Digital Interventions to Understand and Mitigate Stress Response: Protocol for Process and Content Evaluation of a Cohort Study.

BACKGROUND: Staffing and resource shortages, especially during the COVID-19 pandemic, have increased stress levels among health care workers. Many health care workers have reported feeling unable to maintain the quality of care expected within their profession, which, at times, may lead to moral distress and moral injury. Currently, interventions for moral distress and moral injury are limited. OBJECTIVE: This study has the following aims: (1) to characterize and reduce stress and moral distress related to decision-making in morally complex situations using a virtual reality (VR) scenario and a didactic intervention; (2) to identify features contributing to mental health outcomes using wearable, physiological, and self-reported questionnaire data; and (3) to create a personal digital phenotype profile that characterizes stress and moral distress at the individual level. METHODS: This will be a single cohort, pre- and posttest study of 100 nursing professionals in Ontario, Canada. Participants will undergo a VR simulation that requires them to make morally complex decisions related to patient care, which will be administered before and after an educational video on techniques to mitigate distress. During the VR session, participants will complete questionnaires measuring their distress and moral distress, and physiological data (electrocardiogram, electrodermal activity, plethysmography, and respiration) will be collected to assess their stress response. In a subsequent 12-week follow-up period, participants will complete regular assessments measuring clinical outcomes, including distress, moral distress, anxiety, depression, and loneliness. A wearable device will also be used to collect continuous data for 2 weeks before, throughout, and for 12 weeks after the VR session. A pre-post comparison will be conducted to analyze the effects of the VR intervention, and machine learning will be used to create a personal digital phenotype profile for each participant using the physiological, wearable, and self-reported data. Finally, thematic analysis of post-VR debriefing sessions and exit interviews will examine reoccurring codes and overarching themes expressed across participants' experiences. RESULTS: The study was funded in 2022 and received research ethics board approval in April 2023. The study is ongoing. CONCLUSIONS: It is expected that the VR scenario will elicit stress and moral distress. Additionally, the didactic intervention is anticipated to improve understanding of and decrease feelings of stress and moral distress. Models of digital phenotypes developed and integrated with wearables could allow for the prediction of risk and the assessment of treatment responses in individuals experiencing moral distress in real-time and naturalistic contexts. This paradigm could also be used in other populations prone to moral distress and injury, such as military and public safety personnel. TRIAL REGISTRATION: ClinicalTrials.gov NCT05923398; https://clinicaltrials.gov/study/NCT05923398. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/54180.

Resolving Cross-modal Semantic Interference among Object Concepts Requires Medial Temporal Lobe Cortex.

The ability to flexibly categorize object concepts is essential to semantic cognition because the features that make two objects similar in one context may be irrelevant and even constitute interference in another. Thus, adaptive behavior in complex and dynamic environments requires the resolution of feature-based interference. In the current case study, we placed visual and functional semantic features in opposition across object concepts in two categorization tasks. Successful performance required the resolution of functional interference in a visual categorization task and the resolution of visual interference in a functional categorization task. In Experiment 1, we found that patient D. A., an individual with bilateral temporal lobe lesions, was unable to categorize object concepts in a context-dependent manner. His impairment was characterized by an increased tendency to incorrectly group objects that were similar on the task-irrelevant dimension, revealing an inability to resolve cross-modal semantic interference. In Experiment 2, D. A.'s categorization accuracy was comparable to controls when lures were removed, indicating that his impairment is unique to contexts that involve cross-modal interference. In Experiment 3, he again performed as well as controls when categorizing simple concepts, suggesting that his impairment is specific to categorization of complex object concepts. These results advance our understanding of the anterior temporal lobe as a system that represents object concepts in a manner that enables flexible semantic cognition. Specifically, they reveal a dissociation between semantic representations that contribute to the resolution of cross-modal interference and those that contribute to the resolution of interference within a given modality.

Long-term Effects of a Brief Mindfulness Intervention Versus a Health Enhancement Program for Treating Depression and Anxiety in Patients Undergoing Hemodialysis: A Randomized Controlled Trial.

