51 Clinical Trials for Various Conditions
The overall purpose for conducting this research is to improve the safety and efficacy of care for perioperative patients who have developmental delays and behavioral challenges. The specific objectives for this study are to describe distress behaviors and interventions used in the ACT population. The investigators will also determine the relationship between a predictive measure of distress (the Psychosocial Risk Assessment in Pediatrics score) with the actual distress behaviors exhibited by patients in the perioperative area. This study will provide knowledge that is necessary in order to develop best practices and to guide future research for this patient population. Further understanding the techniques used to improve care in the perioperative setting may also provide useful information to consider in other healthcare settings where this patient population has difficulty with coping and cooperating (ex. vaccinations, placing IVs, dental work, etc.).
The purpose of this study is to treat individuals with social anxiety disorder with a Food and Drug Administration-approved medication for the treatment of social anxiety disorder, the antidepressant paroxetine, and to evaluate the impact of an intervention designed to help those individuals cope with anxiety without the use of common coping behaviors.
This study will deploy a scalable secondary prevention program that leverages existing foster youth transition services to improve mental health functioning and service use before and after exiting foster care. Our short-term objective is to remotely test a group intervention called Stronger Youth Networks and Coping (SYNC) that targets cognitive schemas influencing stress responses, including mental health help-seeking and service engagement, among foster youth with behavioral health risk. SYNC aims to increase youth capacity to appraise stress and regulate emotional responses, to flexibly select adaptive coping strategies, and to promote informal and formal help-seeking as an effective coping strategy. The proposed aims will establish whether the 10-module program engages the targeted proximal mechanisms with a signal of efficacy on clinically-relevant outcomes, and whether a fully-powered randomized control trial (RCT) of SYNC is feasible in the intended service context. Our first aim is to refine our SYNC curriculum and training materials, prior to testing SYNC in a remote single-arm trial with two cohorts of 8-10 Oregon foster youth aged 16-20 (N=26). Our second aim is to conduct a remote two-arm individually-randomized group treatment trial with Oregon foster youth aged 16-20 with indicated behavioral health risk (N=80) to examine: (a) intervention group change on proximal mechanisms of coping self-efficacy and help-seeking attitudes, compared to services-as-usual at post-intervention and 6-month follow-up: and (b) association between the mechanisms and targeted outcomes, including emotional regulation, coping behaviors, mental health service use, and symptoms of depression, anxiety, and PTSD. Our third aim is to refine and standardize the intervention and research protocol for an effectiveness trial, including confirming transferability with national stakeholders.
Efficacy of a Multi-level School Intervention for LGBTQ Youth
Many Black Americans continue to be suffer from diabetes especially Black men. Although previous diabetes efforts have reduced overall disease burden, they have failed to eliminate racial and geographic disparities. The story of John Henry, the "steel-drivin' man" represents strength and self-determination among Black Men. But often these traits lead men to "manup" about their health and prevents them from taking care of their diabetes. This study examines how we can assist Black men in improving their diabetes. Based on the traits of John Henry, we will conduct a culturally-tailored study to 1) determine if our education program including coping strategies and motivation text messages lowers A1c; and, 2) how program operates in a rural setting while learning how we can best improve it for a larger study. We hope to have the information to conduct a larger study with Black men in rural areas to improve their diabetes outcomes.
The purpose of this study is to test the feasibility of a virtual, group mind-body resiliency intervention adapted to target fear of recurrence (FOR) among cancer survivors.
This mixed-methods, two-arm, randomized controlled trial will evaluate the impact of Motivational Interviewing (MI) as a follow-up care to patients who received fall prevention recommendations at Oregon Health \& Science University Internal Medicine and Geriatrics Clinic provided over 12 months.
This study is testing whether a 6 week skills-based telehealth intervention can help ovarian cancer patients experiencing PARP inhibitor-related fatigue reduce the impact of fatigue on their daily life and activities.
