15 Clinical Trials for Various Conditions
This is an observational study examining the psychosocial impacts of the COVID-19 pandemic in seven low-and-middle income countries (Indonesia, Iran, Iraq, Malaysia, Pakistan, Somaliland, and Turkiye). The data was obtained on standardised measures of wellbeing (WHO Well-Being Index), psychological distress (Kessler 10), post-traumatic stress (PTSD Checklist for DSM-5), post-traumatic growth (Posttraumatic Growth Inventory), and a novel pandemic-related stress (COVID Psychosocial Impacts Scale). Data was collected employing either a unilingual (in native language) or bilingual online survey (with English as a second language) from participants (N=2574) aged 18 and above using a non-probability convenient sampling. The findings enabled us to examine the psychosocial impacts of COVID-19, validate the translations of the CPIS and standardized measures; and determine the trajectory of study variables with pandemic exposure.
The participants are being asked to take part in this research study because the participant is a child who has been diagnosed with cancer and has completed genetic testing to find out if the participant has a variant in a gene that may predispose the participant to cancer, and/or the participants are the parents (i.e., guardian/caregiver) of this child. This research is being done to understand how finding out the results of genetic testing during childhood impacts the participant and family. The investigator will compare the emotions and behavior of parents and children based on the genetic testing results. Primary Objective * Examine the impact of genetic testing result disclosure for a pathogenic (P)/likely pathogenic (LP) germline variant in a known cancer predisposing gene versus negative results on parent adjustment (i.e., emotional functioning, cancer worry, symptom interpretation, and genetic testing related worry/distress). * Examine the impact of genetic testing result disclosure for a P/LP germline variant versus negative results on parenting (i.e., responses to children's symptoms, overprotectiveness, parent-child communication, cohesion, and expressivity in the family). Exploratory Objectives * Examine the impact of genetic testing result disclosure (P/LP versus negative results) on child adjustment (i.e. emotional functioning, cancer worry, self-perception, and life meaning and purpose). * Examine the impact of disclosing a variant of uncertain significance (VUS) on parent adjustment, parenting, and child adjustment. * Examine the indirect association between genetic testing result disclosure (P/LP versus negative results) and child adjustment through parental adjustment and parenting behavior. * Qualitatively identify children and parents' perspectives of how disclosure of a cancer predisposition has affected children's emotional, social, personal, and familial functioning.
This study investigates the impact of the COVID-19 pandemic on the psychosocial health of employees of MD Anderson Cancer Center. Epidemics have been shown to promote psychological stress among medical staff in high risk areas, which may lead to mental health problems. Assessing how the pandemic is affecting employees may allow for more comprehensive actions to be taken to protect the mental health of employees.
The initial objective of this protocol is to assemble a well-documented group of patients with confirmed diagnoses of the erythropoietic protoporphyrias, including autosomal recessive Erythropoietic Protoporphyria (EPP) and X-Linked Protoporphyria (XLP) for clinical, biochemical, and genetic studies. The long-term objectives are (1) to conduct a longitudinal investigation of the natural history, complications, and therapeutic outcomes in people with erythropoietic protoporphyria, (2) to systematically investigate the psychological effects of the erythropoietic protoporphyrias on children and adults, and (3) to investigate the correlation between the identified genotypes and the resulting clinical presentation, also determining the possible interaction of other genetic markers.
The success of cancer treatment combined with the trend to delay childbearing is increasing the numbers of women survivors whose childbearing has been interrupted by cancer. For some, treatment has resulted in infertility. Others have been advised to delay pregnancy until a certain follow-up interval or have new fears that pregnancy could be a risk to maternal health. Not least is the concern that children born after a mother's cancer would face increased risks for birth defects or cancer. The specific aims of this project are as follows: 1. To measure the impact of cancer-related interruption of childbearing on women's long-term emotional well-being and health-related quality of life, over and above other demographic and cancer-related factors 2. To find out if becoming a biological or social mother after cancer treatment decreases the long-term psychosocial impact of interrupted childbearing compared to remaining childless 3. To refine the psychometric properties of questionnaires for female cancer survivors measuring Distress about Cancer-Related Childbearing Issues and Attitudes towards Parenthood after Cancer 4. To define targets for a future intervention to improve female survivors' knowledge about childbearing after cancer, decrease distress associated with interrupted childbearing, and promote peer support.
