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NCT07485673
Background: Adolescence is a period of intensified emotional responses and occurs when mental health disorders commonly develop since adolescents are learning how to deal with powerful emotions. Globally, 15% of adolescents experience a mental disorder like depression or anxiety. However, adolescent mental health goes beyond mental disorders. It is state of mental well-being that allows individuals to deal with stressors, recognize their abilities, develop their activities well, and participate in society, providing a holistic approach that highlights the interplay between psychological well-being and other aspects of life. Given this perspective, a Lifestyle Medicine (LM) approach based on a multi-component framework is needed for assessing adolescents' mental health. This study aims to evaluate adolescents' (aged 14-19) mental health, identify and mitigate the risks of developing any mental health disorder as well as formulate comprehensive interventions to promote and increase their emotional wellbeing. Methods: Cross-sectional and longitudinal studies will be performed. Adolescents from Quito, Ecuador will be recruited using a simple random sampling technique. The minimum sample size is 385; however, to increase the precision of the estimates, a target sample of approximately 1000 participants will be established. Main outcome measure will be mental health using social determinants of health and lifestyle medicine factors. Conclusion: This research project will evaluate adolescents' mental health through a holistic and multiapproach evaluation and interrelate social determinants of health and lifestyle medicine variables to propose and design multidisciplinary strategies and interventions to prevent and mitigate mental health outcomes in adolescents. Additionally, the results will be useful in informing public health authorities to evaluate or modify current policies
NCT07075081
The goal of this randomized wait-list control study is to understand the relationship between ceremony and substance use (SU), SU risk (e.g., SU severity, depressive symptoms) and protective factors (e.g., spirituality, community support). The main questions it aims to answer are: * Will adults enrolled in Gii'igoshimong show improved SU outcomes compared to those in control groups? * Will self-relevant processing networks activated during stimulus engagement increase from pre- to post- engagement in ceremony and at 6-month follow-up? Researchers will compare adults that complete Gii'igoshimong with those that do not complete Gii'igoshimong to see if health outcomes are different. After completing baseline assessments, participants will be randomized to complete Gii'igoshimong now (intervention) or after the participants have completed the 1 month and 6-month post assessments (waitlist control). All participants (intervention and waitlist control) within a cohort will complete 1 month and 6 month post assessments at the same time.
NCT07465809
This interventional study evaluates the effectiveness of two 10-week self-regulation training programs (coaching-based and mindfulness-based) designed to enhance mental health and employability resources among healthcare workers (HCWs). Participants are allocated into two intervention arms based on their baseline level of emotional self-regulation. The study applies a non-randomized controlled pre-test/post-test design. The primary outcome is change in employability. Secondary outcomes include mental health indicators, such as perceived stress, anxiety, depressive symptoms and self-regulation. A follow-up assessment was conducted six weeks after the post-test. Additionally, qualitative semi-structured interviews were conducted to explore participants' subjective experiences with the interventions.
NCT07391254
This randomized, placebo-controlled double blinded study examined whether placebo, low- or high dose omega 3 fatty acid supplementation had associations with mental health symptoms and vitamin D status in college students aged 18-27.