The goal of this study is to test the efficacy and the feasibility of the Asian Women's Action for Resilience and Empowerment (AWARE) intervention, in the real world setting -- student health service centers at Boston University, Wellesley College, and Harvard University. AWARE is an 8-week group intervention specifically designed to address mental health and sexual health issues among Asian-Pacific Islander (API) women. One AWARE group (final number of 8-10 API women who will be treated) will be held at BU Student Health Services, two groups at Wellesley College, and two groups at Harvard University Health Services for undergraduate and graduate students who meet the demographic and clinical criteria. During the intervention period, participants will attend the AWARE group counseling sessions, which are 90 minutes, once a week, for 8 weeks. Each week's session is focused on a specific theme related to the cultural and gender-specific issues typical among young Asian American women. The sessions are led by staff therapists at either institution. Participants will fill out forms that detail their therapeutic goals ("commitments") and any adverse emotional/behavioral events from the past week. Participants will also receive daily text messages that reinforce the group session themes. Participants will be assessed pre- and post-intervention on clinical outcomes, including depression, anxiety, PTSD, and suicidality, using standardized quantitative instruments. This serves to evaluate the efficacy of AWARE at improving mental health outcomes. Participants will also participate in a post-intervention focus group session to evaluate the program's implementation and suggest ways for future improvement.
Hazardous alcohol consumption is one of the leading causes of preventable deaths in the United States. Further, it is highly comorbid with anxiety and depressive symptoms and disorders; hazardous alcohol use is associated with increased anxiety/depression. Indeed, 'affectively-vulnerable hazardous drinkers' (i.e., drinkers with elevated negative mood states or psychopathology) are 'at risk' for higher drinking rates, more problematic drinking, worsened mental health, and greater disability. Specialty care options are needed to address the unique 'affective needs' of hazardous drinkers. One promising intervention approach is to employ personalized feedback interventions (PFI). These interventions are brief, efficient, and have been shown to be effective in a number of settings and across an array of populations. However, PFIs have not been evaluated among affectively vulnerable hazardous drinkers. In order to address the heterogeneity of negative mood states and disorders among hazardous drinkers, there is a need to theoretically orient the intervention approach on underlying transdiagnostic processes that underpin affective psychopathology. Anxiety sensitivity (AS), the tendency to fear anxiety-related sensations, is a core transdiagnostic vulnerability factor underlying the etiology and maintenance of anxiety disorders, other emotional disorders, and hazardous drinking. AS is malleable in response to psychosocial interventions, making it a prime risk factor to target in prevention/intervention programs, including PFI approaches. Integrated treatments that address hazardous drinking via AS are nonexistant. As most hazardous drinkers typically do not access treatment because of such barriers as cost, time commitments, stigma, and logistics (e.g., travel, scheduling appointments), there is a need to develop an accessible, brief, integrated tool to explicitly address the drinking-affective vulnerability comorbidity via AS. To address this public health gap, the current proposal seeks to employ a computer-delivered integrated PFI that directly addresses hazardous drinking-AS in a personalized manner. Hazardous drinkers with elevated AS will be randomly assigned to receive one session of PFI or attention information control with follow-up assessments at one week and one month post-intervention. The PFI will focus on targeted feedback about drinking behaviors, AS, and adaptive coping strategies.
The purpose of this randomized controlled trial is to evaluate an intervention, Supporting Survivors and Self: An Intervention for Social Supports of Survivors of Partner Abuse and Sexual Aggression (SSS). SSS trains potential recipients of IPV or SA disclosure on the best methods of responding to a victim's disclosure. Consenting college students will be randomized into the SSS intervention or a wait-list control condition. Evaluation data will be multi-informant (i.e., data from both informal supports and victims) and multi-method (i.e., qualitative and quantitative). The investigators hypothesize that individuals receiving the SSS intervention, compared to individuals in the wait-list control condition, will provide less negative and more positive social reactions to victims' disclosure.
PURPOSE: The purpose of this investigation is to determine if a relationship exists between the administration of a dietary supplement containing 5-ALA and sleep and mood. HYPOTHESIS: There are several possible mechanisms for improvement in sleep and mood. In one study involving test mice, researchers found that the regular administration of 5-ALA appeared to raise serotonin levels in the brain. One hypothesis is by increasing serotonin levels, 5-ALA may contribute to improvements with sleep, along with additional improvements in mood, calmness, irritability and coping abilities. 5-ALA may also support hormonal regulation, including melatonin, in the pineal gland and corticosteroid regulation in the adrenal glands. Another hypothesis is that 5-ALA may have an impact on increasing the energy and metabolism of cells, such that its own circadian rhythms are better defined. 5-ALA may support neuronal function and assistance with "mental energy" needed to deal with stress in daily life, producing better feelings of "coping", "less irritability" and lowering an individual's feelings of "fatigue", all of which may contribute to a reduction of "pessimism" regarding the ability to deal with daily tasks. DESIGN: This will be a double-blinded, randomized parallel-group comparison study. SAMPLE: 40 participants will be randomized to the following 2 study groups for each outcome variable (Sleep and Mood): Control Group - 20 participants and Intervention Group - 20 participants. A table of random numbers will be used to assign the participants.
