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Stress, Psychological clinical trials

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NCT ID: NCT06305585 Not yet recruiting - Clinical trials for Psychological Stress

Can a Novel Manual Therapy Technique Help Relieve Stress? Assessing Effects of Primal Reflex Release on the Body's Stress Response

Start date: March 2024
Phase: N/A
Study type: Interventional

Stress, when left unmanaged, can have detrimental effects on both physical and mental health, contributing to conditions such as high blood pressure, anxiety, and even cardiovascular disease. Effective stress management therapies may help maintain overall well-being and reduce the risk of long-term health complications. The Primal Reflex Release Technique (PRRT) is a novel manual therapy that may reduce markers related to stress such as heart rate variability (HRV) and patient-reported outcomes (PROs). Therefore, the purpose of this study is to elucidate the potential for PRRT to improve HRV and PROs.

NCT ID: NCT06294210 Not yet recruiting - Clinical trials for Stress Psychological

Supporting Secondary School Student Wellbeing Through a Mobile App and Wearable Biofeedback

EWSSS
Start date: March 11, 2024
Phase: N/A
Study type: Interventional

This study aims to investigate the effects of an app and wearable device on the wellbeing of secondary school students. The app will offer support for stress management, sleep improvement, and time management. Additionally, it will provide access to educational resources, text-based coaching, and biofeedback monitoring through the wearable device. The device, worn around the wrist, will measure heart rate variability as an indicator of stress response. Throughout the study, students will complete bi-monthly surveys on sleep, stress, and overall wellbeing. To assess the specific impact of each feature, the app features will be released incrementally over the course of a year. The intervention group, comprising students in their last two years of secondary school, will have access to the app and wearable device, while a control group within the same class will not use the system but will complete the same wellness surveys. Coaches on this platform will come from the Centre for Positive Health Sciences MSc in Positive Health Coaching as part of their continued training in coaching. Coaching will be asynchronous so that students can post questions at any time during the day, but coaches will respond within 24 hours, during office hours. It will be made clear that this is not a therapeutic service and will be directed to other resources for these services. Coaches will file an incident report if a risk arises from a message with participants. Participants will be given guidelines for the type of questions they can ask such as asking for advice for setting goals related to their digital habits and sleeping better. The study's findings will provide valuable insights into the effectiveness of the app and wearable device in enhancing student wellbeing leading up to their leaving certification exams.

NCT ID: NCT06270862 Not yet recruiting - Cognitive Change Clinical Trials

A Digital Active Aging Training Program for Older Adults

AAT
Start date: March 1, 2024
Phase: N/A
Study type: Interventional

The proposed project aims to develop and validate a multi-dimensional digital active aging program integrated with resilience to promote the biopsychosocial functions of older adults aged 60, including Chinese older immigrants in Canada (Study 1) and English-speaking White Canadian older adults (Study 2). The proposed study takes a typical pretest-training-posttest design. Pretest and posttest: a battery of outcome measures on physical, psychological, and social functions will be administered to all participants. Data will also be used to identify sociodemographic risk predictors for outcome variables (i.e., biopsychosocial functions and resilience). Training: the participants will be randomly assigned to three arms to receive 4 weeks of 16 training/practice/control treatment sessions delivered via Zoom. In the "active aging with resilience (AR)" condition, participants will complete physical, cognitive, and social engagement training modules, starting with a 30-min resilience-building module. The traditional "active aging" (AA) training involves the same multi-domain active aging training without the initial resilience-building module. The "workshop training" (WT) control condition involves workshops following the same 4-week schedule on aging-related topics.

NCT ID: NCT06238141 Not yet recruiting - Clinical trials for Stress, Psychological

Expressive Writing on Stress and Work-Related Outcomes Among Student Nurse Interns

Start date: July 2024
Phase: N/A
Study type: Interventional

The goal of this interventional study is to assess the effects of an intervention on stress and work-related outcomes among Chinese student nurse interns. The main questions it aims to answer are: - Does expressive writing reduce clinical practice stress and improve coping strategies in student nurse interns? - Does expressive writing increase work engagement and perceived professional benefit among student nurse interns? Participants in the intervention group and control group will perform expressive writing and neutral writing, respectively, based on different given instructions. In both groups, writing will last for 15 minutes each time, twice a week, for ten weeks. Researchers will compare the outcomes of the two groups to see if there are differences between clinical practice stress, coping strategies, work engagement, and perceived professional benefit.