NCT07447921
The goal of this clinical trial is to learn whether improving caregivers' mental health and parenting practices can enhance child wellbeing among Congolese refugee families living in the Nyarugusu Refugee Camp, Tanzania. The WEMA trial ("Wellbeing through combined Evidence-based tools for Mental health and Attuned parenting") is a three-arm, family-level cluster-randomized, controlled superiority trial involving 324 families (approximately 648 children aged 7-10 years and their two primary caregivers). Participants and intervention facilitators will know which program a family receives, but outcome assessors (enumerators) will not know group assignment. The main questions it aims to answer are: * Does Self-Help Plus (SH+), a World Health Organization (WHO) group stress-management program, improve children's emotional and behavioral functioning at 12 months post-intervention, compared with usual care? * Does adding Interaction Competencies with Children for Parents (ICC-P), a participatory parenting program, after SH+ further improve children's emotional and behavioral functioning at 12 months post-intervention, compared with SH+ alone? Researchers will compare (1) Usual Care, (2) SH+, and (3) SH+ followed by ICC-P to see whether SH+ improves outcomes versus usual care, and whether SH+ followed by ICC-P provides additional benefits beyond SH+ alone. Participants will: * Be assigned by chance by family clusters to one of three groups: Usual Care, SH+, or SH+ followed by ICC-P. * Receive either (a) information about available psychosocial and mental health services (Usual Care), (b) SH+ (five group sessions delivered by trained non-specialists), or (c) SH+ followed by ICC-P (a four-day participatory parenting training to strengthen positive parenting and reduce harsh discipline). * Complete study assessments at baseline, 3 months, and 12 months post-intervention. The primary outcome is children's emotional and behavioral functioning, measured using the Pediatric Symptom Checklist-17 (PSC-17) at 12 months post-intervention. Secondary outcomes include children's wellbeing and quality of life, as well as caregivers' mental health, well-being, and parenting practices. Additional exploratory outcomes will also be assessed, including measures collected from caregivers and behavioral tasks with children. The trial is implemented by Uppsala University in collaboration with the Dar es Salaam University College of Education (DUCE) and partners, with funding from the Swedish Research Council (grant no. 2022-02476).
NCT05757050
The proposed design is a randomised, double-blind, controlled, crossover intervention assessing the effects of an active intervention, containing Scutellaria baicalensis and Crataegus, versus placebo, on stress, cognition, sleep and wellbeing in healthy human volunteers. Outcome measures will be assessed acutely on day 1 and following 14 days of supplement consumption. Some interim outcome measures will also be assessed throughout the supplementation period to monitor sub-chronic changes
NCT05934019
The goal of this randomized controlled clinical trial is to investigate the efficacy of the internet-delivered intervention EMPATIA on general psychopathology of adolescents with subclinical symptoms compared to a Care As Usual (CAU) control group. The primary objective is to: * investigate the efficacy of the internet-delivered intervention on general psychopathology of adolescents with subclinical symptoms compared to CAU. * secondary objectives include: clinician-rated interviews and self-report questionnaires on the level of social and role functioning, time until onset of a mental disorder and service use. Furthermore, changes in subclinical symptoms, transdiagnostic mechanisms and therapeutic as well as safety measures are assessed by online self-reports Participants will use the internet-delivered intervention EMPATIA during eight weeks. Researchers will compare intervention group to a Care As Usual (CAU) group to investigate the efficacy of the internet-delivered intervention EMPATIA on general psychopathology.
NCT07440316
The Colorado Community Engagement Alliance (CO-CEAL) is a partnership between the University of Colorado Anschutz Medical Campus, several community-based organizations, and dozens of trusted local community members. Its mission is to address disproportionate impacts on health through active community engagement and outreach, capacity building, and long-lasting community partnerships to improve participation in health research. Funding for CEAL comes from the National Institutes of Health (NIH).
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.
NCT07432243
This study is a sub-study of Mapping Antenatal Maternal Stress (MAMS). Women previously enrolled in MAMS, their children and their partners/spouses were recruited for a set of more comprehensive assessments to characterise early neurodevelopmental outcomes in children, their associations with antenatal and postnatal maternal emotional health, and how paternal genetics, mental health and parenting styles and perceptions may influence this relationship.
NCT07427056
Background: Following the outbreak of war in Ukraine on 24 February 2022, thousands of Ukrainians are crossing the borders every day in search of a place that offers them stability and security. Studies have concluded that the war has affected the mental health of Ukrainian refugees and led to the emergence of psycho-emotional disorders. Hypothesis: The migration process and/or exposure to news related to the war in Ukraine negatively affect the mental health of refugees. Objectives: To explore the impact on mental health caused by the war in Ukraine on the refugee population residing in the province of Tarragona after the start of the Russian invasion in 2022. Methodology: Descriptive observational study of a quantitative and qualitative cross-sectional nature with structured surveys and semi-structured interviews. Statistical analysis will be performed using the SPSS programme and the ATLAS.ti programme or similar will be used for data analysis using qualitative methodology. Expected results: The conditions associated with exposure to war, migration, the search for a home, and the influence of the media on mental health contribute to Ukrainian refugees exhibiting psycho-emotional disturbances and difficulties in adapting to their new location. Applicability and relevance: The lack of scientific evidence developed in Spain on Ukrainian refugees and the need to raise awareness of this situation, as well as the possibility of contributing to the improvement of social and health policies on migration and the reception of refugees.
