Clinical Research Directory

Mindfulness in a College Physiology Course

This proposed study aims to evaluate whether integrating mindfulness into an undergraduate biology course (Mindful Physiology) influences students' trait and applied mindfulness, well-being, and physiological stress reactivity. The primary questions are 1. Would completing the Mindful Physiology course increase applied mindfulness? 2. Would completing the class increase trait mindfulness? 3. Would completing the class increase subjective well-being? 4. Would completing the class reduce physiological stress response to an acute social stressor?

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. As a secondary goal, we aim 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

Stress Reactivity and Mother-Infant Cardiovascular Disease Risk

Prenatal Mindfulness training (MT) shows promise as a preventive intervention against hypertensive disorders of pregnancy (HDP) and may reduce risk for offspring cardiovascular disease (CVD). One proposed mechanism of MT to reduced CVD risk is improved self-regulation following stress. Perhaps the most crucial contributor to the development of self-regulation in the first year is the psychophysiological coregulatory relationship between mother and infant. However, this self-and co-regulation among women exposed to prenatal MT has not been studied and has yet to be examined in relation to CVD risk. The goal of this proposed project is to evaluate maternal-infant physiological reactivity to and recovery from stress at 6 months postpartum following prenatal MT, and to examine the relationship between these maternal infant stress responses and maternal-infant CVD risk at 12 months postpartum. Using a lab-based stress paradigm and well-validated biomarkers of mother and infant CVD risk, the investigators will assess respiratory sinus arrhythmia and heart rate at 6 months postpartum for 40 mother-infant dyads who have completed either prenatal MT or a usual care arm of an RCT examining MT for women at risk for HDP. The investigators will compare maternal, infant, and dyadic stress responses by treatment arm. Then, cardiac stress responses will be examined as predictors of maternal and infant biomarkers of CVD risk at 12 months postpartum.

Dyadic Mindfulness for People With Parkinson's Disease and Their Caregivers

The proposed two-arm randomized waitlist-controlled trial will use a mixed-methods design to investigate the effects of dyadic mindfulness on physio-psycho-spiritual outcomes in people with Parkinson's Disease (PwPD) and their family caregivers. One hundred Chinese patient-caregiver dyads will be randomized to receive eight weekly 90-minute dyadic mindfulness sessions or usual care. Outcome measures include negative emotions (primary outcome), patient-caregiver relationship, mindfulness, HRQOL, gut microbiome, PD-related symptoms, and caregiving burden. An actor-partner interdependence model will be used to explore the interactions of treatment effects within the dyads. The dyads will be assessed at baseline(T0), post-intervention(T1), and 4-months post-intervention(T2). The investigators will also invite 25 dyads to attend in-depth interviews exploring their experiences, perceived changes, and factors attributable to the effectiveness/ineffectiveness of the intervention. Generalized linear mixed-effects (GLME) with intention-to-treat analysis will be used to compare the changes in outcomes over time within and between the two arms. The findings will be triangulated to provide a comprehensive evaluation of the intervention's effectiveness. This study will generate rigorous scientific evidence to inform the application of dyadic mindfulness as a public health practice preventing the progression of psychological distress in PwPD and caregivers to clinically severe levels. Its self-help nature also enriches the primary care for this clinical cohort.

Mindfulness App Training for Cardiovascular Health

This study will investigate the feasibility and effects of a smartphone-based mindfulness training program vs. usual care in a sample of stressed midlife and older adults at risk for cardiovascular disease. 105 participants will be randomly assigned to complete a four-week mindfulness training intervention, which involves 28 audio-guided lessons and practice prompts delivered 3x daily, or to continue with their regular routines. Data will be collected at baseline, post-intervention, and three-month follow-up. The study will involve seven laboratory visits, which will include assessments and training on daily life monitoring and intervention procedures. Data assessing subjective and physiological stress reactivity in daily life will be collected for 3 days at pre-intervention, post-intervention, and 3-month follow-up. Passive sensor data will be continuously collected from participants' smartphones and wearable devices to develop models that predict daily life stress. Data will be used to evaluate feasibility of the intervention and assessments in a sample at risk for cardiovascular disease and to test effects of mindfulness training on subjective and physiological stress reactivity.