NCT ID: NCT06224127 Not yet recruiting - Anxiety Disorders Clinical Trials

Treating Stress and Anxiety in Individuals With Alcohol Use Disorder (AUD)

Start date: July 15, 2024
Phase: Phase 1
Study type: Interventional

CT fibers are found in the skin of most mammals and project to the insular cortex. Stimulation of CT fibers by light touch causes a release of oxytocin and is associated with feelings of comfort and wellbeing. Peripheral TRPV-1 channels are important in pain transmission and modulation of the stress response likely through the central release of oxytocin and are stimulated by heat. In Phase 1 investigators will test stimulation of TRPV1 channels and CT fibers in human subjects to correlate the lab findings with subjective human responses and test whether stimulation of CT fibers and TRPV-1 channels reduce anxiety and stress in subjects who suffer from AUD. Aim 1 and 2. We will define the optimal parameters for CT fiber stimulation for force, temperature, and body location. We will perform similar testing for peripheral thermal stimulation (TRPV-1) using our commercially available heating pods. Parameters tested will include the optimal body location, number of heating pods (2-4) and temperature of pods. In Aim 3 investigators will simultaneously apply both CT fiber and thermal stimulation in a proof of concept study. The experimental group will receive active CT fiber and thermal stimulation and the control group non-physiologic placebo stimulation. Subjects with a history of AUD will be randomized into control versus experimental groups and undergo stress using a validated mental calculation stressors. Stress, cravings, and anxiety will be measured using standardized assessments, and investigators will measure salivary oxytocin and cortisol levels, potentially biomarkers.

NCT ID: NCT06203288 Not yet recruiting - Anxiety Clinical Trials

Well-being in Students and Teachers Study

WIST
Start date: January 15, 2024
Phase: N/A
Study type: Interventional

The goal of this randomized trial is to test the effectiveness of two universal classroom-based mindfulness social and emotional learning (SEL) programs (one for students and one for teachers) by examining behavioral outcomes on 5th and 6th grade students and their teachers. The main questions it aims to answer are: - What are the singular and combined effects of a mindfulness-based SEL education programs for teachers and their students on the development of students' and their teachers' social, emotional, and cognitive competence, and well-being? - Can mindfulness-based SEL education programs for students and teachers foster the creation of caring, inclusive, equitable, and collaborative classroom contexts? - Can mindfulness-based SEL education programs support the development of students' and teachers' prosocial attitudes, mindsets that positively impact student learning? - Are the effects durable beyond the end of the programs with regard to the singular and combined mindfulness-based SEL interventions? A total of 24 classrooms will be randomized into one of three study conditions: 1. Mindfulness SEL program for Educators only 2. Mindfulness SEL program for Educators and Mindfulness SEL program for Students in combination, and 3. "Business as usual" (comparison groups in which regular classroom SEL curricula is implemented). Data will be obtained via multiple objective and subjective methods (e.g., self- and teacher-reports, peer behavioral assessments) from different sources (e.g., self-, peer-, and teacher-reports). Data will also be collected to monitor implementation of the two programs. To explore the ways in which these two programs impact student, teacher, and classroom outcomes, data will be analyzed to compare students and teachers in the three conditions. In Phase One (year one), the investigators will conduct an experimental "outcome" study to examine the singular and combined effects of the two programs by comparing pre-test and post-test measures across the three conditions. In Phase Two (year two), the investigators will conduct a six-month follow up with those teachers and students who participated in Phase One in order to determine the degree to which the program effects are durable after the program has ended.

NCT ID: NCT06179264 Not yet recruiting - Depression Clinical Trials

Evaluating an Online Acceptance and Commitment Training Program for Individuals With Chronic Health Conditions

