Clinical Research Directory

A Pilot Study of RISE for Nurse Managers Retreat

The purpose of this study is to determine the feasibility and acceptability of the RISE for Nurse Managers retreat and its impact on occupational and psychological well-being indicators

The Effect of Progressive Relaxation Exercises and Planned Education on Menopausal Symptoms, Perceived Stress, and Anxiety in Menopausal Women

The Effect of Progressive Relaxation Exercises and Planned Education on Menopausal Symptoms, Perceived Stress, and Anxiety in Menopausal Women

Facial Yoga in Menopausal Women

Purpose: The purpose of this study is to evaluate the effects of a structured facial yoga-based behavioral intervention on perceived stress, cognitive control, cognitive flexibility, and salivary cortisol levels in women during the menopausal period. The study aims to determine whether a non-pharmacological and non-invasive behavioral intervention can support psychological and cognitive functioning and reduce biological stress responses in menopausal women. Design: This study is designed as a randomized, controlled, pretest-posttest experimental trial with a post-intervention follow-up assessment. Eligible participants will be randomly assigned to either an intervention group or a control (usual care) group. Outcomes will be assessed at baseline, immediately after the intervention, and at follow-up to evaluate both the immediate and sustained effects of the intervention. Method: A total of 100 menopausal women aged 45-65 years will be recruited from a menopause outpatient clinic and randomly allocated to either the intervention group or the control group. The intervention group will participate in a 12-week online facial yoga program consisting of two 60-minute sessions per week. In this study, facial yoga refers to a non-pharmacological and non-invasive behavioral intervention focusing on facial myofascial relaxation, breathing regulation, and body awareness for stress regulation and cognitive functioning. The program will include facial myofascial relaxation techniques, basic yoga postures suitable for all physical levels, and structured breathing exercises. All sessions will be conducted online in a group format, and no audio or video recordings will be taken. The control group will continue to receive routine outpatient care during the study period and will be offered the facial yoga program after the completion of follow-up assessments, upon request. Data will be collected at three time points: at baseline prior to the intervention, immediately after completion of the 12-week intervention, and at 8 weeks following the intervention as a follow-up assessment. Perceived stress, cognitive control, and cognitive flexibility will be assessed using validated self-report questionnaires. Salivary cortisol samples will be collected under standardized morning conditions at each assessment point to evaluate biological stress response. Hypotheses: H1: Menopausal women participating in the facial yoga intervention will demonstrate a significant reduction in perceived stress levels compared to the control group at post-intervention and follow-up assessments. H2: Menopausal women participating in the facial yoga intervention will demonstrate a significant reduction in salivary cortisol levels compared to the control group at post-intervention and follow-up assessments. H3: Menopausal women participating in the facial yoga intervention will demonstrate a significant improvement in cognitive control and cognitive flexibility compared to the control group at post-intervention and follow-up assessments.

Examining Effects of Active Plant Engagement on College Student Well-Being and Performance

The goal of this feasibility study is to determine if active engagement with plants (e.g. care, maintenance) improves mental health and academic performance in college students. The main questions it aims to answer are: 1. Does active engagement with plants result in improvements in academic motivation and study habits? 2. Does active engagement with plants result in reductions in stress and improvements in mood? Researchers will compare two interventions groups (campus plant engagement group and home plant engagement group) to the comparison group (no plant engagement or passive exposure) to clarify the practical and potential benefits of active plant care for college students. Participants will: * Complete four surveys over the course of a 16-week semester * Water, prune and check the soil of their assigned plants

Efficacy of Interactive Audio-based Mindfulness ChatGPT-Powered Intervention on Well-being

Brief mindfulness intervention is a short form is a form of short-duration practice, typically delivered for around 30 minutes or less (Howarth et al., 2019). It can be conducted in various formats, including a short breathing exercise or body scan (Palascha et al., 2021), and are increasingly offered through digital platforms, including app-based formats. Empirical evidence has examined the efficacy of brief mindfulness intervention and yielded mixed results. For some studies, positive effects were found, while some studies found no supporting evidence. Such inconsistencies may be due to the several current limitations of brief mindfulness intervention. Firstly, the duration of the intervention is too short. Given this brevity, these short practices may not offer the same immersion and depth that traditional mindfulness may offer. Secondly, most brief mindfulness utilised audio-based formats, which tend to be passive in nature and may not fully engage participants. Lastly, for brief mindfulness delivered through app-based platforms, these applications adopt a self-help approach, which may lower engagement and user commitment. Moreover, these applications also relied on audio guides which lacks the student-facilitator engagement found in traditional classes. To address the current limitations within the literature, a between-within-subjects experiment will be conducted where participants will be randomly assigned to one of the three conditions: (1) an interactive brief mindfulness breathing ChatGPT-powered intervention, (2) an interactive mind-wandering ChatGPT-powered control, or (3) a mindfulness breathing audio control. We hypothesise that the brief mindfulness breathing ChatGPT-powered intervention group will have significant improvements in well-being outcomes as compared to the other two control groups. By exploring the potential of an interactive ChatGPT-powered intervention, this study aims to understand its efficacy in improving well-being.

