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NCT07669038
Type 2 diabetes requires active self-management from the time of diagnosis, but participation in traditional face-to-face diabetes self-management education is often limited by access-related and personal barriers. Online education may provide a more flexible and accessible way to deliver structured diabetes education, particularly for newly diagnosed adults who need timely support in understanding and managing their condition. This study evaluated the effects of online diabetes self-management education compared with traditional face-to-face education on diabetes knowledge retention, body mass index (BMI), and HbA1c in adults newly diagnosed with type 2 diabetes who were not receiving antidiabetic medication. A total of 123 participants were included: 49 participants received online diabetes self-management education, 52 participants received traditional face-to-face education, and 22 participants who declined education formed a non-randomized control group. Diabetes knowledge was assessed at baseline, immediately after the intervention, and at three-month follow-up, while BMI and HbA1c were measured at baseline and follow-up. At three-month follow-up, both online and traditional education groups showed significantly greater diabetes knowledge compared with the control group. The online education group also showed better immediate post-intervention knowledge than the traditional education group. Both education groups had significant reductions in BMI from baseline to follow-up, while no significant short-term effect on HbA1c was observed.
NCT07666802
Sharing Tales That Teach is a randomised study of a shared picturebook reading programme for 4- to 5-year-old children and their primary caregivers. The study will test whether a caregiver-delivered, emotion-focused shared reading programme leads to greater improvements in children's emotion regulation than a standard dialogic shared reading programme. Emotion regulation refers to children's developing ability to understand, express and manage emotions in ways that support learning, relationships and wellbeing. These skills are closely linked with executive function, including children's ability to remember instructions, control impulses and shift flexibly between activities. Shared picturebook reading may provide a natural, low-cost way for caregivers to support these skills through everyday interaction. Families in the randomised part of the study will be allocated to one of two 8-week shared reading programmes. In the emotion-focused group, caregivers will receive training in strategies such as naming emotions, discussing why characters feel as they do, talking about consequences of emotions and modelling ways to manage feelings. In the comparison group, caregivers will receive training in standard dialogic picturebook reading strategies, such as naming, describing, sequencing and asking open questions, without an explicit focus on emotions or emotion regulation. Both groups will use the same picturebooks and will be asked to complete three shared reading sessions per week at home. The main hypothesis is that children in the emotion-focused shared reading group will show greater improvement in emotion regulation from baseline to 12-month follow-up than children in the standard dialogic shared reading group. The study will also examine whether the programme affects children's executive function, caregiver wellbeing and caregiver emotion regulation. Additional exploratory analyses will examine caregiver-child interaction processes and whether caregiver or child characteristics are associated with different intervention effects. The study will recruit caregiver-child dyads through state primary schools in Greater London. Children will complete age-appropriate tasks and caregivers will complete questionnaires at baseline and follow-up. A laboratory subsample may also complete additional behavioural, observational and neurophysiological assessments. The study is low risk, non-invasive and does not involve medical treatment.
NCT07660471
This randomized controlled trial aims to evaluate the effect of a mindfulness-based intervention on childbirth self-efficacy, fear of childbirth, and self-compassion among primiparous pregnant women. Eligible pregnant women will be randomly assigned to either a mindfulness intervention group or a control group receiving routine antenatal education and standard prenatal care. The intervention program will consist of eight sessions delivered over four weeks. Outcomes will be assessed before and after the intervention using validated measurement tools. The findings may contribute to the development of effective psychosocial interventions to improve maternal well-being during pregnancy.
NCT07637461
This research plan aims to establish an effectiveness assessment system for promoting clinical communication, empathy, and emotion regulation in pediatric nursing students through a combination of AI communication simulation and human library narrative. This study sets five specific objectives: 1. To develop and implement a pediatric nursing teaching model that integrates AI communication simulation and human library narrative. 2. To evaluate the effectiveness of this teaching model in improving nursing students' clinical communication skills. 3. To examine the effectiveness of this teaching intervention in enhancing nursing students' empathy. 4. To explore the impact of this teaching intervention on nursing students' emotion regulation abilities. 5. To understand students' learning experiences, feelings, changes in emotion regulation, and suggestions for improvement regarding this integrated teaching intervention.
NCT07607834
This pilot randomized active-comparison study examined two formats of emotional awareness and cognitive reappraisal training for adults with co-occurring anxiety and depressive symptoms. Participants were assigned to either a real-time awareness group or a retrospective awareness group. The real-time awareness group used a smartwatch-based heart-rate prompting system to identify emotions in daily life and later complete cognitive reappraisal exercises. The retrospective awareness group completed daily evening reflection and cognitive reappraisal exercises based on emotional events from that day. The study lasted six weeks and included assessments at baseline, mid-intervention, and post-intervention. Outcomes included anxiety symptoms, depressive symptoms, emotional clarity, mood repair, cognitive reappraisal, expressive suppression, and psychological well-being. The purpose of the study was to examine preliminary patterns of change and compare how the two formats may support emotion regulation processes.
