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37 active trials for Mental Health Wellness 1

Relative Energy Deficiency in Sport Multicenter Study

Relative Energy Deficiency in Sport (RED-S) characterizes a range of negative health and performance outcomes that result from chronically low energy availability. RED-S concerns high performance junior and senior athletes across Canada and has a prevalence rate of 3-60%. Our ability to assess and diagnose RED-S remains poor. Accordingly, we aim to create the best parameters to diagnose and manage RED-S; along with information of the prevalence and severity across Canada and globally. These outcomes are expected to have a significant positive impact on the health and performance of Canadian athletes in preparation for the Olympic Games in 2022 and beyond.

Start: May 2021

Heartfulness Meditation to Improve Resilience Among Health Care Students: A 90 Day Program

This investigation will examine the feasibility of delivery and effect on resilience, depression and anxiety of a 90-day Heartfulness Practice delivered virtually for health care students. It is hypothesized that by providing this program on-line, students will be able to attend easily and complete the sessions. It is also hypothesized that those students who participate in the meditation program will increase resilience.

Start: July 2021

A Guided Mobile-Based Perinatal Mindfulness Intervention

Psychological distress commonly occurs among women during perinatal period. maternal psychological distress can also bring negative influence on neonatal outcomes, such as infant health, child development or mother-child interaction. Hence, developing interventions to improve mental wellbeing during this period is vital. Mindfulness based intervention (MBI) was found effective in reducing psychological distress. Most currently, delivering MBIs via internet, which is more accessible and inexpensive, shows promising positive effect in reducing psychological distress. However, randomized control trial with sufficient power is await to further confirm the positive effect among pregnant women. Moreover, the positive effects of MBIs was found associated with the heart rate variability biofeedback. However, the efficacy of MBI on HRV is rarely studied among pregnant women. Also, the potential association of HRV between MBI and psychological wellbeing needs further examination. This research aims to test the effectiveness of the Guided-Mobile Based Perinatal Mindfulness Intervention (GMBPMI) among pregnant women experiencing psychological distress during the pre and post-natal period, as well as examining the efficacy of GMBPMI on HRV.

Start: January 2021

Southampton Women's Survey COVID-19 Study

The current COVID-19 pandemic has brought many challenges with implications for wellbeing and mental health. The Southampton Women's Survey provides the opportunity to understand influences on these important outcomes amongst women and their offspring in the context of an established longitudinal cohort study.

Start: February 2021

Managing Our Relationship With Food and Eating

There is a need for population-level intervention research to address the impacts of the COVID-19 pandemic on disordered eating and unhealthy eating behaviours. Systematic reviews have demonstrated that psychotherapy and yoga can help to reduce binge eating and disordered eating habits, however, these interventions were tested in person. Studies examining the effectiveness of these interventions in an online, group-based format are warranted. In 2019, the investigators launched a RCT to test gender-stratified group interventions to address mental health and addictive behaviours among community-based adults in southern Alberta. The investigators implemented this intervention with more than 200 adults in person before this study was paused due to COVID-19; In 2020, the investigators adapted this intervention for online delivery to 200 community-dwelling women across Alberta. The most recent iteration of this study indicated the participants were particularly concerned about their relationship with food and how they were engaging in different eating behaviours to cope with the stress of COVID-19.

Start: April 2021

A Primary Prevention Intervention for the Promotion of Psycho-social Wellbeing in Adolescent Young Carers:

