Clinical Research Directory

Exercise Effects on the Neurobiology Underlying Stress-related Eating Behaviors in Veterans

The purpose of this study is to learn more about how common lifestyle interventions, such as exercise, affect how our brains respond to performing thinking tasks and to viewing pictures of foods and various other objects. The investigators are also interested in how changes in hormones that might be different in men and women could affect how lifestyle interventions change these brain responses.

Supporting Mental Health and Reducing Care Stress in Caregivers of Persons With Cardiovascular Disease

The purpose of this study is to evaluate the preliminary efficacy, feasibility, acceptability, and barriers and facilitators to implementation of the Confident Caregiver intervention among family caregivers of persons with cardiovascular disease participating in cardiac rehabilitation. Caregivers receive four individualized intervention sessions focused on assessment of caregiving challenges, tailored coaching, stress reduction, education, and referrals to supportive resources. Outcomes include reductions in caregiving-related challenges, improvements in mental health, and reductions in stress.

A Clinical Trial to Assess the Effect of AP-Brain Collagen Peptides on the Improvement of Attention, Focus, and Memory in Stressed But Otherwise Healthy Individuals

The goal of this clinical trial is to learn about the effects of AP-Brain collagen peptide on attention, focus, and memory in adults who are stressed but otherwise healthy. The main questions it aims to answer are: * How does AP-Brain affect a participant's attention, focus, stress, and memory? * Is there a difference in the effects between a higher dose and a lower dose? * What are the side effects, if any, for participants taking AP-Brain? Researchers will compare two different doses of AP-Brain to see how they affect brain function and stress levels. Participants in this study will be asked to: * Take one of two the doses of AP-Brain once a day for 56 days. * Visit the study center for regular checkups. * Complete tasks that measure memory, focus, and attention. * Answer survey questions about their stress levels. * Provide blood samples and have vital signs checked. * Have the brain's response to tasks monitored to see how it affects attention and alertness.

Internet Based Psychological Support

The investigators have developed interactive, multimedia-intensive, computer-based treatment programs that include depression (Problem-Solving Therapy), stress management, and conflict management. Together the three modules are called PATH. The problem-solving module is based on an evidence-based psychotherapy called Problem-Solving Therapy in which depressed patients identify problems in their lives and work through a structured format for solving these problems. We have subjected the problem-solving module to Phase 1-3 feasibility, acceptability and efficacy trials which have been positive and without adverse events. The conflict program uses a cognitive-behavioral-therapy-based approach. The program includes a conflict briefing, an interactive conflict simulation, a conflict assessment tool, an interactive training exercise in interest-based negotiation, and a cognitive restructuring exercise. The stress program also uses a cognitive behavioral therapy (CBT) approach. In the program, the mentor introduces the "stress pyramid", which demonstrates how stress triggers can lead to different feelings, actions and thoughts, which are analogs to the CBT realms of dysfunctional emotions, maladaptive behaviors, and faulty cognitive processes. The stress management content is delivered over 6 sessions, with each session including exercises in the 3 domains of thoughts, feelings, and actions. The program includes briefings, cognitive restructuring exercises, interactive scenarios, and self-assessments. This program has been evaluated with law and business students and was shown effective in reducing stress levels. The purpose of the current study is to make the problem-solving, stress, and the conflict modules available through the internet for any adult 18 or older in order to assess their feasibility, acceptability and effectiveness under naturalistic conditions.

Adaptive Coping Skills Training to Improve Psychological Distress Among Cardiorespiratory Failure Survivors

Conditions treated in intensive care units (ICUs) such as the acute respiratory distress syndrome (ARDS), congestive heart failure, COVID pneumonia, and sepsis are common. These can lead to high rates of depression, anxiety, and PTSD that worsen quality of life. Yet there are few effective strategies able to overcome barriers of limited access to mental health care. Even less is known about the experiences of patients from racially and ethnically minoritized populations because of they haven't been included well in past research. To address this problem, the investigators developed Blueprint, a mobile app that coaches people to use adaptive coping skills to self-manage their symptoms. The investigators found that it reduced depression symptoms and improved quality of life compared to placebo. To confirm these promising findings, the investigators are doing a formal test of Blueprint. The investigators will enroll 400 people who received ICU care from 4 hospitals (Duke, UCLA, Colorado, and Oregon). These patients will be randomized to receive either the Blueprint mobile app or a special Education Program mobile app the investigators developed. -both delivered through similar mobile app platforms. Our specific aims are to see which program improves symptoms better across 6 months of follow up. This project addresses national research priorities and could advance the field with a personalizable yet population-focused therapy that could be scaled broadly and efficiently to enhance mental health equity.

