A feasibility (pilot) mixed methods study of an innovative non-pharmacological breath-based yoga and social-emotional intervention program in an at-risk youth sample in London, Canada.

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 .

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.

Sudarshan Kriya Yoga Program in Posttraumatic Stress Disorder: A Feasibility Study.

BACKGROUND: Sudarshan Kriya Yoga (SKY), a breath-based yoga intervention, has demonstrated safety and efficacy in posttraumatic stress disorder (PTSD) patients subsequent to natural disaster or war, but has not been explored in civilians with PTSD from a wider range of trauma. We hypothesized that it would be feasible to conduct a clinical trial of SKY in PTSD resulting from a wide range of trauma. METHODS: Outcomes were feasibility measures including rates of enrollment and retention, adherence to study protocol; as well as changes in PTSD symptoms, other mood symptoms, and physiological measures. Male and female participants aged 18-75 years were enrolled in a feasibility trial. They attended a 6-day learning phase of SKY followed by 7 sessions over 11 weeks as an adjunct to their usual treatment. RESULTS: Forty-seven participants were screened and 32 were enrolled over 9 months. Consistent with retention rates of other PTSD trials, 13 withdrew from the study prior to week 12. Twenty-one participants met intervention attendance requirements, completed 95% of planned study assessments and were included in final analyses. Participants experienced clinically significant decrease in PTSD symptoms on the posttraumatic stress disorder checklist (PCL-5) scores at week 12 mean difference, Mdiff (standard deviation [SD]) = -10.68 (14.03), P = 0.004; Cohen's d = 0.58, which was sustained at week 24 Mdiff (SD) = -16.11 (15.20), P < 0.001; Cohen's d = 0.91. CONCLUSIONS: It is possible to conduct a clinical trial of SKY in a routine psychiatry clinic serving patients with PTSD due to a wide range of trauma. Future studies should include an RCT design.

Breath Regulation and yogic Exercise An online Therapy for calm and Happiness (BREATH) for frontline hospital and long-term care home staff managing the COVID-19 pandemic: A structured summary of a study protocol for a feasibility study for a randomised controlled trial.

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.

Sahaj Samadhi Meditation versus a Health Enhancement Program for depression in chronic pain: protocol for a randomized controlled trial and implementation evaluation.

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.

Sahaj Samadhi meditation vs a Health Enhancement Program in improving late-life depression severity and executive function: study protocol for a two-site, randomized controlled trial.

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.

Effects of Sahaj Samadhi meditation on heart rate variability and depressive symptoms in patients with late-life depression.

BACKGROUND: Late-life depression (LLD) is a disabling disorder and antidepressants are ineffective in as many as 60% of cases. Converging evidence shows a strong correlation between LLD and subsequent risk of cardiovascular disease. There is a need for new, well-tolerated, non-pharmacological augmentation interventions that can treat depressive symptoms as well as improve heart rate variability (HRV), an important prognostic marker for development of subsequent cardiovascular disease. Meditation-based techniques are of interest based on positive findings in other samples.AimsWe aimed to assess the efficacy of Sahaj Samadhi meditation (SSM), an underevaluated, standardised and manualised meditation intervention, on HRV and depressive symptoms. METHOD: Eighty-three men and women aged 60-85 years, with mild to moderate depression and receiving treatment as usual (TAU) were randomised to either the SSM or TAU arm. Those allocated to SSM attended 4 consecutive days of group meditation training, using personalised mantras followed by 11 weekly reinforcement sessions. HRV and Hamilton Rating Scale for Depression (HRSD; 17-item) score were measured at baseline and 12 weeks. RESULTS: All time and frequency domain measures of HRV did not significantly change in either arm. However, there was significant improvement in the SSM arm, compared with TAU, on the HRSD (difference in mean, 2.66; 95% CI 0.26-5.05; P = 0.03). CONCLUSIONS: Compared with TAU, SSM is associated with improvements in depressive symptoms but does not significantly improve HRV in patients with LLD. These results need to be replicated in subsequent studies incorporating a group-based, active control arm.Declaration of interestR.I.N. is the Director of Research and Health Promotion for the Art of Living Foundation, Canada and supervised the staff providing Sahaj Samadhi meditation. S.R. has received research funding from Satellite Healthcare for a mindfulness meditation trial in patients on haemodialysis. The remaining authors report no financial or other relationship relevant to the subject of this article.

Mind-Body Interventions in Late-Life Mental Illnesses and Cognitive Disorders: A Narrative Review.

