Stress is a common experience that affects emotional and physical well-being and is studied in clinical trials to assess various interventions aimed at managing its impact. Research for stress often involves evaluating treatment approaches such as be...
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Found 1752 Actively Recruiting clinical trials
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Researchers are investigating the relationship between functional measures of balance and gait and objective kinetic and kinematic parameters in people with Multiple Sclerosis (MS). This cross-sectional observational study aims to understand how biomechanical gait and balance data collected through the Vicon motion analysis system relate to clinical assessments of balance, gait, and physical performance. The study seeks to identify which biomechanical factors are most closely linked to functional abilities and mobility challenges in MS. Participants will attend a single laboratory session where they will undergo biomechanical analysis of balance and gait using the Vicon motion capture system. They will also complete standardized functional tests including the Mini Balance Evaluation Systems Test, Functional Gait Assessment, Short Physical Performance Battery, and a 2-Minute Walk Test. Additionally, they will fill out questionnaires assessing fear of falling and fatigue and have their lower-limb spasticity evaluated with the modified Ashworth Scale. During the session, which takes about 40 minutes for the primary kinetic and kinematic analysis and additional time for functional assessments, researchers will collect detailed movement data alongside clinical measures. This data will be analyzed to explore correlations between biomechanical parameters and functional outcomes. The study includes assessments of postural control, gait performance, physical endurance, fatigue, and spasticity. The findings aim to improve understanding of movement impairments in MS and support better clinical assessments and rehabilitation approaches.
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Researchers are evaluating erectile function changes in male patients who undergo percutaneous coronary intervention (PCI) for either a heart attack or stable angina. The study aims to understand how myocardial infarction affects erectile function over time and to explore whether erectile dysfunction can predict future cardiac events. This observational study compares erectile function between patients with myocardial infarction and those with stable angina using standardized questionnaires. Participants are grouped into two sets: those treated with PCI after a heart attack and those treated due to stable angina. Erectile function is assessed at baseline (after recovery from PCI), and at 3 and 6 months post-procedure using the International Index of Erectile Function (IIEF) questionnaire. Additional assessments include the Beck Depression Inventory and Fear of Cardiac Recurrence and Progression Scale. Researchers also collect clinical data such as cardiac vessel scores, ejection fraction, testosterone levels, body measurements, medication use, and the intervention method. During the study, male participants aged 30 to 75 will complete face-to-face interviews and questionnaires at specified intervals: baseline, 3 months, and 6 months after PCI. The study measures changes in erectile function scores over time and examines associations with cardiac health, depression, and anxiety symptoms. Safety and participation are monitored throughout the follow-up period. The total duration of involvement is up to 6 months, with evaluations focusing on erectile function and related health parameters.
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Researchers are evaluating the "One All" curriculum, which uses the sport Ultimate Frisbee to improve mental health resilience among young tribal people in two communities in South India. The study aims to see if this intervention is feasible and acceptable while assessing its effectiveness in building resilience and mental well-being. The research involves young tribal adults aged 12 to 25 years from Gudalur in Tamil Nadu and BR Hills in Karnataka. The intervention includes a three-year curriculum delivered by trained community facilitators who adapt the program to fit local needs. Participants attend two or more sessions each week, each lasting about one and a half hours. Sessions involve warm-up activities, drills, ultimate frisbee games with modified rules, and group discussions called spirit circles. The program focuses on developing skills such as self-management, social awareness, empathy, identity building, and conflict resolution. Participants undergo assessments before the program starts, after 12 months, and after 18 months. These include questionnaires measuring resilience (Child Youth Resilience Measure and Connor-Davidson Resilience Scale), mental health (GHQ12), and self-efficacy. Researchers will track attendance and reflections from sessions but will not access medical records. The study involves a baseline interview collecting socioeconomic data and assigns participants codes to protect privacy. Total participation lasts at least 18 months to evaluate outcomes.
