Effects of a Video Sequence Based Intervention on Anxiety, Fatigue and Depression in Cancer Patients: Results of a Randomized Controlled Trial.

BACKGROUND: Cancer patients often suffer from psychological symptoms and need psychological support. Especially during the COVID-19 pandemic, eHealth interventions might be helpful to overcome the obstacles of the pandemic. This study evaluates the effectiveness of a video sequence-based eHealth intervention on anxiety, fatigue, and depression in cancer patients. METHODS: Patients (N = 157) with different tumor entities were randomly assigned to the video intervention group (IG) and the waiting control group (CG). Patients in the IG received a video intervention comprising 8 video sequences over 4 weeks. The videos included psychoeducation on distress and psychological symptoms, Acceptance and Commitment Therapy elements, and Yoga and Qigong exercises. Patients' anxiety and fear of progression (primary outcomes) and secondary outcomes were assessed before randomization (T1) and after the end of the intervention for IG or the waiting period for CG (T2) using self-reported questionnaires (GAD-7, PA-F-KF, EORTC QLQ-FA12, PHQ-8). RESULTS: Patients of the IG showed no significant improvement in anxiety (GAD-7; P = .75), fear of progression (FoP-Q-SF; P = .29), fatigue (EORTC QLQ-FA12; P = .72), and depression (PHQ-8; P = .95) compared to patients in the waiting CG. However, symptoms of anxiety, fatigue, and depression decreased in both groups. Exploratory subgroup analysis regarding sex, therapy status, therapy goal, and tumor entity showed no effects. Overall, the intervention had a high level of acceptance. CONCLUSIONS: The video intervention was ineffective in reducing the psychological burden compared to a waiting CG. The findings support prior observations of the value of therapeutic guidance and promoting self-management for improving patients' psychological burdens. Further studies are required to evaluate the effectiveness of psycho-oncological eHealth delivered through video sequences.

Dismantling the Component-Specific Effects of Yogic Breathing: Feasibility of a Fully Remote Three-Arm RCT with Virtual Laboratory Visits and Wearable Physiology.

Despite the growing research base examining the benefits and physiological mechanisms of slow-paced breathing (SPB), mindfulness (M), and their combination (as yogic breathing, SPB + M), no studies have directly compared these in a "dismantling" framework. To address this gap, we conducted a fully remote three-armed feasibility study with wearable devices and video-based laboratory visits. Eighteen healthy participants (age 18-30 years, 12 female) were randomized to one of three 8-week interventions: slow-paced breathing (SPB, N = 5), mindfulness (M, N = 6), or yogic breathing (SPB + M, N = 7). The participants began a 24-h heart rate recording with a chest-worn device prior to the first virtual laboratory visit, consisting of a 60-min intervention-specific training with guided practice and experimental stress induction using a Stroop test. The participants were then instructed to repeat their assigned intervention practice daily with a guided audio, while concurrently recording their heart rate data and completing a detailed practice log. The feasibility was determined using the rates of overall study completion (100%), daily practice adherence (73%), and the rate of fully analyzable data from virtual laboratory visits (92%). These results demonstrate feasibility for conducting larger trial studies with a similar fully remote framework, enhancing the ecological validity and sample size that could be possible with such research designs.

Utilization of Mind-Body Intervention for Integrative Health Care of COVID-19 Patients and Survivors.

Recent findings suggest a correlation between COVID-19 and diabetes, although the underlying causes are still little understood. COVID-19 infection tends to induce severe symptoms in patients with underlying diabetes, increasing their mortality rate. Moreover, COVID-19 itself appears to be a diabetogenic factor. In addition, mental health conditions, such as depression due to lockdown and anxiety about infection, were found to affect glycemic control and immunity, highlighting the importance of mental health care during the pandemic. Mind-Body Intervention (MBI), which includes meditation, yoga, and qigong, has emerged as a tool for mental health management due to its effects on stress reduction and the promotion of mental and physical well-being. Here, we review the latest randomized controlled trials to determine the effects of MBI on glycemic control and the immune system and discuss the underlying mechanisms by which MBI facilitates the virtuous cycle of stress management, glycemic control, and immune modulation. Furthermore, we examine the actual utilization of MBI during the COVID-19 pandemic era through recent studies. With proper online education, non-pharmacological MBI may be more widely used as an important tool for self-health care that complements the usual treatment of COVID-19 patients and survivors.

