A Closed-Loop Digital Health Tool to Improve Depression Care in Multiple Sclerosis: Iterative Design and Cross-Sectional Pilot Randomized Controlled Trial and its Impact on Depression Care.

BACKGROUND: People living with multiple sclerosis (MS) face a higher likelihood of being diagnosed with a depressive disorder than the general population. Although many low-cost screening tools and evidence-based interventions exist, depression in people living with MS is underreported, underascertained by clinicians, and undertreated. OBJECTIVE: This study aims to design a closed-loop tool to improve depression care for these patients. It would support regular depression screening, tie into the point of care, and support shared decision-making and comprehensive follow-up. After an initial development phase, this study involved a proof-of-concept pilot randomized controlled trial (RCT) validation phase and a detailed human-centered design (HCD) phase. METHODS: During the initial development phase, the technological infrastructure of a clinician-facing point-of-care clinical dashboard for MS management (BRIDGE) was leveraged to incorporate features that would support depression screening and comprehensive care (Care Technology to Ascertain, Treat, and Engage the Community to Heal Depression in people living with MS [MS CATCH]). This linked a patient survey, in-basket messages, and a clinician dashboard. During the pilot RCT phase, a convenience sample of 50 adults with MS was recruited from a single MS center with 9-item Patient Health Questionnaire scores of 5-19 (mild to moderately severe depression). During the routine MS visit, their clinicians were either asked or not to use MS CATCH to review their scores and care outcomes were collected. During the HCD phase, the MS CATCH components were iteratively modified based on feedback from stakeholders: people living with MS, MS clinicians, and interprofessional experts. RESULTS: MS CATCH links 3 features designed to support mood reporting and ascertainment, comprehensive evidence-based management, and clinician and patient self-management behaviors likely to lead to sustained depression relief. In the pilot RCT (n=50 visits), visits in which the clinician was randomized to use MS CATCH had more notes documenting a discussion of depressive symptoms than those in which MS CATCH was not used (75% vs 34.6%; χ21=8.2; P=.004). During the HCD phase, 45 people living with MS, clinicians, and other experts participated in the design and refinement. The final testing round included 20 people living with MS and 10 clinicians including 5 not affiliated with our health system. Most scoring targets for likeability and usability, including perceived ease of use and perceived effectiveness, were met. Net Promoter Scale was 50 for patients and 40 for clinicians. CONCLUSIONS: Created with extensive stakeholder feedback, MS CATCH is a closed-loop system aimed to increase communication about depression between people living with MS and their clinicians, and ultimately improve depression care. The pilot findings showed evidence of enhanced communication. Stakeholders also advised on trial design features of a full year long Department of Defense-funded feasibility and efficacy trial, which is now underway. TRIAL REGISTRATION: ClinicalTrials.gov NCT05865405; http://tinyurl.com/4zkvru9x.

Pragmatic phase II clinical trial to improve depression care in a real-world diverse MS cohort from an academic MS centre in Northern California: MS CATCH study protocol.