The Behavioral Effects of Mindfulness-Based Technology Use Training in Preschool Children

With the rapid advancement of technology, the use of digital devices has become widespread even in early childhood. While the conscious and controlled use of technology in the preschool period can contribute to children's development, prolonged and uncontrolled screen use can lead to various negative consequences such as sleep problems, attention issues, increased anxiety levels, and difficulties in social relationships. In particular, exposure to violent media content can cause children to perceive the world as more frightening and experience anxiety. Mindfulness-based training supports individuals in directing their attention to the present moment, recognizing their emotions, and accepting their experiences without judgment. Such training is known to develop self-regulation, attention, and emotional awareness skills in children. The purpose of this study is to examine the effect of mindfulness-based technology use training applied to preschool children on their media usage habits, sleep patterns, fear levels, and parent-child relationship. The study is planned as a randomized controlled trial with an experimental design. The intervention group will receive mindfulness-based technology use training, while the control group will receive no intervention. The study expects that mindfulness-based training will reduce children's screen time, improve sleep quality, decrease fear levels, and strengthen parent-child relationships. This study aims to contribute to the development of intervention programs that support healthy technology use in early childhood.

The Impacts of Mindfulness on Psychological Wellbeing Among Nursing Students

The aims of this study are to develop a mindfulness-based elective course for nursing students and to evaluate its effects on psychological well-being, including mindfulness, depression, anxiety, stress, and problematic internet use, empathy, among nursing students.

Mindfulness Meditation for Insomnia

The investigators will conduct a 3-arm, pilot RCT where participants (N=30) will be randomized in a 1:1:1 design to 4 weeks of instructed bedtime MM practice at night (n=10) vs. uninstructed MM (n=10) vs. sleep hygiene education only (n=10). Aim 1 is to understand the feasibility and acceptability of the intervention and study procedures. Aim 2 is to explore patterns of within-group changes in sleep outcomes (i.e., insomnia severity and sleep quality). Patient-reported outcomes will be collected using a HIPAA-compliant electronic data management system (REDCap). Following informed consent, participants will receive links to REDCap surveys via email at Weeks 0, 4, 8, and 16. The investigators will also conduct a post-intervention interview at the end of Week 4 and an exit interview at Week 16. All participants will also receive a research kit with wearable devices and meet with our staff after they receive the kit for instructions. Data collected in the pilot RCT will help us to preliminarily identify tools for subjective measures and physiological signals to inform a future trial.

Psychosocial Effects of Mindfulness-Based Exercise in Postmenopausal Women

Menopause is a natural biological process characterized by the permanent cessation of the menstrual cycle in women. Hormonal changes associated with menopause commonly lead to mood swings, anxiety, depression, stress, and decreased sleep quality in women. While the current literature indicates that mindfulness-based interventions offer potential benefits in alleviating psychological and physical symptoms in postmenopausal women, the limited number of studies in the literature and methodological differences suggest a need for more randomized controlled trials in this area. The aim of this study is to examine the effect of mindfulness-based exercises on psychosomatic complaints such as anxiety, depression, and sleep quality in postmenopausal women. Designed as a randomized controlled experimental study, it was planned to include at least 20 women in the early postmenopausal period residing in Istanbul and Izmir between March and June 2026. The women included in the study will be randomized into Group 1 (n=10), which will perform mindfulness-based exercises, and Group 2 (n=10), which will receive no intervention as usual. The STAI I-II Form State and Trait Anxiety Scale and Beck Anxiety Inventory will be used to assess state and anxiety level, the Beck Depression Scale for depression level, and the Pittsburgh Sleep Quality Scale for sleep quality. Continuous variables will be presented as mean ± standard deviation, and qualitative variables as number and percentage (%). If parametric test assumptions are met, the Independent Samples t-test will be used to compare independent groups, and the Paired Samples t-test will be used to compare dependent groups. If parametric test assumptions are not met, the Mann-Whitney U test will be used to compare independent groups, and the Wilcoxon test will be used to compare dependent groups. Statistical significance will be set at p≤0.05. This study is expected to contribute to the literature by providing evidence-based data on the effectiveness of mindfulness-based exercises on common psychological symptoms in the postmenopausal period.

