Feasibility of using a biofeedback device in mindfulness training - a pilot randomized controlled trial

Abstract Background Stress can negatively impact an individual’s health and well-being and high levels of stress are noted to exist among college students today. While traditional treatment methods are plagued with stigma and transfer problems, newly developed wearable biofeedback devices may offer unexplored possibilities. Although these products are becoming commonplace and inexpensive, scientific evidence of the effectiveness of these products is scarce and their feasibility within research contexts are relatively unexplored. Conversely, companies are not required, and possibly reluctant, to release information on the efficacy of these products against their claims. Thus, in the present pilot, we assess the feasibility of using a real-time respiratory-based biofeedback device in preparation for a larger study. Our main aims were to assess device-adherence and collaboration with the company that develops and sells the device. Method Data were collected from 39 college students who self-identified as experiencing chronic stress at a Southwestern university in the USA. Students were randomized into either a mindfulness-only control group without a biofeedback device (n = 21), or an experimental group with biofeedback device (n = 18). Both groups received mindfulness meditation training. Pre-test and post-test procedures were conducted 2 weeks apart. Further, both participant compliance and company compliance were assessed and collaboration with the company was evaluated. Results Participant device-adherence as well as the company’s collaboration necessary for a full-scale study was determined to be low. This may also have affected our results which showed a strong main effect for time for all outcome variables, suggesting all groups showed improvement in their levels of stress after the intervention period. No group by time effects were identified, however, indicating no added benefit of the biofeedback device. Conclusions Our findings suggest feasibility of future studies requires full collaboration and detailed and agreed upon data sharing procedures with the biofeedback company. The particular device under investigation added no value to the intervention outcomes and it was not feasible to continue a larger-scale study. Further, as the technology sector is innovating faster than it can validate products, we urge for open science collaborations between public and private sectors to properly develop evidence-based regulations that can withstand technological innovation while maintaining product quality, safety, and effectiveness. Trial registration NCT02837016. Registered 19 July 2016.

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Does Using Social Network Sites Reduce Depression and Promote Happiness?

International Journal of Technology and Human Interaction ◽

10.4018/ijthi.2020070104 ◽

2020 ◽

Vol 16 (3) ◽

pp. 56-69 ◽

Cited By ~ 1

Author(s):

Sen-Chi Yu

Keyword(s):

College Students ◽

Social Networking ◽

Social Networking Sites ◽

Controlled Trial ◽

Social Network Sites ◽

Well Being ◽

Control Group ◽

Positive Interventions ◽

Randomized Controlled

Positive interventions based on theories in positive psychology have proven effective in contributing to well-being. Although college students frequently use social networking sites, few studies have investigated the use of these sites to facilitate positive interventions. For this research, two positive interventions, photo diaries and the expression of gratitude, were developed and implemented in Facebook using a randomized controlled trial. 136 college students were recruited and randomly assigned them to one of two experimental groups or a control group. Results indicated that photo diary reduced depression during the posttest stage, and these effects continued during the follow up stage. Concerning happiness, the photo diary presented no significant effects in the posttest but did present significant effects in the follow up. Expression of gratitude showed no significant effects on happiness in the posttest but did show significant effects in the follow up. The results of the study demonstrate that social networking sites can be used to implement positive interventions.

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Online meditation training for people with multiple sclerosis: A randomized controlled trial

Multiple Sclerosis Journal ◽

10.1177/1352458518761187 ◽

2018 ◽

Vol 25 (4) ◽

pp. 610-617 ◽

Cited By ~ 14

Author(s):

Cesare Cavalera ◽

Marco Rovaris ◽

Laura Mendozzi ◽

Luigi Pugnetti ◽

Massimo Garegnani ◽

...

