112 Clinical Trials for Various Conditions
This clinical trial tests how well acceptance and commitment therapy and compassion based virtual group therapy works to improve psychological wellbeing, such as compassion, understanding, and flexibility, in patients with cancer. Receiving a cancer diagnosis, undergoing cancer treatment, and living with cancer- or treatment-related symptoms have often been found to be associated with elevated distress and decreased quality of life for individuals, even when the disease is stable or in remission. Acceptance and Commitment Therapy (ACT) has demonstrated considerable benefits on individuals' quality of life, psychological flexibility, and amelioration of psychological distress following a cancer diagnosis and in the face of uncertainty, loss, and challenges associated with cancer.
Healthcare systems around the world have faced tremendous stress because of the COVID-19 pandemic. Healthcare workers (HCWs) (ie. physicians, nurses, and support staff), who serve as the foundation of the healthcare system, report high levels of psychological stress and burnout, which will likely worsen as the pandemic continues. The consequences of stress and burnout can reduce quality of life for providers and lead to adverse health behaviors (poor dietary choices, reduced physical activity, increased alcohol intake, increases in weight etc.) among HCWs. In addition, burnout can have dire consequences on healthcare delivery effectiveness including poor quality of care and significant cost implications due to medical errors and HCW absenteeism and turnover. In fact, annual estimates of burn-out related turnover range from $7,600 per physician to \>$16,000 per nurse. However, programs focused on reducing burnout in HCWs have the potential to reduce costs to the healthcare system by $5,000 per HCW per year. Maintaining and recovering psychological and behavioral well-being is essential to ensuring we have a workforce that is resilient to acute and ongoing stressors such as the COVID-19 pandemic, ensuring that they are capable of providing the highest level of quality and compassionate care to patients. In this project, we will strengthen the resiliency of the Northwestern Medicine (NM) healthcare system by implementing an online psychological well-being intervention (PARK). We will assess HCW willingness to engage in PARK, which has been shown in other populations experiencing stress (e.g. dementia caregivers, general public coping with COVID-19) to be effective. We will also assess if the PARK is effective in reducing stress and associated-burnout, absenteeism, and intentions to leave the workforce in a subset of 750 persons who have been participating in a study of HCWs at NM since Spring 2020. In the entire cohort, we will measure the psychological well-being, levels of burnout, health behaviors, absenteeism, and plans to leave the workforce at three time periods: the start, middle, and end of the study period and assess whether they differ by HCW characteristics including gender, race, and role in health care. Results from this study will provide much-needed information: 1) about the current state of psychological well-being and burnout among NM HCWs, now over 1 ½ years into the pandemic; 2) on the role of an online wellness intervention to improve well-being during a protracted pandemic; and 3) about the contribution of PARK to reduce burnout, HCW absenteeism and turnover, and potential impacts on costs. PARK has the potential to have a significant impact on not only NM HCWs but also to be generalizable to other healthcare organizations for addressing burnout and to contribute to lessons learned on how to support HCWs responding to future pandemics; ensuring resiliency in the healthcare delivery system. In addition, we will work with our already engaged stakeholder committee to ensure results can provide actionable policy and fiscal insights. Future opportunities will include collaboration with other healthcare systems to expand roll-out of the successful PARK intervention.
This project examines the development of psychological well-being in children and teachers through a 12- week forgiveness education program conducted in three conflict zones of the world, Northern Ireland, Israel/Palestine, and Taiwan. A 12-week forgiveness education program will be investigated in elementary schools in three conflict zones of the world, Northern Ireland, Israel/Palestine, and Taiwan. The responsibilities of the sub-team in each of the three research sites will be: * a. recruiting schools, assisting the teacher training before the forgiveness education program starts * b. shepherding teachers, doing the fidelity checks, administering the instruments and collecting data during the forgiveness education program. Once a school gives permission to be part of this study, the forgiveness curriculum will be implemented as a 12-week standard curriculum for the grade 5 (US equivalency) students. Teachers of the grade 5 classes will be trained to administer the program. Teachers, students and their parents must give the consent to take part in the measures of the study.