INTRODUCTION: Depression occurs in over 50% of individuals living with multiple sclerosis (MS) and can be treated using many modalities. Yet, it remains: under-reported by patients, under-ascertained by clinicians and under-treated. To enhance these three behaviours likely to promote evidence-based depression care, we engaged multiple stakeholders to iteratively design a first-in-kind digital health tool. The tool, MS CATCH (Care technology to Ascertain, Treat, and engage the Community to Heal depression in patients with MS), closes the communication loop between patients and clinicians. Between clinical visits, the tool queries patients monthly about mood symptoms, supports patient self-management and alerts clinicians to worsening mood via their electronic health record in-basket. Clinicians can also access an MS CATCH dashboard displaying patients' mood scores over the course of their disease, and providing comprehensive management tools (contributing factors, antidepressant pathway, resources in patient's neighbourhood). The goal of the current trial is to evaluate the clinical effect and usability of MS CATCH in a real-world clinical setting. METHODS AND ANALYSIS: MS CATCH is a single-site, phase II randomised, delayed start, trial enrolling 125 adults with MS and mild to moderately severe depression. Arm 1 will receive MS CATCH for 12 months, and arm 2 will receive usual care for 6 months, then MS CATCH for 6 months. Clinicians will be randomised to avoid practice effects. The effectiveness analysis is superiority intent-to-treat comparing MS CATCH to usual care over 6 months (primary outcome: evidence of screening and treatment; secondary outcome: Hospital Anxiety Depression Scale-Depression scores). The usability of the intervention will also be evaluated (primary outcome: adoption; secondary outcomes: adherence, engagement, satisfaction). ETHICS AND DISSEMINATION: University of California, San Francisco Institutional Review Board (22-36620). The findings of the study are planned to be shared through conferences and publishments in a peer-reviewed journal. The deidentified dataset will be shared with qualified collaborators on request, provision of CITI and other certifications, and data sharing agreement. We will share the results, once the data are complete and analysed, with the scientific community and patient/clinician participants through abstracts, presentations and manuscripts. TRIAL REGISTRATION NUMBER: NCT05865405.

Late Potentials and Early Repolarisation Are Associated With Serious Mental Illness and May Portend Increased Arrhythmic Risk.

BACKGROUND: Patients with serious mental illness (SMI) have an increased risk of sudden death. Higher rates of signal-averaged electrocardiogram (SAECG) abnormal late potentials (LP), which may be a predictor of sudden death risk, have been shown in patients with schizophrenia. We aimed to assess the prevalence and predictors of electrocardiograph (ECG) and SAECG abnormalities in a mixed SMI population. METHODS: Consecutive consenting inpatients with SMI had 12-lead ECG and SAECG recorded in addition to demographics, diagnoses and medications. Standard criteria for abnormal SAECG were applied. Multivariate regression analysis was performed to determine predictors of SAECG abnormalities including diagnoses, body mass index, ECG parameters, psychotropic medication use, and medications associated with Long QT or Brugada syndromes. RESULTS: Eighty (80) patients, 49% male, mean age 39±17 years were included. SAECG criteria abnormality for 1, 2 or 3 criteria were seen in 19, 3 and 5 cases (34% in total) respectively. Early repolarisation pattern was seen in 19% of patients. SAECG abnormality was associated with male gender (OR 7.3; 95% CI 2.3-23.4), and schizophrenia/schizoaffective disorder diagnosis (OR 7.4; 95% CI 1.9-29.0), but not with medication type or dose. CONCLUSIONS: In the mixed SMI population studied, there was a high rate of SAECG-detected late potentials (34%) and early repolarisation pattern (19%). Schizophrenia/schizoaffective disorder diagnosis was the strongest multivariate predictor identified. Further studies are needed to define the mechanism and significance of these cardiac abnormalities in SMI patients.

Healthcare communication distress scale: Pilot factor analysis and validity.

OBJECTIVE: To develop psychometrically an evidence-based, patient-centred measure of patient-practitioner communication. We explored the underlying constructs of a self-report questionnaire measuring adult patients' enduring perceptions of their emotional experiences when communicating with primary healthcare practitioners. METHODS: A cross-sectional on-line survey included 16 items from a piloted questionnaire, as well as existing measures of generalised anxiety, psychological distress, and body vigilance. Exploratory factor analysis and hierarchical multiple regression were used to explore underlying constructs in an Australian sample (N = 220). RESULTS: A 6-item communication distress factor and a 3-item environmental arousal factor were supported, indicating good face validity and internal consistency. Bivariate correlations support convergent and discriminant validity for both factors. Hierarchical analysis exploring predictors of communication distress included sex, age, and chronic condition status; and scores on body vigilance, anxiety, distress, and environmental arousal in healthcare. Environmental arousal was the most important significant predictor of communication distress. CONCLUSION: The patient communication questionnaire can be developed into a brief scale to measure patient distress associated with engaging with, and communicating in, healthcare settings. PRACTICE IMPLICATIONS: A brief self-report measure to identify patients' communication distress and environmental arousal could assist in clinical practice and provide useful data in healthcare communication research.

