Active clinical trials for "Stress, Psychological"

The proposed investigation will conduct a randomized, clinical trial to test the efficacy of a cognitive behavioral stress management (CBSM) group intervention on immune response to vaccine and distress among women at elevated risk for breast cancer. Hypothesis 1: Women who participate in the CBSM intervention will have a larger primary and secondary antibody response to vaccines compared to women in the comparison group. Hypothesis 2: Women who participate in a 10-week CBSM group intervention will report lower levels of distress immediately after and 6 months after the intervention compared to women in the comparison group.

The aim of this study is a first evaluation of the effectiveness of the YoBEKA Program (Yoga, Movement, Relaxation, Concentration and Mindfulness) to evaluate potential effects in stress reduction and concomitant psychological parameters.

Early life stress (ELS) is associated with a number of psychiatric and medical conditions later in life, thought to be caused by subsequent disruptions in biological processes involved in regulation of stress responses. Given that these alterations have long-lasting effects, there is a great need for effective preventative interventions. The long-term goal of this project is to identify early interventions that may most powerfully mitigate risk for psychiatric illness among adolescents with exposure to early life stress (ELS), with a focus on interventions that can be widely and effectively implemented, have the potential for long-lasting benefits, and can effectively engage targeted neurobiological processes and networks. The specific aims of the present study are to 1) examine how ELS impacts biological processes associated with regulation of stress, and 2) identify how MBI impacts affective symptoms and biological processes dysregulated by ELS. This study supports the efforts to reduce the effects of early adversity in children by testing an impact of an effective psychological intervention on disrupted biological processes caused by early adversity. Successful achievement of the proposed aims will contribute to a) the knowledge base needed to reduce the effects of trauma and stress in children and families and b) the development of easily implemented and disseminated preventative interventions. The proposed study will utilize a multi-method design to examine the effect of mindfulness on biological processes (i.e., stress responses) disrupted by exposure to ELS among adolescents age 13 to 15. Adolescents will first complete self-report measures of childhood adverse experiences, trauma, and neglect. Forty eligible adolescents will be next randomly assigned to either an eight session mindfulness-based stress reduction intervention for teens or no treatment. Pre- and post-intervention assessment will include (a) self-report measures of symptoms and emotion regulation, (b) a blood draw for assessment of inflammatory markers and gene expression, and (c) a stress task with saliva cortisol collected before and after this task.

Background The flow of asylum seekers and refugees moving to European and bordering countries has progressively increased in the last years. This population is exposed to physical and mental challenges before and during displacement, and suffer continuing hardships after arrival in a High-Income Country. As a consequence, asylum seekers and refugees are extremely vulnerable to some common mental health conditions, i.e., post-traumatic stress disorder, anxiety, depression and other forms of disabling psychological distress. The World Health Organization has developed a new 5-session self-help intervention called Self-Help Plus (SH+) for managing stress and coping with adversity. SH+ has been evaluated in RCTs in low- and middle-income countries, however, there is no rigorous evidence on its cost-effectiveness in preventing the onset of mental disorders in HIC. Objectives To evaluate the effectiveness and cost-effectiveness of the SH+ in asylum seekers and refugees with psychological distress resettled in six sites of five European countries (Italy, Austria, Germany, Finland, and two sites in the UK), as compared with enhanced treatment as usual (ETAU). The primary outcome is the reduction in the incidence of any mental disorders. Secondary outcomes are mental health symptoms, psychological functioning, well-being, drop-out rates, and economic outcomes. Design This is a multicentre parallel-group randomized controlled trial, in which participants will have an equal probability (1:1) of being randomly allocated to the SH+ or the ETAU. Methodology Asylum seekers and refugees who screen positive at the General Health Questionnaire (≥ 3) and without a formal diagnosis of any psychiatric disorders according to the M.I.N.I. International Neuropsychiatric Interview will enter the study. After random allocation they will receive the SH+ or the ETAU. Assessments will be performed by masked assessors immediately after intervention, at 6 months, and a 12 months after randomization. Time frame The recruitment phase will last 12 months. After the screening, eligible participants will be assessed at baseline, post-intervention, and at 6- and 12-month follow-up. The SH+ delivery will be conducted in around 5 weeks. Expected outcomes A reduction in the incidence of psychiatric diagnoses at 6-month follow-up, and a general improvement in mental health symptoms, psychological functioning, well-being, and economic outcomes at each assessment.