This study will consist of a randomized experimental group and a control group, In addition to the control and experimental group, there will also be a non-randomized motivated experimental group. Approximately 75 males and females from the ages of 18 to 80 will take part in this study. Subjects will be randomly divided into a Control and Experimental Group. Subjects for the control and experimental group will be recruited from a Tony Robbins Facebook page, and subjects in the experimental group (DWD Group) will be admitted to the Tony Robbins Date With Destiny Event (December 2019) in West Palm Beach for free, while the subjects randomly assigned to the control group, will not attend the event, but instead be required to a Gratitude Journaling experiment (Three Good Things Intervention). Psychological assessment surveys will be taken before the event, directly after the event, and one month following the event. The control group will take the psychological assessment before beginning journaling, directly after completing journaling, and one month following completion of journaling.
This project examines the psychological construct of decentering - a mindfulness-related construct marked by an observer perspective on one's ongoing mental processes. Specifically, this project seeks to explore the extent to which decentering modulates the relationship between people's affective states and their momentary mental health and well-being, and to test the psychological processes by which decentering might exert these effects. This study includes a baseline assessment followed by a 7-day study completed from home where participants respond to brief surveys about their current experiences six times per day (i.e., an Ecological Momentary Assessment \[EMA\] design). The investigators hypothesize that decentering moderates the association of extreme affect with related symptoms (i.e., elevated negative affect with depression and anxiety; elevated positive affect with mania, narcissism, and histrionic traits) and well-being, such that the association is attenuated at high levels of decentering. This will be examined using the EMA data, analyzing between-person levels (i.e., trait) as well as momentary within-person processes (i.e., concurrent and prospective states). Further, the investigators predict that broadened attentional focus and improved self-regulation are mechanisms that contribute to the beneficial effects of decentering in daily life. This hypothesis will be examined in two ways: 1. as individual differences, wherein greater self-regulatory abilities (e.g., higher heart rate variability) and less attentional biases towards emotional stimuli mediate the association between trait decentering and subsequent daily well-being/symptoms, and 2. as within-person momentary levels, wherein broader attentional processes and greater self-regulation in daily life mediate the concurrent and prospective association between momentary decentering and well-being/symptoms. Note that the study uses a multimodal assessment of each of the proposed processes. For attentional processes, a variety of parameters extracted from an emotional eye tracking paradigm will be examined. For self-regulatory abilities, assessments will include self-report, physiological (heart rate variability), and behavioral ("go / no-go" task) measures of such abilities.
Experimental Approach: (1) Participants: Women (ages 21 to 42) who seek IVF treatment at the Center for Fertility \& Reproductive Surgery will be eligible for the study. Seventy women will be recruited and randomly assigned to either the intervention (acupuncture plus standard care) or the comparison (standard care alone) group. (2) Intervention: Participants in the intervention group will receive 3 acupuncture sessions during the project with the first treatment between day 6-8 of the stimulated IVF cycle, second on the day of embryo transfer and the third one day post transfer. Participants in the comparison group will receive no intervention but will receive standard care. (3) Measures: The primary outcome measures include prostacyclin and thromboxane vasoactive biomarkers. Secondary outcome measures include perceived stress levels. (4) Procedure: Upon IRB approval, an informed consent will be provided to all participants. Pre- and post- acupuncture urinary metabolites of prostacyclin and thromboxane will be assessed. A standardized Perceived Stress Scale will be administered before and after each acupuncture session for the study group, and before and after a 30-40-minute waiting period for the control group.
Recovery following major surgical procedures can be influenced by both physical (optimization of cardiopulmonary function, pain control, activity) and psychological factors. Physical activity recommendations for post-operative patients is difficult, in part because little is known about the short- and long-term benefits of exercise and mobility on post-operative pain and return to normal functioning.
The study examines the experiences of people who have engaged in alternative sexual behaviors, like kink or BDSM, and whether there have been any positive effects on well-being
About 25-51% of adults with acquired spinal cord injury (SCI) have "AIS D" SCI, the lowest severity grade of neurologic injury. Veterans with AIS D SCI generally have better outcomes in mobility, community integration, and employment. However, counterintuitively, they are also at higher risk of poor subjective well-being (SWB) and related psychosocial outcomes. Preliminary evidence suggests that poorer SWB in this group is associated with distinctive, modifiable factors such as less intensity of acute rehabilitation services, limited development of instrumental and social support networks, and underdeveloped disability identity. A significant gap in the care of Veterans with AIS D SCI is that they are unlikely to receive rehabilitation that is responsive to their specific experiences and needs. The proposed study will develop a novel, self-management based program to help Veterans with AIS D SCI. This study is highly significant, as creation of the proposed program is expected to improve SWB and lifetime psychosocial functioning for Veterans with AIS D SCI.