Yoga, Meditation and Mindful Eating Intervention in University Students

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.

The Effectiveness of a Mindfulness Based Program on Short- Form Video Addiction in Adolescents

The purpose of this study is to evaluate the effectiveness of a mindfulness-based program in reducing short form video addiction among adolescents. The study is designed as a randomized controlled trial with a pre-test, post-test, and follow-up design, including an intervention group and a control group. Research Hypothesis: Adolescents who participate in the Mindfulness-Based Program will have significantly lower short video addiction scores compared to those in the control group.

Mindfulness and Meditation Based Lactation Education on Maternal Breastmilk in the Neonatal ICU

The purpose of this research is to investigate associations between mindfulness and meditation techniques and changes in maternal breastmilk in the mother pumping for her NICU infant.

Development of the Online Mindfulness-based Intervention (Mind Space Application) for Thai-university Students: Phase II

Development of the online mindfulness-based intervention (MFU-mindful Application for Thai university students: Phase II Objectives: Phase I: (October 2025 to September 2026) 1. To develop the mindfulness-based intervention (Mind Space application) for Thai university students. 2. To test the feasibility of the mindfulness-based intervention (Mind space Application) for Thai university students. 3. To determine the effect size of mindfulness-based intervention (Mind space Application) on mental health outcomes for Thai university students: A pilot study. Phase II: (October 2026 to December 2026) 1\. To examine the effects of mindfulness-base intervention (Mindspace Application) on mental health outcomes for Thai university students For this research project, investigators will develop the mindfulness-based intervention (Mindspace application) based on mindfulness-based stress reduction (MBSR) and mindfulness-based cognitive therapy (MBCT) by encouraging participants to pay attention to their present thoughts, emotions, feelings, and behaviors without judgment. This attention will help them learn the relationship between their thoughts, emotions, and behaviors and their mental health outcomes (mindfulness, stress, anxiety, and depression), though. mindfulness practice (body scan, sitting meditation, and mindful movement) using an online application). Furthermore, investigators will teach participants how to shape their thoughts and manage their wandering minds and negative and irritable thoughts. Finally, participants will learn how to become an individual with reasonable flexibility and positive thoughts. Settings: the researchers plan to conduct the program in three universities in Northern Thailand. Population and sample: Population: Thai university students who are between years 1 and 4 (undergraduate). Sample: Phase I: Mae Fah Luang University, Phayao University, and Utraradit University students who are studying during the Fall semester, year 2026. Investigators will specifically recruit volunteers who: Inclusion criteria: 1. are current studying in years 1-4 of undergraduate programs 2. can read, speak, and write in Thai 3. be risk of the mental health problem (score higher than 6 on the General Health Questionnaire (GHQ-28) 4. have no history of learning disorders (ADHD, other specific learning disorders) 5. have no psychiatric disorders (schizophrenia, adjustment disorders, delusion disorders, and substance use disorders) 6. have no meditation experience within the past 6 months Exclusion criteria: 1. have a limitation for mindful movement (hearing loss, blindness, and movement limitations) 2. They may feel uncomfortable or distressed and may not be able to participate in each mindfulness-based intervention session. Conceptual frameworks. For this research project, the investigators will develop and refine an online mindfulness-based intervention, the Mind Space Application, grounded in the principles of Mindfulness-Based Stress Reduction (MBSR; Kabat-Zinn, 2003) and Mindfulness-Based Cognitive Therapy (MBCT; Segal et al., 2002). The program is designed to cultivate nonjudgmental awareness of thoughts, feelings, emotions, and behaviors among university students (Kabat-Zinn, 2003). In addition, it aims to enhance participants' understanding of the interrelationships among cognitions, emotions, affective experiences, and behaviors that contribute to psychological distress, including stress, anxiety, and depressive symptoms. The intervention incorporates core mindfulness practices delivered via an online application, including body scan exercises, sitting meditation, and mindfulness-based movement for relaxation. Furthermore, participants will be guided to develop cognitive awareness and adaptive responses to internal and external stressors, with particular emphasis on recognizing and managing automatic thoughts (wandering mind), negative thoughts, and irrational or maladaptive cognitions. Through this process, participants are encouraged to cultivate more rational, flexible, and positive thinking patterns. The researchers anticipate that this program will enhance mindfulness skills and, in turn, contribute to reductions in stress, anxiety, and depressive symptoms among the study participants. The effectiveness of the Mind Space application will be examined across both short-term and long-term periods. Short-term effects will be assessed at baseline and immediately post-intervention (8 weeks), while long-term effectiveness will be evaluated at a 6-month follow-up. Outcomes in the intervention group will be compared with those in a control group. The primary outcome variables include mental health indicators-stress, anxiety, and depressive symptoms-as well as levels of mindfulness among Thai university students. Data will be analyzed using a one-way repeated-measures multivariate analysis of variance (MANOVA).