NCT05572398
School interventions to reduce bullying can be effective but also require substantial time and resources. Online technologies have the potential to deliver effective bullying interventions to a large number of middle school students for less cost. The feasibility of delivering the effective STAC bullying intervention through a mobile web app will be tested using focus groups with middle school students and development and usability testing and the efficacy of the program will be tested using a randomized controlled trial.
NCT07200323
Postpartum depression (PPD) is a frequent complication of the postnatal period but remains underdetected in routine clinical practice. This prospective clinical study, conducted at the high-risk pregnancy clinic of the CHUM, aims to estimate the prevalence of PPD among patients seen in postpartum follow-up. It also assesses the feasibility of implementing a standardized screening protocol that combines the administration of the Edinburgh Postnatal Depression Scale (EPDS) with a clinical decision-support algorithm to guide appropriate medical follow-up. The study also seeks to explore clinical characteristics associated with higher EPDS scores.
NCT06979193
Lesbian, Gay, Bisexual, Transgender, Intersex, Queer, Asexual, and other sexually or gender diverse (LGBTIQA+) communities in many countries face high levels of mental health problems compared to the general population. This is often due to discrimination, being excluded, abuse, and unfair treatment. In many low- and middle-income countries, including Nepal, the mental health needs of LGBTIQA+ people are not met, and the violence they experience is often ignored because they are seen as breaking gender norms. The low number of trained mental health specialists in a country like Nepal imply that any short-term effort to alleviate the mental health problems among LGBTIQA+ must rely on other type of support workers such as peers. There is growing evidence that help from community members-such as counselling given by non-professionals-can improve mental well-being. Considering that discrimination of LGBTIQA+ is common also within the health services, this study will look at whether peer counselling-support provided by trained LGBTIQA+ community members-can work well in Nepal. We have improved a counselling program called 'Problem Management Plus' (PM+), developed by the World Health Organization, by adding new parts that focus on reducing the risk of some of the contributing causes of mental distress, namely violence, marginalisation and loneliness. The added components include safety planning, counselling that builds confidence and strength, and goal setting strategies to help study participants use the skills they learn and reach the desired impact. In addition, peer-led monthly group meetings will be conducted to enhance social cohesion, strengthen interpersonal networks, and reduce feeling of loneliness. The study uses a community based participatory research approach, meaning LGBTIQA+ people are invited to give inputs throughout the study from study design to being involved as peer advocates to deliver the counselling. The trial will recruit at least 960 LGBTIQA+ individuals aged 18 to 55 years living in seven districts of Nepal. Study participants will be randomly allocated to one of three arms: one arm receiving individual augmented PM+ counselling with six weekly sessions; one arm receiving the individual augmented PM+ counselling followed by 11 monthly group sessions; and one control arm. There will be a one year follow-up to examine whether the peer support helps improve mental health and reduce exposure to violence among LGBTIQA+ people. The study findings will help guide programmes to improve the mental health of LGBTIQA+ in other low- and middle-income countries where they also experience discrimination, exclusion, and violence.
NCT07313657
Heart failure is a high-risk, chronic condition that impacts patients' mental health. Approximately 50% of heart failure patients experience comorbid mental health conditions, such as stress, depression and anxiety, which affect their day-to-day lives. Despite this interconnection, the integration of mental health awareness and support into cardiac care remains limited. To address this gap, the FRAME (Foundation, Recognition, Awareness, Management, Engagement) intervention was co-designed by researchers, healthcare providers, health system decisionmakers, and patient partners. This pilot study evaluates the feasibility of implementing the FRAME intervention in pilot clinical sites within two health regions in Ontario, Canada, including team-based family medicine clinics, cardiac rehabilitation/specialist clinics, and emergency departments. Utilizing a pretest-posttest hybrid 1 model intervention design, this study evaluates process indicators and patient-focused outcomes through surveys and semi-structured qualitative interviews. Findings from this study will inform a future large scale cohort study and scalable integration of the FRAME tool into existing cardiac care pathways to enhance mental health awareness and support among heart failure patients.