Operating Room Black Box Supported Debriefings and Their Effect on Healthcare Professionals Effectiveness and Psychological Safety.

This study is enrolled in the European KEEPCARING Project. KEEPCARING aims to (re-)build wellbeing and resilience of healthcare workforce in EU hospitals by co-creating a multi-faceted non-digital, digital, and AI-supported solution package to prevent burnout among (aspirant) healthcare professionals on the individual, team, and organizational level. This study specifically investigate the operating room staff wellbeing and resilience. The healthcare system is currently struggling to retain and attract operating room personnel. A factor of importance to consider here is occupational stress. If not recognized or mitigated well, occupational stress and personal efficacy can eventually evolve into a syndrome labelled as 'burnout'. In addition, communication and resilience patterns between operating room staff members are of influence, poor and/or inadequate communication among staff may be a factor of stress, compromising their work and wellbeing. In contrast, communication patterns that have a high standard and clarity may support resilience. The ability to speak up and being able to advocate concerns of all team members is of the highest importance here. Indeed, psychological safety and effective teamwork patterns are key for the working environment, performance, patient safety, and job satisfaction. To prevent mistakes during surgery, a safe space where team members can freely speak up is vital. To improve psychological safety, and teamwork among OR staff, team debriefing after surgery is known to be effective. What is not known; is whether team debriefing with the additional support derived from audio- and video recordings of the surgery is equally effective as debriefing without. The objective of this study is to evaluate the impact of structured postoperative debriefings with and without procedural, structured audio- and video recordings, on team performance, psychological safety, and non-technical skills in the operating room. Specifically, this study aims to compare augmented debriefings with non-augmented debriefings, to assess differences in perceived usefulness, psychological safety, and observed improvements in teams' non-technical skills. This is an international quasi-experimental comparative study. The intervention consists of postoperative team debriefing using audio and video recordings ('augmented debriefing') from Operating Room Black Box system provided by Surgical Safety Technologies. The control group will have a postoperative team debriefing that is not augmented with Operating Room Black Box derived data. An identical debriefing template will be designed for both groups.

An ISO Principle-Based Music Intervention for Reducing Stress, Anxiety, and Depression

This study aims to evaluate the effectiveness of a music-based intervention, guided by the ISO principle, in reducing stress, anxiety and depression induced by work, family or others among adults. The ISO principle suggests that emotional regulation can be supported by gradually modifying the emotional characteristics of music to help individuals transition to a desired emotional state. Participants in this study will be randomly assigned to either a music intervention group or a control group. The intervention group will receive personalized music playlists designed to help reduce stress, anxiety and depression. The control group will not receive any music intervention during the same period. Outcomes will be measured using self-report questionnaires assessing stress, emotional state, and well-being. The study is designed to contribute to the development of accessible, non-invasive stress management tools using music as a behavioral intervention.

Evaluating Stress Management Strategies Within the School Readiness Parenting Program

The goal of this randomized study is to learn if adding three additional parent training sessions (focused on alleviating parental stress) to an already well-established treatment (School Readiness Parenting Program \[SRPP\]) in improving outcomes up to 6- and 12-months later for families of children with disruptive behavior disorders. The main questions it aims to answer are: The primary objective of this protocol is to evaluate the effects of three additional cognitive behavioral therapy (CBT) based parent training sessions to the SRPP to reduce parent stress and improve parent-child interactions. The secondary objective of this protocol is to evaluate the behavioral, emotional, and physical health-based functioning among young children with ADHD. Researchers will compare families who receive the SRPP alone to families who receive the SRPP + the three additional CBT focused sessions. Parents will be sent surveys to complete prior to the baseline assessment via REDCap (online). Parent and child participants will undergo 2 hours of baseline assessments evaluating behavioral, cognitive, and academic functioning as well as parent-child interactions. Parents will provide contact information for their child's teacher and the teacher will sent three surveys to complete online via REDCap.

