Clinical Research Directory

Self-Help Plus for Distress in University Students

Prrospective, multi-center, randomized controlled trial of a brief, transdiagnostic, guided self-help intervention (Self-Help Plus) for university students who experience significant distress and are behind on their coursework. The intervention will be tested in terms of efficacy and feasibility for outcomes related to distress, anxiety, depression and well-being, assessed immediately after the intervention and at 3-months follow-up.

Effects of Mobilization and Caffeine After Cesarean

This study Maims to assess bowel motility, pain and psychological well-being in women in the post-cesarean period by mobilizing them early and encouraging them to consume coffee.

The Application of Art Therapy to Patients Undergoing Hemodialysis Treatment

Purpose of the Study: This study aims to investigate the effect of art therapy on anxiety and psychological resilience levels in Chronic kidney disease(CKD) patients undergoing hemodialysis patients. Hemodialysis patients undergo long-term treatment, often experiencing psychological issues such as anxiety and depression, which significantly reduce their quality of life. Among non-pharmacological approaches to alleviate these symptoms, art therapy has gained increasing attention. Art therapy helps patients shift their focus away from their illness, fosters self-confidence, reduces anxiety, and promotes relaxation .

Foundational Programs to Combat Clinician Stress

This is a prospective, randomized, controlled clinical trial in which clinicians from University of Pennsylvania Health Systems (UPHS) including Penn Medicine- Lancaster General Health (LGH) and Massachusetts General Hospital (MGH) are offered a well-known program to help reduce clinician burnout: Sudarshan Kriya Yoga (SKY) Breathing and Sahaj Meditation Intervention.

Effect Of Awareness and Occupatıonal Practıces On Menopausal Women's Psychologıcal Wellbeıng And Menopausal Symptoms

Non-drug methods are frequently preferred in menopausal symptoms, especially in mental effects, and their effectiveness on symptoms is remarkable. Non-drug methods mainly used in the management of postmenopausal symptoms are sports, avoiding bad habits, paying attention to diet and increasing fluid intake, wearing comfortable clothes. In addition, there are many supportive methods such as stress reduction meditation practices, garden therapies, breathing and physical exercise practices, aromatherapy. Among the most frequently used coping methods of women experiencing menopausal symptoms such as irritability and anxiety/anxiety, it was found that 'paying attention to different things (housework, cleaning, cooking, handicrafts, etc.)' was among the most frequently used coping methods. In this direction, it is thought that occupational practice may have positive effects on menopausal symptoms in women. Engagement practices are one of the methods widely used in recent years to cope with anxiety, depression and stress. Our study aimed to measure the effectiveness of mindfulness-based practices on menopausal symptoms and psychological well-being in menopausal women by blending mindfulness-based practices and busyness practices, and in this sense, it is anticipated that it will make a significant contribution to the literature. Objective: This study will be conducted to determine the effect of mindfulness-based and occupational practices on psychological well-being and menopausal symptoms in menopausal women. Materials and Methods: The research will be conducted as a randomised controlled experimental study in a four-group, parallel, pretest-posttest design. The research is planned to be conducted between December 2024 and December 2025. The population of the study consists of women in menopause who applied to the ASM in the centre of Kars between December 2024 and December 2025. The sample of the study will consist of women who meet the inclusion criteria among these women. As a result of the power analysis performed in the G\*Power version 3.1.9.7 programme, it was determined that a total of 76 participants, at least 19 people in each of the intervention and control groups, with a sample size, 95% confidence, 95% test power (1-ß), 0.05% margin of error level, d = 0.25 effect size (Kang, 2021). Considering 10% possible data loss in the study, it was planned to include 20 women in each of the intervention and control groups.

MOVI-OLE! [Open Learning Environments]

This study will evaluate the effectiveness of MOVI-OLE! (Open Learning Environment), a school-based intervention designed to reduce sedentary time and enhance multiple aspects of child development, including cognitive function, physical fitness, body composition, psychological well-being, and student engagement. The intervention combines dynamic classroom furniture with student-centered teaching practices. Additionally, a qualitative component will explore how students, teachers, and families perceive the feasibility and acceptability of implementing MOVI-OLE! in real-world school settings.

Brain Function and Psychological Changes Related to Cell Therapy for Autoimmune Hemolytic Anemia

Cell therapy is an innovative treatment with significant efficacy in hematologic and certain autoimmune diseases. Although it offers potential benefits for autoimmune hemolytic anemia (AIHA), it may result in cognitive and other potential impairments, which can adversely affect patients' cognition and behavior. Brain function and psychological assessment are essential for the early detection of potential impairments, allowing timely interventions to prevent complications and ensure patient safety. This study aims to comprehensively evaluate the physical and psychological impacts of cell therapy on AIHA patients to develop safer and more effective treatment strategies that enhance their quality of life.