Feasibility of a Mindfulness Intervention for Endometriosis Surgery

Endometriosis is a common cause of pelvic pain in women which has been historically under-studied and under-diagnosed. The goal of this research is to pilot-test the feasibility and acceptability of a manualized, single-session brief mindfulness-based intervention (BMBI) among participants with endometriosis-related chronic pelvic pain (ECPP) who undergo surgical treatment, and gather preliminary data necessary for future studies assessing BMBI's impact on outcomes in surgically-treated ECPP. This pilot study will enroll 10-20 adult participants with ECPP to receive either a BMBI adjunctive to treatment as usual (TAU; n=5-10) or education with TAU (n=5-10) prior to their ECPP surgery. The central hypothesis is the BMBI is feasible to deliver pre-operatively, acceptable to patients, and may help improve acute post-surgical outcomes through more adaptive stress coping and pain processing, enabled by mindfulness training.

Mindfulness Walking Intervention to Enhance Resilience (iWalk)

This study is a randomized controlled trial of the walking meditation intervention (iWalk) program, a multi-component intervention integrating walking meditation, education, and group sessions designed to enhance resilience in individuals with multiple sclerosis (MS). The objectives are to evaluate: 1. Recruitment capability and retention rates, 2. Acceptability and adherence to the intervention, 3. Feasibility of assessment procedures, and 4. Preliminary effects on psychological, physiological, and behavioral outcomes.

Mindfulness in High Risk Pregnancies

Anxiety, depression and stress are common during pregnancy. These have been found to negatively impact mother and child outcomes. When anxiety, depression, and stress are present in pregnant women, it is therefore important to manage them to improve the outcome of the mother and her child. Although pregnancy itself has been shown to increase anxiety, depression and stress, these issues are further elevated in high-risk pregnancy groups. Mothers at risk of preterm delivery (less than 37 weeks gestational age), have been found to have higher rates of depression, anxiety and stress compared to uncomplicated term pregnancies. In addition, anxiety, depression and stress symptoms themselves increase the risk for preterm delivery, creating a vicious cycle for this high-risk group. Mindfulness is a tool that has been during pregnancy to reduce depression, anxiety, and stress. Many studies have found mindfulness to be an appropriate management option in normal term pregnancies. To date, there have been no studies that have looked at Mindfulness as a tool for mothers admitted due to risk of preterm delivery. This study will explore the impact of teaching mindfulness skills to inpatient mothers at risk of preterm delivery and studying its effects on maternal depression, anxiety, and stress. This study involves providing Mindfulness strategies during the mother's inpatient admission for the risk of preterm delivery for four consecutive weeks. Participants will be enrolled through informed consent. All participants will be given pre and post participation questionnaires to examine the impact of mindfulness on anxiety, depression and stress. The participants will also be encouraged to maintain a weekly mindfulness log. The results of this research may lead to future studies looking at the impact of mindfulness practice for high-risk pregnancies. This will also help open up the possibility of offering such courses for inpatient and outpatient high-risk pregnancies in the future.