Using Mind-Body Modalities via Telemedicine during the COVID-19 Crisis: Cases in the Republic of Korea.

The coronavirus disease 2019 (COVID-19) pandemic affected the world, and its deleterious effects on human domestic life, society, economics, and especially on human mental health are expected to continue. Mental health experts highlighted health issues this pandemic may cause, such as depression, anxiety, obsessive compulsive disorder, and post-traumatic stress disorder. Mind-body intervention, such as mindfulness meditation, has accumulated sufficient empirical evidence supporting the efficacy in improving human mental health states and the use for this purpose has been increasing. Notably, some of these interventions have already been tried in the form of telemedicine or eHealth. Korea, located adjacent to China, was exposed to COVID-19 from a relatively early stage, and today it is evaluated to have been successful in controlling this disease. "The COVID-19 telemedicine center of Korean medicine" has treated more than 20% of the confirmed COVID-19 patients in Korea with telemedicine since 9 March 2020. The center used telemedicine and mind-body modalities (including mindfulness meditation) to improve the mental health of patients diagnosed with COVID-19. In this paper, the telemedicine manual is introduced to provide insights into the development of mental health interventions for COVID-19 and other large-scale disasters in the upcoming new-normal era.

Effect of online counselling on emotional outcomes during the COVID-19 pandemic: An innovative group intervention for university students using the Brain Wave Modulation Technique.

Young people's mental health problems are a matter of concern during the COVID-19 pandemic. Counselling services for university students by means of telemental support can help them to deal with psychological issues that they may be facing due to the pandemic. The present study investigated the effects of four once-weekly online counselling sessions based on a mind-body technique (the Brain Wave Modulation Technique; BWM-T) on enhancing positive affect and on reducing negative affect and anxiety in a sample of 54 university students (96.3% females; M age = 21.31 years, SD = 2.09). An experimental design was conducted: the participants were randomly assigned to the intervention group, which received 15 min of a guided online BWM-T session, or to the control group, which watched a 15-min video on how to sustain their psychological well-being. The results of a two-factor mixed-design analysis of variance (ANOVA) showed that the participants in the intervention group reported a significant increase in positive affect and a decrease in negative affect over time compared to those in the control group. They also reported a slight decrease in state anxiety compared to the control group, although this was just short of statistical significance. The information provided by this study, regarding emotional outcomes among university students after four brief online counselling sessions, suggests that such interventions could be an effective and sustainable way to reinforce young people's mental health during the COVID-19 pandemic, as well as later in their university careers and adult lives.

Resilience-based Integrated IBD Care Is Associated With Reductions in Health Care Use and Opioids.

BACKGROUND & AIMS: Integrated inflammatory bowel disease (IBD) care is effective but not routinely implemented. Validated methods that simultaneously address mind and body targets such as resilience may improve access and outcomes. We describe the development and implementation of the GRITT method and its impact on resilience, health care utilization (HCU), and opioid use in IBD. METHODS: Consecutive patients from an academic IBD center were evaluated for low resilience on the basis of provider referral. Low resilience patients were invited to participate in the GRITT program. Primary outcome was % reduction in HCU. Secondary outcomes were change in resilience and corticosteroid and opioid use. Patients were allocated into 2 groups for analysis: GRITT participants (GP) and non-participants (NP). Clinical data and HCU in the year before enrollment were collected at baseline and 12 months. One-way repeated measures multivariate analysis of covariance evaluated group × time interactions for the primary outcome. Effect size was calculated for changes in resilience over time. RESULTS: Of 456 screened IBD patients 394 were eligible, 184 GP and 210 NP. GP had greater reduction in HCU than NP: 71% reduction in emergency department visits, 94% reduction in unplanned hospitalizations. There was 49% reduction in opioid use and 73% reduction in corticosteroid use in GP. Resilience increased by 27.3 points (59%), yielding a large effect size (d = 2.4). CONCLUSIONS: Mind-body care that focuses on building resilience in the context of IBD care may be a novel approach to reduce unplanned HCU and opioid use, but large, multicenter, randomized controlled trials are needed.

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.