Cannabidiol (CBD) and Stress Response: Psychobiological Mechanisms

The aim of this study is to determine the effects of regular cannabidiol (CBD) use on the psychobiological mechanisms of the stress response. This will be achieved by comparing acute stress responses of adults who either use or do not use CBD regularly. Correlates of CBD use, including tobacco use, will be collected.

Racism-related Stress and Objective Short-sleep as Moderators of Treatment Effect in Cognitive Behavioral Therapy for Insomnia

The purpose of this study is to understand whether Black participants with insomnia with objective short-sleep (ISSD) experience less symptom improvement in response to Cognitive Behavioral Therapy for Insomnia (CBTi) than Insomnia with Normal Sleep Duration (INSD) and whether this difference is driven by downstream racism-related stress and experiences. The investigators propose an innovative pragmatic open-label design in which Black participants with insomnia undergo a standard 6-week protocol of digital CBTi. The investigators will quantify ISSD using wireless EEG and will gather high-resolution naturalistic data of racism-related stress using random smartphone prompts and Ecological Momentary Assessments (EMA).

Influence of Melatonin on Cardiovascular and Thermoregulatory Responses to Stress

This study aims to evaluate the influence of acute oral melatonin supplementation on cardiovascular and skin temperature responses to mental stress. The hypothesis is that acute melatonin will lead to reduced cardiovascular and skin temperature responsiveness to acute mental stress.

MINDFULNESS-BASED EDUCATION FOR WOMEN WITH POLYCYSTIC OVARY SYNDROME

Polycystic ovary syndrome (PCOS), also known as polyendocrine metabolic ovarian syndrome (PMOS), is the most common endocrinologic disorder to affect women. Despite this, the disease's pathophysiology remains unclear. This has hindered the diagnosis of the disease and the appropriate treatment for millions of individuals. The long-term health sequelae associated with PCOS, future directions, and areas of needed research in this often-overlooked disease. Women with PCOS may experience menstrual symptoms, increased stress, and difficulties in managing the physical and emotional effects of the condition. Supportive approaches that improve symptom management and quality of life may be beneficial in addition to routine care. The aim of this randomized controlled study is to evaluate the effect of mindfulness-based PCOS education on menstrual symptoms, stress levels, and quality of life in women with PCOS. The study will examine whether a structured mindfulness-based education program can support women in managing PCOS-related symptoms and improving their overall well-being. Women diagnosed with PCOS who meet the study eligibility criteria will be invited to participate. Participants will be randomly assigned to either the intervention group or the control group. Participants in the intervention group will receive a mindfulness-based PCOS education program, while those in the control group will receive routine care without it. Researchers will assess participants' menstrual symptoms, stress levels, and quality of life using validated measurement tools before and after the intervention. The findings of this study will provide information about the potential role of mindfulness-based education as a supportive approach in the management of PCOS and may contribute to the development of patient-centered education programs for women with PCOS.

Implementation of the ASCEND Training for Supervisors in Dutch Small and Medium-sized Enterprises (SMEs)

