119 Clinical Trials for Various Conditions
By age 45, women's lifetime risk of dementia is estimated to be 1 in 5. Two-thirds of people currently living with a dementia diagnosis are women, and-women make up the majority of carers for people with dementia. Because women bear a larger burden of the dementia epidemic, they tend to be more fearful about dementia compared to men. Women may be especially fearful during the menopause transition, which can impact cognition. These fears can cause significant psychological distress, functional impairment, and avoidance of help seeking. Interventions that acknowledge women's fears and promote adaptive coping during the menopause transition are needed to combat dementia-related fear and its negative impacts. This project aims to develop, and pilot test a brief personalized, psychosocial intervention for middle-aged perimenopausal individuals with elevated dementia risk. The investigators will assess the intervention's acceptability and feasibility for use in this population. The project will be completed in three stages. First, the investigators will conduct focus groups to better understand individual fears about dementia, informational and decisional needs, and strategies to promote adaptive coping as they transition through menopause (case-only, single time point). Second, the investigators will develop an intervention to meet the specific needs identified by the focus groups. Intervention components will address multiple areas of women's health in midlife, including aspects of physical and psychological health, as well as functional health outcomes that have important and long-lasting life implications. Finally, the investigators will conduct pilot testing to assess the acceptability and feasibility of the intervention (cohort, 3-week testing period). This project will deliver a novel psychosocial intervention that can provide middle-aged perimenopausal women with the information and practical skills that can help them manage their dementia-related fears and encourage adaptive coping behaviors. Outputs from the project will serve as preliminary data for a fully powered randomized controlled trial.
Older people with HIV (OPH) often live with significant mental health challenges such as social isolation, loneliness, and depression. The objectives of this study are to develop and test the usability and feasibility of a technology-based psychosocial intervention program designed to: enhance social engagement and support; facilitate resource access and education; reduce loneliness; and improve well-being among older adults with HIV who are long-term survivors (diagnosed with HIV ≥ 20 years). The program, Connecting Older Positive People to Enhance Health and Resilience (COPPEhR), will build on Dr. Sara Czaja's PRISM (A Personal Reminder and Information Management System for Seniors) platform, and will be an easy-to-use software application (app), preloaded onto a standard device, designed to support social connectivity, memory, and access to resources for older adults at risk for isolation and the programs and services available at the Center for Special Studies (CSS) at Weill Cornell Medicine (WCM). This protocol covers Phase 2 of the study, which will be a pilot randomized controlled efficacy trial will compare the COPPEhR intervention to a device-only control condition. Participants in the control condition will receive the same device as those in the COPPEhR condition without the COPPEhR application. The specific aims of this developmental project are to evaluate the feasibility, usefulness, and usability of a state-of-the art technology-based multicomponent COPPEhR intervention for aging adults with HIV. Our hypothesis is the COPPEhR intervention will be feasible, usable and useful. The hypothesis is that those that use the COPPEhR app will experience less loneliness, less depression, and less social isolation and more social support, more resilience, and more connectivity than those that do not use the COPPEhR app.
The goal of this clinical trial is to test the efficacy a new psychosocial symptom management intervention called ENGAGE for patients with Stage IV breast, prostate, lung, or colorectal cancer. Participants will be randomized to ENGAGE or a Supportive Care intervention. Patient-reported outcomes will be assessed at baseline, 2 months, and 4 months.
The goal of this study is to evaluate whether a psychological intervention (BMT-CARE) is effective at improving the quality of life in caregivers and patients treated with hematopoietic cell transplant compared to usual care, and to identify critical facilitators and barriers for BMT-CARE implementation and adoption.
The goal of this clinical trial is to test the feasibility of the Individualized Positive Psychosocial Interaction (IPPI) with 108 nursing home residents living with dementia and distress or depressive symptoms. The main questions it aims to answer are: •is it feasible to deliver the IPPI and track impact through data collected in the electronic medical records. Care partners will engage eligible residents in 2 brief preference-based IPPIs per week over the course of 6 months.