Keyword(s):

Multiple Sclerosis ◽

Randomized Controlled Trial ◽

Mindfulness Meditation ◽

Sleep Problems ◽

Psychological Treatment ◽

Controlled Trial ◽

Well Being ◽

Control Group ◽

Randomized Controlled

Background: Multiple sclerosis (MS) has a relevant impact on quality of life (QOL) and is associated with increased risks of psychological morbidity. Mindfulness-based interventions (MBIs) are among the most studied interventions, although few well-conducted studies have tested them in this field. Furthermore, the participation in typical MBIs may be impaired by time and logistics. Objective: We aimed to test the efficacy of an online MBI to improve QOL, psychological well-being, sleep, and fatigue. Methods: We conducted a randomized controlled trial, in which 139 participants were randomly assigned to an MS-specific online mindfulness meditation intervention or to a psychoeducational (active control) group. Participants were assessed for QOL, depression, anxiety, sleep problems, and fatigue, at three different times: at recruitment, after 2 months, and after 6 months. Results: In comparison to the control group, the experimental subjects reported higher QOL and lower depression, anxiety, and sleep problems at the end of intervention. However, after 6 months these group differences were no longer significant. Conclusion: An online MBI could be an effective psychological treatment for the promotion of well-being in MS in short-term. However, the lack of lasting effects requires the development of new strategies to support long-term changes.

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The utility of self-rated health in population surveys: the role of bodyweight

Population Health Metrics ◽

10.1186/s12963-021-00255-2 ◽

2021 ◽

Vol 19 (1) ◽

Author(s):

Robert Bozick

Keyword(s):

Treatment Group ◽

Large Scale ◽

Well Being ◽

Control Group ◽

Self Rated Health ◽

Risk Of Mortality ◽

Highly Sensitive ◽

The Usa ◽

Group Members ◽

Nationally Representative

Abstract Background Self-rated health (SRH) is one of the most commonly used summary measures of overall health and well-being available to population scientists due to its ease of administration in large-scale surveys and to its efficacy in predicting mortality. This paper assesses the extent to which SRH is affected by its placement before or after questions about bodyweight on a survey, and whether differences in placement on the questionnaire affects SRH’s predictive validity. Methods I assessed the validity of SRH in predicting the risk of mortality by comparing outcomes of sample members who were asked to rate their health before reporting on their bodyweight (the control group) and sample members who were asked to rate their health after reporting on their bodyweight (the treatment group). Both the control and treatment group were randomly assigned via an experiment administered as a module in a nationally representative sample of adults in the USA in 2019 (N = 2523). Results The odds of reporting a more favorable appraisal of health are 30% lower for sample members who were in the treatment group when compared with the control group. Additionally, the SRH of treatment group members is significantly associated with their risk of mortality, while the SRH of control group members is not. Conclusion The findings from this study suggest that for researchers to maximize the utility of SRH, closer attention needs to be paid to the context of the survey within which it asked. SRH is highly sensitive to the questions that precede it, and this sensitivity may in turn mischaracterize the true health of the population that the survey is intending to measure.

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Effect of Inquiry-Based Stress Reduction (IBSR) Intervention on Well-Being, Resilience and Burnout of Teachers during the COVID-19 Pandemic

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18073689 ◽

2021 ◽

Vol 18 (7) ◽

pp. 3689

Author(s):

Tzofnat Zadok-Gurman ◽

Ronit Jakobovich ◽

Eti Dvash ◽

Keren Zafrani ◽

Benjamin Rolnik ◽

...

Keyword(s):