Bridging the Divide: A Pioneering Culturally-Specific Mentoring Intervention to Increase Support for At-Risk Youth

The purpose of this study is to assess the feasibility, acceptability, and effectiveness of a culturally-specific mentoring intervention to improve socio-emotional skills, psychological well-being, and social support among at-risk youth and to evaluate the proposed mentoring intervention's impact on academic outcomes, social behavior, and caregiver perceptions of social-emotional competencies. Additionally, it seeks to gather stakeholder feedback to refine the intervention further.

Depressive Symptoms After Cardiac Surgery

The primary goal of this project is to develop a predictive model for clinically significant depressive symptoms (CSDS) in patients undergoing coronary artery bypass graft (CABG) surgery, using pre- and perioperative data. CSDS occur in about 30 percent of CABG patients, which is four times higher than in the general population. These symptoms are linked to poor quality of life and increased morbidity and mortality. The aim is to create a model that can identify patients at risk for postoperative depression. This tool could help clinicians make informed decisions and take preventive measures to manage depression after surgery.

The Effect of Mindfulness Meditation

Cancer is a disease that causes the most deaths worldwide and is challenging for patients and caregivers both physically and psychosocially. Physicians and nurses working in oncology clinics perform a demanding profession providing compassionate care and treatment to patients struggling with life-threatening diseases. The emotional cost of caring for patients diagnosed with cancer can lead to compassion fatigue, burnout, and decreased psychological well-being among healthcare professionals. For this reason, this research is planned as a randomized controlled study to examine the effect of Mindfulness meditation practice on compassion fatigue, burnout, and psychological well-being in physicians and nurses working in oncology units.

Effects of a Second-generation Mindfulness-based Intervention on Quality of Life, Pain Management, and Psycho-spiritual Wellbeing in Cancer Patients: A Randomised Controlled Trial

Background This study explores the effectiveness of Meditation Awareness Training (MAT), a second-generation mindfulness-based intervention, in enhancing quality of life, pain management, and psycho-spiritual wellbeing among cancer patients. Existing research underscores the benefits of mindfulness-based interventions (MBIs) in alleviating psychological distress and improving overall quality of life for cancer patients. However, first-generation MBIs often exclude traditional Buddhist concepts such as impermanence and emptiness, Consequently, this can result in a superficial application that may not fully engage with the underlying causes of psychological distress or promote long-term spiritual and psychological growth. In contrast, second-generation MBIs like MAT aim to reintegrate these wisdom principles, potentially offering deeper psycho-spiritual benefits. By incorporating concepts like impermanence and emptiness, these interventions encourage a more holistic understanding and acceptance of life's challenges, fostering meaningful perspectives on illness and enhancing both spiritual and psychological wellbeing. This approach seeks to provide a more comprehensive and transformative experience for individuals, particularly those facing serious health challenges such as cancer. Aims The primary aim is to understand the effectiveness of MAT in individuals diagnosed with cancer. The study focuses on: Evaluating the impact of MAT on reducing psychological distress and enhancing pain management and quality of life. Exploring whether practising Buddhist wisdom concepts can foster meaningful perspectives on illness and life, thereby increasing spiritual wellbeing. Determining if MAT participation leads to the establishment of new daily practices and habits among cancer patients. Method The study employs a mixed-methods approach across three phases: Phase 1: A quantitative study using a randomised controlled trial (RCT) design. Participants will be divided into an intervention group (MAT) and a treatment-as-usual (TAU) control group. The effectiveness of MAT will be assessed using psychometric scales at multiple time points (baseline, week 4, week 9 post-intervention, and six-month follow-up). Importantly, participants in the TAU group will be offered the MAT intervention after the completion of the RCT, ensuring that all participants have access to the potential benefits of the intervention. Phase 2: A qualitative exploration using Interpretative Phenomenological Analysis (IPA) to gain insights into participants' lived experiences post-MAT intervention. This phase involves semi-structured interviews conducted at one month and six months post-intervention. Phase 3: A content analysis of diary entries collected from participants during the intervention to capture real-time reflections and experiences. Expected Outputs The study aims to provide empirical evidence on the effectiveness of MAT in improving psychological and spiritual wellbeing among cancer patients. It is expected to offer insights into how Buddhist wisdom can be integrated back into clinical mindfulness practices to enhance their impact. The findings could inform clinical practices and contribute to the development of more holistic mindfulness-based interventions for cancer care. Project Timelines Recruitment: Began in November 2024. Phase 1: The RCT is aimed to begin in the first quarter of 2025, with the intervention lasting 8 weeks, followed by data collection at specified time points. Phase 2: Conduct interviews at one month and six months post-intervention. Phase 3: Collect and analyse diary entries throughout the 8-week intervention. The entire study is structured to ensure comprehensive data collection and analysis, allowing for both quantitative and qualitative insights into the MAT intervention's impact on cancer patients.