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.
This study seeks to evaluate how work conditions affect workers' health and well-being, job attitudes and decisions on the job, and key organizational outcomes. This study is being carried out in partnership with a national retailer's e-commerce division. The study centers on a cluster randomized trial evaluation of changes in workplace policies and practices in order to understand their impact on workers, families, and the firm but also utilize multi-method data to gain a better understanding of the stressors and sources of resilience for this growing, but understudied population of low-wage workers.
This research study is designed to better understand how a virtual reality (VR) exercise application may influence overall physical activity and well-being. VR games can make exercise more enjoyable and interactive, which has been shown to increase engagement in physical activity. Adult participants will do a progressive exercise program and report on overall physical activity, health, and psychological wellbeing. The intervention is expected to have a positive impact on these lifestyle factors.
There is a large body of evidence demonstrating that Acceptance and Commitment Therapy (ACT) can be delivered in a self-guided format to improve mental health among college students. However, previous research indicates there are challenges in engaging students in adhering to these time intensive, multi-session self-guided resources. Brief self-guided single session interventions could provide an accessible and acceptable intervention that is easier to adhere to, given their lower intensity and response effort for participation. This proposed study seeks to evaluate a single session online ACT Guide Lite intervention in a sample (n = 100) of Utah State University (USU) college students 18 years of age or older. A randomized controlled trial (RCT) design will be used in which students are randomized to receive ACT Guide Lite or to a waitlist condition in order to test the following predictions: (1) participants assigned to ACT Guide Lite will improve more on the primary therapeutic process of change, psychological flexibility, relative to those not receiving intervention, (2) participants assigned to ACT Guide Lite will improve more on distress, well-being, and interest in seeking help, relative to those not receiving intervention, (3) ACT Guide Lite will be acceptable to college students as indicated by recruitment rates, rates of completing ACT Guide Lite, and self-reported program satisfaction, and (4) areas for future program revisions will also be identified through participants' written feedback on their experiences using the program. USU students will be recruited to participate in the study through the SONA research platform in the Fall 2023 semester. All study procedures will be completed through the secure Qualtrics online research platform, in addition to email and phone contacts prompting relevant steps for the study. All analyses will be run with multilevel modeling with the full intent-to-treat sample to test time by condition interactions.
This project includes an intervention in five Michigan Medicine family medicine clinics which is designed to improve staff collaboration across different job roles.
We aim to refine and pilot test an 8-week phone- and app-based intervention to promote hope, and thereby mitigate life disruption caused by cancer diagnosis and treatment, among young adults (YAs); our proposal involves (Aim 1) formative research among YA survivors and healthcare providers; and (Aim 2) an randomized controlled trial (RCT) of the intervention vs. attention control among 150 YA cancer survivors. The proposed research is innovative in its use of: 1) a novel intervention target - hope - as a mechanism for addressing goal-disruption and quality of life (QOL) among YA survivors; and 2) novel mHealth components and population-based recruitment strategy (via social media) that are particularly relevant to YA survivors and those with potentially limited access to healthcare. This proposal has potential high impact due to the number of YA cancer survivors for whom the intervention may be relevant, the intervention's potential utility in enhancing hope and QOL among YAs, and its reach/scalability.
In the proposed study, the investigators will examine the effectiveness of Bodie in Motion (BIM) program in improving the body image, eating concerns, and overall psychological well-being, in a racially/ethnically diverse group of female and male-identifying athletes with body image concerns. Based on previous research, participating athletes should have direct and immediate Well-Being (i.e., mental health) benefits from their involvement in BIM.