Stress Reduction ◽

Controlled Trial ◽

Intervention Group ◽

Well Being ◽

Stressful Events ◽

Control Group ◽

Subjective Well Being ◽

Intention To Treat ◽

School Year ◽

Blended Intervention

Objective: The COVID-19 pandemic has had a major impact on teachers professional and personal lives. Our primary aim was to assess the effect of a blended Inquiry-Based Stress Reduction (IBSR), an emerging mindfulness and cognitive reframing intervention on teacher’s well-being. Our secondary aims were to assess the effect of IBSR on resilience, burnout, mindfulness, and stress among teachers during the COVID-19 pandemic. Methods: The study was a prospective controlled trial with an intervention group (N = 35) and a comparison control group (N = 32). The intervention took place in the Jerusalem District throughout the school year from November 2019 to May 2020. The sessions were conducted in blended learning that included traditional learning (face-to-face) and online learning. Data was analyzed on an intention-to-treat basis. Results: IBSR blended intervention enhanced the resilience and improved the subjective and psychological well-being of teachers in spite of the breakout of the COVID-19 pandemic and the first lockdown in Israel. Simultaneously the control group suffered from enhanced burnout levels and a decline in psychological and subjective well-being. Conclusions: Implementation of IBSR blended intervention during the school year may benefit teachers’ well-being and ability to flourish, even during stressful events such as the COVID-19 pandemic.

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Foam Rolling Elicits Neuronal Relaxation Patterns Distinct from Manual Massage: A Randomized Controlled Trial

Brain Sciences ◽

10.3390/brainsci11060818 ◽

2021 ◽

Vol 11 (6) ◽

pp. 818

Author(s):

Yann Kerautret ◽

Aymeric Guillot ◽

Sébastien Daligault ◽

Franck Di Rienzo

Keyword(s):

Skin Conductance ◽

Muscle Pain ◽

Controlled Trial ◽

Muscle Relaxation ◽

Well Being ◽

Self Report ◽

Controlled Study ◽

Control Group ◽

Foam Rolling ◽

Randomized Controlled

The present double-blinded, randomized controlled study sought to compare the effects of a full-body manual massage (MM) and a foam rolling (FR) intervention on subjective and objective indexes of performance and well-being. A total of 65 healthy individuals were randomly allocated to an FR, MM, or a control group who received a cognitively oriented relaxation routine. Self-report ratings of perceived anxiety, muscle relaxation, and muscle pain were used to index changes in affect and physical sensations. The sit-and-reach and toe-touch tests, as well as a mental calculation task, were used to index motor and cognitive performances, respectively. We also conducted resting-state electroencephalography and continuous skin conductance recordings before and after the experimental intervention. Both FR and MM groups exhibited neural synchronization of alpha and beta oscillations during the posttest. Skin conductance increased from the pretest to the posttest in the relaxation group, but decreased in the FR group. All interventions improved range of motion, although only the MM group outperformed the relaxation group for the toe-touch performance. MM was associated with reduced muscle pain and increased muscle relaxation. Reduced perceived anxiety after the intervention was observed in the FR group only. Overall, MM and FR both improved objective and subjective indexes of performance and well-being. Differences between the two massage interventions are discussed in relation to the effects of pressure stimulation on autonomic regulations and the proactive vs. retroactive nature of FR, compared to MM.

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Mindfulness Meditation Apps: An Effective Tool to Improve Mental Health Among Graduate Students in STEM Programs

10.21203/rs.3.rs-873300/v1 ◽

2021 ◽

Author(s):

Kelly A. Grogan

Keyword(s):

Graduate Students ◽

Treatment Group ◽

Mindfulness Meditation ◽

Depression Scale ◽

Well Being ◽

Physical Symptom ◽

Control Group ◽

Free Access ◽

Post Intervention ◽

Stem Programs

Abstract This paper seeks to determine whether or not mindfulness meditation training via a simple meditation app can effectively improve well-being among graduate students enrolled in STEM programs. Graduate students were recruited from STEM programs at the University of Florida. Participants were randomly assigned into treatment and control groups. The control group simply proceeded as they normally would during an academic semester. The treatment group received free access to the Ten Percent Happier app and were asked to meditate once per day for eight weeks. Both groups completed pre-, mid-, and post-intervention surveys that included the Center for Epidemiological Depression Scale (CES-D) and the Generalized Anxiety Disorder 7-Item Scale (GAD-7). The treatment group averaged about 10 minutes of meditation per day, and the average participant meditated on about 82% of days within the intervention period. At the end of the 8-week intervention, the treatment group reported CES-D and GAD-7 scores that were about 35% and 41% lower than the control group and their physical symptom score was about 36% lower. Relative to their own starting scores, CES-D, GAD-7, and physical symptom scores decreased 35%, 50%, and 43%, respectively for the treatment group, while the control group experienced no change in scores.