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This research aims to evaluate how a structured productivity training program affects nurses' perceived job stress and their attitudes toward productivity. The study is designed as a randomized controlled experimental trial with assessments before the training, immediately after, and three months later. Researchers want to see if nurses who receive the training report lower stress and better productivity attitudes compared to those who do not. The study involves two groups: an experimental group that receives a three-week productivity training totaling 20 hours, and a control group that receives no training during the same period. The training covers nursing productivity concepts, time and stress management, teamwork, leadership, digital tools, and coping with job stress. Various teaching methods like lectures, case studies, simulations, and group work are used to improve cognitive, emotional, and practical skills. Participants will complete assessments using the Nurses' Attitudes Toward Productivity Scale and the Perceived Job Stress Scale at three time points: before training, right after the training, and three months later. The control group also completes these assessments without receiving training during the study but will get access to the training materials afterward. The total study duration includes the training period plus follow-up assessments to monitor lasting effects.
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This research aims to evaluate a 5-session cognitive behavioral program called 1MoreStep, designed for Black women living with HIV who have experienced intimate partner violence in the past two years. The study focuses on teaching skills to access personal and external strengths, safety strategies, knowledge about HIV care and stigma, communication skills to handle stigma, and addressing barriers to HIV care. It also examines the program's acceptability and feasibility among participants. Participants are randomly assigned to either the 1MoreStep intervention or an equal attention control group. The intervention includes seven group sessions and one individual session held weekly, led by experienced facilitators from the Black community. Sessions cover topics such as safety planning, HIV care engagement, stigma communication, and goal setting using cognitive behavioral skills. The control group attends weekly support group sessions that cover general health topics important to Black women living with HIV but not directly related to the intervention's goals. Throughout the study, participants complete assessments at baseline, 3 months, and 6 months to measure changes in safety strategies and HIV care engagement. Measures include surveys, medical record reviews, and interviews to evaluate treatment acceptance, session attendance, and participant experiences. The study spans approximately 6 months post-baseline, with follow-up surveys and qualitative interviews to explore program fit and barriers to participation.
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Researchers are investigating how the antidepressant citalopram affects the brain's response to emotional information, focusing on the amygdala, a key brain area involved in depression. This study explores how different parts of the amygdala react to positive and negative emotional stimuli, using advanced brain scanning technology to understand the underlying brain mechanisms. Participants will receive a single oral dose of either 20 mg citalopram or a placebo in a randomized, double-blind design. After dosing, participants will undergo high-strength 7T fMRI brain scans while viewing emotional faces. This precise imaging allows researchers to observe how citalopram influences specific subfields of the amygdala during emotional processing. Participants will be screened for medical and psychiatric health before joining. During the study, brain activity and behavioral responses such as accuracy and reaction time during a gender discrimination task will be measured about three hours after dosing. The study includes safety monitoring and lasts for a few hours on the study day, focusing on neural and behavioral outcomes related to emotional processing.
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Researchers are evaluating a community health worker-delivered mental health counseling intervention delivered remotely via a mobile health app to reduce anxiety and depression among people living with HIV in Florida. This pilot randomized controlled trial aims to assess the preliminary effectiveness of this adapted positive affect counseling approach compared to the standard version of the app and usual mental health care. The study is sponsored by the University of Florida and focuses on improving mental health outcomes in this population. Participants will be randomly assigned to one of two groups. The intervention group will receive approximately five weekly 60-minute individual counseling sessions via secure video calls through a modified PositiveLinks app that includes enhanced mental health resources. If symptoms do not improve, participants may be referred to a licensed mental health professional. The control group will use the standard PositiveLinks app, which provides feedback on anxiety and depression symptoms and a list of local mental health resources without counseling. During the study, data will be collected from participants' electronic medical records and the app for about six months after enrollment. Researchers will measure changes in anxiety and depression levels at three months as primary outcomes. Participants will provide informed consent before joining, and there is no masking or blinding in the trial. The study will monitor mental health symptoms and the use of counseling through app data and medical records to evaluate the intervention's preliminary effectiveness.