High rates of respiratory symptoms and airway disease in mental health inpatients in a tertiary centre.

BACKGROUND: People with severe mental illness (SMI) have a lower life expectancy due in part to a higher prevalence of cardiac and metabolic disease. Less is known of the prevalence of respiratory disease in this group. AIMS: This cross-sectional, observational study aimed to assess the prevalence of symptoms associated with respiratory disease in patients admitted to an inpatient mental health unit. METHODS: A convenience sample of 82 inpatients had a structured interview and questionnaire completed. The questionnaire included self-reported diagnoses of common diseases and screening questions designed to detect respiratory disease and sleep disordered breathing. Targeted spirometry was performed on the basis of symptoms and smoking status. RESULTS: Patients reported high rates of respiratory symptoms, including wheezing (38%) and dyspnoea (44%); 52% of patients reported daily tobacco use. Productive cough was significantly associated with tobacco use (P < 0.005). Ten patients (18%) had spirometry consistent with chronic obstructive pulmonary disease (COPD) of whom six did not have a formal diagnosis of COPD previously. CONCLUSIONS: People with SMI have high rates of respiratory symptoms with a high prevalence of COPD on spirometry. Half of the COPD cases were not previously diagnosed, suggesting a hidden burden of respiratory disease in patients with SMI.

Psychometric Analysis of the Multidimensional State Boredom Scale and Its Condensed Versions.

The Multidimensional State Boredom Scale (MSBS) is a promising new self-report measure of state boredom. Two condensed versions of the scale have also been introduced. This study helped explore the psychometric qualities of these scales, using a large sample of Australian adults ( N = 1,716), as well as two smaller samples ( N = 199 and N = 422). Data analyses indicated strong convergent validity and very high internal consistency for the scales. Test-retest reliability over a 6- to 8-day period was moderately high. Confirmatory factor analyses of the MSBS authors' suggested factor structure indicated good fit for this model. However, some of the data analyses raise questions as to whether the scale includes meaningful subfactors. Overall, the MSBS (and Short Form) is recommended for researchers who wish to assess state boredom.

Depression and Pain in Heart Transplant Recipients: An Observational Study.

Characterizing how physical and psychological symptoms interact in heart transplant recipients may lead to advances in therapeutic options. This study examined associations between pain and major depression. METHOD: A cross-sectional study was conducted with adult heart transplant recipients. Pain was measured with the bodily pain domain of the Short Form-36 Health Survey and psychological distress with the Kessler Psychological Distress Scale (K-10). The Mini International Neuropsychiatric Interview, version 6.0, was used to identify participants meeting the criteria for major depression. Hierarchical linear regression was used to determine if there was an association between pain and major depression, controlling for pharmacological treatment of depression, severity of psychological distress, and clinical characteristics including immunosuppression medication which may induce pain as a side effect. RESULTS: Average pain score of the 48 heart transplant recipients was 43 ( SD ± 10, range 0-100, lower scores indicate worse pain), with moderate pain reported by 39% ( n = 19). Major depression was associated with worse pain ( R2 change = 36%, ß = -16, 95% confidence interval [CI] = [-30, -4], p = .012). Pharmacological treatment for depression was associated with better pain scores ( R2 change = 1.5%, ß = 13, 95% CI [4, 23], p = .006). CONCLUSIONS: Heart transplant recipients with major depression had worse pain after controlling for pharmacological treatment of depression, severity of psychological distress, and clinical characteristics. Thus, it is imperative that clinicians devising a treatment regimen for pain in heart transplant recipients take into account co-occurring depression and vice versa.

Accuracy of anxiety and depression screening tools in heart transplant recipients.