The study aims to deliver a robust pre-post evaluation of the wellbeing impacts of an innovative, brief, and scalable psychosocial intervention, delivered to refugee youth living in urban settlements in Jordan. The study was conducted using two waves of data collection: the first featured an intervention and a matched control group, the second featured a full randomized control trial.
This study is Phase 3 of Project SERVE (Study Evaluating Returning Veterans' Experiences). Through two prior phases, SERVE has followed a cohort of post-9/11 Veterans since 2010 and has identified numerous risk and protective factors. SERVE's overall objective is to understand and improve the long-term functional outcomes of post-9/11 Veterans. Consistent with the investigators' conceptual model, the central hypothesis is that psychological flexibility and other trans-diagnostic treatment targets mediate the effects of the most common mental and physical wounds of war on long-term functioning and self-directed violence (i.e., suicide risk). Thus, integrated interventions specifically designed to improve functioning associated with these conditions are most likely to promote long-term recovery among the most impaired Veterans. The investigators will test the central hypothesis and accomplish the overall objective by pursuing the following specific aims: Aim 1: Identify treatment targets that prospectively predict functional disability, family functioning and self-directed violence (SDV) in post-9/11 Veterans with PTSD, depression, chronic pain, TBI, and/or AUD. To achieve this aim, the investigators will follow 500 Veterans for 2 years in order to prospectively evaluate the impact of several novel, treatment-relevant factors on functional disability and SDV over time. H1: Novel factors (mindfulness, perceived burdensomeness, thwarted belongingness, and moral injury) along with established treatment targets (psychological flexibility, self-compassion, and emotion regulation) will prospectively predict functional disability and SDV after accounting for covariates.
Lower attainment of cardiovascular health (CVH), indicated by the American Heart Association's Life's Simple 7 (LS7; physical activity, diet, cholesterol, blood pressure, body mass index, smoking, glycemia) and Life's Essential 8 (LE8; LS7+sleep) metrics, is a major contributor to Black men having the shortest life-expectancy of any non-indigenous race/sex group. Unfortunately, a paucity of literature exists on interventions aimed at improving CVH among Black men. The team of clinician scientists and community partners co-developed a community-based lifestyle intervention titled Black Impact: a 24-week intervention for Black men with less-than-ideal CVH (\<4 LS7 metrics in the ideal range) with 45 minutes of weekly physical activity, 45 minutes of weekly health education, and engagement with a health coach, group fitness trainer, and community health worker. Single-arm pilot testing of the intervention (n=74) revealed high feasibility, acceptability, and retention and a 0.93 (95% confidence interval: 0.40, 1.46, p\<0.001) point increase in LS7 score at 24 weeks. Secondary outcomes included improvements in psychosocial stress (i.e., perceived stress, depressive symptoms), patient activation, and social needs. Thus, robustly powered clinical trials are needed to determine the efficacy of Black Impact and to evaluate the underlying interpersonal and molecular pathways by which Black Impact improves psychosocial stress and CVH. Thus, the investigators propose a randomized, wait-list controlled trial of Black Impact. This novel, community-based intervention to provide a scalable model to improve CVH and psychosocial stress at the population level and evaluate the biological underpinnings by which the intervention mitigates cardiovascular disease risk. The proposed study aligns with American Heart Association's commitment to addressing CVH equity through innovative, multi-modal solutions.
