental health and well-being (MHWB). Psychological measurement plays a key role on this platform, providing users with insights on their current MHWB, the ability to track it over time, and personalized recommendations, while providing employers with aggregate information about the MHWB of their workforce. OBJECTIVE: Due to the limitations of existing measures for this purpose, we aimed to develop and validate a novel well-being index for digital use, to capture symptoms of common mental health problems and key aspects of positive well-being. METHODS: In Study 1A, questionnaire items were generated by clinicians and screened for face validity. In Study 1B, these items were presented to a large sample (n=1104) of UK adults, and exploratory factor analysis was used to reduce the item pool and identify coherent subscales. In Study 2, the final measure was presented to a new nationally representative UK sample (n=976), along with a battery of existing measures, with 238 participants retaking the Umind Index after 1 week. The factor structure and measurement invariance of the Unmind Index was evaluated using confirmatory factor analysis, convergent and discriminant validity by estimating correlations with existing measures, and reliability by examining internal consistency and test-retest intraclass correlations. RESULTS: Studies 1A and 1B yielded a 26-item measure with 7 subscales: Calmness, Connection, Coping, Happiness, Health, Fulfilment, and Sleep. Study 2 showed that the Unmind Index is fitted well by a second-order factor structure, where the 7 subscales all load onto an overall MHWB factor, and established measurement invariance by age and gender. Subscale and total scores correlate well with existing mental health measures and generally diverge from personality measures. Reliability was good or excellent across all subscales. CONCLUSIONS: The Unmind Index is a robust measure of MHWB that can help to identify target areas for intervention in nonclinical users of a mental health app. We argue that there is value in measuring mental ill health and mental well-being together, rather than treating them as separate constructs.

Five-year predictive validity of DSM-IV conduct disorder research diagnosis in 4(1/2)-5-year-old children.

OBJECTIVE: This longitudinal study of a non-referred, population-based sample tested the 5-year predictive validity of the DSM-IV conduct disorder (CD) research diagnosis in children 4(1/2)-5 years of age. METHOD: In the E-Risk Study, a representative birth cohort of 2,232 children, mothers were interviewed and teachers completed mailed questionnaires to assess children's past 6-month CD symptoms. A follow-up assessment was conducted when children were 10 years old. RESULTS: CD-diagnosed 5-year-olds were significantly more likely than controls to have behavioural and educational difficulties at age 10. Increased risk for age-10 educational difficulties persisted after controlling for age-5 IQ and ADHD diagnosis. Although the majority of CD-diagnosed 5-year-olds had no CD symptoms at age 10, findings suggest that these "remitted" children continued to experience behavioural and educational problems 5 years later despite their apparent remission from CD. CONCLUSIONS: DSM-IV CD symptoms validly identify preschool-aged children who continue to have behavioural and educational problems in middle-childhood.

Increased set shifting costs in fasted healthy volunteers.

We investigated the impact of temporary food restriction on a set shifting task requiring participants to judge clusters of pictures against a frequently changing rule. 60 healthy female participants underwent two testing sessions: once after fasting for 16 hours and once in a satiated state. Participants also completed a battery of questionnaires (Hospital Anxiety and Depression Scale [HADS]; Persistence, Perseveration and Perfectionism Questionnaire [PPPQ-22]; and Eating Disorders Examination Questionnaire [EDE-Q6]). Set shifting costs were significantly increased after fasting; this effect was independent of self-reported mood and perseveration. Furthermore, higher levels of weight concern predicted a general performance decrement under conditions of fasting. We conclude that relatively short periods of fasting can lead to set shifting impairments. This finding may have relevance to studies of development, individual differences, and the interpretation of psychometric tests. It also could have implications for understanding the etiology and maintenance of eating disorders, in which impaired set shifting has been implicated.

Mental health context of food insecurity: a representative cohort of families with young children.

OBJECTIVE: Children from food-insecure families (ie, families that lack access to sufficient, safe, and nutritious food) are at risk for developmental problems. Food insecurity disproportionately occurs among low-socioeconomic status (SES) and low-income families; however, interventions that supplement families' income or diet have not eradicated food insecurity. This may be because food insecurity is also related to nonfinancial factors such as the presence of maternal mental health problems. To clarify whether addressing mothers' mental health problems may be a promising strategy for reducing the burden of food insecurity, we tested the hypothesis that low-SES families are especially vulnerable to food insecurity when the mother experiences depression, alcohol or drug abuse, psychosis spectrum disorder, or domestic violence. METHODS: We used data from a nationally representative cohort of 1116 British families (the Environmental Risk Longitudinal Study). Food insecurity, family SES, maternal mental health and exposure to domestic violence, and children's behavioral outcomes were measured by using validated methods. RESULTS: Overall, 9.7% of study families were food-insecure. Among low-SES families, controlling for income variation, food insecurity co-occurred with maternal depression (odds ratio [OR]: 2.82 [95% confidence interval (CI): 1.62-4.93]), psychosis spectrum disorder (OR: 4.01 [95% CI: 2.03-7.94]), and domestic violence (OR: 2.36 [95% CI: 1.18-4.73]). In addition, food insecurity predicted elevated rates of children's behavior problems. CONCLUSIONS: Among families with young children, food insecurity is frequent, particularly when the mother experiences mental health problems. This suggests that interventions that improve women's mental health may also contribute to decreasing the burden of food insecurity and its impact on the next generation.