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NCT04661774
Diaphragm dysfunction, are refractory to drug therapy. This encourage investigators to explore new non-drug therapeutic paths, such as plantar reflexology (RP). The investigators proposed a comparison of the evolution of different parameters, quantitative and qualitative, to identify biomarkers and highlight the specific effect of RP on the diaphragm function, compared to placebo.
NCT07560072
The aim of this clinical trial is to evaluate whether AGENCIA, a brief psychological program supported by digital technology and artificial intelligence, can help reduce emotional and behavioral difficulties in adolescents aged 12 to 18. These difficulties may include irritability, impulsive behaviors, conflicts at home or at school, or difficulties in managing intense emotions. The study also aims to determine whether the effects are similar across adolescents with different symptom profiles or neurodevelopmental characteristics. Participants will be randomly assigned to one of three groups: AGENCIA Digital: a self-guided online version completed at home. AGENCIA in-person with a digital assistant: a clinician-delivered version supported by an interactive digital assistant to guide the exercises. Digital psychoeducation (control): a self-guided online program providing general information about adolescent well-being. The main research questions are: Does AGENCIA reduce overall emotional and behavioral difficulties? Does the program improve functioning, family accommodation, and personal agency (a young person's sense of being able to act and make changes)? Are the effects similar across adolescents with different profiles or neurodevelopmental characteristics? Participants will: * Complete three structured sessions depending on their assigned group. * Complete brief online questionnaires at baseline (T0), immediately after the sessions (T1), and at 1-month (T2) and 6-month (T3) follow-ups. * Receive brief phone calls during follow-ups to support questionnaire completion. A total of 465 adolescents will take part in the study. Participation is voluntary and does not replace usual clinical care. The study does not involve medication or invasive procedures, and all digital tools operate within secure institutional systems.
NCT06935604
The study aims to evaluate the impact of a bedside-delivered virtual reality (VR) mindfulness experience on well-being and psychosocial outcomes among hospitalized adult patients compared to standard of care (SOC; no added mindfulness intervention).
NCT02257853
Background: \- People who have an allogeneic hematopoietic stem cell transplant (HSCT) need help as they recover. Being a caregiver can be stressful to the body and mind. Researchers want to find ways to reduce this stress. Objective: \- To see how a stress reduction intervention affects the stress levels and health of an HSCT caregiver. Eligibility: \- Adults age 18 and older who plan to be an active caregiver for a person having their first allogeneic HSCT at the NIH Clinical Center. An active caregiver is someone who will be caring for the person from just before admission for the HSCT until at least 6 weeks after. Design: * Participants will be put in either the intervention group or the control group. * All participants will get the usual caregiver education given to all patients and caregivers having a stem cell transplant at the NIH Clinical Center. * All participants will have 2 study visits. They will give blood samples. They will have health assessments and brief physical exams. They will fill out study questionnaires and have an exit interview. * The intervention group will get an MP3 player. It will have an audio file with a stress reduction intervention on it. Participants will do this intervention daily. It takes 20 minutes. They will do gentle stretches and breathing exercises. They will get a diary to track their practice. * The intervention group also will have follow-up phone calls 2 and 4 weeks after their first clinic visit. * The person getting the HSCT will not be actively involved in the study. * The study will last about 2 months.
NCT07129590
Trauma-informed approaches have been shown to support recovery from other substance use disorders and involve four key elements: (1) Realizing the prevalence of trauma and pathways to recovery, (2) Recognizing symptoms of trauma, (3) Responding by embedding knowledge of trauma into practices and policies and (4) Resisting re-traumatization (the 4Rs). In close partnership with Breathe California and a public safety-net clinic in San Francisco that serves primarily racial and ethnic minoritized (REM) pregnant women, the 4Rs along with the Ask, Advise, Assess, Assist and Arrange (the 5As) evidence-based intervention for tobacco cessation that is delivered by health care professionals and is a US Public Health Services clinical practice guideline for treating tobacco will be used to create and implement a smoking cessation intervention for pregnant women with experiences of trauma.