PURPOSE: The aim of this study was to assess the validity and reliability of psychological screening tools in outpatient heart transplant recipients. METHODS: Forty-eight heart transplant recipients completed the Patient Health Questionnaire 9-item scale (PHQ-9), Generalized Anxiety Disorder 7-item Scale (GAD-7), Kessler Psychological Distress 10-item Scale (K-10) and Medical Outcomes Short Form 36-item Health Survey. A structured psychological interview (Mini International Neuropsychiatric Interview Version 6) was conducted after completion of the questionnaires. Internal consistency, criterion validity and construct validity of the PHQ-9, GAD-7 and K-10 were evaluated. RESULTS: Internal consistency supported the reliability of the screening tools. The optimal cut-off on the PHQ-9 for depression was 10 (sensitivity=0.86; specificity=0.93). A score of 6 on the GAD-7 maximized sensitivity (0.75) and specificity (0.89) for anxiety. A score of 17 on the K-10 was the optimal cut-off for diagnosis of either anxiety or depression (sensitivity=0.83; specificity=0.84). Increasing scores on the screening tools were associated with lower health-related quality of life. CONCLUSION: Psychometric analyses support the reliability and validity of the PHQ-9, GAD-7 and K-10 as screening tools for detection of anxiety and depression in heart transplant recipients.

Pilot testing a model of psychological care for heart transplant recipients.

BACKGROUND: Anxiety and depression are common after heart transplantation. This study aimed to pilot test the feasibility of a clinical model of psychological care for heart transplant recipients. The model of care involved nurse-led screening for anxiety and depression followed by referral for a course of telephone-delivered cognitive behaviour therapy as well as co-ordination of communication with on-going specialist and primary care services. METHODS: A pilot randomised controlled trial was conducted. Heart transplant recipients who self-reported at least mild anxiety or depressive symptoms were randomised (defined as a score higher than 5 on the Patient Health Questionnaire-9 or the Generalized Anxiety Disorder-7 [GAD-7], or a score higher than 20 on the Kessler Psychological Distress Scale [K10]). The primary outcome was assessment of feasibility of conducting a larger trial, which included identification of recruitment and attrition rates as well as the acceptability of the intervention. Follow-up was conducted at 9 weeks and 6 months. RESULTS: One hundred twenty-two of the 126 (97 %) heart transplant recipients assessed on their attendance at the outpatient clinic met the study eligibility criteria. Of these patients, 88 (72 %) agreed to participate. A moderate proportion of participants (n = 20; 23 %) reported at least mild symptoms of anxiety or depression. Five participants were excluded because they were currently receiving psychological counselling, two withdrew before randomisation and the remaining 13 were randomised (seven to intervention and six to usual care). The majority of the randomised participants were male (n = 9; 69 %) and aged over 60 (range 35-73). Median length of time post-transplant was 9.5 years (ranging from 1 to 19 years). On enrolment, 3 randomised participants were taking anti-depressants. One intervention group participant withdrew and a further 3 (50 %) declined the telephone-delivered CBT sessions; all because of restrictions associated with physical illnesses. Attrition was 30 % at the 6 month follow-up time-point. CONCLUSIONS: Due to the poor acceptability of telephone-delivered cognitive behavioural therapy observed in our sample, changes to intervention components are indicated and further pilot testing is required. TRIAL REGISTRATION: ACTRN12613000740796 Date registered: 03/07/2013.

Posttraumatic growth in post-surgical coronary artery bypass graft patients.

Recent research in posttraumatic growth has been applied to people with life-threatening illnesses to optimise recovery. There is a lack of research exploring posttraumatic growth in coronary artery bypass graft patients. This article describes the recovery experience of 14 coronary artery bypass graft patients (13 males and 1 female) at their first outpatient review post-surgery. Grounded theory analysis was used to develop a model of distinct and shared pathways to growth depending on whether patients were symptomatic or asymptomatic pre-coronary artery bypass graft. Outcomes of posttraumatic growth in this sample included action-based healthy lifestyle growth and two forms of cognitive growth: appreciation of life and new possibilities. The model of posttraumatic growth developed in this study may be helpful in guiding future research into promoting posttraumatic growth and behaviour change in coronary artery bypass graft patients.

Back to basics: informing the public of co-morbid physical health problems in those with mental illness.

