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NCT07236918
The Concert Therapy is an arts-based, pilot interventional study designed to explore the effects of live music, guided breathing, and movement on stress reduction and overall wellbeing. Participants take part in one in-person session and one online session integrating musical performance, collective breathing rhythms, and body awareness techniques. The study aims to evaluate pre- and post-intervention changes in perceived stress and emotional wellbeing among adult participants.
NCT07062341
This study evaluates whether the group-based mental health program Self-Help Plus (SH+) can improve the mental health, wellbeing, and functioning of refugee mothers and their preschool-aged children living in Rhino Refugee Settlement (Rhino Camp), Uganda. SH+ is a stress management course developed by the World Health Organization for people affected by adversity. A previous study in this setting found that SH+ improved mental health outcomes among South Sudanese refugee women (Tol et al., 2020). However, it remains unclear whether these effects are sustained over time and whether improvements in maternal mental health also lead to positive outcomes for children. This study asks two main research questions: * Does SH+ lead to lasting improvements in maternal mental health one year after the intervention? * Does SH+ administered to mothers improve children's wellbeing? The trial's main focus is on two outcomes assessed 12 months post-intervention: the primary outcome is maternal psychological distress (Kessler-6; K6), and the key secondary outcome is children's psychosocial wellbeing (Kiddy-KINDLR; parent report). To answer these questions, this study will employ a cluster-randomized controlled trial with two arms. Villages are randomized to receive either SH+ plus Enhanced Usual Care (EUC) or EUC only (active control). Outcomes are assessed at baseline, 3 months post-intervention, and 12 months post-intervention (the primary endpoint). In addition to the primary outcome and key secondary outcome, the study includes a broader set of secondary outcomes capturing maternal mental health and functioning, parenting, and child wellbeing. The study also collects prespecified exploratory outcomes, including socio-behavioral skills of mothers and children measured using incentivized economic games, as well as child cognitive development. The study uses caregiver reports, direct child assessments, and incentivized tasks to measure outcomes. By integrating mental health, developmental, and behavioral measures, this study examines whether SH+ produces lasting mental health benefits and whether improvements in maternal mental health translate into positive outcomes for preschool-aged children in an adverse humanitarian setting.
NCT07380074
The goal of this observational study is to learn about the relationship between physical activity levels and mental health outcomes in French medical residents. The main questions it aims to answer are: Do lower physical activity levels or reductions in exercise since medical school relate to higher anxiety, depression, and burnout among medical residents? Do these associations differ by gender or training-related factors? Participants will complete online questionnaires assessing their physical activity, changes in exercise habits since medical school, and symptoms of anxiety, depression, and burnout at a single point in time.
NCT07361159
This is a pilot study examining the effects of telephonic health and wellness coaching on self-efficacy and caregiving burden for caregivers of patients awaiting heart or lung transplant.
NCT07247149
First responders are frequently exposed to high-stress and traumatic events, putting them at increased risk for mental health challenges such as posttraumatic stress disorder, anxiety, and depression. Access to traditional mental health services is often hindered by stigma, time constraints, and a lack of tailored resources. Mobile app-based interventions offer a promising solution due to their accessibility and potential to address mental health proactively and in a time sensitive way. Attention training has emerged as a simple way to prevent distress and the emergence of future mental health concerns. The proposed research will test a mobile app: FirstFocus which will leverage targeted attention training to prevent stress/distress during shifts and enhance the wellbeing of rural first responders. The specific aims are to (1) test the feasibility and acceptability of FirstFocus as an intervention for rural first responders; (2) to test the short-term preventative efficacy of attention training on state stress/distress and its longer-term efficacy for improving professional quality of life and reducing symptoms of anxiety and depression.
NCT06908447
The behavioral within-subject cross-over design study "CoVa" aims to investigate the effect of a short-term full-body cold-water immersion vs. warm-water immersion control on value-based choice, psychological well-being, and peripheral physiology.