NCT07521878
Objective of the study: The primary aim of this study is to evaluate the feasibility of a proposed intervention designed to support the daily movement practices and fostering joy of movement in Danish kindergartens, as well as the implementation strategies intended to facilitate adoption. Additionally, the feasibility of the planned measurement and procedures for a future effectiveness study will be examined. Methods: The study uses a mixed-methods design to examine the feasibility of the intervention and the future evaluation design. The planned duration of the intervention period is 10 weeks. The intervention consists of multiple integrated components co-designed with pedagogical staff, leaders, experts in kindergarten movement culture, and a team of researchers, to collectively support the daily movement practice in kindergartens. Alongside the intervention components, tailored strategies are developed to facilitate adoption and implementation. The intervention elements are categorized into four main types: 1) Formal establishment of the project; 2) Components of physical activity integrated in existing structures in the kindergarten; 3) Organizational and staff training; 4) Inspirational materials, tools and exemplary plans. The use of a co-design approach in close collaboration between kindergartens, experts, and a team of researchers will ensure contextual relevance and shared ownership. This approach is expected to enhance acceptability, feasibility, and sustainability of the intervention. The mixed-methods evaluation design, use of theoretical implementation frameworks, and tailored strategies further strengthen the study. The findings from this feasibility study will inform the refinement of the final intervention and guide the planning of a forthcoming effectiveness study.
NCT07018765
This randomized controlled trial aims to evaluate the effects of a Mindfulness-Based Stress Reduction (MBSR) program on birth memory and perception of traumatic birth among women who have undergone vaginal delivery. The study will be conducted between July and October 2025 at Malatya Training and Research Hospital. Participants in the intervention group will attend an 8-week MBSR program, while the control group will receive no intervention. Data will be collected using validated scales before and after the intervention. The primary outcomes are changes in birth memory and traumatic birth perception scores.
NCT05696353
To translate our evidence-based, parent-engagement safe teen driving intervention to a high-risk, rural and urban teen drivers with a traffic violation, and to test the implementation, effectiveness, and cost-effectiveness of the proposed intervention.
NCT07474363
Depression is a common and serious mental health condition that affects mood, thoughts, behavior, and overall quality of life. It arises from a complex interaction of biological, psychological, and environmental factors. While depression is more frequently diagnosed in women, research suggests that men may experience and express depressive symptoms differently. Men are more likely to display symptoms such as irritability, anger, impulsivity, or increased alcohol use, and they may be less likely to seek professional psychological support due to social expectations and fear of stigma. Stigma-both self-stigma (internalized negative beliefs about having a mental illness) and perceived social stigma (concerns about being judged by others)-can negatively influence individuals' willingness to seek help and adhere to treatment. In addition, psychological resilience, defined as the ability to cope effectively with stress and adversity, may play an important role in how individuals experience depressive symptoms and respond to treatment. This study aims to compare women and men diagnosed with Major Depressive Disorder in terms of depression severity, gender-sensitive depressive symptoms, self-stigma, perceived social stigma, and levels of psychological resilience. It will also examine the relationships among these factors to better understand how gender-related differences influence the experience and management of depression. Findings from this study may contribute to improved recognition of gender-specific features of depression, reduction of stigma, and the development of more individualized and effective mental health interventions for both women and men.
NCT06566118
During the recovery process, the activity of the sympathetic system decreases, while the activity of the parasympathetic system increases. In line with this information, the nervous system can be regulated in a noninvasive and practical way by using transcutaneous auricular vagus nerve stimulation in order to achieve rapid recovery in the athlete after the activity.