OBJECTIVE: Those with mental illness are at increased risk of physical health problems. The current study aimed to examine the information available online to the Australian public about the increased risk and consequences of physical illness in those with mental health problems and the services available to address these co-morbidities. METHODS: A structured online search was conducted with the search engine Google Australia (www.google.com.au) using generic search terms 'mental health information Australia', 'mental illness information Australia', 'depression', 'anxiety', and 'psychosis'. The direct content of websites was examined for information on the physical co-morbidities of mental illness. All external links on high-profile websites [the first five websites retrieved under each search term (n = 25)] were examined for information pertaining to physical health. RESULTS: Only 4.2% of websites informing the public about mental health contained direct content information about the increased risk of physical co-morbidities. The Australian Government's Department of Health and Ageing site did not contain any information. Of the high-profile websites, 62% had external links to resources about physical health and 55% had recommendations or resources for physical health. Most recommendations were generic. CONCLUSIONS: Relative to the seriousness of this problem, there is a paucity of information available to the public about the increased physical health risks associated with mental illness. Improved public awareness is the starting point of addressing this health inequity.

Employee psychological distress and treated prevalence by indices of rurality.

OBJECTIVE: Although there is population data on the prevalence and treated prevalence of mental disorders by urban-rural indices, there is a lacuna of information pertaining to employees. This paper examines the prevalence and treated prevalence of psychological distress in employees by urban-rural indicators. METHODS: Cross-sectional employee Health and Performance at Work Questionnaire responses (n=78,726 from 58 large companies) are interrogated by indices of remoteness (Accessibility/Remoteness Index of Australia), psychological distress (Kessler 6) and treatment-seeking behaviours for mental health problems. RESULTS: The overall prevalence of moderate or high psychological distress in employees was 35.2%. The prevalence varied only slightly (maximum to minimum difference of 4.6%) by rural/remote indices. Overall treatment-seeking behaviour for psychological distress was low (22.5%). The percentage of employees seeking treatment for high levels of psychological distress was the lowest in very remote regions (15.1%). CONCLUSION: Very remote employees are less likely to access mental health treatments and may be an employee subgroup that would benefit from specific employer health interventions aimed to increase treatment-seeking behaviours. IMPLICATIONS: Employees in very remote Australia could benefit from specific interventions aimed to increase mental health awareness/literacy.

The association between mental disorders and productivity in treated and untreated employees.

OBJECTIVES: In a large cross-sectional study, this article investigates associations between employee work productivity, psychological distress, and the treatment of mental disorders. METHODS: Sixty thousand five hundred fifty-six Australian employees completed the Health and Work Performance Questionnaire (HPQ). The HPQ quantified treatment seeking behavior for depression, anxiety, or other mental disorders. The HPQ also evaluated the level of psychological distress (Kessler 6 [K6]) and employee productivity measures. RESULTS: The productivity of employees without psychological distress and who have not been in treatment of a mental disorder was 20% (SE = 0.3%). The productivity of a successfully treated employee (low K6) for a mental disorder was 17% (SE = 0.6%). CONCLUSIONS: Treatment of mental disorders resulting in normalization of symptoms is associated with employees' productivity returning to values approaching those of employees without a history of a mental disorder.

The impact of mental health symptoms on heavy goods vehicle drivers' performance.

High levels of psychological distress in fulltime employees are prevalent (4.5% per month). Symptoms of impaired mental health include difficulties with attention, concentration, motivation, decision-making, visuo-motor control, and psychomotor reaction times. There is limited research on the impact these symptoms have on heavy goods vehicle (HGV) drivers' performance. In this study 1324 HGV drivers were surveyed using the Depression, Anxiety, Stress Scale (DASS) and the Health and Performance at Work Questionnaire (HPQ). Depression, anxiety and stress had little effect on driver absenteeism rates or self-rated driving performance. However, severe (1.5% of drivers) and very severe (1.8% of drivers) depression was associated with an increased odds ratio (OR=4.5 and 5.0, respectively) for being involved in an accident or near miss in the past 28 days. This odd ratio is akin to driving with a blood alcohol content of about 0.08%. Given the number of HGV vehicles and the prevalence of depression this equates to 10,950 HGV drivers with an increased statistical risk of an accident or near miss. As the impact of HGV accidents is potentially large, including loss of life, it would be sensible to extend the research findings here into an action plan.

