scholarly journals Comparing Effectiveness of HRV-Biofeedback and Mindfulness for Workplace Stress Reduction: A Randomized Controlled Trial

2020 ◽  
Vol 45 (4) ◽  
pp. 307-322
Author(s):  
Amelie Edith Brinkmann ◽  
Sophia Antonia Press ◽  
Eduard Helmert ◽  
Martin Hautzinger ◽  
Inna Khazan ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Stress Reduction ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Small Sample ◽  
Workplace Stress ◽  
Effect Sizes ◽  
Medium Effect ◽  
Control Group ◽  
Randomized Controlled

Abstract Psychophysiological disorders due to work-related stress continue to be highly costly for health systems and approaches for cost-effective and easily accessible interventions are much needed. Both heart rate variability-biofeedback (HRV-Bfb) and mindfulness-based interventions (MBI) have been empirically shown to reduce stress. This study compares these two interventions in the work context to a wait-list-control-group (WLC). In this three-armed randomized controlled trial (RCT), 69 healthy adults employed in the same organization were randomized to participate in HRV-Bfb, MBI or the WLC. Participants were assessed for psychophysiological parameters of stress (stress perception, coping, HRV parameters and cortisol) and stress related symptoms (depressive symptoms, psychological wellbeing, mindfulness and self-compassion). Participants trained using either HRV-Bfb or MBI for 6 weeks on a daily basis. Outcomes were assessed at baseline, after the intervention and at follow-up 12 weeks later. Results did not show any statistically significant differences between HRV-Bfb and MBI groups, and neither of the intervention groups (IGs) differed from the WLC. Findings suggest an overall reduction in stress for all groups, including the WLC, with mostly small to medium effect sizes. However, it is important to note that participants with higher baseline stress levels might benefit more from mindfulness and biofeedback-based stress reduction interventions. The results have to be interpreted with caution due to the relatively small sample size. MBI might have a slightly stronger effect on stress reduction in comparison to HRV-Bfb, as suggested by the effect sizes. This study highlights issues and challenges of the implementation of such interventions in corporate health management.

scholarly journals Imaginal retraining decreases craving for high-calorie food in overweight and obese women: A randomized controlled trial

2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Steffen Moritz ◽  
Anja S. Göritz ◽  
Stella Schmotz ◽  
Roland Weierstall-Pust ◽  
Josefine Gehlenborg ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Overweight And Obesity ◽  
Medium Effect ◽  
Favorable Effect ◽  
Control Group ◽  
Obese Women ◽  
Randomized Controlled ◽  
High Calorie

AbstractOverweight and obesity are epidemic conditions. Obesity is associated with somatic and psychological sequelae, including serious life-shortening disorders (e.g., diabetes). This study aimed to evaluate the efficacy of a newly developed imaginal variant of approach bias modification (i.e., imaginal retraining) for the reduction of craving for high-calorie food. In a randomized controlled trial, 384 women with a body mass index above 25 were allocated to a wait-list control group or to two variants of imaginal retraining (ratio: 1; 0.5; 0.5). The two intervention groups were sent a manual on imaginal retraining. One group was explicitly encouraged and instructed to use electronic reminders (RER); the standard retraining group (RS) was not encouraged to use electronic reminders. Assessments were 6 weeks apart and were carried out online. Craving for high-calorie food represented the primary outcome (based on the Visual Analog Scale, VAS). Secondary outcomes included the Food Cravings Questionnaire (FCQ-T-R). The study was registered as DRKS00017220. Women in the RER group utilized the retraining technique more often than those in the RS condition, and utilization frequency in turn was associated with improvement on craving and eating behavior scales. Both intention-to-treat and per-protocol analyses showed a favorable effect of the RER group, which achieved significance on the primary outcome, as well as on several other outcomes relative to controls at a small to medium effect size. For those participants who measured their weight before and after the assessment using a scale, weight loss in the RER group was significantly greater compared to the control group. Both retraining groups (RER: 39.4%; RS: 31.1%) reduced their subjective amount of eating relative to controls (24.2%). Approximately two-thirds of the sample (68.3%) performed the exercises at least once during the study period. The present results show that, when used regularly, imaginal retraining may reduce craving for high-calorie food in overweight and obese women. Of note, there was also evidence suggestive of weight reduction, although no diet or lifestyle change was recommended in the manual. Because a large subgroup neither read the manual nor performed the exercises, we recommend that future imaginal retraining be conveyed via short video clips.

