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Interreality for the management and training of psychological stress: study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Psychological stress occurs when an individual perceives that environmental demands tax or exceed his or her adaptive capacity. Its association with severe health and emotional diseases, points out the necessity to find new efficient strategies to treat it. Moreover, psychological stress is a very personal problem and requires training focused on the specific needs of individuals. To overcome the above limitations, the INTERSTRESS project suggests the adoption of a new paradigm for e-health--Interreality--that integrates contextualized assessment and treatment within a hybrid environment, bridging the physical and the virtual worlds. According to this premise, the aim of this study is to investigate the advantages of using advanced technologies, in combination with cognitive behavioral therapy (CBT), based on a protocol for reducing psychological stress. METHODS/DESIGN:The study is designed as a randomized controlled trial. It includes three groups of approximately 50 subjects each who suffer from psychological stress: (1) the experimental group, (2) the control group, (3) the waiting list group. Participants included in the experimental group will receive a treatment based on cognitive behavioral techniques combined with virtual reality, biofeedback and mobile phone, while the control group will receive traditional stress management CBT-based training, without the use of new technologies. The wait-list group will be reassessed and compared with the two other groups five weeks after the initial evaluation. After the reassessment, the wait-list patients will randomly receive one of the two other treatments. Psychometric and physiological outcomes will serve as quantitative dependent variables, while subjective reports of participants will be used as the qualitative dependent variable. DISCUSSION:What we would like to show with the present trial is that bridging virtual experiences, used to learn coping skills and emotional regulation, with real experiences using advanced technologies (virtual reality, advanced sensors and smartphones) is a feasible way to address actual limitations of existing protocols for psychological stress. TRIAL REGISTRATION:http://clinicaltrials.gov/ct2/show/NCT01683617.

SUBMITTER: Pallavicini F

PROVIDER: S-EPMC3699393 | biostudies-literature | 2013 Jun

REPOSITORIES: biostudies-literature

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Interreality for the management and training of psychological stress: study protocol for a randomized controlled trial.

Pallavicini Federica F Gaggioli Andrea A Raspelli Simona S Cipresso Pietro P Serino Silvia S Vigna Cinzia C Grassi Alessandra A Morganti Luca L Baruffi Margherita M Wiederhold Brenda B Riva Giuseppe G

Trials 20130628

<h4>Background</h4>Psychological stress occurs when an individual perceives that environmental demands tax or exceed his or her adaptive capacity. Its association with severe health and emotional diseases, points out the necessity to find new efficient strategies to treat it. Moreover, psychological stress is a very personal problem and requires training focused on the specific needs of individuals. To overcome the above limitations, the INTERSTRESS project suggests the adoption of a new paradig ...[more]

PMID: 23806013

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Project description:BackgroundApproximately 1 million individuals experience a mild traumatic brain injury (TBI) and cost the United States nearly $17 billion each year. Many trauma survivors with mild TBI have debilitating and long-term physical, emotional, and cognitive impairments that are unrecognized at trauma centers. Early intervention studies are needed to address these impairments, especially cognitive deficits in executive functioning. Goal management training (GMT) is a structured cognitive rehabilitation program that has been found to improve executive functioning in patients with moderate to severe TBI. The current study adapted the GMT program for telephone delivery in order to improve the accessibility of rehabilitation services in a patient population with multiple barriers to care and significant yet unrecognized cognitive impairment. The primary objective of this study is to examine the efficacy of telephone-based GMT for improving executive functioning, functional status, and psychological health in trauma survivors with mild TBI.Methods/designThis study is a three-group randomized controlled trial being conducted at a Level I trauma center. Ninety trauma survivors with mild TBI and cognitive deficits in executive functioning will be randomized to receive telephone-based GMT, telephone-based education, or usual care. GMT and education programs will be delivered by a physical therapist. The first in-person session is 1 h and the remaining six telephone sessions are 30 min. A battery of well-established cognitive tests will be conducted and validated questionnaires will be collected that measure executive functioning, functional status, and depressive and posttraumatic stress disorder symptoms at 6 weeks, 4 months, and 7 months following hospital discharge.DiscussionThis study supports a telephone-delivery approach to rehabilitation services in order to broaden the availability of evidence-based cognitive strategies.Trial registrationThis trial was registered with Clinicaltrials.gov on 10 October 2012, registration number: NCT01714531.