BACKGROUND: Current pharmacological treatments and psychotherapeutic approaches often have adverse effects or are ineffective in late-life cognitive and mental illnesses. Mind-body interventions offer a holistic approach and are of interest because of potential patient acceptability and scalability. OBJECTIVE: To synthesize current evidence on mind-body interventions in treating or preventing mental illnesses and cognitive disorders in older adults. SEARCH STRATEGY: A search was conducted using Ovid MEDLINE, EMBASE, and PsycINFO articles published from 1993 to 2017. SELECTION CRITERIA: 1) Randomized controlled trials, 2) involving older adults (>60 years old), 3) suffering from mental illness or cognitive decline, 4) comparing mind-body interventions with a control group. Mind-body interventions included: imagery, meditation, prayer, autogenic training, tai chi & variants, and yoga. Control group included: health education, other non-pharmacological interventions, treatment as usual, or no treatment at all. DATA COLLECTION AND ANALYSIS: Data included number of patients, age, psychiatric diagnoses, type of intervention, frequency andduration, control conditions, outcomes measures and treatment results. RESULTS: 3916 articles were reviewed and ten met inclusion criteria. Six were on Tai Chi and four assessed meditation-based therapies. Clinically significant improvement in depressive and anxiety symptoms were reported, as well as improvement insomedomains of cognition and reduced risk of cognitive deterioration. CONCLUSION: There is increasing evidence that mind-body interventions may potentially be useful in the treatment or prevention of geriatric mental illnesses and cognitive disorders. There are important methodological limitations of the current literature such as small sample sizes, heterogeneous study populations, and varying clinical outcomes.

SYNERGIC TRIAL (SYNchronizing Exercises, Remedies in Gait and Cognition) a multi-Centre randomized controlled double blind trial to improve gait and cognition in mild cognitive impairment.

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 .

A training programme involving automatic self-transcending meditation in late-life depression: preliminary analysis of an ongoing randomised controlled trial.

Late-life depression affects 2-6% of seniors aged 60 years and above. Patients are increasingly embracing non-pharmacological therapies, many of which have not been scientifically evaluated. This study aimed to evaluate a category of meditation, automatic self-transcending meditation (ASTM), in alleviating symptoms of depression when augmenting treatment as usual (NCT02149810). The preliminary results of an ongoing single-blind randomised controlled trial comparing a training programme involving ASTM with a wait-list control indicate that a 12-week ASTM programme may lead to significantly greater reductions in depression and anxiety severity. As such, ASTM may be an effective adjunctive therapy in the treatment of late-life depression. DECLARATION OF INTEREST: R.I.N. is Director of Research and Health Promotion for the Art of Living Foundation, Canada and supervised the staff providing ASTM training. COPYRIGHT AND USAGE: © The Royal College of Psychiatrists 2016. This is an open access article distributed under the terms of the Creative Commons Non-Commercial, No Derivatives (CC BY-NC-ND) licence.

Music therapy in patients with dementia and behavioral disturbance on an inpatient psychiatry unit: results from a pilot randomized controlled study.

The prevalence of dementia continues to grow worldwide due to an aging population and is projected to affect 65.7 million people by 2030 (World Health Organization, 2012). Behavioral and psychological symptoms of dementia (BPSD), including agitation, anxiety, aggression, depression, and psychosis, can occur in as much as 80% of the affected population, frequently necessitating psychiatric admission. Traditionally BPSD have been treated using pharmacological approaches. However, such medications could have serious adverse effects and additionally have limited efficacy in reducing such symptoms (Ballard et al., 2009).

A randomized controlled longitudinal naturalistic trial testing the effects of automatic self transcending meditation on heart rate variability in late life depression: study protocol.

BACKGROUND: The prevalence and socioeconomic cost of late life depression (LLD) is on the rise, while the response rate to antidepressant trials remains poor. Various mind-body therapies are being embraced by patients as they are considered safe and potentially effective, yet little is known regarding the effectiveness of such therapies to improve LLD symptoms. Among the mind-body therapies currently in practice, the results of our pilot study have shown that a particular meditation technique called Sahaj Samadhi Meditation, which belongs to the category of meditation termed automatic self-transcending meditation (ASTM) may have some promise in improving cardiovascular autonomic disturbances associated with LLD as well as ameliorating symptoms of depression and anxiety. METHODS/DESIGN: Patients between the ages of 60 and 85 with LLD will be randomized either to ASTM plus treatment as usual (TAU) or TAU alone to assess changes in cardiovascular autonomic parameters, neuropsychological symptoms of depression and anxiety as well as quality of life. The instructional phase of the intervention consists of 4 consecutive days of meditation training, after which participants are encouraged to meditate twice daily for twenty minutes each time at home. The intervention also includes once weekly follow up sessions for the subsequent 11 weeks. The planned study has one and a half year recruitment period. Participants will be assessed at baseline and at 4, 8, 12 and 24 weeks post intervention. DISCUSSION: This study should provide a unique data source from a randomized, controlled, longitudinal trial to investigate the effects of a form of ASTM on cardiovascular autonomic and neuropsychological health in LLD. TRIAL REGISTRATION: Clinicaltrials.gov NCT02149810, date registered: 05/28/2014.