There is a broad consensus that preventing or delaying initiation of adolescent alcohol, tobacco, and other drug (ATOD) use can substantially improve both short- and long-term adolescent health. Despite the existence of effective prevention programs, adolescent ATOD use continues to be a substantial issue. Continued research on preventive interventions is needed. School-based mindfulness-based interventions (MBIs) have been shown to be feasible and effective at improving adolescent psychological well-being. Evidence from both quasi-experimental studies and randomized controlled trials suggests that incorporating MBIs into school-settings can lower levels of anxiety, depression, and stress, while improving capacity for emotional regulation. Greater mindfulness also been linked to reduced adolescent ATOD use via observational studies. There are strong theoretical reasons to believe that MBIs delivered in school settings can prevent or reduce ATOD use among youth. In particular, MBIs have been shown to improve psychological well-being among youth via multiple mechanisms also relevant for adolescent ATOD use. These mechanisms include enhanced attentional control, negative emotion regulation, promotion of positive emotion generation, and increased feelings of connectedness. Despite these connections, school-based MBIs are yet to demonstrate the ability to prevent or reduce adolescent ATOD use. The current study will examine psychological well-being and ATOD use among approximately 80 participants in a quasi-experimental, school-based MBI. In early 2022, approximately 40 high school seniors were provided with one semester of a weekly, classroom-based MBI embedded into their Social Studies curriculum; approximately 40 high school seniors participated in the standard curriculum. The intervention group was provided with an adaptation of Mindfulness-Oriented Recovery Enhancement (MORE). MORE is an evidence-based therapeutic program that integrates mindfulness, cognitive-behavioral therapy, and positive psychology to treat addiction and enhance well-being. MORE has been shown to produce therapeutic benefits in the treatment of alcohol, tobacco, and other drug addiction in adult populations, but is yet to be tested as a preventive intervention for youth. Follow up data collection is planned for spring 2023 to assess psychological well-being, ATOD use, and proposed therapeutic mechanisms pre-intervention, post-intervention, and at 9-month follow up.
The Military Identity Project is an exploration of military identity in Active Duty Service Members of the Army, Navy, Air Force \& Marine Corps. The purpose of this project is to discover common identity attributes shared by active duty members across Service branches and to see if specific traits are related to levels of well-being and resilience.
This study is testing the acceptability and efficacy of an AI enabled mental health chatbot (Elomia) as a resource of college student wellness.
This present study will examine the effectiveness of a single session, virtually delivered body empowerment program for decreasing participants thin ideal internalization. The intervention asks participants to identify cultural norms surrounding appearance and attractiveness, then challenge these ideals. Participants will answer questions about thin ideal internalization before and after the program.
The investigators developed a responsive mobile-web app, "Jauntly," which was designed to take advantage of the known connections between positive emotions, stress reduction and stress resilience. The app's goal was to lead users through research-proven positive emotion-enhancing exercises and relevant educational materials. Intervention activities covered five well-being-generating content areas: 1) promoting the experience and recognition of gratitude; 2) encouraging positive social relationships and feelings of social support; 3) improving stress resilience via mindfulness and other relaxation-focused activities; 4) focusing and capitalizing on individual strengths (as opposed to limitations and weaknesses); and 5) general positive mood inducing activities. Program content was adapted from a variety of stress-relevant research areas including health psychology/psychosomatic medicine, social/personality psychology, positive psychology, and clinical psychology.
The purpose of this 2-group randomized clinical trial is to: 1) examine the feasibility and acceptability of a 3-month positive-emotion focused therapy (Quality of Life Therapy) modified specifically for patients with implantable cardioverter defibrillator (ICD); and 2) obtain estimates of effect size for QOLT compared to Heart Healthy Education on the changes in arrhythmia frequency and biomarkers of autonomic function, as well as changes in emotion, mood, and well-being across time (baseline, 3 \& 9-months). It is hypothesized that the QOLT will promote improvements in autonomic function, reduced arrhythmia frequency, and improved psychological well-being.
This project is designed to explore the feasibility and preliminary efficacy of a remote Tai Chi program on older adults' 24-hour movement behaviors (i.e., physical activity, sedentary behavior and sleep patterns).