Adolescent young carers (AYCs) are young people aged 15-17 years old, who take on significant or substantial caring tasks and assume a level of responsibility that would usually be associated with an adult. In Europe, the estimated prevalence rate of YCs is around 4-8%.Taking on care responsibilities so early in life may have considerable negative consequences for YCs' mental and physical health and psychosocial development. Psychosocial interventions to support YC worldwide are generally quite limited. The H2020 Me-We project (Psychosocial Support for Promoting Mental Health and Well-being among Adolescent Young Carers in Europe) aims to develop an innovative framework of primary prevention interventions for adolescent YCs (AYCs) aged 15-17 to be tested in six European countries (Italy, Netherlands, Slovenia, Sweden, Switzerland, United Kingdom). The theoretical framework chosen for the intervention is the DNA-V Model. The DNA-V model is a psychological intervention, addressed to adolescents and young people, used in educational and clinical settings. This model has its roots in the contextual and functional science and it is based on Acceptance and Commitment Therapy, a third-generation cognitive-behavioural therapy. The intervention programme designed for the ME-WE project builds on the DNA-V model but it was adapted to fit the specific needs of adolescent young carers (AYCs) and the goals of the ME-WE project. The study aim is to evaluate the efficacy of DNA-V based program for AYCs (so-called ME-WE intervention), using a cluster-randomized controlled trial (C-RCT) design. The evaluation of the intervention will be carried out using as primary outcome variables: Psychological flexibility; Mindfulness skills; Resilience; Subjective mental health; Quality of life; Subjective health complaints; Caring-related quality of life; Cognitive and emotional impact of caring and Social support. As secondary outcome variables will be included Self-reported school, training or work experience, performance, and attendance. COVID-19 Amendment: Recruitment, should be moved to a cluster- based online recruitment or individual, social media recruitment, face-to-face sessions should be moved to online sessions using video-conferencing instruments, allowing for visual presentations of participants and session materials (e.g. ZOOM, Microsoft Teams). Four open-ended items were added to evaluation questionnaire assessing impact of COVID-19 pandemic.

Start: October 2019

Examining the Feasibility of the Ask RoSE Mobile Mental Health Application

Students are one of the most at-risk groups for mental illness and suicide. Up to 40% of persons with serious mental illnesses do not receive care or stop intervention programs due to negative stigma. Focusing on students, only 30% of universities provide mental health counseling as part of universities' student health services. There is an urgent need to better understand and manage the mental health burden among students. The investigators will use a mental health-focused application that utilizes artificial intelligence to identify symptoms and provides targeted, tailored in-person therapy solutions for its users. Once a patient is matched with a therapist, the application provides solutions to supplement ongoing in-person psychotherapy. This includes journaling and daily assessments that provide curated content and feedback. The current feasibility study aims to recruit 45 Johns Hopkins graduate students with at least mild depressive and/or anxiety symptoms who will be consented and enrolled in a five-week study. There are two study arms: (1) the intervention arm and (2) a waitlist control arm. During the course of the study, the participants in the intervention arm will use the application daily. Participants will receive weekly in-person psychotherapy for a total of four sessions over four weeks. Licensed therapists will provide the in-person psychotherapy. The participants in the waitlist arm will serve as controls unless there is attrition from the intervention group at which time waitlist participants will be offered a spot in the intervention arm. The primary objectives of the study are (1) To assess the usability of the application and (2) To evaluate the short-term impact on mood and anxiety of using the application to augment in-person psychotherapy.

Start: December 2021

Feasibility and Implementation of a Healthy Lifestyles Program

Chronic conditions, such as obesity and diabetes, are increasing worldwide. Lifestyle changes (e.g., physical activity, healthy diet, sufficient sleep, managing stress, smoking cessation) are often recommended to prevent or manage these conditions, but changing habits is difficult. Mental health can play a role in the ability to seek out and follow through on the changes necessary to achieve or maintain a healthy lifestyle, yet this aspect is rarely addressed, and access to mental health services is often limited. Furthermore, individuals are influenced by factors at the individual, interpersonal, community and policy levels (e.g., lack of socialization, unsafe neighborhoods). These factors can act as barriers and need to be addressed in order for individuals to make sustainable lifestyle changes. A new year-long person-centered healthy lifestyles program is proposed to address the "how to" gap in making lifestyle changes through a combination of individual and group sessions. The feasibility and implementation of this new program will be evaluated through a pilot study looking at the full healthy lifestyles program compared to a less intensive version of the program. The study's hypothesis is that the full program will be feasible, acceptable and more effective for helping participants move across stages of change and for meeting their goals than the less intensive program.

Start: February 2018

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

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.

Start: March 2021

Supporting the Wellness of Ontario Physicians During COVID-19

In light of the coronavirus pandemic, the challenge of physician burnout has taken on a new urgency. Long-hours and difficult, sometimes unsafe work conditions are creating a severe strain for emergency physicians and others on the frontlines of Ontario's response to COVID-19. There are a variety of evidence-informed ways that physicians can protect their wellbeing with modest investments of time and energy that will be applied. The evaluation will be a randomized trial comparing the outcomes from each of the three treatment arms. Researchers may also use a pre-post comparison with control parameters to conduct an exploratory analysis to assess efficacy.