Project description:BackgroundPsychological distress in University settings has grown and became a public health concern. In this context, contemplative practices such as mindfulness have been proposed as a strategy to help students on stress management.MethodsForty university students (20 female), aged between 18 to 30 years (mean = 24.15; SD = 3.56), with no previous experience with meditation or yoga were recruited at the Federal University of Rio Grande do Norte and randomized to a mindfulness training (MT) or active control (AC) groups. We analyzed measures of anxiety, affect, stress, as well as state and trait mindfulness in order to evaluate the effects of trait mindfulness and a brief mindfulness intervention in forty healthy young students. Participants were classified as Low (n = 27, females = 13) or High (n = 13, females = 7) Trait Mindfulness by k-means clustering and compared between them using Wilcoxon sum rank test. Furthermore, the sample was randomly allocated to an AC (n = 20, females = 10) or a MT (n = 20, females = 10) group, and mixed analysis of variance was performed to analyze the effect of interventions. The mechanisms and role of trait mindfulness in the intervention was assessed by a moderated mediation analysis.ResultsWe found that High Trait individuals have lower anxiety trait, anxiety state and perceived stress levels. Only the MT group reduced their anxiety state and perceived stress after the intervention and increased their state mindfulness. Both groups reduced negative affect and cortisol, and no change was found in positive affect. Moderated mediation analysis showed that the training-induced change in state mindfulness mediated the increase in positive affect and the decrease in perceived stress and cortisol, regardless of trait mindfulness. For anxiety state the decrease only occurred in individuals with High Trait Mindfulness.ConclusionsTogether, these results suggest that higher trait mindfulness is associated with low levels of psychological distress and that a brief mindfulness-based intervention seems to be useful to reduce distress measures in university students.Trial registrationReBEC, U1111-1194-8661. Registered 28 March 2017-Retrospectively registered, http://www.ensaiosclinicos.gov.br/rg/RBR-7b8yh8.

Project description:BackgroundOne-third or more of breast cancer survivors report stress and other psychological and physical complaints that can negatively impact their quality of life. Psychosocial stress management interventions, shown to mitigate the negative impact of these complaints, can now be delivered as accessible and convenient (for the patient and provider) eHealth interventions. In this randomized controlled trial (RCT), Coping After Breast Cancer (CABC), 2 modified versions of the stress management eHealth intervention program StressProffen were created: one with predominantly cognitive behavioral stress management content (StressProffen-cognitive behavioral therapy intervention [StressProffen-CBI]) and another with predominantly mindfulness-based stress management content (StressProffen-mindfulness-based intervention [StressProffen-MBI]).ObjectiveThis study aims to investigate the effects in breast cancer survivors of using StressProffen-CBI and StressProffen-MBI compared with a control group (treatment as usual).MethodsWomen diagnosed with breast cancer (stage I-III, unequivocally human epidermal growth factor receptor 2-positive or estrogen receptor-negative tumors) or ductal carcinoma in situ (DCIS) aged 21-69 years who completed the Cancer Registry of Norway-initiated health survey on quality of life are invited to the CABC trial about 7 months after diagnosis. Women who give consent to participate are randomized (1:1:1) to either the StressProffen-CBI, StressProffen-MBI, or control group. Both StressProffen interventions consist of 10 modules of stress management content delivered through text, sound, video, and images. The primary outcome is between-group changes in perceived stress at 6 months, assessed with Cohen 10-item Perceived Stress Scale. The secondary outcomes comprise changes in quality of life, anxiety, depression, fatigue, sleep, neuropathy, coping, mindfulness, and work-related outcomes approximately 1, 2, and 3 years after diagnosis. Long-term effects of the interventions on work participation, comorbidities, relapse or new cancers, and mortality will be assessed using data from national health registries.ResultsRecruitment is scheduled from January 2021 to May 2023. The goal is to recruit 430 participants (100 in each group). As of April 14 2023, 428 participants have been enrolled.ConclusionsThe CABC trial is possibly the largest ongoing psychosocial eHealth RCT in patients with breast cancer. If 1 or both interventions prove to be effective in reducing stress and improving psychosocial and physical complains, the StressProffen eHealth interventions could be beneficial, inexpensive, and easily implementable tools for breast cancer survivors when coping with late effects after cancer and cancer treatments.Trial registrationClinicaltrials.gov NCT04480203; https://clinicaltrials.gov/ct2/show/NCT04480203.International registered report identifier (irrid)DERR1-10.2196/47195.