Mind-body Resilience Program for Cardiac Arrest Survivors and Their Caregivers: Recovering Together After Cardiac Arrest

The purpose of this study is to pilot two resilience interventions for cardiac arrest survivors and their informal caregivers, Recovering Together after Cardiac Arrest 1 and Recovering Together after Cardiac Arrest 2 . The data the investigators gather in this study will be used to further refine the interventions.

Mindful-Breath for People With COPD

Individuals living with chronic obstructive pulmonary disease (COPD) often suffer from stress and behavioral risks such as physical inactivity. In an attempt to promote healthy behaviors and overall wellbeing among this particular population, this study aims to develop and evaluate a personalized Mindful-Breath intervention combining telehealth technology and mindfulness for COPD patients. This is an assessor-blinded, two-arm exploratory randomized controlled trial with a sequential mixed-method design. A total of 60 participants will be recruited and randomly assigned to either intervention or control group using 1:1 ratio. Intervention group will go through 8 weekly 60-min hybrid group sessions, combining mindfulness-based pulmonary rehabilitation and lifestyle modification. Personalized mindfulness-based lifestyle counselling through instant messages with chat-based support throughout the 8-week intervention period will also be provided. Control group will receive a single in-person 60-min group session on general education on pulmonary rehabilitation and lifestyle modification and will only receive reminder messages for follow-ups. Variables such as time spent on physical activity, lung function, perceived stress, symptom burden and health-related quality of life will be collected at three time-points (T0: baseline, prior to randomization; T1: immediate post-intervention; T2: 3-month post-intervention).

Effects of Mindfulness or Brain Stimulation Intervention for Late-life Adults in Taiwan Urban and Rural Areas

This randomized controlled trial will examine the effects of mindfulness-based interventions and brain stimulation interventions on cognitive function and psychological well-being in older adults. The study will employ a comprehensive assessment approach incorporating psychological evaluations, behavioral assessments, psychophysiological measurements, and neuroimaging analyses to characterize the outcome of nonpharmaceutical interventions in improving geriatric well-being or reducing depression severity.

Mindful-Med: the Evaluation of the Mindfulness-based Stress-coping and Burnout Prevention Programme for Medical Interns.

The aim of this study is to evaluate the feasibility and acceptability of a mindfulness-based healthcare education (MBHC) programme with medical interns. Specific objectives are to: * Recruit at least 24 participants to the study. * Examine the feasibility (recruitment and retention rates) and acceptability of the MBHC programme. * Conduct a focus group process evaluation, exploring the interns' perceptions of the MBHC programme, including their adherence to and views on the acceptability of the MBHC programme for medical interns.

Combined Guanfacine and Mindfulness Meditation as an Adjunct to Buprenorphine Maintenance in Opioid Use Disorder