The goal of this clinical trial is to explore possible benefits and mechanisms through which the Somatic Psychoeducational Intervention can improve health and wellness. The main goals of the study are: * To understand how the participants are doing with regard to their mindfulness, coping behaviors, emotional, physical, and work health, and autonomic reactivity (the degree participants physiologically respond). * To examine regulation of the oxytocinergic system * To investigate whether pre-intervention measures relate to the overall functioning * To determine the 1-week and 1-month post-intervention effects of the Intervention(s) * To identify individual characteristics that influence the effectiveness of the intervention at the 1-week and 1-month post-intervention assessments. Participants will: * complete the online pre-assessment measures regarding how they are doing emotionally and with respect to their work situation. * listen to 15-minutes of calming music and provide pre and post-music salivary samples * complete pre-intervention, post-intervention, 1-week post-intervention, and 1-month post-intervention assessments that involve completion of online measures and collection of saliva samples. * participate in the intervention (which involves 4 hours; the 1-hour classes will be administered over four weeks). Researchers will compare the Intervention Group A (in-person) to Intervention Group B (virtual) to see if the Intervention Group A experiences greater improvements in their health and wellness.
The goal of this clinical trial is to explore possible benefits and mechanisms through which the Somatic Psychoeducational Intervention can improve health and wellness in health care providers (HCP). The main goals of the study are: * To understand how the participants are doing with regard to their mindfulness, coping behaviors, emotional, physical, and work health, and autonomic reactivity (the degree participants physiologically respond). * To investigate whether pre-intervention measures relate to the overall functioning of the HCPs. * To determine the 1-week and 1-month post-intervention effects of the Intervention(s) * To identify individual characteristics that influence the effectiveness of the intervention at the 1-week and 1-month post-intervention assessments. Participants will: * complete the online pre-assessment measures regarding how they are doing emotionally and with respect to their work situation. * complete pre-intervention, 1-week post-intervention, and 1-month post-intervention assessments that involve completion of online measures and collection of saliva samples. * participated in the intervention (which involves 4.5 hours; the 1.5-hour classes will be administered over three weeks). Researchers will compare the Intervention Group A to Intervention Groub B to see if the Intervention Group B experiences greater improvements in their health and wellness.
Functional abdominal pain (FAP), a pediatric pain condition without significant organic pathology, is a precursor to chronic pain and high healthcare utilization in young adulthood. This project aims to identify child and family characteristics that predict differential responses to a Cognitive Behavior Therapy intervention administered online to patients with FAP and their parents. The goal is to acquire scientific knowledge to guide individualized treatment of patients with FAP.
This study evaluates whether a 2 hour group session, "The Living Well with Hearing Loss Workshop," can successfully teach hard of hearing people how to best use hearing aids and a variety of personal skills to compensate for the limitations of their impaired ears.
The purpose of this study is to determine whether beginning an enriched educational/behavioral program for parents of premature infants, very early in the Neonatal Intensive Care Unit (NICU) stay, and lasting until the child is 3 years old, has beneficial results for both the parents and their infants. The hospital phase of the program gives parents an understanding of what to expect in the NICU environment; physical characteristics and needs of their premature baby; and how and when to best support their infant's development during this time. The information given during the home phase of the program continues with information specific to the growth and development and the effective parenting of an infant/toddler who has been born prematurely. It is believed that this information will help decrease parents' stress, anxiety and depression levels that can be related to giving birth to a premature infant. It is also expected that it will strengthen the mother's and father's ability to parent their premature child in a way that will help support their child's brain development and learning ability and to also decrease negative behaviors as the child grows.
Stress is an important determinant of pregnancy health behaviors, maternal physiology and maternal-infant health outcomes. The purpose of this study is to explain the relationship between dimensions of lifetime stress and the stress hormone cortisol in pregnant women. Additionally, the study will examine how coping styles help pregnant women to better manage stress and improve their health behaviors to achieve the goal of having a healthy baby.