Background: Depression and anxiety affect approximately 50% of patients with kidney failure receiving hemodialysis and are associated with decreased quality of life and increased risk of hospitalization and mortality. A Brief Mindfulness Intervention (BMI) may be promising in treating depressive and anxiety symptoms in this population, but the long-term sustainability of the intervention's effects is unknown. Objective: We previously conducted a randomized controlled trial (RCT; n = 55) comparing an 8-week BMI with an active control (Health Enhancement Program [HEP]) for patients receiving dialysis, with depression and/or anxiety. Here, we examine the 6-month follow-up data to determine the long-term sustainability of BMI versus HEP in reducing (1) depressive symptoms, (2) anxiety symptoms, and (3) the efficacy of BMI versus HEP in reducing the likelihood of hospitalization. Design: In this study, we analyzed 6-month follow-up data from an 8-week assessor-blinded parallel RCT, which evaluated the efficacy of a BMI against an active control, HEP, in patients receiving hemodialysis with symptoms of depression and/or anxiety. Setting: The study took place at hemodialysis centers in 4 tertiary-care hospitals in Montreal, Canada. Participants: Participants included adults aged ≥18 years who were receiving in-center hemodialysis 3 times per week and had symptoms of depression and/or anxiety as indicated by a score ≥6 on the Patient Health Questionnaire-9 (PHQ-9) and/or the General Anxiety Disorder-7 (GAD-7). Methods: Participants were randomized to the treatment arm (BMI) or the active control arm (HEP) and completed assessments at baseline, 8 weeks, and 6-month follow-up. Depression was assessed using the PHQ-9, and anxiety was assessed by the GAD-7. Hospitalization rates were assessed using medical chart information. Results: We observed significant decrease in depression scores over 6 months in both BMI and HEP groups, with no significant difference between groups. Anxiety scores significantly decreased over 6 months, but only in the BMI group. Brief Mindfulness Intervention and Health Enhancement Program were comparable in terms of hospitalization rates. Limitations: The limitations of our study include the modest sample size and lack of a third arm such as a waitlist control. Conclusions: Our results suggest that the beneficial effects of BMI and HEP for improving mood disorder symptoms in patients receiving dialysis persist at 6-month follow-up. Both interventions showed sustained effects for depressive symptoms, but BMI may be more useful in this population given its efficacy in reducing anxiety symptoms as well. Trial registration: Prior to recruitment, the trial had been registered (ClinicalTrials.gov Identifier: NCT03406845).

Contexte: La dépression et l'anxiété touchent environ 50% des patients atteints d'insuffisance rénale sous hémodialyse et sont associées à une diminution de la qualité de vie et à un risque accru d'hospitalisation et de mortalité. Une brève intervention basée sur la pleine conscience pourrait s'avérer prometteuse pour le traitement des symptômes liés à l'anxiété et à la dépression dans cette population. On ignore toutefois la viabilité à long terme des effets d'une telle intervention. Objectifs: Nous avons précédemment mené un essai contrôlé randomisé (n = 55) comparant une brève intervention de pleine conscience (IPC) de huit semaines à un témoin actif (Programme d'amélioration de la santé [PAmS]) chez les patients sous dialyse présentant des symptômes de dépression et/ou d'anxiété. Nous examinons ici les données après six mois de suivi pour déterminer la viabilité à long terme de l'IPC par rapport au PAmS sur la réduction (1) des symptômes dépressifs, (2) des symptômes d'anxiété, et (3) l'efficacité de l'IPC par rapport au PAmS à réduire la probabilité d'hospitalisation. Type d'étude: Un essai contrôlé randomisé, d'une durée de huit semaines, mené en parallèle et en aveugle pour l'évaluateur, lequel évaluait l'efficacité d'une IPC par rapport au témoin actif (PAmS) chez les patients sous hémodialyse présentant des symptômes de dépression et/ou d'anxiété. Cadre: L'étude a eu lieu dans les centres d'hémodialyse de quatre hôpitaux de soins tertiaires de Montréal (Canada). Participants: Des adultes qui recevaient des traitements d'hémodialyse en centre 3x/semaine et qui présentaient des symptômes de dépression et/ou d'anxiété tels que définis par un score ≥6 au questionnaire sur la santé des patients (PHQ-9) et/ou sur le trouble général d'anxiété-7 (GAD-7). Méthodologie: Les participants ont été répartis aléatoirement dans le groupe de traitement (IPC) ou le groupe témoin actif (PAmS) et ont répondu aux questionnaires au début de l'étude, après huit semaines et après six mois de suivi. La dépression a été évaluée à l'aide du PHQ-9 et l'anxiété par le GAD-7. Les taux d'hospitalisation ont été évalués à l'aide des dossiers médicaux. Résultats: Nous avons observé une diminution significative des scores de dépression sur six mois dans les groupes IPC et PAmS, sans différence significative entre les groupes. Seul le groupe IPC a montré une diminution significative des scores d'anxiété sur six mois. Les taux d'hospitalisation étaient comparables dans les deux groupes. Limites: Taille modeste de l'échantillon et absence d'un troisième bras tel un groupe témoin constitué de patients sur une liste d'attente. Conclusion: Nos résultats suggèrent que les effets bénéfiques de l'IPC et du PAmS sur les symptômes des troubles de l'humeur des patients sous dialyse persistent après six mois de suivi. Les deux interventions ont montré des effets durables sur les symptômes dépressifs, mais l'IPC pourrait s'avérer plus pertinente dans cette population puisqu'elle a également montré une efficacité à réduire les symptômes d'anxiété. Enregistrement de l'essai: L'essai avait été enregistré avant le recrutement (ClinicalTrials.gov Identificateur : NCT03406845).

Obesity and metabolic comorbidity in bipolar disorder: do patients on lithium comprise a subgroup? A naturalistic study.