NCT07281365
The goal of this study is to develop and test an outpatient intervention for preadolescents (ages 7-12) with self-injurious thoughts and behaviors (SITBs). The main questions it aims to answer are: 1. Does the newer intervention lead to better engagement of families in treatment compared to treatment as usual (TAU)? 2. Is the new intervention feasible, acceptable, and appropriate? 3. Does the new intervention lead to more improvements in SITBs, mental health symptoms, and treatment targets compared to TAU? Preadolescent participants with SITBs and their families will be randomized to either the new intervention or TAU, which will consist of the typical interventions the study therapist would use for preadolescents with SITBs. Participants will: 1. Complete an initial baseline assessment to determine eligibility and assess SITBs, mental health symptoms, executive functioning, and emotion regulation 2. Participate in a \~weekly, outpatient intervention lasting around 3-4 months 3. Complete additional assessments at mid-treatment, post-treatment, and 3-month follow-up 4. Participate in an interview sharing their perceptions of the intervention
NCT06877013
The purpose of this study is to determine the optimal dose of soluble fibers that induces tolerable gastrointestinal symptoms.
NCT06555172
This feasibility clinical trial aims to assess the feasibility of implementing a 1-month app-based meditation program with officers in the juvenile legal system and other professionals working directly with legal-involved youth.
NCT07560072
The aim of this clinical trial is to evaluate whether AGENCIA, a brief psychological program supported by digital technology and artificial intelligence, can help reduce emotional and behavioral difficulties in adolescents aged 12 to 18. These difficulties may include irritability, impulsive behaviors, conflicts at home or at school, or difficulties in managing intense emotions. The study also aims to determine whether the effects are similar across adolescents with different symptom profiles or neurodevelopmental characteristics. Participants will be randomly assigned to one of three groups: AGENCIA Digital: a self-guided online version completed at home. AGENCIA in-person with a digital assistant: a clinician-delivered version supported by an interactive digital assistant to guide the exercises. Digital psychoeducation (control): a self-guided online program providing general information about adolescent well-being. The main research questions are: Does AGENCIA reduce overall emotional and behavioral difficulties? Does the program improve functioning, family accommodation, and personal agency (a young person's sense of being able to act and make changes)? Are the effects similar across adolescents with different profiles or neurodevelopmental characteristics? Participants will: * Complete three structured sessions depending on their assigned group. * Complete brief online questionnaires at baseline (T0), immediately after the sessions (T1), and at 1-month (T2) and 6-month (T3) follow-ups. * Receive brief phone calls during follow-ups to support questionnaire completion. A total of 465 adolescents will take part in the study. Participation is voluntary and does not replace usual clinical care. The study does not involve medication or invasive procedures, and all digital tools operate within secure institutional systems.
NCT07459764
The investigators are conducting an observational trial examining young women over the course of 28 days in which we are monitoring movement, sleep, heart rate, oxygen saturation, gut physiology, light, and menstrual cycle. The inter- and independence of the cyclicity of these variables with each other, the circadian cycle, the menstrual cycle, and the sleep cycle will be tested.
NCT07173608
This study will evaluate how a comprehensive meditation-based program, Inner Engineering, supports teens ages 15-18 in becoming more joyful, focused, resilient, and better equipped to manage stress and thrive. Through this study, researchers will examine whether practices like meditation, yoga, and cognitive reframing can help adolescents view and respond to challenges with greater clarity and balance. The study will assess mental and physical impacts through self-report, physiological, and neuroimaging methods.
NCT07543965
The Plasma Protein Therapeutics Association (PPTA) sponsors the Cohort of Repeat Donor Experiences (CORE) Study. This is a prospective, observational cohort study that will follow Source Plasma donors for up to 2 years during the main study (anticipated to begin in summer 2026) and up to 3 months during the pilot launching in mid-March 2026. This study aims to confirm a lack of negative health effects Source Plasma donors may experience as a result of frequent plasmapheresis. The study will use data obtained through self-report surveys for the duration of the study along with periodic whole blood sample collections to test for CRP, ferritin, and IgG.
NCT07323446
This is a double-blind randomized controlled study. The study will last up to 16 weeks from the initial phone screen (it could take up to eight weeks to schedule and complete the initial screening process and schedule the 2 MRI visits). Once subjects have completed the screening process, they will begin the 8-week trial phase. Subjects will be assessed weekly throughout the study for efficacy and tolerability. The investigators plan to recruit 80 participants with emotional dysregulation (ED) in the treatment arm. In addition, the investigators will aim to recruit 40age-, sex-, and parental-education matched participants without emotional dysregulation, and major psychopathology as Typically Developing (TD) control participants in the control arm. Upon scheduling the baseline visit, only the emotional dysregulation (ED) participants will be randomized 1:1 to be exposed to NAC or placebo treatment for 8 weeks. Participants will complete baseline and post-treatment (endpoint) brain MRI acquisition. TD participants will complete the same screening and characterization process as the ED group and then will be invited to complete MRI eligibility screening and to be scanned twice, separated by an eight-week interval, but the TD will not complete the NAC treatment or receive a placebo. See Table 1 (Study Schema) for a complete list of characterization measures to be completed by each group.