This study will conduct a two-arm randomized controlled trial to test the efficacy of a culturally tailored version of the NYU Caregiver Intervention (NYUCI) plus enhanced support (ES) through online chat groups (the NYUCI plus WeChat/Kakaotalk \[population social media app for Chinese/Korean\] peer support which we call the NYUCI-ES in reducing health risks for cardiometabolic disease among older Chinese and Korean American adults caring for relatives with ADRD. In collaboration with community organizations across the New York and northern New Jersey metropolitan area, we will enroll 300 caregivers of people with ADRD (150 Chinese and 150 Korean) in this study. Aim 1: Develop culturally adapted informational and educational materials about dementia and caregiving issues for social service providers of the intervention and for family caregivers. Aim 2: Test the hypothesis, H1: A counseling and support intervention (the NYUCI-ES) will significantly improve psychosocial factors such as depression, stress self-rated health and chronic disease management among Chinese and Korean-American ADRD caregivers and these changes will be mediated by improvement in social support. H1a: By the first (6- month) follow-up, the mediators (increases in social support, stress reaction) will improve significantly in the intervention group compared to baseline values and the control group. H1b: These improvements will be maintained, and lead to reduction in depressive symptoms, and improvement in self-reported health and chronic disease self-management by the 12-month follow-up compared to the control group. Aim 3: Test the hypothesis, H2: the NYUCI-ES will reduce biologic risk factors, including metabolic health (glycosylated hemoglobin) and inflammation (Oxidative stress, lipid metabolism, etc.) within 6 months of enrollment compared to baseline and a control group; these changes will be mediated through increases in social support and decreases in depressive symptoms and will be maintained at the 12-month follow-up. The public health significance of these findings will likely have an impact on health care policy for CGs from diverse underserved ethnic and cultural backgrounds, potentially reducing morbidity, and improving their quality of life.
The psychosocial needs of children with cancer and their families are well-documented in the literature, including the increased risk of parental posttraumatic stress, parental anxiety, and decreased family functioning. There is a critical need to provide evidence-based psychosocial care to parents of children with cancer, although many challenges exist with regard to in-person intervention delivery. eHealth interventions represent an exciting potential opportunity to address many of the barriers to in-person intervention delivery in this population, but are not yet widely utilized in pediatric psychosocial cancer care. eSCCIP is an innovative eHealth intervention for parents of children with cancer, delivered through a combination of self-guided interactive online content and telehealth follow-up with a therapist. eSCCIP aims to decrease symptoms of anxiety, distress, and posttraumatic stress while improving family functioning by delivering evidence-based therapeutic content through a flexible, easily accessible intervention tool. The four self-guided online modules feature a mix of didactic video content, novel multifamily video discussion groups featuring parents of children with cancer, and hands-on interactive activities. Preliminary Think Aloud testing has been completed and led to several rounds of design and functionality improvements. The objective of the proposed study is to establish feasibility and acceptability of eSCCIP in a diverse group of parents of children with cancer. A secondary, exploratory goal is to evaluate preliminary intervention effectiveness for key psychosocial outcomes. Specific Aim 1 is to identify strategies for increasing participant engagement and retention by conducting focus groups with a diverse sample of parents of children with cancer prior to pilot testing. Specific Aim 2 is to demonstrate the feasibility of eSCCIP through pilot testing with a diverse sample of parents of children with cancer. Specific Aim 3 is to evaluate preliminary effectiveness of eSCCIP through pilot testing with parents of children with cancer. The proposed study is an important first step in meeting a critical need for families of children with cancer and collecting data to power a randomized clinical trial to establish clinical efficacy.
It is critical to provide accessible evidence-based psychosocial support to parents and caregivers of children with cancer (PCCC) in order to mitigate individual and family-level psychosocial risks. This effectiveness trial evaluates an eHealth intervention for English- and Spanish-speaking (PCCC) with study endpoints focused on decreasing negative psychosocial sequelae (acute distress, posttraumatic stress, and anxiety) and improving coping abilities (coping self-efficacy, cognitive coping strategies). The long-term goal of this research program is to sustain and disseminate an effective, scalable, high-reach, and cost-effective intervention to provide crucial support to PCCC across the pediatric cancer trajectory.
This project proposes to conduct the first study of the predictive utility of olfactory hedonic measurement for targeted psychosocial rehabilitation in schizophrenia. The information gathered from the project is of considerable public health relevance, in that, through simple, reliable olfactory assessment, it will provide knowledge about which individuals are most likely to benefit from these psychosocial interventions. Such information is crucial for tailoring existing interventions and developing new approaches to optimize outcomes in schizophrenia.