Mind-Body Conditioning Course for University Dance Students

Mindfulness in Motion (MIM) is an eight-week evidenced based program designed specifically to help participants learn practical stress reduction, burnout and resiliency building techniques. Content includes didactic instruction, community-building group discussion, mindfulness practices, and gentle yoga. Weekly themes include Willingness to Daily Practice, Mindful Sleep, Vision of Self, Supported by the Breath, Mindful Eating and Yoga, Movement Through Balance, Awareness of Sensation, Clarity and Release, and Staying Grounded and Moving Forward. An Ohio State University endorsed, ADA compliant companion smartphone app reinforces weekly content and offers a variety of individual mind-body and mediations practices. The evidence-based MIM content has been tailored to meet the physical, mental, and emotional needs of student Dance majors at The Ohio State University and integrated into the Dance 2802 course content as Mind-Body Conditioning for second year students. Over the course of the second year student's fall semester, this study will evaluate the effectiveness of this integrated course content on students' perceived stress, burnout, resilience, musculoskeletal injury and discomfort, and weekly respiratory rates. After the semester long course is completed, the students will also assess how well the Mind-Body Conditioning course content was integrated into the required first year seminar for University Dance majors.

Resilience Enhancement Training Program to Confront Nursing Students' Perceived Stress

The goal of this clinical trial is to assess if a resilience enhancement training program can help nursing students manage stress more effectively. The main question it aims to answer is: Does the program improve nursing students' resilience levels? Does the program lower nursing students' perceived stress levels? Researchers will compare students who receive the training during the semester with students who do not receive it until after the study is completed to see if the training has an effect. Participants will: 1. Complete questionnaires on resilience and stress before and after the training. 2. Attend a structured resilience enhancement training program for 10 weeks alongside their usual studies. 3. Be part of either the study group (receiving the training first) or the comparison group (receiving the training after study completion).

Evaluation of the School-based SIM Program in Upper Secondary School Students

Söderqvist et al. recently reported on a new school-based program designed to promote mental well-being in adolescents: the Solution-Focused Intervention for Mental Health (SIM, https://doi.org/10.1016/j.ssmmh.2025.100493). While previous studies on SIM were designed mainly to test, develop, refine and improve the program and its feasibility in a school setting, the current project aims to test the efficacy of SIM on adolescent mental health, primarily mental well-being. A two-arm, cluster, randomized, controlled trial will be conducted. The intervention group will receive the SIM program, and the control group will receive a lecture on mental well-being along with the usual school provisions. Randomization is done by class because the intervention takes place in mentor groups. Based on the results of our largest feasibility study, 559 students are required for paired measurements to detect a small effect on mental well-being with 80% power and a significance level of 0.05. The evaluation is based on validated instruments, with measurements taken before and after the intervention, as well as six and nine months later. The project is being implemented in collaboration with six upper secondary schools in Sweden. Recruitment and anchoring at the participating schools, as well as class randomization strafied on educational program, took place in 2025. Enrollment of participating students will begin in January 2026. This project will contribute new knowledge to the field by evaluating a universal program for schools to use in their health promotion work. The latter is important since high levels of mental well-being independently predict a lower incidence of subsequent mental illness and have a range of positive effects on individuals and society.

Enjoying Affordable and Tasty Food Together

The goal of this pilot study is to examine the feasibility of a novel meal kit and nutrition education intervention among adults aged 40 years and older, who are lower income, and to evaluate the preliminary impact of the meal kit and nutrition education intervention on food insecurity, dietary quality, mental health, quality of life and cardiovascular risk factors compared with general nutrition education materials in this population. The main questions are: What is the acceptability and satisfaction with the meal kits and nutrition education intervention? What are the participation rates in the nutrition education program and the evaluation of the intervention? What is the impact of the intervention on food insecurity, dietary quality and cooking and food preparation self-efficacy compared with general nutrition education materials? What is the impact of the intervention of psychosocial health, quality of life and cardiometabolic outcomes compared with general nutrition education materials?

Using Life's Essential 8 in Midlife Black Women

This research seeks to improve the Midlife Black Women's Stress Reduction and Wellness Intervention (B-SWELL), a program designed to lower heart disease risk in midlife Black women. The B-SWELL leverages stress reduction to facilitate the adoption and adherence to healthier lifestyle behaviors. This research study will use choice to increase engagement and minimize the effect of social determinants of health on research participation among midlife Black women. A comparative clinical trial will be conducted. Midlife Black women (ages 45-64) who reside in the Greater Cincinnati area will be recruited for participation. Women are eligible if they self-identify as Black/ African American, are between the ages of 45-64, and are willing to commit to the requirements of the study (e.g., attend 8 weekly sessions and 4 phone interviews). Participants will be randomly placed (like the flip of a coin) into either the B-SWELL or WE group. Both the B-SWELL and WE groups are 8-week programs that focus on healthy lifestyle behaviors and heart disease awareness. Women will have the choice to participate in person or virtually. Survey phone interviews will be conducted at baseline, 8-, 12-, and 16-weeks. Data collected will provide information about adherence, healthy lifestyle behaviors, and cardiovascular health. Heart health will be measured using the American Heart Association's Life's Essential 8 metric. Outcome measures include heart disease awareness, Life's Essential 8 score, stress, self-efficacy, depressive symptoms, and symptoms.

Psychological Counseling Program for Alzheimer's Patients' Caregivers

Purpose: To investigate the effects of a psychological counseling program (PsychoCP) applied to caregivers of Alzheimer's patients on perceived stress, psychological well-being and care burden. Design: The study will be conducted in a pre-test post-test control group, randomized controlled experimental research design. Method: The study is planned to be carried out in Bağcılar Municipality Vefahâne Life Center, Antalya Alzheimer Patients and Patient Relatives Meeting Center and Osmaniye Family and Social Policies Directorate. The sample of the study will consist of 80 caregivers. They will be assigned to intervention (n=40) and control groups (n=40) by randomization. Hypotheses Hypothesis1: The perceived stress level of caregivers who received PsychoDP is lower than those who did not receive PsychoCP. Hypothesis2: The psychological well-being levels of caregivers who received PsychoDP are higher than those who did not receive PsychoCP. Hypothesis3: The care burden of caregivers who received PsychoDP is lower than those who did not receive PsychoCP.