Evaluation of First Year Implementation of Komtü Programme to Improve Emotional Well-being in School.

Objectives: (1) To analyse the benefits of Komtü Programme implementation in children's and teachers' well-being (primary outcomes); (2) to analyse the benefits of Komtü Programme implementation in teacher's assertiveness, mentalization and self-efficacy (secondary outcomes). (3) and to analyse the benefits of Komtü Programme implementation according to children's prosocial behaviour, self-esteem and mentalization (secondary outcomes). Participants: Teachers will be placed in one of the 3 groups, according to the school's support needs they work at. In this case, randomization would not be possible in the allocation process. In one of the interventions, the participants will receive the planned actions for the first school year of the Komtü Programme. In the other intervention, the participants will only receive the training and the reflective practice planned for the Komtü. The last group will complete the school year as usual (TAU, control group). Comparisons: Researchers will compare all 3 groups among them to see to what extent: * Komtü Programme shows efficacy in fostering children's well-being compared with the training and TAU (control group). * Komtü Programme shows efficacy in fostering teachers' well-being compared with the training and TAU (control group). * Training and reflective practice shows efficacy in fostering children's well-being compared with TAU (control group). * Training and reflective practice shows efficacy in fostering teachers' well-being compared with TAU (control group). And as for the secondary outcomes, researchers will also compare all 3 group to observe possible inter-group differences.

Impact of Preventive Mental Health Programme on Social/Emotional Functioning and Resilience in Children in South Africa

The goal of this clinical trial is to test the effectiveness of a mental health prevention and promotion programme delivered to children (ages 8 to 13) living in under-resourced communities in South Africa. The main question it aims to answer is: Does the programme increase resilience and improve psychological well-being? Participants will be asked to attend the programme twice a week after school for a period of six weeks and complete a series of questionnaires. Researchers will compare children who attended the programme to those who did not to see if the programme resulted in better social/emotional functioning and resilience.

Aspirational Rehabilitation Coaching for Holistic Health (ARCH): A Pilot Pre-Post Experimental Study

The ARCH programme is a novel, strength-based, dyadic, multicomponent psychosocial intervention that blends together psychoeducation, psychosocial support and self-compassion practices to aid first-time stroke survivors and their family caregivers with their psycho-socio-emotional and spiritual challenges following discharge from in-patient care. A pre-post experimental design with a feasibility and acceptability assessment is adopted to evaluate and refine the ARCH intervention in promoting wellbeing, self-compassion, independence, quality of life, hope, resilience, self-efficacy and dyadic mutuality.

Effectiveness of Self-Compassion Intervention on Enhancing Self-Compassion and Psychological Well-Being of Children With Attention Deficit/Hyperactivity Disorder

The study aims to investigate the underlying mechanism between Attention Deficit/Hyperactivity Disorder traits (AD/HD traits) and psychological well-being through studying the role of perceived criticism, rejection sensitivity, self-compassion and growth mindset. It also aims to explore the effectiveness of self-compassion intervention on enhancing self-compassion and psychological well-being of children with AD/HD in Hong Kong. The study will contribute to the current understanding of the supportive measures for children with AD/HD, and hopefully help to mobilize more resources to preserve children with AD/HD's mental health. The intervention program includes the following components: Participants will be randomly assigned to the self-compassion intervention group or the waitlist control group. The intervention group consists of two parts: children training session and parent group sessions. All children participants will complete a total of 6 training sessions, and each session will last around 90 minutes. Parents of the children participants will also complete a total of 3 group sessions, and each session will last around 90 minutes. To investigate the intervention effectiveness, children will be asked to complete a questionnaire assessing their levels of self-compassion, emotional regulation, as well as psychological well-being in terms of life satisfaction, positive and negative affect. Parents and teachers of participants will also be asked to complete a questionnaire covering children's emotional regulation, positive and negative affect. Questionnaire data collection will be conducted prior to the intervention (i.e., Time 1), immediately after the 6-session student and 3-session parent sessions (i.e., Time 2), and 2 months after the intervention (i.e., Time 3, a 2-month follow up). It takes approximately 20-30 minutes for children and parents to complete their questionnaires. Study Objectives: 1. To investigate the underlying mechanism of the relationship between AD/HD traits and psychological well-being 2. To explore the effectiveness of self-compassion intervention on enhancing self-compassion and psychological well-being of children with AD/HD in Hong Kong Hypotheses: 1. AD/HD traits negatively predicts psychological well-being 2. AD/HD traits positively predicts perceived criticism or rejection sensitivity 3. Perceived criticism or rejective sensitivity negatively predicts psychological well-being 4. Perceived criticism or rejective sensitivity mediates the relationship between AD/HD traits and psychological well-being 5. Self-compassion moderates the relationship between perceived criticism or rejection sensitivity and psychological well-being 6. Growth mindset moderates the relationship between perceived criticism or rejection sensitivity and psychological well-being 7. Children with AD/HD from self-compassion intervention group yield greater improvement in self-compassion, emotional regulation and psychological well-being, than waitlist-control group.