NCT06619015
The two main aims of this clinical study is; 1. To investigate if the results from a series of physiological tests and questionnaires prior to treatment, can be used to predict the treatment response to obesity medication 2. To investigate the effect of combining semaglutide and pramlintide on various aspects of appetite, food preference and eating habits. The study is planed as a 26 week, double blinded, randomized, placebo controlled trial. The goal is to include N=40. They will all receive weekly semaglutide injections. After 24 weeks they will be randomized to receive either an amylin analog (pramlintide) or placebo as a continuous infusion for two weeks, in addition to weekly semaglutide. The results from this study will contribute to identifying possible predictors of treatment response, enabling optimal individualized medical weight loss treatment. As well as providing knowledge on the complex interplay between incretin hormones and their effects on appetite and eating habits.
NCT05558527
This study will examine the effects of social support on threat vigilance and arousal using eye tracking. We will also test the moderating effects of trauma and discrimination history.
NCT06502574
Self-management of chronic diseases requires the ability to manage the symptoms, treatment, and lifestyle changes inherent in living with achronic disease. Rational drug use by older adults is of particular importance. Mobile applications are being developed to facilitate thecompliance of older adults with chronic diseases with medication treatment and to increase their disease self-management skills. The researchwas planned to strengthen participation in social life through rational drug use and disease self-care management in older adults with chronicdiseases. The research will be conducted in a parallel group randomized controlled manner. In the research, a mobile application will bedeveloped for the use of older adults. Older adults will be asked to use the mobile application for at least 6 months, and the scales will be re-administered face to face or online in the 3rd and 6th months of the intervention.
NCT06333925
Misophonia, the inability to tolerate certain repetitive distressing sounds that are common, is gaining, recognition as an impairing condition. It is not a well-understood condition and there are no known treatments. The purpose of this study is to test a new misophonia intervention that uses emotion regulation strategies and different types of brain stimulation on misophonic distress. This study will examine changes in brain activity during presentation and regulation of misophonic versus distressing sounds. The study team plans to alter activity in a key area of the brain responsible for emotion regulation circuitry over 4 sessions with the goal to test if this intervention helps misophonic distress. Sixty adult participants with moderate to severe misophonia will be recruited and taught an emotion regulation skill and randomly assigned to receive one of two types of repetitive transcranial magnetic stimulation (rTMS). The study includes 9-10 visits: the remote screening visit(s), the initial MRI, the four neurostimulation sessions, the follow-up MRI, and two additional remote 1- and 3-month follow-up visits.
NCT07474402
This study tests a breastfeeding support program for mothers who give birth by cesarean section. The purpose of the study is to see whether the program helps mothers feel more confident about breastfeeding and improves mother-baby bonding.
NCT07491835
Here are both updated sections: Brief Summary: The goal of this clinical trial is to learn if two different doses of dietary supplements delivered to the lower gut can reduce appetite and food intake in obese adults (men and women aged 18-60 with a BMI of 30-40 kg/m²). The main questions it aims to answer are: Does the dose of DIM and Perilla oil delivered to the colon affect circulating levels of appetite-suppressing hormones (PYY, GLP-1, ghrelin, GIP and 5-HT)? Does the dose of DIM and Perilla oil delivered to the colon affect total caloric food intake? Does the dose of DIM and Perilla oil delivered to the colon affect hunger and appetite perception? Researchers will compare a medium dose (250mg DIM + 1050mg Perilla oil) to a low dose (125mg DIM + 525mg Perilla oil) to see if both doses are effective at suppressing appetite and reducing food intake. Participants will: Fast from 20:00 h the evening before their study visit Attend a single study visit at the Wingate Institute Clinical Trials Unit, London Take 4 specially coated capsules (targeting the lower gut) at 08:00 and again at 12:00 Have blood samples taken every 30 minutes across 17 time points to measure hormone levels Complete hunger and appetite questionnaires (VAS) every 30 minutes from 08:00 to 16:00 Eat a standardised gender-adjusted breakfast (max 903 kcal) and lunch (max 1340 kcal)
NCT07194902
The purpose of this study is to test the feasibility and acceptability of a combination intervention to promote HIV self-testing (HIVST) for Partners and PrEP uptake for HIV-uninfected Postpartum Women ("H4P"). H4P includes evidence-based cognitive behavioral therapy (CBT) strategies, such as communication skills training, motivational interviewing, and problem-solving. The investigators will conduct a randomized pilot trial of the H4P intervention to evaluate the feasibility, acceptability, and preliminary effectiveness of a multi-step PrEP uptake and HIV self-test kit intervention for postpartum HIV-uninfected women (N = 60 and their male partners) who report a partner of unknown serostatus, and their partners, in the province of KwaZulu-Natal, South Africa.