The goal of this clinical trial is to compare two core intervention skills among adolescents with a history of engaging in at least 3 lifetime incidents of self-inflicted injury (SII), at least one of which was a suicide attempt of at least moderate lethality and moderate intent to die. The main questions it aims to answer are: Whether and when youth use skills in daily life, how quickly skill use declines after teaching, and whether exposure to life stress influences skill learning and retention. The Investigators also want to know whether brain-related, family-related, and physiology-related factors influence skills practice and any associated changes in self-harm/suicide risk and emotion dysregulation. Participants will complete surveys 5 times a day on their phones at baseline, and following each skill learning session. All participants will learn and practice the two skills with a parent while discussing topics they often argue about. During these discussions, participants will be hooked up to psychophysiological equipment to measure their cardiovascular functioning and their palm sweat. Participants' discussions will be coded for skill use and also for indices of family functioning. Approximately half of the participants will undergo two sets of fMRI scans to assess potential neural underpinnings of skill use.
This proposal seeks to adapt an existing peer navigation protocol (by adding coping skills and using telehealth) to be feasible, acceptable, and capable of supporting both PrEP uptake and P-E adherence for YBMSM ages 15-24.
266 family caregivers will be randomly assigned to either immediate intervention or delayed intervention groups. All caregivers will complete baseline surveys and 3 weeks of daily diaries. The immediate intervention group will receive 12 weeks of CuRB-IT. They will complete 3 rounds of 3-week daily diaries followed by an intermittent survey at 12 week intervals for the next 33 weeks. The delayed intervention group will receive 12 weeks of attention, complete 1 round of 3-week daily diaries followed by an intermittent survey, then complete 12 weeks of CuRB-IT, and complete 2 rounds of 3--week daily diaries followed by an intermittent survey at 12-week intervals for the next 18 weeks.
Using an adapted stress-reduction intervention called the CEDARS, the investigators will pilot the intervention in adolescents (N=40) to determine the feasibility and acceptability of CEDARS implementation and to investigate adolescent stress reduction. As an exploratory aim, the investigators will explore the influence of the CEDARS on CMH-related behaviors and CMH. The investigators expect that those adolescents who undergo the intervention will have the greatest improvement in mental health symptoms than their waitlisted counterparts. Our secondary hypothesis is that those who report more adversity will also report greater improvement in mental health symptoms than their peers.
Children without consistent access to sufficient and nutritious food show sustained disadvantages. To improve food security, households utilize three types of coping strategies- participating in governmental feeding and financial assistance programs; obtaining food from nongovernment providers; and using individually developed strategies. To understand the interdependencies among strategies and decision-making processes used to select them, the investigators conducted a two-phased, mixed-methods study using a socio-ecological theoretical framework. First, employing a cross sectional, observational design the investigators administered in-person surveys to 320 adults in very low food secure (VLFS) households with children. Over 1 year later, the investigators repeated select questions and conducted in depth interviews with a cohort (n=28) of participants. Descriptive statistics defined magnitude of associations among strategies. Following bivariate analysis, the investigators assessed interdependencies and factors affecting relationships with log-linear models. The investigators analyzed interviews using an hierarchically ordered, analytical coding structure. With Qualitative Comparative Analysis (QCA), the investigators developed typologies of VLFS and created models treating food security as an outcome. The association of soup kitchen use and nutritionally risky behavior was altered by Supplemental Security Income (SSI) or Social Security Disability Insurance (SSDI). Food safety-related risky behavior level related to intensity of food pantry use by participation in school food programs. Supplemental Nutrition Assistance Program (SNAP) did not affect the association between soup kitchen use and risky food safety behaviors. Key interview constructs included becoming and being short of food; coping strategies; decisions used to inform choice of strategies; and managing a devalued social status. Improved income stability was a necessary condition for improving food security.
This study evaluates the effectiveness of Behavioral Activation (BA) therapy vs Support and Information for reducing risk for emotional and cardiovascular diseases in Alzheimer's caregivers. Half of participants will receive BA and the other half will receive support and information.
The overall objective of the project is to develop and assess the feasibility of a brief, practice-friendly approach to psychotherapy for children, entitled Behavioral and Affective Skills in Coping (BASIC) and designed for use as a first step toward evidence-based practice by practitioners in clinical service settings.