The purpose of this study is to strengthen school achievement and positive mental health, and to prevent and reduce school dropout and mental distress among high school students. The researchers will scale up techniques that have already been proven highly effective in preventing common mental disorders (depression, anxiety) in high risk groups (indicated and selective prevention). The researchers will disseminate these techniques to entire first year classes of high school students irrespective of risk factors (universal prevention). The study will report whether universal delivery in school of "Mind Power" - a Cognitive Behaviour Therapy (CBT) based programme - will strengthen school grades, self-efficacy, self-esteem, self-regulation, mental perceptions and well-being, and prevent and reduce school dropout, and symptoms of anxiety and depression. In addition the researchers will analyse whether such universal delivery prevents more mental distress, and is more cost-effective than when it is delivered only to those at high risk for school failure, dropout, or mental distress.

L-tyrosine is a chemical precursor of dopamine. Under specific conditions, tyrosine administration can increase brain dopamine levels and therefore several studies have explored whether tyrosine supplementation can have a beneficial effect on cognitive and behavioural performance that is dependent on dopaminergic function. However, the effects of tyrosine supplementation are mixed: some studies show positive effects while others do not. Stress leads to an increase in dopaminergic activity and turnover in the brain, resulting in a decrease in brain dopamine levels. We propose to study the contribution of tyrosine to decision making and more particularly to the processes of response selection (mediated by the prefrontal cortex and under the influence of the dopaminergic system) in stressful situations.

The current pandemic highlighted an urgent need for early interventions to mitigate the psychological effects of extreme work demands that healthcare workers currently experience. This project aims at developing a data driven monitoring system to efficiently track work-related stress reactions over time. The system will also include a self-awareness intervention grounded on evidence-based strategies to improve workers' recovery. The solution will be delivered through a mobile application for a rapid implementation among healthcare workers and related professions. The mobile application will be developed through an initial analysis of pilot data, a factorial experiment and a user-experience analysis. Qualitative user experience data will also be used to validate the functionality of the monitoring system. The solution developed in this project will be easily scalable to related occupations, for example workers at elderly homes and social workers. After the pandemic, it can also be used as a preventive intervention for workers who are at risk of burnout and as a support for patients returning to work after treatment for common mental disorders.

In this study, a new psychosocial training for social relationships for adults will be evaluated. In a 6-module course, with four 3-day modules and two 5-day modules in the timeframe of one year, participants learn ways to strengthen their personal resources to establish effective social relationships and to develop skills as a social being. In between the module courses, the participants take 5 single sessions with an instructed trainer and document 10 conversations/social situations where they successfully apply the acquired personal and social skills. For my study, I will recruit a total of 200 persons. Approx. one hundred participants for the intervention group and 100 individuals for the control group. During the course of the training, the participants are taught social and personal skills that should result in a lower perceived stress level in daily life, improved health behaviour, a decreased presence of common somatic symptoms, a higher satisfaction with their lives, improved quality of their social relationships and a higher wellbeing. Data from study participants having accomplished additional training programs with the same training provider will be used to evaluate the influence on the results compared to participants without the extra addition for this study. The training participants will be assessed together with the controls. All study participants will be evaluated with standardized online questionnaires.

The aim of this study is to evaluate how different combinations of prebiotics and polyphenols affect the gut microbiota and perceived cognitive state. 40 volunteers will take part in this study who will be randomised into 4 different groups. One group will consume a placebo, whereas the other groups will consume prebiotics, polyphenols, or a combination of the two.

The goal of this project is to adapt and test the efficacy of the National Institute of Environmental Health and Safety (NIEHS) Disaster Worker Resilience Training (DWRT) Program for Superstorm Sandy responders. The DWRT is a brief, 4-5 hour training program designed to improve resilience for stress reactions in active emergency responders. A total of 120 participants will be recruited. 60 will receive the DWRT, and 60 will be assigned to a waitlist control condition. A three-month assessment period will be utilized to enable us to evaluate the effects of the intervention. Participants assigned to the waitlist condition will be offered the option to participant in the course following completion of the 3 month wait period. It is hypothesized that, participants attending the DWRT program, as compared to those in the waitlist condition, will show increased resilience at three months post-intervention as indicated by lower perceived stress, greater posttraumatic growth, more positive health behaviors (e.g., sleep, nutrition, exercise), and fewer new PTSD and depression symptoms. It is predicted that participants attending the DWRT program, as compared to those in the waitlist condition, will demonstrate greater awareness of the mental health effects of disasters, including the symptoms of PTSD and depression. It is predicted that, participants attending the DWRT program, as compared to those in the waitlist condition, will endorse more positive attitudes towards mental health care, including willingness to seek treatment if needed.