NCT07417839
Goal To compare the effectiveness of a toy nebulizer versus distraction cards in reducing fear among children during nebulization therapy while improving parental satisfaction. Aim To evaluate and measure children's fear levels and parents' satisfaction when using toy nebulizers compared to distraction cards in nebulization sessions. Null hypothesis: (Hᴏ) There is no statistically significant difference in fear levels among children, and parental satisfaction scores in in the toy nebulizer, distraction cards, and control groups. Alternative hypothesis: (H₁) There is a statistically significant difference in fear levels among children, and parental satisfaction scores in the toy nebulizer, distraction cards, and control groups.
NCT07464860
Postoperative complications after surgical procedures, including following total knee arthroplasty (TKA), have a negative impact on the health and well-being of surgical patients. Older adults (≥65 years) are particularly vulnerable to postoperative complications and their associated morbidities due to the biological aging process. Older adults comprise nearly half of surgical patients worldwide, and this number is expected to increase in the next 10-20 years as the aging population continues to grow. TKA is the most common procedure undergone by older adults, and the rate of TKA procedures is also expected to rise. Despite perioperative guidelines and protocols to prevent postoperative complications, the prevalence of postoperative complications following TKA is approximately 12%. Given these statistics, millions of older adults undergoing TKA may be at risk for postoperative complications and their associated morbidities in the coming decades. Therefore, additional interventions are needed to combat postoperative complications in this population. The body's natural response to surgery, also known as the surgical stress response (SSR), contributes to postoperative complications through complex mechanisms involving the autonomic nervous system (ANS). Increased sympathetic nervous system (SNS) activity, or the body's fight-or-flight response, causes dysregulation in feedback systems that regulate the stress response, potentially leading to poorer outcomes. Interventions, such as breathwork, that induce the parasympathetic nervous system (PNS), or the body's rest-and-digest response, have been shown to balance the ANS, regulate stress biology, and improve outcomes. This study will examine the feasibility of adding a breathwork intervention (Box Breathing), compared to an attention control, to standard perioperative care for older adults undergoing TKA. This study will also examine the proof of concept that Box Breathing, compared to an attention control, may help regulate the SSR by assessing an objective measure of stress-related biology, diurnal cortisol rhythm, and gathering self-report information on pain, anxiety, depression, and quality of recovery following TKA.
NCT06771167
Established in 2021, NYCEAL consists of approximately 40 organizational partners and 120 Community Health Workers (CHWs). Over the next four years (2024-2028), NYCEAL will work with this network to implement the following intervention: Building Community Resilience Program (BCR). To assess the impact of this intervention, an implementation research framework will be used, and pre- and post-surveys conducted, and other process evaluation measures collected. Changes in outcomes measures such as stress, resilience, overall wellbeing, and other related outcomes for participants in the BCR program will be measured for community healthcare workers and/or frontline workers that receive educational workshops.
NCT05523414
The goal of this pilot SKY (Sudarshan Kriya Yoga) Breath Meditation study is to establish feasibility and acceptability of the intervention; and investigate preliminary effectiveness of the intervention at the DNA methylation, RNA and protein levels in blood samples collected from participants before and after the 8 week SKY intervention. Primary outcomes also include preliminary effectiveness at the physiological level using a wearable device used for continuous monitoring. Secondary outcome measures include behavioral inventories.
NCT06941428
Trauma-focused cognitive behavior therapy (TF-CBT) has the strongest evidence of any clinical intervention for youth trauma but is rarely adopted in the education sector - the most common setting for youth mental healthcare. Use of TF-CBT in schools is limited by (1) problems with its usability (e.g., rigid structures, complicated patient identification workflows) and (2) provider perceptions that some core elements (e.g., exposure) are not contextually appropriate for schools; both of which hinder provider and student engagement with TF-CBT. Our preliminary studies identified that TF-CBT demonstrates "below average" usability, suggesting that many providers are likely to experience it as excessively onerous (e.g., due to lengthy sessions, low caregiver engagement). Without a systematic process for redesign, treatment adaptations made to improve intervention-setting fit can be reactive and risk omitting their core elements or functions. Locally driven, user focused redesign of TF-CBT for schools that maintains its core functions can enhance the accessibility and impact of evidence-based trauma treatment for youth. In light of the need for usable, contextually appropriate, and engaging interventions for youth trauma, the current project will iteratively adapt TF-CBT for use by school-based providers (e.g., school counselors, school social workers) via the University of Washington ALACRITY Center's (UWAC) Discover, Design/Build, Test (DDBT) approach and methods drawn from the field of human-centered design.