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Gamification as an entrepreneur well-being intervention: A study protocol for a single-blinded randomised controlled trial

10.21203/rs.3.pex-1323/v1 ◽

2021 ◽

Author(s):

Waqar M. Naqvi

Keyword(s):

Controlled Trial ◽

Life Quality ◽

Well Being ◽

Likert Scale ◽

Control Group ◽

Group A ◽

Measuring Scale ◽

Group B ◽

Randomised Controlled

Abstract Entrepreneurs usually work for long hours resulting in exhaustion, stress, and burnout. The prevalent symptoms of burnout are reduced levels of physical and mental energy, reduced job efficiency and diminished productivity. Therefore, it is important to improve the health of entrepreneurs. Gamification has a positive relationship with improvements in health and well-being as it influences positive experiences and satisfaction. This trial aims to study how 30-minutes of virtual reality game use via Kinect Azure and Oculus platforms 3-times per week, for 4 weeks, relates to differences in entrepreneur stress, burnout, subjective life quality, and downstream firm performance. We will recruit entrepreneurs over the age of 18 for the gamification analysis. Analysis of previous power using G*Power will determine the sample size. We will divide the participants into 3 groups, wherein Group A will undergo gamification on the Kinect platform, Group B will undergo the Oculus Quest intervention, and Group C will be the control group. We will conduct the study at two sites, one at the HuMen research. The outcome measures include a five-point Likert scale for measuring entrepreneurial stress, burnout-measuring scale (BMS) for burnout, five-point Likert scale for performance and SF-12 for Quality of life. Since current strains pave ways to future accomplishment, entrepreneurs' eudemonic well-being might particularly relate to forward-looking challenge stressors and burnouts. The results will provide an insight into how gamification could help entrepreneurs to deal with work stress and maintain high well-being.

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Effects of self-conditioning techniques in promoting weight loss in patients with severe obesity: a randomized controlled trial protocol

International Journal of Clinical Trials ◽

10.18203/2349-3259.ijct20170304 ◽

2017 ◽

Vol 4 (1) ◽

pp. 20 ◽

Cited By ~ 1

Author(s):

Simona Bo ◽

Farnaz Rahimi ◽

Bice Properzi ◽

Giuseppe Regaldo ◽

Ilaria Goitre ◽

...

Keyword(s):

Weight Loss ◽

Standard Care ◽

Traditional Approach ◽

Controlled Trial ◽

Well Being ◽

Control Group ◽

Randomized Controlled ◽

Rapid Induction ◽

Conditioning Approach

Background: Obesity is a worldwide epidemic; most obese individuals who lose weight after lifestyle educative treatments, soon regain it. Our aim is to evaluate the effectiveness of a training to teach self-conditioning technique (self-hypnosis) added to standard care in determining weight loss compared with standard care in patients with obesityMethods: This randomized controlled open trial will recruit 120 obese patients (BMI 35-50 Kg/m2), aged 20-70 years. The control group will receive a traditional approach: diet + exercise + behavioral recommendations. The experimental group will receive self-conditioning techniques + traditional approach.Three individual sessions of hypnosis with rapid-induction techniques will be administered by trained personnel. All the participants of both groups will be assessed at three, six, nine and twelve months after randomization. The primary outcome is weight loss difference between groups at 12 months after randomization; secondary outcomes are changes in adherence to dietetic and exercise recommendations, appetite and satisfaction/well-being, waist circumference and body fat, blood pressure and blood metabolic and inflammatory variables.Conclusions: The results of this trial will assess whether a self-conditioning approach, based on self-hypnosis, is able to help participants to modulate unhealthy patterns of eating and sustain weight loss in the long term.