This cluster randomized controlled trial (cRCT) aims to evaluate the effectiveness of the Dutch adaptation of an in-person group intervention for workplace supervisors - Advancing Supervisors' Capacity for Mental Health at Work (ASCEND) - in Dutch Small and Medium-sized Enterprises (SMEs). The ASCEND intervention is designed to equip supervisors with the skills to: i) know when to support their workers; ii) how to direct workers to support, and iii) advocate for action on mental health at work. The primary objectives of this project are to: * Assess to what extent the Dutch adaptation of the WHO-developed ASCEND intervention is effective in enhancing supervisors' confidence, responsiveness, mental health literacy, and self-care practices, and in reducing supervisor stigma towards mental health conditions within Dutch SMEs. * Evaluate the impact of the ASCEND intervention on employee outcomes, including mental health and work-related outcomes among supervisees (i.e., subordinates), as well as overall organizational absenteeism rates. * Identify barriers, facilitators, and key implementation and adoption indicators to support future opportunities for scaling up the ASCEND intervention. Researchers will compare two groups to evaluate the effectiveness of the ASCEND intervention. One group will receive the training (the intervention group), while the other group will receive the training after the final follow-up period (the control group). Data will be collected from both supervisors and their supervisees (i.e., subordinates) via online questionnaires at various time points. In addition, general organizational information, including absenteeism rates, will be gathered through a representative from each participating organization. To further explore the feasibility of scaling up the ASCEND intervention within the Netherlands, qualitative data will be collected through interviews and/or focus group discussions.

Ecological Momentary Intervention (E-Breathing) to Reduce Psychological Distress in Adolescents

A two-arm randomized controlled trial (RCT) will be conducted to test a mobile-based intervention, E-breathing, for early detection and intervention to address psychological distress in at-risk adolescents in Hong Kong. E-breathing harnesses the science of real-time, in-situ assessment approach - Ecological Momentary Assessment (EMA) - to capture the psychological symptoms and needs of adolescents. Based on the real-time data collected via smartphone, the mobile application prompts the practice of slow-paced breathing as an Ecological Momentary Intervention (EMI) to reduce psychological distress. This RCT will recruit a total of 100 participants who will be randomly allocated to either (1) an intervention group (EMI group), where they will receive a feedback prompt when they score high on negative affect (i.e., E-breathing) or (2) the control group (EMA group), where they will only complete EMAs without feedback. This project aims to investigate the feasibility and effectiveness of E-breathing in improving psychological symptoms in Hong Kong adolescents. This project also examine the underlying physio-mechanisms of the effects of E-breathing on psychological outcomes in this target population.

Mothers' Heartbeat Intervention in Newborn's Phototherapy Treatment at Maternity Ward

Neonatal jaundice is a common condition among newborns and may require phototherapy during the early postnatal period. Although phototherapy is an effective treatment for hyperbilirubinemia, it may be associated with maternal stress, anxiety, concern and disruption of closeness between the mother and newborn. This mixed methods feasibility study evaluates a mothers' heartbeat intervention designed to support maternal well-being and newborn comfort during phototherapy in a maternity ward setting. The intervention uses a multisensory sleep pad placed under the newborn's mattress during phototherapy. At the beginning of the intervention, each mother's heartbeat, breathing sounds and chest vibrations are recorded and transferred to the pad. During phototherapy, the newborn can hear and feel these individually recorded maternal sounds and vibrations while lying on the mattress. The intervention is intended to provide womb-like auditory and tactile stimulation and to promote calmness, comfort and a sense of closeness during treatment. The study includes mothers whose term newborns require phototherapy for jaundice at a maternity ward in Finland. A total of 40 mothers and newborns are included: 20 in the intervention group and 20 in the control group. Data are collected before and after phototherapy. Maternal outcomes include anxiety, stress and experience of phototherapy. The feasibility, usability and acceptability of the intervention are assessed among mothers in the intervention group. In addition, semi-structured interviews are conducted to explore mothers' experiences of successful factors related to the intervention. The primary purpose of this feasibility study is to evaluate whether the mothers' heartbeat intervention is acceptable, usable and feasible in a maternity ward during newborn phototherapy. The study also examines preliminary effects on maternal anxiety, maternal stress and mothers' experiences of phototherapy. The findings will be used to inform the planning of a future larger randomized controlled trial.

