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Abstract Background Various service provision models for youth at risk of homelessness have been researched and implemented, including access to housing and physical and mental health resources. However, even with these interventions, we remain unaware of how best to manage symptoms of depression and anxiety and the rate of drug use in these populations primarily because of a lack of feasibility data. Methods This paper presents the results of a mixed-methods study in London, Canada, that examined the feasibility of implementing a biopsychosocial intervention, SKY Schools, in at-risk youth aged between 16 and 25 (n = 49). The study also recorded qualitative responses about the program’s usefulness from the perspective of the service users. The SKY Schools intervention consisted of social-emotional learning combined with Sudarshan Kriya Yoga, a standardized yoga-based breathing exercise routine. The intervention program was divided into two phases: an active learning phase and a reinforcement phase. The following feasibility outcome measures were collected: (1) the number of potential participants approached per month, (2) number (proportion) who were successfully screened, (3) the proportion of screened participants who enrolled, (4) the rate of retention in the study, (5) rate of adherence to study protocol, (6) proportion of planned ratings that were completed, (7) intervention cost per case, (8) completeness of final data for analysis, (9) length of time to collect all data, (10) quality of all collected data, (11) determining if partnering community organizations were willing to conduct the study as per study protocol, (12) determining if there were any capacity issues with partners providing intervention and investigators being able to perform the tasks that they were committed to doing, (13) determining if there were any problems of entering the data into a computer, (14) preliminary data about the safety of the intervention, and (15) preliminary estimate of treatment effects. Results All feasibility outcome measures were collectible. In the city of London, Canada it was feasible to conduct a pilot study in this population of youth at risk of homelessness. Foremost among the findings was a high retention rate (61.2%) and overall positive qualitative feedback with a number of potential suggestions to improve the delivery and quality of the intervention. However, we had a significantly low recruitment rate (0.27 participants per week) suggesting that multiple sites will be needed to achieve an adequate sample size for a subsequent definitive trial. Conclusions Future researchers may consider the findings of this feasibility study when designing a randomized control trial to further assess the efficacy and tolerability of SKY Schools. Trial registration Trial registration: Clinicaltrials.gov, identifier NCT02749240. Registered April 22, 2016, https://clinicaltrials.gov/ct2/show/NCT02749240 .

Abstract Background Despite the high prevalence of comorbid chronic pain and depression, this comorbidity remains understudied. Meditation has demonstrated efficacy for both chronic pain and depression independently, yet there have been few studies examining its effectiveness when both conditions are present concurrently. Furthermore, while meditation is generally accepted as a safe and effective health intervention, little is known about how to implement meditation programs within or alongside the health care system. Methods We will conduct a hybrid type 1 effectiveness–implementation evaluation. To measure effectiveness, we will conduct a randomized controlled trial comparing Sahaj Samadhi Meditation and the Health Enhancement Program in 160 people living with chronic pain, clinically significant depressive symptoms, and on long-term opioid therapy. Changes in depressive symptoms will be our primary outcome; pain severity, pain-related function, opioid use, and quality of life will be the secondary outcomes. The primary end point will be at 12 weeks with a secondary end point at 24 weeks to measure the sustainability of acute effects. Patients will be recruited from a community-based chronic pain clinic in a large urban center in Mississauga, Canada. The meditation program will be delivered in the clinical environment where patients normally receive their chronic pain care by certified meditation teachers who are not regulated health care providers. We will use a mixed-methods design using the multi-level framework to understand the implementation of this particular co-location model. Discussion Results of this hybrid evaluation will add important knowledge about the effectiveness of meditation for managing depressive symptoms in people with chronic pain. The implementation evaluation will inform both effectiveness outcomes and future program development, scalability, and sustainability. Trial registration ClinicalTrials.gov: NCT04039568 . Registered on 31 July 2019.

Abstract Objectives Objective 1: To determine if it is feasible to conduct an RCT of online Sudarshan Kriya Yoga (SKY) for frontline hospital and long-term care home staff under the constraints imposed by the COVID-19 pandemic and need for remote trial monitoring. Objective 2: To assess whether online versions of SKY and/or Health Enhancement Program (HEP) result in improvement in self-rated measures of insomnia, anxiety, depression, and resilience. Trial design This is an open-label feasibility randomized controlled trial (RCT), comparing an online breath based yogic intervention SKY versus an online control mind-body intervention HEP in frontline hospital and long-term care home staff managing the COVID-19 pandemic. Participants Participants will include frontline hospital and long-term care home staff that are involved in the management of COVID-19 patients in London, Ontario, Canada. Participants will be willing and able to attend via online video conferencing software to participate in the study interventions. Participants must have an adequate understanding of English and be able to sit without physical discomfort for 60 minutes. Intervention and comparator Sudarshan Kriya Yoga (SKY): The online version of SKY will be delivered by at least one certified Canadian SKY teacher, with at least one back up teacher at all times, under the supervision of Ms. Ronnie Newman, Director of Research and Health Promotion, Art of Living Foundation, USA. The online version of SKY for healthcare workers has a total duration of 3 hours. Phase I will consist of 5 self-paced online modules of 4-10 minutes each to learn the breath control techniques. Participants will be sent an online survey in REDCap requesting that they self-confirm completion of the Phase I modules. In Phase II, 2 interactive online sessions of 1 hour each will be held on consecutive days with a certified SKY teacher, during which participants will learn the fast, medium and slow breaths. For ease of scheduling, multiple time windows will be offered for Phase II. There will be at least one back up teacher at all times. Both Phase I and II will be completed in the first week. Health Enhancement Program (HEP): The active control arm, HEP, will consist of time-matched online self-paced modules for Phase I. Phase II will consist of mindfulness-based meditation sessions delivered by mental health staff. HEP will be an active treatment program that incorporates mind-body interventions. HEP will consist of time-matched online self-paced modules with psychoeducation on healthy active living as well as interactive modules comprising of guided de-stressing exercises including music therapy, mindfulness and progressive muscle relaxation. Weekly follow up sessions will be offered to all recruited participants for 30 minutes each for the subsequent 4 weeks in both study arms. Main outcomes The following feasibility outcomes will be measured at the end of the study: (1) rate of participant recruitment, (2) rate of retention, (3) completeness of data entry, (4) cost of interventions, and (5) unexpected costs. Such measures will be collected on a daily basis through-out the study and tabulated 5 weeks later at the end of the study. Randomisation Participants will be randomized after they have electronically signed the consent form and the research staff have confirmed eligibility. We will use REDCap to perform randomization in a 1:1 ratio as well as allocation concealment. REDCap is widely used by health researchers worldwide to significantly reduce data entry and study management errors to improve data fidelity. Blinding (masking) All study participants will be blinded to the study hypotheses so as to prevent any expectation bias. Group allocation will be masked during analysis. Numbers to be randomised (sample size) This study will randomize a total of 60 participants in a 1:1 ratio to either SKY or HEP interventions. Trial Status Protocol version number 2.0 (June 5, 2020). Recruitment is currently ongoing (starting June 25, 2020). We anticipate to complete recruitment by June 30, 2021 and complete the study by September 30, 2021. Trial registration ClinicalTrials.gov protocol ID NCT04368676 (posted April 30, 2020). Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

