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Mental Health Wellness 1 clinical trials

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NCT ID: NCT05865782 Not yet recruiting - Physical Inactivity Clinical Trials

Reconstructing Schoolyards With Greenery to Increase Schoolchildren's Physical Activity and Mitigate Climate Changes

Start date: May 22, 2023
Phase: N/A
Study type: Interventional

By reconstructing schoolyards with greenery, physical activity levels among children can be increased at the population level and also mitigate health and environmental risks resulting from rising climate changes in urban areas. The overarching purpose of the proposed project is to: i. increase physical activity levels among school-aged children, independent of socioeconomic factors, and thus affect short- and long-term health outcomes on a population level ii. establish an evidence-based bottom-up approach for schoolyard reconstructions iii. evaluate the cost-effectiveness of schoolyard reconstructions with greening on health outcomes and its environmental impact

NCT ID: NCT05853666 Not yet recruiting - Clinical trials for Mental Health Wellness 1

Connecting Families to Improve Parental Self-efficacy and Parent Psychosocial and Infant Health Outcomes in the NICU

Start date: June 2023
Phase: N/A
Study type: Interventional

Preterm infants, 1 in 12 Canadian births, are at a significant increased risk of poor health outcomes, resulting in high healthcare burden. Parents of these infants report lower self-efficacy and worse mental health when compared to parents of term infants. There is an urgent need to use effective ways to improve parental self-efficacy and associated parent psychosocial and infant health outcomes. To improve parent and baby outcomes, the investigators will build on an existing eHealth solution to create Chez NICU Home+ (CNH+), which offers web-based, parent-targeted, interactive educational tools, virtual communication, and text message support during a baby's NICU stay. We will evaluate whether Chez NICU Home+ improves parental self-efficacy (primary outcome), parent psychosocial, and infant health outcomes in parents of babies requiring a NICU stay, and the implementation (ease and uptake) of Chez NICU Home+ in multiple sites. This study will be a multicentre implementation study, with a stepped wedge cluster randomized controlled trial across four Canadian NICUs. At the beginning of the study, data regarding current care will be collected from all sites to determine a baseline. Following baseline data collection, every five months one of the sites will start using the Chez NICU Home+ solution. A total of 800 parents and their babies, who are expected to stay at least 5 days in the NICU, will be recruited. Parents will complete a survey on psychosocial adjustment and infant outcomes when the study begins, as well as at 14 and 21 days after enrollment, at infant discharge from the NICU, and at 6 months post-discharge. Infant health and development outcomes will be collected at discharge, 6 and 18 months post-discharge via health records. The investigators predict that Chez NICU Home+ will be a positive, interactive care option, combining virtual parent education, tailored communication, and support, which will improve parental self-efficacy and parent psychosocial and infant health outcomes, and have long-term benefits for families.

NCT ID: NCT05825040 Not yet recruiting - Mental Health Issue Clinical Trials

Randomized Controlled Trial on Precision Mental Health

Start date: September 1, 2023
Phase: N/A
Study type: Interventional

The current study aims to evaluate the effectiveness of different online psychological interventions, including guided and unguided transdiagnostic cognitive behavioural therapy, and unguided mindfulness-based intervention, on mental well-being in comparison to waitlist control. It is hypothesized that participants with the guided psychological intervention will show (H1) a greater reduction in mental health symptoms, and (H2) better mental well-being compared with participants with unguided psychological intervention and the control condition.

NCT ID: NCT05818579 Not yet recruiting - Clinical trials for Mental Health Wellness 1