Congenital heart disease (CHD) is the most common birth defect and is increasingly diagnosed prenatally. Mothers describe their prenatal experiences as highly stressful and traumatic after a diagnosis of CHD. Maternal stress during pregnancy exerts a powerful influence on birth outcomes and developmental trajectories, particularly for children in underserved populations. In partnership with diverse parent and clinician stakeholders, our team designed HEARTPrep, an innovative, virtually-delivered psychosocial intervention for mothers expecting a baby with CHD. This project will pilot HEARTPrep with mothers expecting a baby with CHD to obtain preliminary data for a larger future trial. This intervention has the potential to improve emotional wellbeing in mothers expecting a baby with CHD, thereby altering developmental trajectories for this large population of children.
The purpose of the study is to examine the effect of Problem Adaptation Therapy for Pain (PATH-Pain) on cognitive functioning, depression and pain-related disability in 100 older adults with cognitive impairment, chronic pain, and depression. The study will test if PATH-Pain has better cognitive, affective, and functional outcomes than Attention Control Usual Care.
Parental illness and death from HIV/AIDS has a profound and lasting impact on a child's psychosocial well-being, potentially challenging the basic needs for survival and compromising the child's future. Therefore, the impact of parental HIV/AIDS on children needs to be treated from both a public health and a developmental perspective. However, to date the role of a resilience-based approach among children affected by HIV is hypothesized but not evidence-based. In this application, we propose to develop a theory-guided, resilience-based, multimodal intervention by culturally adapting and integrating components from three SAMHSA model programs which show strong evidence in promoting protective factors among young children. The multimodal intervention will include three approach levels: the individual child (peer-group activities), the family (caregiver parenting skill training), and the local community (community advocacy). The short, medium, and long-term efficacy of the Child-Caregiver-Advocacy-Resilience \[ChildCARE\] intervention to improve health and psychosocial well-being of children will be evaluated over 36 months through a cluster randomized controlled trial. About 800 HIV/AIDS-affected children (8 to 11 years of age) and their primary caregivers will be recruited from central China where we have built a strong research infrastructure and community collaboration during our previous study. The primary outcome measures for the children will include physical health, mental health, growth and development, school performance, and a biological indicator of neurobiological stress response (salivary cortisol). The outcome measures at caregiver level will include parenting style, parental engagement, and mental health well-being. The changes at the community level will be measured using children's and caregivers' perceptions of social support and HIV-related public stigma. We will also examine the potential mechanism through which the ChildCARE intervention is exerting its impact by identifying improvement in protective factors and other individual and contextual factors that potentially mediate or moderate the intervention effect. This proposed project will examine whether the multilevel protective factors we identified in our initial project are amenable to intervention and whether their hypothesized changes explain improvement in children outcomes.
This is a randomized controlled trial to test effectiveness of the SurgeryPal intervention vs. education control to improve acute and chronic pain and health outcomes in youth undergoing major musculoskeletal surgery. Youth will be randomized on an individual level using a factorial design to SurgeryPal or Education during 2 phases of intervention: 1) pre-operative phase (4 week duration delivered over the 4 weeks leading up to surgery), and 2) post-operative phase (4 week duration following surgery). Thus there will be 4 treatment arms. Participants will undergo 4 assessments, independent of their treatment assignment: T1: Baseline (pre-randomization); T2: acute post-surgery outcomes (daily assessment of acute outcomes beginning day 1 through day 14 after hospital discharge from surgery); T3: Post-surgery follow-up (assessment of outcomes at 3-months post-surgery); T4: Final post-surgery follow-up (assessment of outcomes at 6-months post-surgery).
Psychosocial conditions are common in young adults with hip pain including depression, anxiety, pain catastrophizing, and narcotic use. The incidence of these conditions is not well defined. Interventions to optimize psychosocial conditions with non-surgical or surgical treatments has not been investigated. The goal of this project is to determine the incidence of psychosocial conditions in the young adult population with hip pain and determine if cognitive based therapy can improve clinical outcomes in these individuals.
Palliative Care focuses on symptom management and quality of life and helps patients with life-limiting illness match goals and preferences for care. While there has been interest in and acknowledgement that palliative care is an important part of training patient navigators, there have been no previous studies examining the effectiveness of a navigation intervention to improve palliative care for patients. This study will examine the feasibility to implement patient navigator and psychosocial interventions.
This trial studies how well online psychosocial intervention works in improving social well-being and support in women who are undergoing treatment for stage I-IV non-small cell lung cancer. Psychosocial intervention techniques, such as mindfulness, compassion, and emotional processing, may improve distress and help patients manage symptoms related to non-small cell lung cancer.