The primary objectives of this study are to: (1) determine the longitudinal course and impact of injury-related injustice appraisals among civilians and Veterans who have recently acquired a spinal cord injury (SCI), and (2) use qualitative inquiry to gain a rich, contextual understanding of appraisals of injustice during the first year after acquired SCI. The long-term goal of this research is to inform the development of new treatment approaches targeting appraisals of injustice.
The Investigators propose a two-year, longitudinal pilot study of TS adults (\>18) to determine impact of lifetime environmental stress exposure on tic severity, psychiatric comorbidity severity, and health-related quality of life (HRQOL).
This study evaluates the impact of the hybrid closed-loop insulin delivery systems on sleep in youth with type 1 diabetes and their parents. Activity watches, surveys and device downloads are used to evaluate sleep in these participants.
This project evaluates the effects of piano training and computerized cognitive training on cognitive performance in healthy older adults compared to controls. The project is intended for healthy older adults (60-80 years) with little to no previous musical training (less than three years of prior musical training or cognitive training and not currently engaged in music reading or musical performance, less than 10 hours of previous cognitive training). Investigators anticipate that musical engagement will serve as an enjoyable cognitive intervention for older adults. Investigators believe that piano training will enhance cognitive performance on executive functions essential for maintaining independence in older adulthood. Learning a musical instrument, while challenging, will improve self-efficacy, mood, and qualtiy of life. Participants engaged in piano training will demonstrate reduced cortisol levels and increased immune function responses. Investigators predict that adults enrolled in computerized cognitive training will demonstrate enhanced memory, working memory and self-efficacy post-training.
RATIONALE: Telephone sessions and survivorship booklets may increase knowledge about the psychological and physical impact of breast cancer and increase awareness of available resources. It is not yet known whether survivorship booklets are more effective when given alone or together with individual telephone sessions in informing breast cancer survivors. PURPOSE: This randomized clinical trial is studying individual telephone sessions given together with survivorship booklets compared with survivorship booklets alone to see how well they work in increasing knowledge about the impact of breast cancer in African American and Latina breast cancer survivors.
Background: * Mutations detected in the BRCA1 or BRCA2 genes have been show to produce very high risks of breast and ovarian cancer (as high as 90% and 60%, respectively), as well as accompanying risks for several other types of cancer. Women who have these genetic anomalies and who do not have cancer are aware of their high-risk status, which can have an effect on their ability to make decisions about personal choices and health care. * Researchers are interested in learning more about how people who know their cancer risk status make decisions on personal relationships, family formation, and risk-reduction options. Objectives: - To study young women s experiences and decision-making processes regarding family history, genetic testing, couple relationships, family formation, and cancer risk management within the context of their experiences as BRCA1/2 mutation carriers. Eligibility: * Women between the ages of 18 and 35 years of age and older who have been identified as having a BRCA1 or BRCA2 mutation. Participants must be contemplating or have experienced couple relationships, family formation, and/or risk management and reduction. * Participants must be willing to have their interviews digitally recorded Design: * Researchers will conduct between 30 and 50 telephone interviews of study participants. Each interview will be approximately 90 minutes in length. The interview consists of open-ended questions that ask about the participants and their experiences before, during, and after they underwent genetic testing for BRCA1/2. * At least one focus group will be coordinated at a national conference for individuals who are aware of their genetically based cancer risk. If more than 25 individuals are interested in participating in the group, an additional focus group will be convened. * No medical treatments are specifically offered as a part of this study.
This study seeks to evaluate the impact of Starbright World (SBW) on hospitalized children. SBW is a virtual environment designed to link seriously ill children into an interactive online community where they can play games, learn about their condition, or talk with other ill children who are connected to the network. Our outcome evaluation of SBW will include assessments of pain, mood (anxious, depressed and energetic), anger, loneliness, and willingness to return to the NIH for treatment of children who are being treated at NIH. They will be assessed while engaging in "normal" recreational activities (in one of two available playrooms) and while using Starbright World. In addition, we will conduct a process evaluation of the implementation of Starbright World.