Virtual Reality for Mental Well-being in Older People With Physical Disabilities

Start date: February 15, 2024
Phase: N/A
Study type: Interventional

Objectives This study aims to examine the effects of the therapeutic virtual reality (VR) experience in older people with physical disabilities in long-term care facilities (LTCF) in 1) increasing mental well-being, 2) reducing depressive symptoms, 3) reducing loneliness, 4) increasing health-related quality of life, and 5) increasing perceived social support. If this intervention is successful, this study will yield new knowledge about the effects of this innovative intervention. Also, an innovative VR intervention will be available to promote the mental well-being of older residents in LTCF. Trial design This study employs a single-blinded, two-parallel-group (intervention-to-control group ratio=1:1), non-inferiority, randomized controlled trial. Study setting This study will be conducted in the LTCF. Participants will be recruited from Care & Attention Homes for the Elderly and Nursing Homes under the governance of the Social Welfare Department in Hong Kong. Eligibility criteria Inclusion: 1) Aged 60 years or above; 2) LTCF residents; and 3) Physical disability, defined as the Modified Barthel Index (MBI) score of ≤ 90 (i.e., moderately dependent or worse). Exclusion: 1) Probably dementia, as defined by a Montreal Cognitive Assessment score of < 20, 2) Severe visual impairment, as defined by a lens-corrected visual acuity score of < 6/60, 3) Severe hearing impairment, as defined by failed whispered voice test, 4) Bilateral upper limb paralysis, as defined by the Medical Research Council Muscle Power Scale of < 4, or 5) Participated in any VR activities in the past six months or concurrently. Consent All participants will be asked to give their written informed consent to participate in the proposed study. Groups Participants allocated to the intervention group will participate in the 6-week VR experience programme. Participants allocated to the control will receive the usual care provided by the LTCF, such as personal care, regular basic medical and nursing care, and social support, as committed by the Social Welfare Department. The participants allocated to the intervention group receive the same usual care provided by the LTCF. The research team does not interfere with the services provided to the participants in either group. Outcomes Demographic data including age, gender, level of education, number of chronic illnesses, length of stay in the LTCF, and experience of participation in VR activities will be collected. Outcomes include mental well-being, depressive symptoms, loneliness, health-related quality of life, and perceived social support. Participant timeline Potential participants will be recruited in the phase of Enrolment, in which the eligibility screen and informed consent will be implemented. Then, in the phase of the Pre-treatment Assessment (i.e., T0,), demographic and outcome data will be collected. Subsequently, in the phase allocation, participants will be randomly allocated to either the therapeutic virtual reality experience group or the control group. Then, interventions will be implemented. In the phase of the Post-treatment Assessment (i.e., T1), outcome data will be collected once again. Analysis methods Demographic and outcome data collected at baseline will be reported either as means with standard deviation or as frequencies with percentages according to their levels of measurement as a whole sample and by groups. Generalized estimating equations (GEE) will be employed to separately test the hypothesis on the five outcomes as dependent variables (i.e., mental well-being, depressive symptoms, loneliness, health-related quality of life, perceived social support), The independent variables will be the same across all GEEs: group (two categories: intervention and control groups), timepoint (two categories: T0 and T1), and group x timepoint. The primary interpretation of the results will be based on the intention-to-treat analysis without adjusting for covariates. The level of significance will be set at 0.05. Missing data will be managed following a practical guide with flowcharts using various methods (e.g., multiple imputation, single imputation, or no imputation).

NCT ID: NCT05542537 Not yet recruiting - Obesity Clinical Trials

Nurturing Healthy Teachers

NHT
Start date: September 2022
Phase: N/A
Study type: Interventional

The purpose of this trial is to compare the impact of a fruit and vegetable access plus nutrition education intervention to a nutrition education-only control on the health, well-being, and food security of early care and education (ECE) professionals. The intervention, called Nurturing Healthy Teachers, combines strategies from two evidence-based programs - Create Healthy Futures (CHF) and Brighter Bites (BB).

NCT ID: NCT05282537 Not yet recruiting - Clinical trials for Mental Health Wellness 1

Health Parameters of University Students After Pandemic Isolation

Start date: March 14, 2022
Phase:
Study type: Observational

The COVID-19 pandemic caused by the SARS-CoV-2 coronavirus represents threats to global health and economy. The high pathogenesis of SARS-CoV-2 extent that the Mexican government declared a national health emergency, agreeing to take extraordinary measures such as the suspension of non-essential work, including the suspension of academic activities at all levels, in order to minimize the dispersion and transmission of the virus and its consequences. Several previously reported quarantine evaluations have shown that psychological stress reactions can arise from the experience of physical and social isolation, so the current global threat of isolation has shaken the usual practices of the general population, including young people, and resulting in the modification of their academic, labor and social dynamics. The usual behavior in this phenomenon establishes that greater social isolation is associated with less satisfaction with life, higher levels of depression and lower levels of psychological well-being or performance as well as changes in diet. Understanding the factors related to coping with COVID-19 is essential to issue guidance on health in the student population, for that, the present proposal intends to evaluate changes in health parameters derived from the resumption of academic activities in person for a year in university students of health sciences area.