The purpose of this study is to incorporate multidimensional self-management programs into the routine care of epilepsy patients. Consenting patients will enroll in one of four interventions that help improve medication adherence, increase seizure awareness and documentation, improve memory and deal with stress and depression.
The purpose of this study is to examine the effects of various factors such as emotions, stress, stress management techniques (for example relaxation and coping techniques), and health information on quality of life, distress, depression, coping, and physical health in men diagnosed with advanced prostate cancer. The investigators also evaluate the effectiveness of a 10-week group-based internet delivered psychosocial intervention. Primary outcomes are symptom burden (e.g., urinary function, fatigue, pain) and HRQOL (e.g., general, physical \& social functioning). Participation in this study includes three face-to-face assessments: baseline (at the beginning of the research study), 6-month follow-up, and 12-month follow-up. The 6- and 12-month follow-up interviews are conducted after the participant has completed the 10-week group intervention. Participants are randomized into either an intervention group (targets stress management skills - relaxation, coping) or a control group (health information and health promotion strategies - benefits of proper nutrition and treatment compliance). Both groups meet for 10 consecutive weeks through an internet video conferencing platform. At the baseline, 6- and 12-month follow-ups, the investigators collect blood and saliva samples. The blood samples go through a three-day process in which the investigators extract and store serum, plasma, and cells for further analysis and gather proliferation data. The investigators use the saliva to measure the cortisol diurnal rhythm.
Parental cancer can cause substantial behavioral and emotional distress in both parent and child. Parents struggle with talking with their child about their cancer and supporting the child during treatment. Over 73% of patients with children desire information and services to support their children yet only 9% of these families report receiving this support. The purpose of this study is to evaluate the Wonders \& Worries psychosocial intervention designed for children ages 5-14 who have a parent diagnosed with early stage cancer.This study is a randomized controlled clinical trial (RCT) evaluating the Wonders \& Worries group and individual intervention for school age children (5 -14 years old) who have a parent with cancer. Families will be enrolled at the time of initial parent consultation, given informed consent, and then randomized either to the intervention group of 30 families or the wait-listed control group of 30 families. Both groups will be given a series of standardized validated assessment instruments including the Revised Children's Manifest Anxiety Scale (RCMAS), the Child Behavior Checklist (CBCL), and the Family Communication Scale FACES IV at baseline, post intervention, and 8 week follow up. Upon completion of the follow up measures, families in the wait-listed control group will be enrolled into the intervention. Parent exit interviews for both groups will be used to measure parent-reported child outcomes and program utility.
Opiate drug abuse/addiction is a significant co-morbidity in pregnancy. Opiate maintenance program enhances the outcome of pregnancies for the mother and the infant. Our objective was to assess if provision of structured psychosocial support in addition to methadone maintenance program adds incremental benefits with regards to the outcome of pregnancy.
This study will develop and evaluate the preliminary efficacy and cost-effectiveness of a mobile phone-delivered psychosocial intervention for opioid-dependent adults (N=219) in methadone maintenance treatment (MMT). A three-arm, randomized clinical trial will evaluate the relative efficacy of: (1) standard MMT; (2) standard MMT plus the mobile intervention; and (3) a mobile-based control condition on the primary outcomes of treatment retention and opioid use (assessed via urine toxicology). If results are promising, this novel therapeutic tool may have a tremendous impact on improving access to and effectiveness of substance abuse treatment in a variety of other populations (and could also be adapted for an array of other behavioral health applications), while significantly limiting costs.
The aim of the study is to compare the benefits of three types of individual treatment programs for cancer patients: Meaning-Centered counseling, Supportive counseling, and Enhanced Usual Care. We would like to train therapists in administering these types of counseling, so that they have expertise to work on the study. The therapists will administer either the Meaning-Centered counseling or the Supportive counseling, as part of their training. Many cancer patients use counseling or other resources to help with the emotional burden of their illnesses. Counseling often helps them cope with cancer by giving them a place to express their feelings. "Meaning-Centered" counseling aims to teach cancer patients how to maintain or even increase a sense of meaning and purpose in their lives, despite cancer. "Supportive" counseling is intended to help the patient cope with cancer by giving them a place to express their feelings and get support. Enhanced Usual Care is intended to offer the patient referrals and resources that are matched to their individual needs in addition to the care they are already receiving at MSKCC.