scholarly journals Mindfulness-Based Program Plus Amygdala and Insula Retraining (MAIR) for the Treatment of Women with Fibromyalgia: A Pilot Randomized Controlled Trial

2020 ◽  
Vol 9 (10) ◽  
pp. 3246
Author(s):  
Juan P. Sanabria-Mazo ◽  
Jesus Montero-Marin ◽  
Albert Feliu-Soler ◽  
Virginia Gasión ◽  
Mayte Navarro-Gil ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Post Treatment ◽  
Effect Sizes ◽  
Control Group ◽  
Active Control Group ◽  
Treatment As Usual ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

The lack of highly effective treatments for fibromyalgia (FM) represents a great challenge for public health. The objective of this parallel, pilot randomized controlled trial (RCT) was two-fold: (1) to analyze the clinical effects of mindfulness plus amygdala and insula retraining (MAIR) compared to a structurally equivalent active control group of relaxation therapy (RT) in the treatment of FM; and (2) to evaluate its impact on immune-inflammatory markers and brain-derived neurotrophic factor (BDNF) in serum. A total of 41 FM patients were randomized into two study arms: MAIR (intervention group) and RT (active control group), both as add-ons of treatment as usual. MAIR demonstrated significantly greater reductions in functional impairment, anxiety, and depression, as well as higher improvements in mindfulness, and self-compassion at post-treatment and follow-up, with moderate to large effect sizes. Significant decreases in pain catastrophizing and psychological inflexibility and improvements in clinical severity and health-related quality of life were found at follow-up, but not at post-treatment, showing large effect sizes. The number needed to treat was three based on the criteria of ≥50% Fibromyalgia Impact Questionnaire (FIQ) reduction post-treatment. Compared to RT, the MAIR showed significant decreases in BDNF. No effect of MAIR was observed in immune-inflammatory biomarkers (i.e., TNF-α, IL-6, IL-10, and hs-CRP). In conclusion, these results suggest that MAIR, as an adjuvant of treatment-as-usual (TAU), appears to be effective for the management of FM symptoms and for reducing BDNF levels in serum.

Infant-Mother Attachment Can Be Improved through Group Intervention: A Preliminary Evaluation in Spain in a Non-Randomized Controlled Trial

2011 ◽  
Vol 14 (2) ◽  
pp. 630-638 ◽  
Author(s):  
Bárbara Torres ◽  
Itziar Alonso-Arbiol ◽  
María José Cantero ◽  
Amina Abubakar
Keyword(s):  
Randomized Controlled Trial ◽  
Group Intervention ◽  
Controlled Trial ◽  
Medium Effect ◽  
Similar Proportion ◽  
Control Group ◽  
Preliminary Evaluation ◽  
Randomized Controlled ◽  
Mother Attachment

The quality of infant-mother attachment has been linked to competence in different domains of child development. Research indicates that early intervention can enhance the quality of infant-mother attachment, though its efficacy in a group format has yet to be evaluated. The current study is aimed at examining the usefulness of a group intervention in enhancing infant-mother attachment. An intervention aimed at addressing aspects such as maternal responsivity, sensitivity and childrearing behaviour was developed by the researchers and experienced psychologists. The intervention spanned a period of 14 months starting from the third quarter of pregnancy. The intervention was evaluated among 24 mothers from the Basque region of Spain. The sample consisted of children of both genders in a similar proportion: 45.8% were boys and 54.2% were girls. The children in this sample were full-term born and did not present symptoms of any serious pre- or postnatal complications. The intervention had a statistically non-significant medium effect. Infants whose mothers had received the intervention showed higher rates of secure attachment compared to children from the control group, as assessed by the Strange Situation observation procedure. A potentially significant confounding variable, maternal attachment, was balanced across the intervention and comparison groups. We can tentatively point out that a group intervention may enhance the quality of infant-mother attachment. Nevertheless, because the study design was not randomized, the results of this study remain preliminary and need replication in a full randomized controlled trial designed study.

scholarly journals Mindfulness-Based Stress Reduction Specifically Improves Social Anhedonia among Adults with Chronic Stress