A Mindfulness-based Intervention for Sexual Assault Survivors

The goal is this pilot randomized trial is to learn if intervention 1 is feasible and acceptable. A secondary aim is to learn if intervention 1 reduces alcohol misuse and tobacco use in sexual assault survivors. The main questions it aims to answer are: * Is intervention 1 feasible to implement? * Is intervention 1 an acceptable intervention among the primary population, sexual assault survivors? * Does intervention 1 reduce alcohol misuse and tobacco use? Researchers will compare intervention 1 to an attention-placebo control group (e.g., online resources on healthy eating and nutrition). Participants will: * take online surveys at baseline, 1 month follow-up, and 3-month follow-up * answer text-message questions at baseline and post-test * view and engage in an educational program

Preoperative Stress Assessment in Patients Undergoing Surgery for Rotator Cuff Tendinopathy

Orthopedic surgery of the limbs presents a unpredictable postoperative course, which can be more or less lengthy in terms of functional recovery and resumption of personal or professional activities. Not uncommon, convalescence can require many months with dramatic personal and/or socio-professional consequences (disability, unemployment, etc.), particularly in the postoperative development of complex regional pain syndrome (CRPS) and/or adhesive capsulitis. Among the suspected contributing factors, the existence of an unfavorable preoperative psychological context in patients is often mentioned. This research is based on the hypothesis that a high level of preoperative stress in patients could contribute to the occurrence of more significant postoperative complications in patients who have undergone shoulder surgery. The main objective is to measure the level of preoperative stress in patients undergoing surgery for rotator cuff tendinopathy.

Mushrooms, Mood and Mental Wellbeing in Gen Z Women

The aim of the study is to investigate the effects of 28 days supplementation of Lions mane mushroom and mushroom blend of Lions mane and reishi mushroom, on wellbeing in stressed or anxious women. The study will follow a randomized, double-blind, placebo-controlled, parallel group design. Participants will receive either lion's mane mushroom mane (1.8 gram per day, consisting of 3 x 600mgcapsules), a blend of lion's mane mushroom and reishi mushroom 1.8 gram per day, consisting of 3x600mg capsules) or placebo (1.8-gram microcrystalline cellulose placebo powder, 3x600mg capsules). The trial will utilise Generalised Anxiety Disorder Assessment (GAD-7); the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS); Chalder Fatigue Scale; Rosenberg's Self-Esteem Scale; Perceived Stress Scale (PSS) and Stress Visual Analogue Scales (S-VAS) at baseline and after 28 days supplementation. Participants will complete the HADS and S-VAS at home on days 7, 14 and 21. On day 42 (14 days after treatment ending) participants will complete the GAD-7, HADS and S-VAS. 135 healthy women (who self-report being stressed and/or anxious) aged 18-26 (and born between 1997 and 2013) will be recruited using opportunity sampling. Participants will be supplied with either one of the active treatments or the placebo (allocated by a randomised schedule) whilst visiting the research centre for the testing appointments and will take treatment home to consume daily for the duration of the study. Participants will record time of taking treatment each day in a treatment diary which will be returned to the research centre, along with any unused treatment, upon completion of the study.

Diaphragmatic and Box Breathing on Heart Rate Variability and Perceived Stress

The goal of this clinical trial is to learn if diaphragmatic breathing and box breathing work to enhance resilience and manage stress in physical therapy students. It will also learn about their effects on overall physiological and psychological parameters. The main questions it aims to answer are: Do these breathing techniques improve heart rate variability (HRV)? How do these interventions affect participants' perceived stress levels, cognitive performance, and academic achievement? Researchers will compare diaphragmatic breathing and box breathing to a control group to see if these non-invasive methods work to improve physiological adaptation and manage stress. Participants will: Be randomly assigned to practice diaphragmatic breathing, practice box breathing, or join a control group Have their heart rate variability (HRV) measured as a primary sign of physiological adaptation Complete assessments to evaluate their perceived stress, cognitive performance, and academic achievement

A Study of Oral Kavalactones Effect on Nurses

This research study is being done to assess the impact of taking Kava extract (Piper methysticum), a dietary supplement on cortisol in a healthy nursing population.