BACKGROUND: Bipolar disorders (BD) are associated with increased prevalence of obesity and metabolic syndrome (MetS). Nevertheless, there is a wide range in prevalence estimates, with little known about the contributions of pharmacotherapy. It has been suggested that lithium might have a more favorable metabolic profile. We hypothesized that lithium use is associated with less increased body mass index (BMI), MetS, and type II diabetes, when compared with non-lithium users (those on anticonvulsants, second-generation antipsychotics). METHODS: Cross-sectional study of 129 patients aged 18-85 with bipolar disorder, followed at tertiary care clinics in Montreal. Patients using lithium were compared with those not on lithium, for body mass index and metabolic syndrome. RESULTS: The prevalence of obesity and metabolic syndrome in the sample of lithium-using patients with BD was 42.4 and 35.7% respectively, with an average BMI of 29.10 (+/- 6.70). Lithium and non-lithium groups did not differ in BMI or prevalence of MetS. However, compared to the non-lithium group, lithium users had lower hemoglobin A1C (5.24 +/- 0.53 versus 6.01 +/- 1.83, U = 753.5, p = 0.006) and lower triglycerides (1.46 +/- 0.88 versus 2.01 +/- 1.25, U = 947, p = 0.020). CONCLUSIONS: There is a high prevalence of obesity and metabolic syndrome among patients with bipolar disorder. However, this did not appear to be associated with lithium use, when compared to those not on lithium. The lithium subgroup was also associated with lower prevalence of type II diabetes. Future prospective and intervention studies with larger sample sizes are necessary to further explore the association between lithium and insulin resistance, as well as its underlying mechanisms.

Brief Mindfulness Intervention vs. Health Enhancement Program for Patients Undergoing Dialysis: A Randomized Controlled Trial.

BACKGROUND: Between 20-50% of patients undergoing maintenance dialysis for end-stage kidney disease experience symptoms of depression and/or anxiety, associated with increased mortality, greater health care utilization, and decreased quality of life. It is unknown whether mindfulness-based interventions can improve depression and anxiety symptoms in patients receiving this treatment. METHODS: We conducted an 8-week multicenter randomized controlled trial comparing a brief mindfulness intervention (BMI) vs. an active control (Health Enhancement Program [HEP]) in 55 patients receiving dialysis with symptoms of depression and/or anxiety. The primary outcome was change in Patient Health Questionnaire-9 (PHQ-9) depression scores, with a primary analysis in participants with baseline PHQ-9 ≥ 10, and a secondary analysis including all participants. The secondary outcome was change in Generalized Anxiety Disorder-7 (GAD-7) anxiety scores with corresponding primary and secondary analyses. RESULTS: Both BMI and HEP reduced depressive symptoms, with no difference between trial arms (PHQ-9 change = -7.0 vs. -6.1, p = 0.62). BMI was more effective than HEP in reducing anxiety (GAD-7 change = -8.7 vs. -1.4, p = 0.01). Secondary analyses revealed no differences between arms. CONCLUSIONS: For patients undergoing dialysis, both BMI and HEP may be helpful interventions for depression symptoms, and BMI may be superior to HEP for anxiety symptoms. Mindfulness-based and other psychosocial interventions may be further evaluated in those undergoing dialysis as treatment options for symptoms of depression and anxiety.

Connecting During COVID-19: A Protocol of a Volunteer-Based Telehealth Program for Supporting Older Adults' Health.

Introduction: Social-distancing due to COVID-19 has led to social isolation, stress, and mental health issues in older adults, while overwhelming healthcare systems worldwide. Telehealth involving phone calls by trained volunteers is understudied and may be a low-cost, scalable, and valuable preventive tool for mental health. In this context, from patient participatory volunteer initiatives, we have adapted and developed an innovative volunteer-based telehealth intervention program for older adults (TIP-OA). Methods and analysis: To evaluate TIP-OA, we are conducting a mixed-methods longitudinal observational study. Participants: TIP-OA clients are older adults (age ≥ 60) recruited in Montreal, Quebec. Intervention: TIP-OA volunteers make weekly friendly phone calls to seniors to check in, form connections, provide information about COVID-19, and connect clients to community resources as needed. Measurements: Perceived stress, fear surrounding COVID-19, depression, and anxiety will be assessed at baseline, and at 4- and 8-weeks. Semi-structured interviews and focus groups will be conducted to assess the experiences of clients, volunteers, and stakeholders. Results: As of October 15th, 2020, 150 volunteers have been trained to provide TIP-OA to 305 older clients. We will consecutively select 200 clients receiving TIP-OA for quantitative data collection, plus 16 volunteers and 8 clinicians for focus groups, and 15 volunteers, 10 stakeholders, and 25 clients for semi-structured interviews. Discussion: During COVID-19, healthcare professionals' decreased availability and increased needs related to geriatric mental health are expected. If successful and scalable, volunteer-based TIP-OA may help prevent and improve mental health concerns, improve community participation, and decrease healthcare utilization. Clinical Trial Registration: ClinicalTrials.gov NCT04523610; https://clinicaltrials.gov/ct2/show/NCT04523610?term=NCT04523610&draw=2&rank=1.