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Background: Virtual reality (VR) based meditation has been shown to help increase relaxation and decrease anxiety and depression in younger adults. However, this has not been studied in Randomized Controlled Trials (RCT) in the older adult population. The aim of this RCT is to assess the feasibility and acceptability of a VR-guided meditation intervention for community-dwelling older adults and its effect on stress and mental health. Methods: We will recruit 30 participants aged ≥ 60 years, whose perceived stress score (PSS) is > 14 (moderate stress), and randomize them 1:1 to the intervention or control waitlist group. The intervention will involve exposure to eight 15-min VR-guided meditation sessions distributed twice weekly for 4-weeks. Two modalities will be offered: in-home and at the hospital. Data analysis: Baseline and post-intervention assessments will evaluate perceived stress, anxiety, depression, sleep quality, quality of life, and mindfulness skills. Analyses will employ mixed methods repeated ANOVA tests. Qualitative analyses through semi-structured interviews and participant observation will be used to assess participants' experiences. Study outcomes include: (A) feasibility and acceptability compared to a waitlist control (B) stress, using the Perceived Stress Scale (PSS); (C) anxiety, and depression, using the Generalized Anxiety Disorder-7 (GAD-7) and Patient Health Questionnaire-9 (PHQ-9); (D) insomnia, quality of life and mindfulness skills, using the Athens Insomnia Scale (AIS), Quality of Life Questionnaire (EQ-5D-5L) and Five Facets Mindfulness Questionnaire Short Forms (FFMQ-SF), respectively. We will also measure immersive tendencies, sickness and sense of presence using the Simulator Sickness Questionnaire (SSQ) and the Presence Questionnaire (PQ). Discussion: Virtual reality-guided meditation could be an acceptable, feasible, safe, and cost-effective novel alternative health intervention for improving older adults' mental health.Clinical trial registration: NCT05315609 at https://clinicaltrials.gov.
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Consciousness is constituted by a structure that includes contents as foreground and the environment as background. This structural relation between the experiential foreground and background presupposes a relationship between the brain and the environment, often neglected in theories of consciousness. The temporo-spatial theory of consciousness addresses the brain-environment relation by a concept labelled 'temporo-spatial alignment'. Briefly, temporo-spatial alignment refers to the brain's neuronal activity's interaction with and adaption to interoceptive bodily and exteroceptive environmental stimuli, including their symmetry as key for consciousness. Combining theory and empirical data, this article attempts to demonstrate the yet unclear neuro-phenomenal mechanisms of temporo-spatial alignment. First, we suggest three neuronal layers of the brain's temporo-spatial alignment to the environment. These neuronal layers span across a continuum from longer to shorter timescales. (i) The background layer comprises longer and more powerful timescales mediating topographic-dynamic similarities between different subjects' brains. (ii) The intermediate layer includes a mixture of medium-scaled timescales allowing for stochastic matching between environmental inputs and neuronal activity through the brain's intrinsic neuronal timescales and temporal receptive windows. (iii) The foreground layer comprises shorter and less powerful timescales for neuronal entrainment of stimuli temporal onset through neuronal phase shifting and resetting. Second, we elaborate on how the three neuronal layers of temporo-spatial alignment correspond to their respective phenomenal layers of consciousness. (i) The inter-subjectively shared contextual background of consciousness. (ii) An intermediate layer that mediates the relationship between different contents of consciousness. (iii) A foreground layer that includes specific fast-changing contents of consciousness. Overall, temporo-spatial alignment may provide a mechanism whose different neuronal layers modulate corresponding phenomenal layers of consciousness. Temporo-spatial alignment can provide a bridging principle for linking physical-energetic (free energy), dynamic (symmetry), neuronal (three layers of distinct time-space scales) and phenomenal (form featured by background-intermediate-foreground) mechanisms of consciousness.