NCT07429968
DSPPea34 (Shared Care Program for Children and Adolescents) is an experimental health program designed to provide rapid, guided care orientation for youth aged 6-18 when a first-line psychological follow-up is considered by a general practitioner or pediatrician. The program links hospital-based services and community providers by offering prompt contact and assessment by a registered nurse and/or psychiatrist, with structured feedback to the referring physician. Primary objective: To identify facilitators that support the engagement of all professionals involved in the care pathway of children and adolescents with psychological difficulties. Facilitators will be mapped across five stages of the pathway: (1) intake, (2) assessment, (3) orientation/referral, (4) inter-partner collaboration, and (5) discharge from the program. Results will be used to refine DSPPea34 specifications to inform broader implementation. Methods and study population (primary objective): A Delphi survey will be conducted with stakeholders directly interacting with families and youth within DSPPea34 (e.g., general practitioners (GP), pediatricians, program clinicians) as well as with program users. Secondary objectives and data sources: To describe (i) the sociodemographic and clinical characteristics of youth using DSPPea34 services and (ii) their care trajectories using quantitative methods. Data will be extracted from DSPPea34 records via the SPICO coordination file (the tool used to facilitate exchanges between the GP/pediatrician, DSPPea34, and the psychologist in charge of follow-up) and complemented by soliciting longitudinal outcome information from the referring physician based on DSPPea34 follow-up. Findings from this mixed-methods evaluation are expected to guide the optimization and potential scale-up of the DSPPea34 model.
NCT07360301
This study is exploring how psilocybin (a psychedelic drug) may improve mood and wellbeing. Many people report feeling better after taking psilocybin, but it is not clear why. The CoPEWell study will test whether these improvements come from the psychedelic experience itself (the "trip") or from direct effects on the brain. To study this, up to 120 participants will be enrolled to receive psilocybin either while awake or asleep and can expect to be on study for up to 4 months.
NCT04317664
The purpose of this study is to test the effects of an in-vehicle driving feedback technology, with and without parent communication training, on risky driving events, unsafe driving behaviors, and subsequent traffic violations among teens who have recently received a moving traffic violation.
NCT07280078
The aim of this study is to learn whether a program that combines yoga, meditation, and mindful eating can help reduce stress, anxiety, and depression, and improve mindfulness in university students. The main questions the study aims to answer are: * Does participating in yoga, meditation, and mindful eating sessions lower students' levels of stress, anxiety, and depression? * Does the program improve students' mindfulness and general well-being? What will happen in the study: Participants will: * Attend weekly sessions of yoga, meditation, and mindful eating for 32 hours total. * Practice physical postures (Asanas), breathing exercises (Pranayama), relaxation, and meditation. * Receive short lessons about mindful nutrition and healthy lifestyle habits. * Complete questionnaires before and after the program to measure stress, anxiety, depression, and mindfulness.
NCT07417579
Mindfulness and meditation based relapse prevention has been proposed as an adjunctive approach for individuals with substance use disorders (SUDs). This completed pilot observational case series describes outcomes from three de-identified participants who completed an eight-week mindfulness and meditation program designed to reduce stress, enhance coping skills, and support sustained recovery. Participants demonstrated improvements in perceived stress and mindfulness following the intervention. Two participants experienced relapse within 10-12 months, while one participant maintained long-term sobriety. This small case series provides descriptive clinical insights and supports the feasibility of mindfulness-based interventions in real-world treatment settings.