Face-to-face vs Online Physical Exercise in Seniors Living in Nursing Homes (ExerMOT-NH)

The benefits of multicomponent physical exercise (MPE) in the mental and physical health of older adults are widely accepted. However, during Covid19 pandemic, some face-to-face programs for physical exercise were canceled. The situation was particularly complex in nursing homes (NHs) because residents were often confined to their floors and many leisure activities were canceled. Online physical exercise sessions increased their popularity during the pandemic. However, there is no evidence that online physical exercise sessions are an effective alternative to face-to-face sessions for older people living in NHs. The current project aims to assess a synchronous online MPE program's feasibility, acceptability, and effects. With this aim, first a synchronous online MPE intervention was designed and then a multicenter randomized controlled trial with 3 branches was developed: face-to-face MPE, online MPE and control. Participants in the control group will receive advice to maintain physical activity and reduce sedentary behavior. Additionally, those in the intervention groups will also participate in 24-week individualized and progressive MPE programs performed at moderate intensity that will be focused on strength, balance, and endurance. MPE will be performed through supervised sessions (2 per week). One of the intervention groups will be supervised face-to-face whereas the other will be supervised synchronously online. Study assessments will be conducted at baseline, at the end of the 24-week intervention, and after 24-week follow-up. The primary outcomes of the study will be changes in mental and physical health. Secondary outcomes will include other parameters of mental and physical health, together with physical activity, frailty, quality of life, and biological markers. The dropout rate, the adherence, the injuries and other adverse events suffered by the participants, and technical incidences produced in the online modality will be recorded. A mixed-model ANCOVA will be performed to compare the data between intervention and control groups, considering as co-variables baseline measurements. The statistical analysis will be performed on the whole sample and separated for sex/gender. The study received ethical approval (M10\_2022\_405\_IRAZUSTA ASTIAZARAN). The results of this project will be transferred to institutions and entities involved in managing NHs to increase the opportunities for the residents to remain physically active.

The Effect of Kegel Exercise and Ba Duan Jin Applications on Premenopausal Women With Urinary Incontinence

This study aimed to determine the effects of Kegel exercise and Ba Duan Jin applications applied to premenopausal women with urinary incontinence on quality of life and psychological well-being. Study Group of the Research: Premenopausal women between the ages of 45-55 who come to the family health center with any complaint and have urinary incontinence. The research will be conducted as a randomized pre-test, post-test and control group intervention study design. The research will be conducted with women aged 45-55 with urinary incontinence who came for examination for any reason to a Family Health Center in Sinop between March 2024 and July 2024. According to the power analysis, the number of participants was calculated to be at least 54 when the type 1 error was taken as 0.05, the power was 0.95 and the effect size was medium (0.25) for the two-group design with two repeated measurements. To prevent possible data loss, the sample size was increased by 10% and the total number of participants was determined as 60. A total of 60 women, 30 experimental and 30 control, coming to the Family Health Center will be randomly included in the study. No information, Kegel exercise program and Ba Duan Jin applications will be given to the women in the experimental group, and no intervention will be given to the control group during the research process. Participants will be assigned to 2 groups: experimental and control. Those who come to FHC on odd days of the month will be included in the experimental group, and those who come on even days of the month will be included in the control group. Each group will be determined as 30 people. After the research is completed, the interventions applied to the experimental group will be applied to the women in the control group. Personal Information Form, Psychological Well-Being Scale and Incontinence Quality of Life Scale will be applied to women in the experimental and control groups as pre-test measurements. As a final test, the same measurements will be made to both the control group and the experimental group 16 weeks after the first measurement.

E-bibliotherapy for Informal Caregivers of People With Dementia

The objective of this study is to test the efficacy of e-bibliotherapy on improving the psychological well-being of informal caregivers of people with dementia as compared with a control group.