The US is currently going through an opioid crisis, and while Medication Assisted Treatments such as buprenorphine (BUP) have proved highly effective at stabilizing the neurobiology underlying acute withdrawal, they have been less effective at preventing longer-term relapse and adherence. This may be due to the fact that they do not fully engage the neural processes sub-serving the emotional control of sensitized negative mood and reward sensitivity during stress- and opioid-cue provocation, respectively. In contrast while the alpha2 agonist, guanfacine, may attenuate stress-provoked opioid craving by mediating top-down prefrontal control over sensitized dysphoria, the behavioral intervention, Mindfulness Oriented Recovery Enhancement (MORE) may reduce opioid cue-provoked craving by mediating top-down prefrontal control over hedonic dysregulation. Furthermore, while both interventions separately may prove effective as longer-term adjunctive therapies, they may offer greater efficacy together, providing a unique medication/behavioral combination able to target both stress and reward provocation mechanisms. To optimally test this hypothesis, a staged approach is proposed to first confirm the efficacy of both GXR and MORE, independently and combined (R61), prior to elucidating underlying neural mechanisms (R33). Using a 2 X 2 design, N=80 OUD individuals on BUP will be randomized to either 6-weeks of Guanfacine extended release (GXR; 3mgs, n=40) or placebo (PBO; n=40). Half of all participants in each group will then receive either weekly MORE, or a Support Group (SG) control, creating four intervention groups (Control Grp: PBO+SG, n=20); (GXR Grp: GXR+SG, n=20); (MORE Grp: PBO+ MORE, n=20); (Combined Grp: GXR+MORE, n=20). A pre- and post-laboratory study will be conducted before and after six weeks of intervention where participants will be randomly exposed to 3 personalized guided imageries (stress, opioid cue, neutral). Subjective measures of opioid craving, anxiety, mood, stress, emotional reappraisal, and heart rate will be collected before and after imagery exposure. Following milestone completion, an identical design is proposed in N=144 individuals, where participants will be exposed to imageries in the MRI scanner (R33). On the basis of prior research, it is hypothesized in that GXR will attenuate opioid craving and improve emotion regulation during stress, while MORE will demonstrate the same effects during opioid cue exposure. Combined GXR and MORE will also demonstrate additive or synergistic improvements compared with each intervention alone (R61). The effects of GXR on opioid cue- and MORE on stress-provoked opioid seeking will be explored. In the R33 component, it is hypothesized that GXR will improve regulatory and affective brain function during stress, and MORE will improve regulatory and reward function during opioid cue exposure. Combined GXR and MORE may improve regulatory function in an additive or synergistic manner (R33). Findings will help elucidate the efficacy and neural mechanisms underpinning a novel integrated pharmaco-behavioral therapy for OUD individuals maintained on BUP.

Interactions Between Placebo Effects and Mindful Awareness State

In this experiment,the investigators study the effects of interpersonally induced placebo effects and a mindful awareness induction on negative affect. Specifically, it will be examining the effects of interpersonally induced placebo effects (sham tDCS vs. control) and a mindful awareness induction (mindful state vs. control), as well as their interaction. Each group will undergo fMRI scanning and physiological recording will performing the Multimodal Negative Affect Task (MNAT).

Effects of Awareness-based Parenting and Birth Preparation Education Given to Couples on Materna-paternal Bonding, Birthparameters and Postpartum Harmony

Nurses, who play a key role in maternal and infant health, take action with evidence-based practices to reduce fear of childbirth, encourage natural birth, and improve negative pre-pregnancy, pregnancy, and post-pregnancy outcomes caused by fear.Considering the increasing rates of elective cesarean sections in developed countries, interventions against fear of childbirth have become more important. The negative effects of cesarean section on both maternal and infant health and the damage it causes to the health system due to increased costs are clear . For all these reasons, the inclusion of awareness-based interventions such as MBCP in childbirth preparation class education programs not only aims to reduce the increasing cesarean section rates, but also aims to provide awareness that women and their partners can benefit from not only during pregnancy, birth, and parenthood, but throughout their lives.

Mindfulness and Compassion Program for the Improvement of Emotional and Behavioral Problems, Academic Performance and School Climate in Students in the Last Cycle of Primary Education.

This randomized controlled trial aims to evaluate the efficacy of a Mindfulness and Compassion program to improve emotional and behavioral problems, academic performance and school climate of students in the last cycle of Primary Education. Participants will be randomly assigned to the Cuida2 program or to an active control group practicing relaxation. The different variables studied will be evaluated before and after the intervention, and at a three months follow-up. These evaluations will be carried out by the students and their families. In addition, a qualitative exploration will be carried out at the end of the programs, also including the teachers' perceptions.