2021 ◽  
Author(s):  
Corinne Carlton ◽  
Ligia Antezana ◽  
Katelyn Mallory Garcia ◽  
Holly Sullivan-Toole ◽  
John Richey
Keyword(s):  
Randomized Controlled Trial ◽  
Chronic Stress ◽  
Stress Reduction ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Social Anhedonia ◽  
Randomized Controlled ◽  
Waitlist Control Group ◽  
The Relationship

This randomized controlled trial examined the effects of mindfulness on anhedonic symptoms in a sample of adults reporting high levels of chronic stress. Meditation-naïve adults (N=68, Mage=32, 62% female) were randomized to either an 8-week MBSR intervention group (N=35), or to a waitlist control group (N=33). We hypothesized that changes in mindfulness would mediate the relationship between condition and changes in anhedonic symptoms. Additionally, the present study aimed to determine if other theoretically-linked mechanisms (i.e., stress, negative affect(NA), depression) were involved in producing changes in anhedonic symptoms. Results provided evidence for full mediation of the effect of MBSR on social anhedonia through its essential mechanism of ΔMindfulness. These results highlight specificity of anhedonic symptoms targeted by MBSR, with social anhedonia symptoms being modified by changes in mindfulness whereas other anhedonic domains were not. Additionally, although associative relationships were present for stress, depression, NA, and anhedonic symptoms, no mediational relationships emerged.

scholarly journals Yiqi Fumai Injection for patients with Septic Shock: study protocol for a randomized controlled trial

2021 ◽  
Author(s):  
Bo-jun Chen ◽  
Zeng Jing ◽  
Cai Xingui ◽  
Cai Hairong ◽  
Luo Sicong ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Septic Shock ◽  
Randomized Controlled Trial ◽  
Conventional Treatment ◽  
Controlled Trial ◽  
Small Sample ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Randomized Controlled

Abstract Background: Septic shock is an important problem in critical care medicine and one of the leading causes of death in intensive care units (ICU). In China, Traditional Chinese medicine (TCM) has been widely used as the adjuvant treatment to improve the symptoms and prognosis in patients with septic shock. Yiqi Fumai Injection (YFI) is one of the most important proprietary TCM for septic shock, previous studies have demonstrated its efficacy and safety. However, these conclusions were limited due to the small sample size and low quality of methodologies of these studies. Therefore, we designed this study to evaluate the efficacy and safety of using YFI as an adjunct treatment for septic shock.Methods/design: This is a double-blind, randomized, parallel, placebo-controlled clinical trial. A total of 800 participants will be randomly assigned to receive either treatment or placebo in a 1:1 ratio. The treatment group will receive YFI combined with conventional treatment, and the control group will receive 0.9% sodium chloride injection combined with conventional treatment for 2 weeks. The primary outcome is the 28-days mortality. Secondary outcomes are blood lactate levels, hemodynamics, blood gas analysis, immune function indicators, inflammatory indicators, acute physiology improvement and chronic health assessment (APACHE) II scores, and sepsis-related organ failure score (SOFA). Adverse events will be observed and recorded at the same time for safety assessment.Discussion: This randomized controlled trial will help evaluate the efficacy and safety of YFI for the treatment of septic shock. The results of this trial will provide recommendations for the management of septic shock.Trial registration {2a and 2b}：China Clinical Trial Registry, ChiCTR-1900026424.Registered on 15 June 2019.

Electroconvulsive therapy (ECT) for treating agitation in dementia (major neurocognitive disorder) – a promising option

2017 ◽  
Vol 29 (5) ◽  
pp. 717-726 ◽  
Author(s):  
Oliver M. Glass ◽  
Brent P. Forester ◽  
Adriana P. Hermida
Keyword(s):  
Randomized Controlled Trial ◽  
Electroconvulsive Therapy ◽  
Rating Scales ◽  
Controlled Trial ◽  
Case Series ◽  
Small Sample ◽  
Control Group ◽  
Neurocognitive Disorder ◽  
Randomized Controlled ◽  
Wide Range