NCT06805682
A significant number of children are abused or neglected every year. This exposure is associated with short- and long-term consequences for their mental and somatic health. In France, 308,000 minors are benefiting from at least one child protective service or measure. There are few data on the health status of this population, and how it is evolving. Against this backdrop, interventions are needed to address the many needs of these children early and comprehensively, both in the short and long term. The PEGASE program, funded by the French government under Article 51, aims to ensure adequate medical follow-up - both somatic and psychiatric - for children taken into care by child protective services (CPS). An evaluation of the program's effectiveness and efficiency is needed to inform public decision-making on the appropriateness of extending it to all children under CPS's care. This requires the creation of a control cohort of children followed by CPS but not benefiting from the PEGASE program, the ESPER cohort (Prospective cohort study of protected children), which will enable us to carry out a comparative evaluation of the PEGASE program, as well as to provide information on the health of children followed by the CPS at the time of their placement and its evolution over time, data which are rare in France. The main objective is to evaluate the effectiveness of the PEGASE program on the evolution of the mental health of children followed by the CPS after 2 years of follow-up.
NCT06513845
Mental health vulnerability due to stress is increased in People of African Descent (PADs) in America due to disproportionate effects of racism, poverty, education, and criminal justice sentencing. Various meditation and mindfulness approaches have provided evidence of measured reductions in multiple negative dimensions of stress. However, the majority of these studies do not have an adequate representation of PADs or other marginalized groups and are not designed to be culturally relevant or community based. Music has been shown to alleviate multiple symptoms of stress and has been shown to be a preferred and effective support for meditation and mindfulness. However, its role in stress management in PADs engaged in meditation or mindfulness is seldom studied. This study aims to evaluate the effects of a virtual, community-based music mindfulness program on stress management in PAD community members with anxiety and depression during COVID19. 2c.a. Drum Circle Synchrony Study: This study will investigate the role that synchrony plays in subjective feelings of connection.
NCT06513858
Mental health vulnerability due to stress is increased America due to disproportionate effects of social factors such as racism, poverty, education, and criminal justice sentencing. Various meditation and mindfulness approaches have provided evidence of measured reductions in multiple negative dimensions of stress. However, the majority of these studies do not have an adequate representation of Persons of African Descent(PAD) or other marginalized groups and are not designed to be culturally relevant or community based. Music has been shown to alleviate multiple symptoms of stress and has been shown to be a preferred and effective support for meditation and mindfulness. However, its role in stress management in PADs engaged in meditation or mindfulness is seldom studied. This study aims to evaluate the effects of a community-based music mindfulness program on stress management in PAD community members with anxiety and depression during COVID19. Component 2c. Drum Circle Study: Investigators will study the impact of participation in drum circles on anxiety and feelings of connectedness.
NCT06505226
Mental health vulnerability due to stress is increased in People of African Descent (PADs) in America due to disproportionate effects of racism, poverty, education, and criminal justice sentencing. Various meditation and mindfulness approaches have provided evidence of measured reductions in multiple negative dimensions of stress. However, the majority of these studies do not have an adequate representation of PADs or other marginalized groups and are not designed to be culturally relevant or community based. Music has been shown to alleviate multiple symptoms of stress and has been shown to be a preferred and effective support for meditation and mindfulness. However, its role in stress management in PADs engaged in meditation or mindfulness is seldom studied. This study aims to evaluate the effects of a virtual, community-based music mindfulness program on stress management in PAD community members with anxiety and depression during COVID19. Music Mindfulness Study: Investigators will compare the effects of music-backed guided mindfulness mediation and guided mediation alone in alleviating anxiety and depression.
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.