Abstract Background Recent estimates suggest an 11% prevalence of current late-life depression (LLD) and a lifetime prevalence of 16–20%. LLD leads to cognitive disturbance as well as a nearly two to three times increased risk of dementia. We conducted a recent randomized controlled trial (RCT) which demonstrated that Sahaj Samadhi meditation (SSM), an easy-to-implement, meditation-based augmentation strategy, led to higher rates of symptom remission when compared to treatment as usual (40.0 vs 16.3%; odds ratio, 3.36; 95% CI 1.06–10.64; p = 0.040). Here we present a protocol describing a two-site, blinded, RCT, comparing an SSM arm to an active-control arm – a Health Enhancement Program (HEP) intervention – in their ability to reduce depressive symptoms and improve executive functioning, among several other exploratory outcomes. Methods/design One hundred and ninety-two (n = 192) participants with LLD will be recruited at two sites (London, ON, Canada, and Montreal, QC, Canada). Participants will undergo stratified randomization with regards to site and the presence of treatment-resistant-LLD (TR-LLD) or not, to either SSM or HEP. We will assess change in (1) depression severity using the Hamilton Depression Rating Scale (HAM-D), (2) executive functioning, and (3) other exploratory physiological and mood-based measures, at baseline (0 weeks), post intervention (12 weeks), and 26 weeks after baseline. Raters, clinicians, and care providers will be blinded to group allocation while participants will be blinded to the study hypotheses. Discussion This study should more definitively assess whether SSM can be used as an augmentation strategy in routine clinical care for patients suffering from LLD and TR-LLD. If the effects of SSM are significantly better than HEP, it will offer support for the routine use of this intervention to manage LLD/TR-LLD and comorbid declines in executive dysfunction. The results of this study could also inform whether SSM can improve/prevent cognitive decline in LLD. Trial registration ClinicalTrials.gov, ID: NCT03564041. Registered on 20 June 2018.

Abstract Background Physical exercise, cognitive training, and vitamin D are low cost interventions that have the potential to enhance cognitive function and mobility in older adults, especially in pre-dementia states such as Mild Cognitive Impairment (MCI). Aerobic and progressive resistance exercises have benefits to cognitive performance, though evidence is somewhat inconsistent. We postulate that combined aerobic exercise (AE) and progressive resistance training (RT) (combined exercise) will have a better effect on cognition than a balance and toning control (BAT) intervention in older adults with MCI. We also expect that adding cognitive training and vitamin D supplementation to the combined exercise, as a multimodal intervention, will have synergistic efficacy. Methods The SYNERGIC trial (SYNchronizing Exercises, Remedies in GaIt and Cognition) is a multi-site, double-blinded, five-arm, controlled trial that assesses the potential synergic effect of combined AE and RT on cognition and mobility, with and without cognitive training and vitamin D supplementation in older adults with MCI. Two-hundred participants with MCI aged 60 to 85 years old will be randomized to one of five arms, four of which include combined exercise plus combinations of dual-task cognitive training (real vs. sham) and vitamin D supplementation (3 × 10,000 IU/wk. vs. placebo) in a quasi-factorial design, and one arm which receives all control interventions. The primary outcome measure is the ADAS-Cog (13 and plus modalities) measured at baseline and at 6 months of follow-up. Secondary outcomes include neuroimaging, neuro-cognitive performance, gait and mobility performance, and serum biomarkers of inflammation (C reactive protein and interleukin 6), neuroplasticity (brain-derived neurotropic factor), endothelial markers (vascular endothelial growth factor 1), and vitamin D serum levels. Discussion The SYNERGIC Trial will establish the efficacy and feasibility of a multimodal intervention to improve cognitive performance and mobility outcomes in MCI. These interventions may contribute to new approaches to stabilize and reverse cognitive-mobility decline in older individuals with MCI. Trial Registration Identifier: NCT02808676. https://www.clinicaltrials.gov/ct2/show/NCT02808676.