ABSTRACTBackground:Agitation in patients with dementia increases caretaker burden, increases healthcare costs, and worsens the patient's quality of life. Antipsychotic medications, commonly used for the treatment of agitation in patients with dementia have a box warning from the FDA for elevated mortality risk. Electroconvulsive therapy (ECT) has made significant advances over the past several years, and is efficacious in treating a wide range of psychiatric conditions. We provide a systematic review of published literature regarding the efficacy of ECT for the treatment of agitation in patients with dementia (major neurocognitive disorder).Methods:We searched PubMed, Medline, Google Scholar, UptoDate, Embase, and Cochrane for literature concerning ECT for treating agitation in dementia using the title search terms “ECT agitation dementia;” “ECT aggression dementia;” “ECT Behavior and Psychological Symptoms of Dementia;” and “ECT BPSD.” The term “dementia” was also interchanged with “Major Neurocognitive Disorder.” No time frame restriction was placed. We attempted to include all publications that were found to ensure a comprehensive review. We found 11 papers, with a total (N) of 216 patients.Results:Limited to case reports, case series, retrospective chart review, retrospective case-control, and an open label prospective study, ECT has demonstrated promising results in decreasing agitation in patients with dementia. Patients who relapsed were found to benefit from maintenance ECT.Conclusions:Available studies are often limited by concomitant psychotropic medications, inconsistent use of objective rating scales, short follow-up, lack of a control group, small sample sizes, and publication bias. A future randomized controlled trial will pose ethical and methodological challenges. A randomized controlled trial must carefully consider the definition of usual care as a comparison group. Well-documented prospective studies and/or additional case series with explicit selection criteria, a wide range of outcome measures, and less selection bias of the study sample that may favor treatment response, is warranted. ECT may be a promising option for the treatment of aggression and agitation in patients with severe dementia who are refractory to other treatment options, but the limitations of available studies suggest that a cautious approach to future randomized controlled trials is warranted.

scholarly journals A Pilot RCT Investigating the Effects of Targeted Compression on Athletes With Pelvic/Groin Pain

2019 ◽  
Vol 28 (2) ◽  
pp. 133-143 ◽  
Author(s):  
Leanne Sawle ◽  
Jennifer Freeman ◽  
Jonathan Marsden
Keyword(s):  
Randomized Controlled Trial ◽  
Performance Measures ◽  
Groin Pain ◽  
Controlled Trial ◽  
Effect Sizes ◽  
Control Group ◽  
Clinical Effects ◽  
Randomized Controlled ◽  
And Performance ◽  
Straight Leg Raise

Context: Athletic pelvic/groin pain is a common yet often challenging problem to both diagnose and manage. A new tool has been developed based on the clinical effects of applied force on the pelvis. Early findings indicate that this customized compression orthosis may have a positive effect on pelvic/groin pain and performance measures. Objectives: To inform the design and test the practicality of procedures for a future definitively powered randomized controlled trial and to provide an estimate of the effect size of this orthosis on selected clinical and performance measures. Design: Pilot randomized controlled trial with participants randomly allocated to an intervention or waiting-list control group. Setting: The training location of each athlete. Participants: 24 athletes with subacute and chronic pelvic conditions were proposed to be recruited. Intervention: A customized compression orthosis, delivering targeted compression to the pelvic girdle. Outcome Measures: Measures were the active straight leg raise (ASLR) test, squeeze test, broad jump, and the multiple single-leg hop-stabilization test. Results: A total of 16 athletes completed the study. The invention group demonstrated moderate to large estimated effect sizes on the squeeze test and active straight leg raise tests (d = 0.6–1.1) while wearing the orthosis. Small effect sizes (d = 0.2) were seen on jump distance and the dominant leg balance score. Compared with the control group, the intervention group also showed moderate to large estimated effect sizes on the active straight leg raise measures (d = 0.5–0.9) when wearing sports shorts. Conclusions: The protocol was feasible. Effect sizes and recruitment/attrition rates suggest that the intervention holds promise and that a future definitively powered randomized controlled trial appears feasible and is indicated.

scholarly journals Feasibility of collection and analysis of microbiome data in a longitudinal randomized trial of community gardening

2020 ◽  
Vol 15 (8) ◽  
pp. 633-648 ◽  
Author(s):  
Mireia Gascon ◽  
Kylie K Harrall ◽  
Alyssa W Beavers ◽  
Deborah H Glueck ◽  
Maggie A Stanislawski ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Human Microbiome ◽  
Small Sample ◽  
Community Gardening ◽  
Analysis Pipeline ◽  
Participant Satisfaction ◽  
Randomized Controlled ◽  
Microbiome Data