Start: January 2021

Be a Mom: Effectiveness of an eHealth Intervention for Promoting Maternal Mental Health

Be a mom (a web-based cognitive-behavioral intervention) is being tested in another trial as a preventive intervention in the postpartum period (NCT03024645). However, given its content and the focus on developing and strengthening psychological resources, it is important to understand if Be a Mom is also effective in promoting maternal mental health of postpartum women who are not at risk of developing postpartum depression. Thus, the main goal of this research is to apply and evaluate Be a Mom for the promotion of mental health, in terms of its efficacy, acceptability and feasibility (user's adherence, dropout), user's satisfaction and cost-effectiveness. The RCT will be a two-arm trial. Women with a child aged up to 3 months old will be enrolled in the study. A minimum number of 1000 women will be enrolled in the study. After agreeing to participate in the study, the women will be screened for the absence of risk factors for PPD (PDPI-R < 5.5). In case of a negative screen, women will be randomly assigned to one of two conditions: the intervention (Be a Mom program) or the control condition. The sample will be recruited online. Participation in this study will last 15 months. The Be a Mom program will last 5 weeks. Participants in both conditions will be invited via email to complete baseline, post-intervention and follow-up assessments (4-months and 12-months after post-intervention). Assessments will include self-report questionnaires to assess several indicators (e.g., positive mental health, quality of life, marital satisfaction, depressive and anxiety symptoms, maternal self-efficacy), mechanisms that may be involved in the treatment response (e.g., self-compassion, emotional regulation), user's acceptability and satisfaction and cost-effectiveness.

Start: January 2019

Testing the Causal Effects of a Civic Engagement Intervention on Health and Wellbeing Among Youth (I-ACTED)

The purpose of this research is to understand how participating or not participating in an action civics curriculum may affect the health and wellbeing of young people. Participants will be chosen from students who attend certain schools that choose to participate in the action civics curriculum. Participation in this research involves completing surveys during class time in the Spring 2021 semester and then completing online surveys outside of class in the future.

Start: August 2021

BRIGHT Coaching Program for Families

Children with, or at elevated risk for, brain-based developmental disabilities can experience lifelong consequences and challenges throughout their development. In particular, preschool years (3-6 years of age) can be stressful as families wait to get services and care for their child. Nationally and internationally, service delivery models during this critical period are not standardized, and differ within and across provinces and across patient conditions, leading to long wait times, service gaps and duplications. This study has two main hypotheses: A standardized approach to "coaching" (i.e. coach + online education tools + peer support network) is feasible in the real-life context, and acceptable to caregivers and can be delivered across multiple sites in urban/suburban/rural settings. A standardized approach to "coaching" enhances parental health (parents' empowerment and sense of competence, quality of life, and minimizes parenting stress), family health care experience (care coordination experience and process of care) at similar health care cost (economic analysis), when compared to usual and locally available care.

Start: August 2018

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

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.

Start: February 2021

Effects of the 5 Ways to Wellbeing Course Effects of the 5 Ways to Wellbeing Course

Norway and other Western industrialized countries are facing major challenges in terms of preventable health problems, high work absence, largescale demographic changes and rising social inequalities in health. By applying an interdisciplinary research approach - integrating perspectives from psychology, sociology, medicine and economics, using multiple samples and complementary analytical strategies, this project addresses the need for effective means to meet these important challenges. The project will scientifically evaluate The 5 Ways to Wellbeing course (5Ways), a novel measure aiming to promote wellbeing and integration, health and work adherence. Subjective wellbeing is systematically and prospectively related to important individual and societal outcomes, including social connectedness and integration, innovation, productivity, work performance, healthy behaviours, health and longevity. Promotion of wellbeing may therefore contribute to address the urgent societal ailments of today. Intervention effects and cost effectiveness of the 5Ways will be examined in-depth in four real-life settings, using quantitative and qualitative methods. Specifically, we will investigate course impact on i) sickness absence for employees in work places with high sickness absence rates, ii) wellbeing, health and social participation among immigrants attending the municipalities? Introduction Programmes, and iii) wellbeing, health and work adherence among users of The Norwegian Labour and Welfare Administration (NAV) and iv) clients in Healthy Life Centres. If effective, the course may be implemented nationwide and contribute to increase wellbeing and work participation and reduce immigrants? exclusion. Findings from the study may thus contribute to enable municipalities and workplaces to make better priorities for promoting work presence, reducing suffering and improving mastery and quality of life among their employees and inhabitants