NCT06801093
The goal of this study is to learn the feasibility of a digital psychosocial tool (Wysa) in improving life skills and overall wellbeing of English-speaking college students in IIT-Gandhinagar, a university in India. This will be conducted using pre-post assessments examining resilience, self-efficacy, problem solving, and wellbeing as well as examining app usage during the intervention period. The main questions it aims to answer are: 1. The feasibility and acceptability of Wysa amongst college students enrolled at the university 2. The effectiveness of Wysa in improving the life skills and well-being of college students enrolled at the university
NCT06883708
The general objective of this pilot feasibility study is to implement the pilot randomised controlled trial (RCT) and evaluate the feasibility of its methods and procedures for iSupport-Malaysia intervention. Another objective is to assess the acceptability and preliminary impacts of the iSupport-Malaysia web-based intervention on the psychological well-being of informal caregivers (ICs) of persons living with dementia (PLWDs) in Malaysia, compared to iSupport-Malaysia eBook. The main questions this pilot study aims to answer are: 1. How feasible is it to implement iSupport-Malaysia as an accessible resource for ICs of PLWD in Malaysia? 2. Does the use of iSupport-Malaysia lead to a reduction in caregiver burden among the ICs of PLWD in both web and eBook conditions? 3. Does the use of iSupport-Malaysia lead to improvements in psychological well-being (e.g. reduced depression, anxiety, stress; and increased quality of life) among the ICs of PLWD in both web and eBook conditions? 4. What are the perceptions of ICs of PLWD on the usability, satisfaction and perceived usefulness of the modules in iSupport-Malaysia? To answer these research questions: Seventy ICs of PLWD who met the study criteria will be recruited from the geriatric facilities of three hospitals, as well as via social media and referrals from elderly care centres. Eligible participants will sign an informed consent form, and be randomly assigned to the intervention (iSupport-Malaysia web program) or active comparison group (iSupport-Malaysia eBook) using stratified block randomisation. In both arms, participants are required to complete at least 10 out of 23 lessons within 3 months. Outcome measures will be administered online at baseline, 1-month and 3-month follow-up. Feasibility outcomes will also be measured. Upon completion of the program, ICs in the experimental group will be invited for in-depth interviews via an online teleconferencing platform. Expected outputs: A free, adaptive web-based iSupport-Malaysia in the local Malay language. iSupport-Malaysia can facilitate self-directed training in public and private dementia services, integrate into caregiver training programs, and promote self-directed public education on dementia care.
NCT06590077
The goal of this pilot study is to learn if aromatherapy helps to reduce stress and improve relaxation and wellbeing in gynaecological cancer patients after they have finished their treatment for cancer. The main questions this study aims to answer are: Is there a benefit in using an aromatherapy product for relaxation and wellbeing after completion of cancer treatment. Researchers will compare a commercially available aromatherapy test oil blend to a control oil (an oil at high dilution with a faint aroma) to see if the oil blend helps to reduce stress and increase wellbeing and relaxation. Participants will: Use a commercially available aromatherapy product or a control every evening for 4 weeks and complete a questionnaire at the start, after 2 weeks and at the end of the 4 week period. During the four weeks of the study, the participants may wish to record their experience with the test oil and assess its impact on relaxation and wellbeing in a personal diary.
NCT06724757
There are more and more informal caregivers (PPA) in Quebec. Their increase between 2012 and 2018, according to data from the "General Social Survey - Care Given and Received," was significant, around 32%. The available data paint a typical portrait of a Quebec caregiver: (a) she is a woman, (b) aged between 50-55 years, (c) who devotes at least 3 hours of her time per week, on a regular basis, (d) to caring for an elderly parent. To this date, there is no reliable data on the health status-whether mental, physical, or social-of caregivers in Quebec. Yet this information is crucial because it affects the ability of caregivers to fulfill their role and, consequently, the stable health of the individuals they care for, allowing them to continue living at home. This situation exposes caregivers to a decline in their own health, and by extension, the health of those they care for. The fact that the typical Quebec caregiver is 50 years old or older increases the risk of health deterioration within the caregiver-care receiver pair. Indeed, age 50 is when the effects of physiological and pathological aging begin to impact the physical capacities of the elderly. Developing new practices that focus on the health characteristics of both caregivers and care receivers, in order to prevent health deterioration, is therefore a crucial step in supporting caregivers in their role and ensuring that care receivers can stay at home in good conditions for as long as possible. The issue of caregivers' health is still under-addressed in Quebec, both in the scientific literature and in population surveys. It seems that caregivers need a comprehensive evaluation of their health status (physical, mental, and social), given the significant impact caregiving has on their health. Research conducted within the Living Lab, led by Dr. Beauchet's team, has helped develop tools and questionnaires that effectively assess the frailty of individuals aged 50 and over and produce reports that raise awareness about their health status, enabling them to implement future care solutions that meet their needs. The overall objective is to assess the health status (mental, physical, social) of caregivers aged 50 and over, living in Quebec-through self-assessment to make them aware of their actual health condition and engage them in a process of self-care.
NCT06695234
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.
NCT06334328
The current proposal aims to 1) develop a technical platform and implementation plan for the delivery of a virtual reality-based mindful movement therapy (VR-MMT) protocol for older adults; and 2) conduct a clinical trial to examine the feasibility and preliminary efficacy of an 8-week, 16-session module VR-MMT intervention for this population. The findings of this study will help us to identify engagement barriers and refine the intervention contents as well as the study protocol necessary for the preparation of grant applications to conduct a controlled clinical trial. This study is innovative and high impact as this is the first study to examine the feasibility and preliminary efficacy of a VR-MMT intervention that could potentially ameliorate cognitive and mobility decline and promote psychological wellbeing in older adults by combining a widely accessible technology and creative embodiment-based approach.