The purpose of this study is to develop and evaluate the acceptability and preliminary efficacy of a web-based, skills training program for adolescents with substance use disorders.
The goal of this project is to test an intervention designed to reduce the incidence and magnitude of the negative effects, specifically stress, anxiety, and depression, frequently experienced by adult children who are caregivers of a parent with Alzheimer's disease (AD).
The purpose of this study is to determine if osteoarthritis patients and their spouses experience greater health benefits from a couples-oriented psychosocial intervention than a patient-oriented psychosocial intervention, and to determine if each intervention is more beneficial than patient usual medical care.
The purpose of this study is to test whether short, time-limited parent education programs designed to help children diagnosed with ADHD and disruptive behaviors can be helpful to families that may not be able to participate in "traditional" forms of mental health care. In short, the researchers want to know if a new program is acceptable and helpful for parents or caregivers looking for ways to help their child with problem behaviors related to ADHD. The researchers hope to enroll 60 families in the study. Half will be randomly assigned to participate in a 7-session therapy program and the other half will be asked to wait 24 weeks before being offered the treatment. Parents in the study will fill out questionnaires at week 1, week 14, and week 24. The researchers' goal is to answer 2 specific questions. 1) Is this protocol acceptable to families and do they choose to participate and 2) Are the researchers able to accurately measure our outcomes of interest, specifically, changes in children's behavior problems, changes in parenting practices, and parents' perceptions of mental health care. This study is focused on whether the intervention and study methods are acceptable. The researchers will compare the two groups to see if there are differences, but it would require a larger group of children and parents before the researchers can determine whether these differences are meaningful .
This study will evaluate the comparative effectiveness of Therapeutic Education System (TES), a computer-based, psychosocial treatment program, relative to standard care when offered to individuals with substance use disorders in prison settings. The study will assess the comparative effectiveness of these interventions primarily by examining changes in: (1) substance use (e.g., weeks of abstinence), (2) HIV risk behavior (evaluated as both sex-related and drug-related HIV risk behavior) and (3) reincarceration rates. The study will also examine the extent to which these interventions improve psychosocial functioning (e.g., employment, health, and psychological status) and quality of life, and promote relevant skills acquisition (e.g., improve communication skills, reduce "criminal thinking"). The investigators predict significantly better outcomes for E vs. C due to TES' research-based content and use of proven informational technologies.
The goal of this study is to learn if the Mind Over Matter (MOM) Intervention, a 5-week group program, can help Black and African American women deal with the fears, worries and sadness that often accompany cancer diagnosis and treatment. The main question this study aims to answer is: • Whether the MOM Intervention is feasible and acceptable among Black and African American women. We would also like to find out if: * The MOM Intervention decreases anxiety, depression and physical symptom severity for Black and African American women. * The MOM Intervention is culturally and linguistically appropriate, and identify barriers, strengths, and areas of improvement. Participants will: * Attend a Pre-Program Orientation * Attend 5 weekly MOM Sessions * Complete 2 questionnaires (one will be given before the first MOM Session begins, and the other will be given after the last MOM Session) Participants also have the choice to attend an optional Focus Group, which will be offered after the last MOM Session. Please note, this entire Intervention will be offered online. There will be no in-person sessions or visits.
Researchers at the University of North Carolina at Greensboro conduct a single-arm intervention trial to investigate the efficacy of a music-based group exercise program for community-dwelling older adults. Up to forty participants will be recruited to participate in a music-based light-to-moderate intensity group exercise program for 20 weeks (30 - 40 min/day, up to 6 days/week), which is designed for older adults with or without functional limitations to exercise with chairs for the improvement of aerobic capacity, upper and lower body strength, and balance control at a gradually increasing pace. During the exercise sessions, participants will be trained to move in time with music playlists in synchronous tempos. Primary outcomes are cognitive performance, mobility, and health-related quality of life measured before and after the intervention. Secondary outcomes are adherence to the exercise program as a potential mediator of the treatment.
This study is a 6-week micro-randomized trial investigating the feasibility of a mobile health platform. Its long-term objective is to develop a mobile health platform for the translation of a psychosocial intervention for bipolar disorder (BP) into an effective and evidence-based adaptive intervention. In this aim of the study, investigators will evaluate how individuals with BP respond to a microintervention based in acceptance and commitment therapy (ACT) that is delivered with a mobile app.