Impact of Serial Bedside Video Calls on Stress Level in Parents of Infants Admitted to NICU

The goal of this randomized prospective interventional study is to determine if serial bedside video calls w/audio feature to NICU parents in addition to the routine phone and/or bedside updates can reduce parental stress level. The main question it aims to answer is if the impact of audio-visual calls to nicu parents can improve parent-infant relationship in the form of reduced parental anxiety/stress level. Participants will be parents of infants admitted to NICU for more than seven (7) days. Parents in Group A will receive serial video call communication, 2-3 days a week in addition to the daily phone and/or bedside updates. Parents in Group B will receive daily phone and/or bedside updates per our NICU routine. Parents will complete a series of questionnaires (PSS-NICU, STAI Y-1 \& 2 and MSPSS) at 3 designated periods during an 8-week time frame. Researchers will compare Group A (intervention group) and Group B (control group) to see if there is any difference in the stress levels in relation to the intervention (serial video calls) at the end of the study time frame.

Determination of Chronic Pain, Anxiety, Depression and Perceived Stress in Adults With Temporomandibular Disorders

The aim of the study was to asses levels and relationship of chronic pain, anxiety, depression and perceived stress in TMD patients .

Biofield Therapy for the Support of Immunotherapy-related Symptoms Among Adult Cancer Patients - A Pilot Study

Cancer treatment with immunotherapy is often associated with symptoms such as fatigue, pain, and emotional distress, which may affect patients' daily functioning and quality of life. Additional supportive care approaches are being studied to better understand their potential role in supporting these symptoms. The purpose of this study is to learn whether a biofield therapy, called Reiki may help to support adults with cancer who are receiving immunotherapy and currently struggling with fatigue. Reiki is a non-invasive complementary therapy delivered by a trained practitioner who places their hands lightly near the body. It is intended to promote relaxation and support general well-being. Reiki is used as a supportive practice and is not considered a medical treatment or replacement for standard care. The secondary goal of this study is to evaluate the feasibility of delivering Reiki in this clinical setting. This includes examining recruitment, retention, adherence to study procedures, and overall participant engagement. Lastly, the third aim is to explore participants' experiences with Reiki through guided interviews. Participants enrolled in this study will first be asked to participate in a one-hour, one-on-one interview about their experiences with cancer treatment, their symptoms, and their thoughts about integrative care practices such as Reiki. After the interview, they will be randomly assigned to one of two groups: Immediate Reiki Group: If participants are assigned to this group, they will receive six weekly, in-person 30-minute Usui Reiki sessions from a Reiki master at the Susan Samueli Integrative Health Institute. Before and after each session, participants will complete questionnaires about fatigue, pain, and stress. At the first and final sessions, a small blood sample will be collected to measure inflammatory biomarkers, and Electroencephalogram (EEG) hyperscanning will be conducted to measure brain activity and connectivity between the participant and the practitioner. Four weeks after the final session, they will complete the questionnaires again, followed by a short satisfaction survey about their experience. Waitlist Group: If they are assigned to the waitlist group, they will first complete a 6-week observation period that includes brief weekly fatigue questionnaires and two in-person 30-minute sessions with EEG measurements at Week 1 and Week 6. This will be followed by a 4-week period with no sessions, after which they will complete questionnaires about fatigue, pain, and psychological distress. Participants will then begin the same six weekly, in-person 30-minute sessions described above. As with the Immediate Group, they will complete questionnaires before and after each session. At the first and final sessions, a small blood sample will be collected and EEG hyperscanning will be conducted. At the end of the study, participants will also complete a short satisfaction survey about their experience. The investigators hypothesize that participants receiving Reiki will report improvements in symptoms and well-being compared to those not yet receiving Reiki, and that the intervention will be feasible to implement and acceptable to participants.

Effect of Magnesium-, Vitamin C- and Grape Seed Extract-Enriched Date Bars on Perceived Stress and Salivary Cortisol Levels in Young Women

This randomized controlled trial aims to evaluate the effect of a 4-week daily consumption of a functional date bar enriched with magnesium, vitamin C, and grape seed extract on perceived stress and salivary cortisol levels in healthy young women. Participants will be randomly assigned to either an intervention group receiving the enriched bar or a control group receiving a placebo bar identical in appearance and taste. Primary outcomes include changes in salivary cortisol levels and perceived stress (PSS-14).