Start date: January 29, 2024
Phase: N/A
Study type: Interventional

Chronic health conditions (CHC) commonly share the challenge of impaired health-related quality of life, negatively impacting the lives of millions of people in the United States. Long term effects for living with a chronic health condition are likely to include poor self-management behaviors, which are related to avoidance of disease related thoughts and feelings (e.g., health anxiety) and can be addressed directly with psychosocial interventions. With the focus on fostering values driven and meaningful behavior while accepting thoughts and feelings, ACT may prove to be a particularly effective approach for individuals coping with the challenging symptoms and effects of having a chronic health condition. Previous web-based ACT interventions for CHCs have focused on building ACT skills for a narrow subset of CHCs (e.g., breast cancer, diabetes, tinnitus). While there is added benefit for a self-help program for populations with specific stressors or conditions, there is also a high prevalence of comorbidity in CHCs, shared challenges in illness management and coping, and clear evidence that ACT works effectively across CHCs to improve quality of life. Thus, our goal of this research project is to evaluate a new 6 session, online, self-guided ACT program for adults with chronic health conditions broadly to improve their quality of life and wellbeing through a randomized controlled trial. The specific aims are: 1. To evaluate the feasibility of an initial prototype of ACT program for adults with CHC's as indicated by recruitment, retention, and adherence rates. 2. To evaluate the acceptability as indicated by self-reported program satisfaction and qualitative feedback following the course completion. 3. To identify ways to further refine the program based on participant self-reported satisfaction with sessions and open-ended text-based feedback. 4. To test the efficacy of the program on improving quality of life among adults with CHC's.

NCT ID: NCT06085105 Not yet recruiting - Clinical trials for Stress, Psychological

Caring for Providers to Improve Patient Experience (CPIPE) Trial

CPIPE
Start date: March 2024
Phase: N/A
Study type: Interventional

The activities described in this proposal are aimed at addressing health care provider stress and unconscious bias to improve quality of maternal health care, particularly related to the person-centered dimensions of care-i.e. care that is respectful and responsive to women's needs, preferences, and values. The investigators focus on health provider stress and unconscious bias because they are key drivers of poor-quality care that are often not addressed in interventions designed to improve quality of maternal health care. The investigators plan to (1) test the effectiveness of an intervention that targets provider stress and bias to improve PCMC; (2) assess the cost-effectiveness of CPIPE; (3) examine the mechanisms of impact of CPIPE on PCMC; and (3) assess impact of the CPIPE intervention on distal outcomes including maternal health seeking behavior and maternal and neonatal health.

NCT ID: NCT05969431 Not yet recruiting - Clinical trials for Stress, Psychological

Hair Cortisol as Marker of Chronic Stress in Preterm and Term Fathers - Fathair-study

Start date: January 1, 2024
Phase:
Study type: Observational

The goal of this observational study is to compare the paternal hair cortisol as a marker for chronic stress in prematurely born children to maturely born children. The main questions it aims to answer are: - How differ the cortisol level between groups? - How change the cortisol level over time? - Are there secondary outcomes associated to the cortisol level of fathers? Participants will give a hair sample to analyse the cortisol level and fill out questionnaires at three time points. At six months of the infant's age, the investigators will also measure the paternal sensitivity.

NCT ID: NCT05891223 Not yet recruiting - Trauma Clinical Trials

The Effect of "Mindfulness-Based Compassionate Life Training" for University Students Affected by the Earthquake

Start date: February 5, 2024
Phase: N/A
Study type: Interventional

In this study, aimed to determine the effect of "Mindfulness Based Compassionate Life Training" given to university students on coping with post-earthquake trauma stress and grief process. According to the experimental design with pre-test and post-test control group, the participants selected from the universe will be assigned to the experimental and control groups impartially. In this study, a priori power analysis will be performed to determine the sample size. For the independent groups, in which the effect of "Mindfulness-Based Compassionate Life Training" on coping with post-earthquake trauma stress and grief will be compared, 80% power will be achieved at a significance level of 0.05 at a 95% confidence interval. A total of 68 participants will be reached by taking into account data losses and including 30% backup sample in the research. Participants included in the study will be numbered from 1 to 68 and 34 experimental and 34 control groups will be created from www.random.org. Pre-test data will be collected before applying to earthquake survivors in the experimental group and control group. 8 sessions of Mindfulness Based Compassionate Life training will be given to earthquake survivors in the experimental group. Training sessions will be held online. For its effectiveness and continuity, each session will be held between 3 days and 7 days. One week after the Mindfulness-Based Compassionate Living training (after 8 sessions were completed), the "Post-earthquake Trauma Stress Level Determination Scale (NSSTDBÖ)", "The Grief Scale" was administered to the earthquake survivors. The "Self-Compassion Scale Short Form (STS-F)" post-test will be filled in by face-to-face interview. Post-test data from the experimental and control groups will be obtained simultaneously.