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Background: A pressing challenge during the COVID-19 pandemic and beyond is to provide accessible and scalable mental health support to isolated older adults in the community. The Telehealth Intervention Program for Older Adults (TIP-OA) is a large-scale, volunteer-based, friendly telephone support program designed to address this unmet need. Methods: A prospective cohort study of 112 TIP-OA participants aged ≥60 years old was conducted in Quebec, Canada (October 2020-June 2021). The intervention consisted of weekly friendly phone calls from trained volunteers. The primary outcome measures included changes in scores of stress, depression, anxiety, and fear surrounding COVID-19, assessed at baseline, 4 and 8-weeks. Additional subgroup analyses were performed with participants with higher baseline scores. Results: The subgroup of participants with higher baseline depression scores (PHQ9 ≥10) had significant improvements in depression scores over the 8-week period measured [mean change score = -2.27 (±4.76), 95%CI (-3.719, -0.827), p = 0.003]. Similarly, participants with higher baseline anxiety scores (GAD7 ≥10) had an improvement over the same period, which, approached significance (p = 0.06). Moreover, despite peaks in the pandemic and related stressors, our study found no significant (p ≥ 0.09) increase in stress, depression, anxiety or fear of COVID-19 scores. Discussion: This scalable, volunteer-based, friendly telephone intervention program was associated with decreased scores of depression and anxiety in older adults who reported higher scores at baseline (PHQ 9 ≥10 and GAD7 ≥10).
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Background: Late-life depression (LLD) affects up to 18% of older adults and has been linked to elevated dementia risk. Mindfulness-based cognitive therapy (MBCT) holds promise for treating symptoms of depression and ameliorating cognitive deficits in older adults. While preliminary findings are promising, a definitive RCT investigating its effects on late life depression and cognition have not yet been conducted. We present a protocol describing a multi-site blinded randomized controlled trial, comparing the effects of MBCT and of an active control, a Health Enhancement Program (HEP), on depressive symptoms, executive functioning, and brain biomarkers of LLD, among several other exploratory outcomes. Methods: Two-hundred and thirteen (n = 213) patients with LLD will be recruited at various centers in Montreal, QC, Canada. Participants will undergo stratified randomization to either MBCT or HEP intervention groups. We will assess changes in (1) depression severity using the Hamilton Depression Rating Scale (HAM-D17), (2) processing speed and executive functioning, (3) brain biomarkers of LLD (hippocampal volume, default network resting-state functional connectivity and executive network resting-state functional connectivity), and (4) other exploratory physiological and mood-based measures, at baseline (0 weeks), post intervention (8 weeks), and 26 weeks after baseline. Discussion: The proposed study will assess the clinical potential of MBCT to improve symptoms of depression, as well as examine its impact on cognitive impairments and neurobiological markers, and thus inform its use as a promising adjunct in the treatment of LLD. Clinical trial registration: www.ClinicalTrials.gov, identifier: NCT05366088.
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BACKGROUND: Levothyroxine replacement therapy may decrease the risk of adverse pregnancy outcomes among women with subclinical hypothyroidism (SCH). The aim of this study is to conduct a systematic review and meta-analysis to examine the risk of adverse pregnancy, perinatal, and early childhood outcomes among women with SCH treated with levothyroxine. METHODS: A systematic literature search was conducted using Ovid-Medline, Ovid-EMBASE, Pubmed (non-Medline), Ebsco-CINAHL Plus with full text and Cochrane Library databases. Randomized controlled studies (RCTs) and observational studies examining the association between treatment of SCH during pregnancy and our outcomes of interest were included. Studies that compared levothyroxine treatment versus no treatment were eligible for inclusion. Data from included studies were extracted and quality assessment was performed by two independent reviewers. RESULTS: Seven RCTs and six observational studies met our inclusion criteria. A total of 7342 individuals were included in these studies. RCTs demonstrated several sources of bias, with lack of blinding of the participants or research personnel; only one study was fully blinded. In the observational studies, there was moderate to serious risk of bias due to lack of adjustment for certain confounding variables, participant selection, and selective reporting of results. Pooled analyses showed decreased risk of pregnancy loss (RR: 0.79; 95% CI: 0.67 to 0.93) and neonatal death (RR: 0.35; 95% CI: 0.17 to 0.72) associated with levothyroxine treatment during pregnancy among women with SCH. There were no associations between levothyroxine treatment and outcomes during labour and delivery, or cognitive status in children at 3 or 5 years of age. CONCLUSION: Treatment of SCH with levothyroxine during pregnancy is associated with decreased risks of pregnancy loss and neonatal death. Given the paucity of available data and heterogeneity of included studies, additional studies are needed to address the benefits of levothyroxine use among pregnant women with SCH.