Start: February 2020

Telepsychoeducation for the Prevention of Emotional Distress in Professionals and Students From Essential Services in the Context of COVID-19

A pragmatic superiority randomized controlled trial comparing Telepsychoeducation plus personalized videos vs. Telepsychoeducation without personalized videos for the prevention of future emotional distress in professionals and students from essential services with low to moderate levels of emotional distress in Brazil. Note: This study was approved by the Ethics and Research Committee of the Hospital de Clínicas de Porto Alegre and is originally registered at Plataforma Brasil, a Brazilian study registration platform (under CAAE: 30608420.5.0000.5327). Recruitment began in May 28th 2020.

Start: November 2020

Effectiveness of Implementation of a Patient-centered Self-management Program in Patients With Hypertensive Nephropathy

This study is a 2-years project. The year 1 project: to assess the effectiveness of implementation of the program in patients with HN. The experimental research design of 2×2 randomized controlled trial with pre and post-testing will be adopted. A total of 70 subjects will be enrolled, and 35 subjects will be randomized into the control group (conventional program) and experimental group (patient-centered self-management program), respectively, using the single-blind design. Firstly, this study will collect the pretest data of the control group and experimental group. The data to be collected include physiological indicators, physical and psychological health, self-efficacy, self-management, and satisfaction, etc. The experimental group will receive the 4-week intervention of program after the pre-test. This study will assess the effectiveness of intervention 1 month later. This study will use generalized estimating equation (GEE) to collect the longitudinal data and test the effectiveness of implementation of program in patients with HN at different time points (after 1, 3, and 6 months). It is expected that the completion of this research project may help improve the effective disease control in the care for patients with HN in Taiwan and improve self-management of disease. Hopefully, the incidence of patients with dialysis can be significantly reduced and the progression into ESRD in patients can be effectively delayed. Moreover, this study also intends propose specific suggestions about the care of patients with HN for industry, government, and academia.

Start: December 2019

PanDirect: Self-care Tools and Telephone Coaching for Depression and Anxiety During Pandemics

During pandemics older adults with chronic physical conditions are a particularly vulnerable population for unmet mental health needs. This is a consequence of a number of factors which include decreased access to their doctors because of restrictions in visits in order to decrease risk of disease transmission and because doctors are seconded to provide medical services in areas of high priority. Since Public Health authorities worry that pandemics may be a reality of the future, this study is being operationalized during the present COVID-19 pandemic in order to see what can be learned about different ways to provide mental health care under such constraints. The study offers evidence-based approaches to managing feelings of anxiety or depression that may have existed prior to the onset of a pandemic, or that have arisen during a pandemic. It uses principles of cognitive behavioural therapy in which participants are offered self-care tools to help them develop strategies for dealing with their various symptoms. These tools have already been shown by the team to be effective in other contexts in studies DIRECT-sc (Effectiveness of a supported self-care intervention for depression compared to an unsupported intervention in older adults with chronic physical illnesses) and CanDIRECT (Effectiveness of a telephone-supported depression self-care intervention for cancer survivors). The present study, PanDIRECT (Assisting Family Physicians with Gaps in Mental Health Care Generated by the COVID-19 Pandemic), aims to answer the following questions: Can these tools be used in the community care of mental health problems during pandemics? Are they acceptable to patients? Using a randomized control trial, does lay-coaching of use of these tools improve their use and patient outcomes? Do family practitioners value patient information sent to them at the end of the trial

Start: October 2020

HealthAtWork - a Measure for Increased Coping and Work Inclusion

HealthAtWork - a measure for increased coping and work participation -An effect analysis of a health- and work environment intervention at the workplace. Part 1:quantitative data collection The main objective of this study is to investigate the effect of the workplace intervention in the new Norwegian national concept HealthAtWork (HelseIArbeid) through a pragmatic cluster-randomized study. The main hypothesis is that this interdisciplinary health and welfare intervention at the workplace reduces sick leave and improves mastering of common health problems more efficiently than a conventional welfare intervention. More specifically, it is hypothesized that the HealthAtWork intervention has a better cost-effectiveness in terms of sick leave, use of health services and coping with common health problems indicated by an increased health-related quality of life.

Start: March 2019

Patient Empowerment Study

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.

Start: September 2020