NCT ID: NCT05199675 Not yet recruiting - Clinical trials for Mental Health Wellness 1

Implementing Digital Peer Support Training for Adolescent Mental Health

Start date: January 31, 2022
Phase: N/A
Study type: Interventional

Using a hybrid type III trial with a cluster randomized design, the digital peer support training for adolescent mental health protocol aims to implement a multidisciplinary program, which translates theoretical and empirical work from implementation science, communication science, and developmental psychology, to train adolescents in effective digital peer support for mental well-being. With the lack of theoretically driven and empirically grounded program to train adolescents in providing digital peer support for mental well-being, this study involves the design and implementation of such a program using that addressed four research questions: (a) what is digital peer support for adolescents, (b) how do peers provide effective peer support online, (c) how do we implement digital peer support training among adolescents, (d) what are the facilitators and barriers in training adolescents to provide effective peer support, and (e) how do we scale up and sustain digital peer support training among adolescents for far-reaching and long-lasting effectiveness?

NCT ID: NCT04814576 Not yet recruiting - Clinical trials for Mental Health Wellness 1

Collaborative Nursing Care-based Intervention in Mental Health Day Hospital Users

Start date: March 26, 2021
Phase: N/A
Study type: Interventional

OBJECTIVES: 1. To evaluate the impact of an intervention based on collaborative nursing care in terms of the changes produced in the recovery process, in positive mental health and in the nurse-patient therapeutic relationship among users of mental health day hospitals. To explore the changes produced in the recovery process of users who receive collaborative nursing care through the co-design and implementation of group activities. DESIGN: A sequential and transformative mixed methods design is proposed. METHODS. The study is structured in three phases. In phase one (baseline) and phase three (follow-up), quantitative data will be collected from patients at a mental health day hospitals based on a two-armed, parallel-design, non-randomized trial. In phase two, two groups will be established: an intervention group (GI) in which the intervention based on collaborative nursing care will be carried out through the co-design and implementation of activities through Participatory Action Research, and a control group (CG) in which the usual care dynamics will be continued. All the users of three mental health day hospitals who agree to participate in the study will be studied consecutively until the necessary sample size is reached. The outcomes used to evaluate the impact of the intervention will be the stage of the recovery process, the quality of the therapeutic relationship and the patient's level of positive mental health. DISCUSSION: Very few collaborative nursing care interventions have been studied and shown to be effective in the context of the paradigm shift toward recovery in mental health nursing. IMPACT: Understanding the changes produced in the recovery process, as well as in the quality of the therapeutic relationship and in the maintenance and/or increase of the levels of positive mental health of people with mental health problems, can contribute to the design and implementation of new methodologies to offer effective and person- centered care.

NCT ID: NCT04537676 Not yet recruiting - Quality of Life Clinical Trials

Patient Empowerment Study

Start date: September 15, 2020
Phase:
Study type: Observational

The Patient Empowerment Study is an observational longitudinal study among adults with diabetic foot ulcer (DFU). The scope of this study is to better understand how a patient's DFU disease process and usage of the Podimetrics System can impact patient health-related quality of life. Health-related quality of life will be measured by both the generic 36-item Short-Form Health Survey (SF-36) questionnaire and the ulcer-specific Diabetic Foot Ulcer Scale Short Form (DFS-SF) questionnaire.

NCT ID: NCT04343664 Not yet recruiting - Depression Clinical Trials

Mental Health Assessment Among Community Member During the Covid-19 Pandemic in Indonesia

New
Start date: February 1, 2021
Phase:
Study type: Observational [Patient Registry]

The Covid-19 pandemic in Indonesia makes several changes in daily living. The Indonesian government suggests that everyone should stay at home by implements the work from home and school from home. Therefore, the issues related with Covid-19 are also worrying such as death because of the infection, virus transmission, doing everything from home such as Friday praying for Moslem, Sunday service at home, etc. People is anxious whenever meeting people because they are not really understand whether people is infected or not. Therefore, this study tries to identify the impact of Covid-19 pandemic in Indonesia towards mental well-being of the community.