Employee absenteeism measures reflecting current work practices may be instrumental in a re-evaluation of the relationship between psychological distress/mental health and absenteeism.

Absenteeism rates are the cornerstone metrics guiding corporate policy for health care investment in employees. However, traditional absenteeism measures do not reflect the contemporary workplace milieu. It is accepted practice that employees work evenings or weekends to makeup time. Using a hours-based absenteeism measure, that accounts for time made-up as well as time lost, this paper evaluates the impact of psychological distress on employee absenteeism.Psychological distress and absenteeism data were collected from 54,264 full-time employees. Consistent with traditional approaches, employees indicated how many days they were absent. Hours based absenteeism was formulated from the ratio of how many hours the employees worked and how many hours were they expected to work in the past seven-days.Concordant with previous concinnous evidence, traditional absenteeism computation indicated that elevated psychological distress is associated with increasing absenteeism. Using the hours-based method psychological distress did not significantly influence absenteeism.Traditional calculations of absenteeism do not reflect the current work practices of the majority of employees. Employees with psychological distress may take time off work but it appears that they make up for lost time possibly to stay up to speed with task driven occupations and avoid performance review.

Mental ill-health and the differential effect of employee type on absenteeism and presenteeism.

OBJECTIVE: Mental ill-health results in substantial reductions in employee productivity (absenteeism and presenteeism). This paper examines the relationship between employee psychological distress, employee type and productivity. METHOD: Utilizing the Health and Performance at Work Questionnaire, in a sample of 60,556 full-time employees, the impact that psychological distress (Kessler 6) imposes on employee productivity by occupation type is examined. RESULTS: Comparison of white-collar workers absenteeism rates by low and high psychological distress reveals no statistically significant difference. Nevertheless, the same comparison for blue-collar workers reveals that high psychological distress results in an 18% increase in absenteeism rates. High K6 score resulted in a presenteeism increase of 6% in both blue and white-collar employees. CONCLUSION: The novel finding is that mental ill-health produces little to no absenteeism in white-collar workers yet a profound absenteeism increase in the blue-collar sector.

The prevalence of psychological distress in employees and associated occupational risk factors.

OBJECTIVE: There is limited occupational health industry data pertaining to 1) the prevalence of psychological distress in various employee subtypes and 2) risk factors for employee psychological distress. METHOD: The employees of 58 large public and private sector employers were invited to complete the Kessler 6 (K6) as part of the Health and Performance at Work Questionnaire. A K6 score of > or =13 was chosen to indicate high psychological distress. RESULTS: Data on 60,556 full-time employees indicate that 4.5% of employees have high psychological distress of which only 22% were in current treatment. Occupational risk factors identified include long working hours, sales staff and non-traditional gender roles. CONCLUSION: High psychological distress is pervasive across all employee subtypes and remains largely untreated. Risk factors identified will guide the targeting of mental health promotion, prevention and screening programs.

Hallucinations in adolescents with post-traumatic stress disorder and psychotic disorder.

OBJECTIVE: The aim of the study was to compare the phenomenology of hallucinations in hospitalized adolescents diagnosed with post-traumatic stress disorder (PTSD) and psychotic disorder. METHODS: Diagnoses were ascertained in 66 adolescents consecutively admitted to an acute adolescent unit in Australia. Hallucinations were examined to compare their phenomenology in PTSD with psychotic disorder. RESULTS: On most measures, hallucinations did not differ significantly in form or content between those adolescents with PTSD and those with psychotic disorder. In a minority of patients with PTSD, the hallucinations reflected a previous traumatic experience. CONCLUSIONS: Hallucinations were found to be unreliable in distinguishing adolescent inpatients with PTSD from those with psychotic disorder.