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Women who have experienced interpersonal violence often face a higher risk of developing post-traumatic stress disorder (PTSD). In France, female victims can request a medico-legal examination at a clinical forensic medicine unit, which also offers initial psychological assessment. However, many women do not attend follow-up appointments. This research is a prospective, multicenter, open-label, randomized controlled trial aiming to evaluate the effectiveness of a case management algorithm that uses early phone contact to improve clinical outcomes after such consultations for female victims of violence. Participants are divided into two groups. The experimental group, called VIGITRAUMA, will receive a phone call three weeks after their consultation, with a second call if needed. If contact is not made after the second call, a postcard will be sent. The control group will receive the usual follow-up care without this additional phone contact. The study is conducted by the University Hospital, Lille. Participants will be assessed through phone calls at 3, 6, and 12 months after their consultation to monitor clinical outcomes. Researchers will measure PTSD symptom severity, general psychopathology, somatic symptoms, medical costs, judicial outcomes, suicidal thoughts, and suicide attempts. The study aims to track these outcomes over a full year to understand the impact of the case management algorithm compared to standard care.
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This research aims to evaluate interventions to support family members who act as surrogate decision makers for critically ill patients in Intensive Care Units (ICUs). These surrogates often face intense grief and stress that can affect their mental health and the quality of decisions made for their loved ones near end-of-life. The study focuses on reducing symptoms of prolonged grief disorder (PGD), post-traumatic stress disorder (PTSD), and related emotional challenges through a psychological intervention called EMPOWER. The study compares two approaches: the EMPOWER intervention, which is a brief, cognitive-behavioral and acceptance-based treatment delivered by trained mental health professionals, and a Supportive Conversation (SC) that provides empathetic support without specific skill-building. EMPOWER includes six 15-minute modules and two booster phone sessions, totaling about 90 minutes plus follow-ups, while the Supportive Conversation matches this time with supportive interaction and follow-up calls. Participants are assessed up to four times before and after the intervention within three months. Participants, who are surrogate decision makers of ICU patients near end-of-life, will complete assessments on grief, PTSD, depression, regret, anxiety, and distress before the intervention, immediately after, and at 3 and 12 months follow-up. The study also includes interviews with some participants to better understand the intervention's effects and contextual factors during the COVID-19 pandemic. The primary outcomes focus on changes in grief and PTSD symptoms over twelve months, with safety and mental health monitored throughout the study period.
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Researchers are investigating the effects of the PAX Good Behavior Game (GBG) in Swedish primary schools to address growing concerns of mental health issues among children and stress-related symptoms in teachers. This cluster-randomized controlled trial involves 28 schools and about 84 teachers, aiming to improve student well-being and reduce teacher stress. The study compares PAX GBG to active control interventions that also provide teacher training but with different content. The trial includes extensive measurements over two years, including self-assessments, classroom observations, sound level monitoring, sick leave data, and qualitative interviews. Teachers randomized to the PAX GBG group receive a two-day training on ten specific tools designed to promote prosocial and focused behaviors in classrooms, including a team-based game rewarding good behavior. Control schools choose between two alternatives: 'Count On Me!', a math fluency application for pupils, or a Collegial Learning Community intervention focused on professional development for teachers. Both groups receive similar amounts of training and supervision, including multiple sessions during the school year. The interventions are integrated into regular classroom activities starting in grade 1 through grade 3. Participants include approximately 2200 pupils and their teachers, with data collected through various methods such as questionnaires, standardized tests, observer ratings, and registry data. Measurements occur at multiple time points over two years, focusing on pupil well-being, teacher stress, classroom behavior, noise levels, and implementation fidelity. The study also evaluates cost-effectiveness by comparing health outcomes and related expenses. Safety and adverse events are monitored through teacher reports and interviews, ensuring comprehensive assessment of the interventions' impact.
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