Aim: We explored the feasibility of collecting and analyzing human microbiome data in a longitudinal randomized controlled trial of community gardening. Methods & materials: Participants were randomly assigned to gardening (N = 8) or control (N = 8). Participants provided stool, mouth, hand and forehead microbiome samples at six timepoints. Analyses combined mixed models with Qiita output. Results: Participant satisfaction was high, with 75% of participants completing evaluations. While no microbial effects were statistically significant due to small sample size, the analysis pipeline utility was tested. Conclusion: Longitudinal collection and analysis of microbiome data in a community gardening randomized controlled trial is feasible. The analysis pipeline will be useful in larger studies for assessment of the pathway between microbiota, gardening and health outcomes.

scholarly journals Yiqi Fumai Injection for patients with Septic Shock: study protocol for a randomized controlled trial1

2020 ◽  
Author(s):  
jing zeng ◽  
Hai-rong Cai ◽  
Shu-ling Liu ◽  
Shuai Zhao ◽  
Zhi-shang Li ◽  
...  
Keyword(s):  
Septic Shock ◽  
Conventional Treatment ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Small Sample ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Randomized Controlled

Abstract Background Septic shock is an important problem in critical care medicine and one of the leading causes of death in intensive care units (ICU). In China, Traditional Chinese medicine ( TCM) has been widely used as the adjuvant treatment to improve the symptoms and prognosis in patients with septic shock. Yiqi Fumai Injection (YFI) is one of the most important proprietary TCM for septic shock, previous studies have demonstrated its efficacy and safety. However, these conclusions were limited due to the small sample size and low quality of methodologies of these studies. Therefore, we designed this study to evaluate the efficacy and safety of using YFI as an adjunct treatment for septic shock.Methods This is a double-blind, randomized, parallel, placebo-controlled clinical trial. A total of 800 participants will be randomly assigned to receive either treatment or placebo in a 1:1 ratio. The treatment group will receive YFI combined with conventional treatment, and the control group will receive 0.9% sodium chloride injection combined with conventional treatment for 2 weeks. The primary outcome is the 28- days mortality. Secondary outcomes are blood lactate levels, hemodynamics , blood gas analysis, immune function indicators, inflammatory indicators, acute physiology improvement and chronic health assessment (APACHE) II scores, and sepsis-related organ failure score (SOFA). Adverse events will be observed and recorded at the same time for safety assessment.Discussion This randomized controlled trial will help evaluate the efficacy and safety of YFI for the treatment of septic shock. The results of this trial will provide recommendations for the management of septic shock.

scholarly journals Examining the effect of a wearable, anxiety detection technology on improving the awareness of anxiety signs in autism spectrum disorder: a pilot randomized controlled trial

2021 ◽  
Vol 12 (1) ◽  
Author(s):  
Jenny Nguyen ◽  
Robyn E. Cardy ◽  
Evdokia Anagnostou ◽  
Jessica Brian ◽  
Azadeh Kushki
Keyword(s):  
Autism Spectrum Disorder ◽  
Randomized Controlled Trial ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Autism Spectrum ◽  
Small Sample ◽  
Deep Breathing ◽  
Randomized Controlled ◽  
Children With Asd ◽  
Detection Technology

Abstract Background Anxiety is prevalent in autism spectrum disorder (ASD) and can negatively impact physical and mental health. Self-awareness of anxiety signs is a key barrier to success of anxiety interventions for many children. Methods To address this, we conducted a randomized controlled trial to assess whether the Anxiety Meter, a wearable, real-time anxiety detection technology, can improve awareness of anxiety symptoms and the initiation of relaxation techniques in children with ASD. Twenty-eight children with ASD were trained on the use of the Anxiety Meter and taught a diaphragmatic breathing relaxation technique over three visits. On the fourth visit, participants were randomized to either receive feedback of their anxiety level or no feedback from the Anxiety Meter while completing a stress-eliciting task (public speaking) and asked to engage in deep breathing if anxious. Results Feedback from the Anxiety Meter was associated with increased likelihood of initiating deep breathing in response to anxiety. Limitations Limitations include the small sample size, imbalanced group matching for IQ and sex, and the controlled-laboratory settings which limit the statistical power and generalizability of the results to real-world settings. Conclusions Although these results are limited by the relatively small sample size, they support the feasibility of using a wearable device and real-time feedback to improve anxiety symptom awareness. Trial Registration ClinicalTrials.gov Identifier: NCT02160691, registration date: 06/05/2014.

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