Project description:BackgroundFatigue is a multifactorial condition that leads to disease and loss in production, and it affects a large number of workers worldwide. This study aims to demonstrate a resistance exercise protocol that individuals will perform during the work schedule, and to evaluate the effectiveness of this exercises program for fatigue control.Methods/designThis is a cluster randomized controlled trial with two arms and is assessor blinded. A total of 352 workers of both sexes, aged 18-65 years, from a medium-sized dairy plant were enrolled in this study. Participants will be recruited from 13 production sectors according to the eligibility criteria and will be randomized by clusters to either the Progressive Resistance Exercise (PRE) intervention group or the Compensatory Workplace Exercise (CWE) comparative group. A resistance exercise program will be implemented for both groups. The groups will receive instructions on self-management, breaks, adjustments to workstations, and the benefits of physical exercise. The PRE group will perform resistance exercises with gradual loads in an exercise room, and the CWE group will perform exercise at their workstations using elastic bands. The exercise sessions will be held 3 times a week for 20 min. The primary outcome measures will be symptoms of physical and mental fatigue, and muscular fatigue based on a one-repetition maximum (1RM). The secondary outcome measures will be level of physical activity, musculoskeletal symptoms, physical condition, perceived exposure, and productivity. The workers will be assessed at baseline and after a 4-month program. A linear mixed model will be applied on an intention-to-treat basis.DiscussionThis intervention is expected to reduce symptoms of fatigue in the workers. The exercise program is indicating in the workplace, although there are few studies describing the effects of exercise on the control of fatigue in the workplace. Emphasis will be placed on adherence to the program, which may result in significant and clinically important reductions in fatigue. It is also expected that the findings of this study will contribute significantly to the decision-making capacity of professionals working in the field of occupational health.Trial registrationU.S. National Institutes of Health, ClinicalTrials.gov Identifier: NCT02172053 . Date registered 19 June 2014.

Project description:BackgroundSmoking remains the leading cause of preventable illness and mortality in the United States. Individuals with Posttraumatic Stress Disorder (PTSD) have smoking rates higher than that of others and fewer individuals with PTSD have quit smoking. This randomized controlled trial was designed to test the effectiveness of integrating telehealth care management and smoking cessation with motivational interviewing for Veterans with PTSD.Methods/designAll smokers with PTSD, regardless of their desire to quit, were invited to participate. Enrollment occurred between November 2009 and April 2013. Target enrollment was 120 participants. Enrolled participants were randomized to either the control group, receiving usual care including a telehealth PTSD program, with a device that delivered PTSD information and in-home care management, or the intervention group, which included (1) a telehealth PTSD program, (2) motivational interviewing-based smoking cessation curricula via the telehealth device, and (3) weekly motivational interviewing counseling phone calls. Outcomes are self-reported 24-hour quit attempts, progression along the stages of change and 7-day point prevalence quit smoking rates for the intervention group compared to usual care alone. Secondary outcomes include participants' perception of care coordination, patient satisfaction with motivational interviewing, PTSD symptoms, pain, depression and quality of life.DiscussionMotivational interviewing has been shown to increase readiness for change and smoking cessation care has been shown to be more successful when incorporated into in-person mental health care. Our study builds on previous studies. It integrates a written smoking cessation curriculum and phone-based motivational interviewing counseling into an established PTSD home telehealth care coordination program. This paper describes the design and methods of our randomized control trial.Trial registrationClinicalTrials.gov, NCT00908882, May 22, 2009.