The total number of military personnel is over 3.5 million and approximately 43% have children. The deployment cycle can be associated with depression, anxiety, and behavior problems in children as well as psychological distress in the military spouse. Further, the health of family members can affect the physical and psychological functioning of the military service member during the deployment and re-integration periods. While research and federal funding has been dedicated toward developing treatments for the returning service member, intervention protocols for mental health problems in the children of military families have not been tested. In collaboration with the Family Readiness Program of the Rhode Island National Guard \& Reserves, the purpose of this proposal is to develop a cognitive behavioral treatment protocol for adolescents experiencing depression, anxiety, and/or behavior problems associated with the deployment and re-integration phases of the military deployment cycle. This protocol will be created by modifying an NIH funded cognitive behavioral protocol for the treatment of adolescent mental health problems with initial demonstrated efficacy (PI, C. Esposito-Smythers). There are three primary aims in this project: 1) develop the manualized intervention protocol for adolescents experiencing mental health problems associated with the deployment cycle; 2) refine and pilot the intervention protocol with 12 families; and 3) test the intervention in a randomized pilot trial. To accomplish these aims, a two step sequence of treatment development is proposed. Stage Ia includes initial manual development, focus groups, therapist training, and an open pilot trial. Stage Ib includes a randomized pilot trial. Seventy-two adolescents and their caretakers will be enrolled through the Rhode Island Family Readiness program and randomly assigned to the experimental intervention or non-directive supportive therapy for their outpatient care. The experimental intervention includes 12 adolescent group sessions which address depression, anxiety, and behavior problems associated with the deployment cycle and 12 parent group sessions that address stress management and parenting skills. The non-directive supportive therapy condition includes 12 adolescent and 12 parent group sessions which involve patient initiated discussions focused on issues surrounding military deployment and re-integration. Outcome will be assessed at post-treatment and 3 month follow-up. The long term objective of this research is to yield an effective outpatient intervention for teens of military service members experiencing mental health problems associated with the deployment and re-integration phases of the deployment cycle.
This study will evaluate whether heart failure patients receiving a 16 week telephone delivered, intervention using cognitive behavior therapy to facilitate self-management of heart failure will have better clinical outcomes than heart failure patients receiving a 16 week heart failure education intervention via telephone.
Osteoarthritis (OA) is the leading cause of disability in the United States. Studies have shown that training patients to cope with pain improves physical and social functioning, increases self-efficacy, and reduces psychological distress. However, this type of training is not available to the vast majority of OA patients. This study will determine the effectiveness of a training program for coping with pain that will be administered in community medical practices. A THIRD ARM OF THE TRIAL WAS FUNDED 09/09. TREATED PATIENTS WILL BE RANDOMIZED TO (1)A 4-MONTH COMPUTER-DRIVEN TELEPHONE PROGRAM TO ENHANCE MAINTANENCE OF TREATMENT GAINS OR (2)USUAL CARE. THIS ARM WILL ONLY BE CONDUCTED AT THE STONY BROOK SITE.
Cognitive-behavioral coping skills therapy (CBT) is a widely used and recognized treatment that has been empirically validated for a range of substance use disorders, often with emergent effects and continuing improvement even after treatment ends. Treatment retention and compliance are associated with enhanced treatment outcomes in CBT. Contingency management (CM) also has very strong support and is associated with rapid, robust effects on targeted outcomes. Despite their many strengths, neither CBT nor CM is universally effective. It is now essential to seek strategies to maximize and extend the effectiveness of these two approaches and to better understand how these treatments exert their effects.
This study will try to determine what causes learning, behavioral and emotional problems in children with chronic granulomatous disease (GCD) and other phagocyte disorders. (Phagocytes are a type of white blood cell.) Children with these disorders have frequent severe infections that require hospitalization, sometimes for long periods of time. Many of them also have problems with school, learning, behavior, anxiety and depression. This study will explore whether these latter problems are a direct result of the illness itself or are a consequence of frequent, long hospitalizations, or are due to other factors. Test findings in these children will be compared with those of children with cystic fibrosis-another disease that causes frequent infections requiring prolonged hospitalization. Patients age 2 or older with GCD or other phagocytic disorders or cystic fibrosis may be eligible for this study. Participants (or a parent or guardian) will complete questionnaires including personal information such as age, gender and marital status, a family medical history, and information on their illness. Patients will be given various psychological and intelligence tests, and they and their parents or guardians will be interviewed by a child psychiatrist. The tests and interviews take a total of about 5 hours and are given in two or three separate sessions. The tests may reveal problems such as learning disorders, attention-deficit hyperactivity disorder, anxiety, or depression. If any of these problems are identified, appropriate referrals will be made for specialized services, such as special school placement, tutoring, or counseling.