The goal of this clinical trial is to learn if the SAGE LEAF (Social Augmentation of self-Guided Electronic delivery of the Life Enhancing Activities for Family caregivers) online positive emotion skill-building program delivered through Caregiver Serving Organizations can help family caregivers of individuals with dementia cope with stress. The main questions it aims to answer are: * How does SAGE LEAF affect positive emotion, caregiver burden, loneliness, and depression for family caregivers? * What are the challenges and successes when rolling out an online program in partnership with Caregiver Serving Organizations? Participants will complete the 8-week online SAGE LEAF intervention as well as two survey assessments, one before the intervention and one after.
The goal of this clinical trial is to evaluate the feasibility and acceptability of a 4-week mindfulness program among young women in Puerto Rico with elevated stress. The main questions it aims to answer are: * how feasible and acceptable is a s a 4-week mindfulness program among participants with elevated stress * what are the changes in psychological resilience, psychological distress, health behaviors, and cardiometabolic markers Participants will be asked to * attend 4 weekly virtual sessions and daily mindfulness exercises at home * complete online study questionnaires
Adolescents will complete a 4-week intervention, during which they will either complete a kind act for others, complete a kind act for others with a reflection component, or report their daily activities three days per week. Psychological measures will be indexed before and after the intervention.
Study Design, Aims, and Population: The present study is a three-arm randomized controlled trial (RCT). The primary aim is to test the relative efficacy of two 8-week online interventions - Compassion Cultivation Training (CCT) and Mindfulness-Based Stress Reduction (MBSR) - in promoting diverse university students' social well-being (i.e., reduced loneliness, and enhanced social connectedness and perceived social support) compared to a Waitlist (WL) control group. The secondary aim is to examine the effects of CCT versus MBSR on the mental health of diverse university students compared to the WL group. Mental health is defined in this research as both positive mental health (i.e., happiness, positive emotions, meaning and purpose) and negative mental health (i.e., stress, anxiety, and depression). Additionally, another aim is to enroll 75% students of color and 50% male identifying students, whose social well-being and mental health is currently understudied, to better represent the sociodemographic diversity of the university student population in the literature. Study Rationale: The COVID-19 pandemic triggered widespread disruptions in social connections and relational bonds that robustly support a variety of mental and physical health-protective processes. University students' social well-being may have been especially impacted as universities provide a central context for socialization. At the same time, the pandemic exacerbated a pre-existing rise in cases of mental health conditions in university students. If found effective, online-based CCT and MBSR might serve as scalable psychological interventions to foster social thriving and mental health among diverse university students.
In this study investigators are examining the feasibility and acceptability of an expanded and technology-assisted aftercare program with persons released from a crisis stabilization unit (CSU) who were brought to the CSU by choice of law enforcement. Investigators are assessing the critical elements of CSUs, examining the feasibility and acceptability of pairing mobile and technology-assisted aftercare to improve treatment access and retention; and developing a study protocol to be used in a future multisite randomized controlled trial (RCT). Crisis stabilization units provide law enforcement officers an alternative to jail for individuals experiencing a substance use or mental health disorder crisis contributing to criminalized behavior. This study is designed to assist with the diversion of individuals toward treatment and away from subsequent contact with law enforcement through piloting mobile and technology assisted aftercare services to persons released from a CSU. One of the largest barriers to the effectiveness of CSUs is retaining the individual in treatment after discharge. Logistical factors including transportation, stable housing, and long waitlists for community-based treatment decrease treatment access. These factors may also be complicated by an individual's understanding of the importance of remaining in treatment as well as their motivation to continue. To overcome these barriers and enhance the impact of CSUs, investigators are developing an expanded model which includes mobile and technology-assisted modalities that address psychological, behavioral, and medication-assisted treatment.
The overall goal of this project is to evaluate the effect of enhanced psychological well-being on sleep quality. This study will demonstrate whether combining an intervention designed to promote psychological well-being with sleep hygiene education improves sleep quality in a non-clinical population of distressed adults reporting poor sleep in the absence of a diagnosed sleep disorder. The investigators expect an intervention combining elements of psychological well-being and sleep hygiene education to result in significant improvements in sleep quality measures from baseline to post-intervention, and greater improvements in sleep quality measures at post-intervention as compared with sleep hygiene education alone.
The purpose of this study is to look at how mindfulness training may influence how the participant thinks, feels, and acts.