Project description:BACKGROUND: The number of people with diabetes is increasing worldwide, especially in developing South Asian countries. Therefore, preventing diabetes at the early stages has become an important issue. Recent clinical trials, systematic reviews, and meta-analysis have shown that zinc has beneficial effects on glycemic and metabolic control in those with diabetes. The present study is designed to evaluate the effects of zinc supplementation on glycemic control and other metabolic parameters in those with pre-diabetes. METHODS/DESIGN: The study will be conducted as a randomized, double-blind, placebo-controlled clinical trial for a period of 12 months at the Faculty of Medicine, University of Colombo, Sri Lanka. The study has been approved by the Ethics Review Committee of Faculty of Medicine, University of Colombo (EC/11/189). A total of 200 adults (age 18-60 years) with pre-diabetes will be recruited for the study. They will be stratified according to age, gender, and body mass index and randomly assigned into the test and placebo groups on a 1:1 ratio. The zinc capsules, each weighing 456 mg, will contain the following ingredients:zinc sulfate monohydrate 55.096 mg (elemental zinc 20 mg), lactose monohydrate 399.504 mg, and stearic acid 1.400 mg. The placebo capsule with the same weight will be comprised of lactose monohydrate 454.600 mg and stearic acid 1.400 mg. The subjects will receive either zinc 20 mg capsules or placebo daily for a period of 12 months. The study drugs will be double blinded to both investigators and subjects. The visits and the evaluations will be done as follows: screening (visit 0), 1 month (visit 1), 3 month (visit 2), 6 month (visit 3), and 12 month (visit 4). The following primary outcome measures will be evaluated:fasting plasma glucose (FPG), post oral glucose tolerance test (OGTT), serum insulin, HbA1c, total/low-density lipoprotein (LDL)/high-density lipoprotein (HDL) cholesterol, triglycerides, serum zinc, and appetite using a visual analog scale. Secondary outcome measures include: blood pressure, anthropometry, and dietary assessment using a validated food frequency questionnaire. Data will be analyzed using SPSS v16. DISCUSSION: The present protocol will aim to establish the beneficial effects of zinc supplementation on disease progression in those with pre-diabetes and also establish its effectiveness in the prevention of diabetes mellitus. TRIAL REGISTRATION: Sri Lanka Clinical Trial Registry: SLCTR/2012/010.

Project description:The number of falls experienced by people with knee osteoarthritis (OA) is almost double the number experienced by people with no OA. The neuromuscular elements required to arrest a fall are more impaired in people with knee OA compared to their asymptomatic counterparts. Therefore, these elements may need to be incorporated into an exercise intervention to reduce the risk of falling. The aim of this study will be to examine the feasibility, safety and patient satisfaction of a high-speed resistance-training program, with and without balance exercises, in people with knee OA compared to a control group. The effect of these exercise programs on lower-limb muscle strength and physiological and functional risk factors for falls will also be examined.This study will be a pilot randomized controlled trial with a pre- and post-intervention design (outcome assessments at baseline and 8 weeks after participation commencement) comparing three groups: a control group (no intervention), a high-speed resistance-training group and a high-speed resistance-training plus balance exercises group. Thirty people with knee osteoarthritis aged 60-90 years will be recruited and randomized to one of the three groups. Feasibility and safety will be assessed by examining adherence to the exercise program, dropout rate, pain level during and following exercise, number of exercises stopped due to pain, and any adverse event or any incident that prevents the participant from completing the prescribed exercise. Secondary measures of lower-limb strength, physical function, self-reported pain and function, fear of falls, and executive function and quality of life will also be assessed. To determine statistical trends of effectiveness and hence to inform sample size for a fully powered study, analyses of the secondary outcomes will be performed to assess the changes within and between groups over time (pre-post) using repeated measure ANOVA.The results of this study will improve understanding of what type of exercise is safe and beneficial for people with knee OA to reduce their risk of falling, and hence will inform the development of a future large research trial.Australian New Zealand Clinical Trials Registry, ID: ACTRN12616001382460 . Registered on 6 October 2016.