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The Effectiveness of Traditional Chinese Yijinjing Qigong Exercise for the Patients With Knee Osteoarthritis on the Pain, Dysfunction, and Mood Disorder: A Pilot Randomized Controlled Trial

Frontiers in Medicine ◽

10.3389/fmed.2021.792436 ◽

2022 ◽

Vol 8 ◽

Author(s):

Shuaipan Zhang ◽

Guangxin Guo ◽

Xing Li ◽

Fei Yao ◽

Zhiwei Wu ◽

...

Keyword(s):

Knee Osteoarthritis ◽

Outcome Measurement ◽

Controlled Trial ◽

Well Being ◽

Functional Mobility ◽

Exercise Session ◽

Control Group ◽

Serious Adverse Events ◽

Clinical Trial Registration ◽

Randomized Controlled

Background: Although traditional Chinese Yijinjing Qigong Exercise (YJJQE) is popularly used in China, to alleviate symptoms of people with knee osteoarthritis (KOA), no randomized controlled trials (RCTs) are available to evaluate the effects of YJJQE in patients with KOA. The purpose of this trial is to assess the clinical efficacy of YJJQE for patients with KOA.Methods: A total of 50 participants clinically diagnosed with KOA are randomly (1:1) assigned to the YJJQE group (n = 25) and to the stretching training exercise (STE) group (n = 25), for a 40-min exercise session twice a week for 12 weeks. All outcome measures are collected at baseline and at 12-week ending intervention, which includes the primary outcomes of Western Ontario and McMaster Universities Osteoarthritis Index Scale (WOMAC), the secondary outcomes of visual analog scale (VAS), mental component summary (MCS), physical component summary (PCS), Beck depression inventory (BDI), perceived stress scale (PSS), Berg balance scale (BBS), and the Gait functional mobility data.Results: The YJJQE group did not have any significant changes compared to the control group on the WOMAC score after the 12-week intervention (P > 0.05), though the YJJQE group demonstrated better performance in MCS, BDI, and PSS (P = 0.002, P = 0.001, and P = 0.026, respectively) than the control group. No serious adverse events occurred in either group, and only mild muscle soreness was reported during both exercise treatments.Conclusion: Because no difference between both groups was shown, with regards to the primary outcome measurement (WOMAC), it can hardly explain that the YJJQE had an advantageous effect on patients experiencing the pain and dysfunction of knee osteoarthritis. However, compared to the control group, YJJQE appeared to be associated with improvements in psychological well-being including reduced stress, anxiety, depression, and mood disturbance to manage KOA. Further trials with larger sample sizes and follow-up studies will be required.Clinical Trial Registration:https://www.chictr.org.cn/edit.aspx?pid=60357&htm=4, ChiCTR2000037256.

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A Randomized Controlled Trial of Tai Chi for Tension Headaches

Evidence-based Complementary and Alternative Medicine ◽

10.1093/ecam/nel050 ◽

2007 ◽

Vol 4 (1) ◽

pp. 107-113 ◽

Cited By ~ 46

Author(s):

Ryan B. Abbott ◽

Ka-Kit Hui ◽

Ron D. Hays ◽

Ming-Dong Li ◽

Timothy Pan

Keyword(s):

Mental Health ◽

Intervention Program ◽

Tai Chi ◽

Controlled Trial ◽

Adult Population ◽

Well Being ◽

Control Group ◽

Physical And Mental Health ◽

Tension Type Headaches ◽

Headache Impact

This study examined whether a traditional low-impact mind–body exercise, Tai Chi, affects health-related quality-of-life (HRQOL) and headache impact in an adult population suffering from tension-type headaches. Forty-seven participants were randomly assigned to either a 15 week intervention program of Tai Chi instruction or a wait-list control group. HRQOL (SF-36v2) and headache status (HIT-6™) were obtained at baseline and at 5, 10 and 15 weeks post-baseline during the intervention period. Statistically significant (P< 0.05) improvements in favor of the intervention were present for the HIT score and the SF-36 pain, energy/fatigue, social functioning, emotional well-being and mental health summary scores. A 15 week intervention of Tai Chi practice was effective in reducing headache impact and also effective in improving perceptions of some aspects of physical and mental health.

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