NCT06064474
The investigators are conducting a randomised-controlled trial comparing high ventilation breathwork with retention (HVBR) to a breathwork placebo (paced breathing at 15breaths/min with brief retentions). The metric of 15b/min aligns with guidance from the British Journal of Nursing, Royal College of Physicians and Johns Hopkins Medicine which state that the average, healthy rate should range from: 12-20, 12-18 and 12-16b/min, respectively. The main questions the study attempts to address are: Does HVBR lead to improved state and trait mental health and wellbeing in a general population adult sample? The study will be conducted entirely online through the research platform Prolific, so participant data will be anonymous. The investigators will collect self-reports of mental health and wellbeing before and after the three-week breathwork period, in addition to a follow-up three weeks later. Pre-post intervention and follow-up questionnaires will be completed online via the survey platform Qualtrics which will be linked to Prolific. Data on self-reported adherence to, and credibility/expectancy of, the breathwork will also be collected, along with participants' experiences to gauge the safety and tolerability of the breathwork protocol.
NCT06093737
The goal of this clinical trial is to examine the impact of the Communities Organizing for Power through Empathy (COPE) intervention in adults in communities having recently experienced or at risk of experiencing disaster. The main questions it aims to answer are: * How does the COPE intervention affect individual mental health? * How does the COPE intervention affect protective factors like coping and social support? * How does the COPE intervention affect community resilience? * How does delivery of the COPE intervention in partnership with a broad-based organization affect participant recruitment and retention, as well as outcomes? Participants will participate in the three session COPE intervention. Researchers will compare individuals who participate in the COPE intervention to individuals who participate in house meetings to see if the COPE intervention improves mental health, coping, social support and community resilience. Researchers will also examine factors that affect implementation and intervention delivery.
NCT06059092
To meet adolescents' needs regarding mental health vulnerability, this study aims to propose and evaluate three original school-based preventive interventions delivered to French 13y-adolescents, with respect to their effects on mental health outcomes, as well as users' experiences of intervention, evaluated through questionnaires. Based on cognitive-behavioral therapies (CBT) techniques, these interventions target three strategic process areas: reactive adaptation, proactive adaptation, and interpersonal adaptation. Their effectiveness will be evaluated through a four-arm randomized controlled trial, conducted in an ecological context. Intra-group and inter-group comparisons will be carried out for our different variables of interest, namely targeted psychological processes, levels of distress, functional impairment, and well-being, and user experience indicators of acceptability, utility, and usability.
NCT05229835
The aim of this project is to demonstrate the synergistic effect of TRE and NW training on health indicators for older women. The women will be divided into four groups, i.e. Control group (CG); time-restricted eating group (TRG) which will follow 12 weeks of TRE protocol; Nordic walking training group (NWT) which will follow 12 weeks of supervised Nordic walking training and Nordic walking training combined with a time-restricted eating group (NW-TRG). In addition, it is assumed to prove that among young men, TRE will improve adaptation to endurance training and improve the metabolism. The study will be divided into two groups: 1. a group undergoing endurance training and 2. a group combining endurance training with TRE. In all subject's changes in the metabolism of iron, tryptophan, vitamin D and lipids will be evaluated. Endocrine function of skeletal muscles, mental state and cognitive abilities of the subjects will also be examined. The investigators expect that the applied procedure of temporary restriction of food intake will be easy to apply and continue for much longer than the study period. In order to maintain this time window, test subjects will be asked to delay their breakfast and early dinner intake. In addition, it is expected that the improvement in wellbeing, vitality and a significant improvement in performance and biochemical indicators of health, especially in the NWT plus TRE group, will allow to better understand the physiology of exercise, which may result in future specific health recommendations for people of different ages.
NCT05590975
This study aims to evaluate the effectiveness of PACT intervention in improving resilience, life skills, and psychosocial skills among children and peer supporters. The evaluation will be carried out in the Public Schools of Karachi, Sindh, Pakistan.
NCT05519267
Social work is a stressful occupation with social workers at high risk of job-related stress and burnout. Mindfulness has been evidenced as a promising approach for improving: recovery from stress; behavioural responses to stress; and resilience. The main aim of the study is to examine the efficacy of a bespoke, innovative, 6-session Mindfulness Intervention for social workers (MBSWSC) in reducing social worker stress, feelings of burnout, anxiety, low mood and improving well-being. The study will also compare outcomes from the MBSWSC with a briefer, condensed 3 session mindfulness programme (MBSC).
NCT04430465
KORN investigates the effects of wholegrain oat and rye intake on health and cognitive wellbeing in children with overweight.
NCT04168463
This study will assess the use and impact of the affordable 'Joy for All' robot pets for older people with and without dementia living in the care homes in South West England. Robot pets such as Paro have shown potential in improving wellbeing (including reduced agitation, loneliness, medication use, anxiety and depression), however previous work conducted by the investigators suggests Paro is less acceptable to older adults than alternative devices; the Joy for All cat and dog. Paro is also much more expensive (£5000 compared to £100) limiting its use within the real world, and limiting the number of people able to benefit. The investigators therefore wish to explore the potential of these more affordable robots in achieving wellbeing benefits.