Project description:BackgroundProblems with sustained attention, impulsivity, and hyperactivity are the most prominent symptoms of attention-deficit hyperactivity disorder (ADHD), but many children with this diagnosis also present with poor organizational skills that are important in relation to school. These problems tend to increase from childhood to adolescence and are often not well managed by medication. Organizational skills training (OST) is a range of behavioral interventions that specifically target organizational skills deficits. Evidence supports the effect of OST on improving organizational skills, inattention, and academic performance in children with ADHD. Because previous clinical trials included mostly children above the age of 8 years, this trial includes children in the age range 6-13 years to expand the knowledge on the effects of OST in younger children. Previous OST research has also shown improvement on inattention in parent ratings; we will investigate if a change in inattention can be confirmed with neurocognitive tests. Finally, little is known about predictors of treatment response in OST.ObjectivesThe primary objective is to investigate if OST has positive effects on organizational skills in children with ADHD. The primary outcome measurement is the parent-rated Children's Organizational Skills Scale (COSS), collected before and at the end of the 10 week intervention. Secondary and exploratory outcomes include inattention ratings, family and school functioning, and cognitive functions measured before the intervention period, immediately after, and at a 6 month follow-up. Additional objectives are to investigate both neurocognitive outcomes and age as predictors of treatment response.MethodsThis is a randomized clinical superiority trial investigating the effect of OST vs a treatment-as-usual (TAU) control group for children with ADHD in the age range of 6-13 years. All participants (n = 142) receive TAU. OST is administered in a group format of 10 weekly sessions. Adverse events are monitored by study clinicians during weekly therapy sessions and all assessments. Data analyses will be conducted using mixed linear regression models with random intercepts for patients, adjusted for the stratification variables and the baseline value.PerspectivesThis study will provide important new knowledge and expand on existing research in the field of non-pharmacological treatment of children with ADHD. OST can potentially have a significant impact on the lives of children with ADHD by helping them learn how to cope with their present deficits and to become more independent and self-reliant. It is also important to investigate predictors of treatment response in order to optimize OST.Trial registrationClinicalTrials.gov NCT03160378 . Registered on May 19, 2017.

Project description:A relevant innovation about sedation of long-term Intensive Care Unit (ICU) patients is the 'conscious target': patients should be awake even during the critical phases of illness. Enteral sedative administration is nowadays unusual, even though the gastrointestinal tract works soon after ICU admission. The enteral approach cannot produce deep sedation; however, it is as adequate as the intravenous one, if the target is to keep patients awake and adapted to the environment, and has fewer side effects and lower costs.A randomized, controlled, multicenter, single-blind trial comparing enteral and intravenous sedative treatments has been done in 12 Italian ICUs. The main objective was to achieve and maintain the desired sedation level: observed RASS = target RASS ± 1. Three hundred high-risk patients were planned to be randomly assigned to receive either intravenous propofol/midazolam or enteral melatonin/hydroxyzine/lorazepam. Group assignment occurred through online minimization process, in order to balance variables potentially influencing the outcomes (age, sex, SAPS II, type of admission, kidney failure, chronic obstructive pulmonary disease, sepsis) between groups. Once per shift, the staff recorded neurological monitoring using validated tools. Three flowcharts for pain, sedation, and delirium have been proposed; they have been designed to treat potentially correctable factors first, and, only once excluded, to administer neuroactive drugs. The study lasted from January 24 to December 31, 2012. A total of 348 patients have been randomized, through a centralized website, using a specific software expressly designed for this study. The created network of ICUs included a mix of both university and non-university hospitals, with different experience in managing enteral sedation. A dedicated free-access website was also created, in both Italian and English, for continuous education of ICU staff through CME courses.This 'educational research' project aims both to compare two sedative strategies and to highlight the need for a profound cultural change, improving outcomes by keeping critically-ill patients awake.Clinicaltrials.gov #NCT01360346.

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Interreality for the management and training of psychological stress: study protocol for a randomized controlled trial.

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Interreality for the management and training of psychological stress: study protocol for a randomized controlled trial.

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