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Tundra lists 21 Psychosocial Functioning clinical trials. Each listing includes eligibility criteria, study locations, and direct links to research sites in the Tundra directory.
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NCT07424521
Psychosocial Effects of Mindfulness-Based Exercise in Postmenopausal Women
Menopause is a natural biological process characterized by the permanent cessation of the menstrual cycle in women. Hormonal changes associated with menopause commonly lead to mood swings, anxiety, depression, stress, and decreased sleep quality in women. While the current literature indicates that mindfulness-based interventions offer potential benefits in alleviating psychological and physical symptoms in postmenopausal women, the limited number of studies in the literature and methodological differences suggest a need for more randomized controlled trials in this area. The aim of this study is to examine the effect of mindfulness-based exercises on psychosomatic complaints such as anxiety, depression, and sleep quality in postmenopausal women. Designed as a randomized controlled experimental study, it was planned to include at least 20 women in the early postmenopausal period residing in Istanbul and Izmir between March and June 2026. The women included in the study will be randomized into Group 1 (n=10), which will perform mindfulness-based exercises, and Group 2 (n=10), which will receive no intervention as usual. The STAI I-II Form State and Trait Anxiety Scale and Beck Anxiety Inventory will be used to assess state and anxiety level, the Beck Depression Scale for depression level, and the Pittsburgh Sleep Quality Scale for sleep quality. Continuous variables will be presented as mean ± standard deviation, and qualitative variables as number and percentage (%). If parametric test assumptions are met, the Independent Samples t-test will be used to compare independent groups, and the Paired Samples t-test will be used to compare dependent groups. If parametric test assumptions are not met, the Mann-Whitney U test will be used to compare independent groups, and the Wilcoxon test will be used to compare dependent groups. Statistical significance will be set at p≤0.05. This study is expected to contribute to the literature by providing evidence-based data on the effectiveness of mindfulness-based exercises on common psychological symptoms in the postmenopausal period.
Gender: FEMALE
Ages: 45 Years - 60 Years
Updated: 2026-02-20
NCT06043778
Digital Implementation Support to Achieve Uptake and Integration of Task-Shared Care for Schizophrenia in Primary Care in India
Schizophrenia represents a significant contributor to the global burden of disease, with this burden disproportionately impacting low- and middle-income countries (LMICs). In India, the burden due to schizophrenia is further exacerbated by low access to effective psychosocial interventions aimed at promoting recovery, rehabilitation, and community tenure, as well as inadequate attention to managing co-occurring chronic medical conditions that result in significantly reduced life expectancy among those living with schizophrenia compared to the general population. A major driver of these alarming gaps in access to care for persons with schizophrenia in India is the limited capacity within primary care settings aimed at addressing the complex co-occurring mental health, physical health, and functional needs of this patient population. There now exists strong evidence demonstrating that community programs delivered in primary care and leveraging psychosocial interventions combined with linkage to specialty psychiatric services are effective for supporting treatment and recovery of schizophrenia in low-resource settings. We will leverage our existing collaboration and robust research infrastructure in both rural and urban settings in Madhya Pradesh and Karnataka, India to conduct a hybrid type 1 effectiveness-implementation trial to evaluate whether the use of a digital platform offers added clinical benefit and can support integration of this task shared care for schizophrenia into routine primary care settings. We will address the following aims: 1) evaluate whether the use of the mindLAMP digital platform can enhance the clinical effectiveness of task-shared community-based psychosocial rehabilitation (COPSI) for individuals with schizophrenia, and 2) determine whether the addition of mindLAMP to the delivery of the COPSI program has an impact on implementation metrics when compared to delivery of COPSI alone.
Gender: All
Ages: 18 Years - Any
Updated: 2026-02-12
NCT07387692
Peer Support for Whole Health for Veterans
This project is evaluating a new intervention, Peer Support for Whole Health. Peer Support for Whole Health is delivered by peer support specialists, Veterans who are in recovery from mental health or substance use concerns who are employed to help other Veterans. Peer Support for Whole Health uses the Whole Health model to talk about values and self-care in all areas of life. Peer Support for Whole Health is designed to help Veterans who have difficulty with their relationships, work, or day-to-day life and may have behavioral health concerns. Peer Support for Whole Health is designed for Veterans in primary care who are not engaged in mental health or substance use treatment. The goal of this study is to find out whether Peer Support for Whole Health helps Veterans with relationships, work, or day-to-day life. This project will also study whether Peer Support for Whole Health improves well-being and mental health. Finally, this study will seek to understand how Peer Support for Whole Health works and which Veterans it helps the most.
Gender: All
Ages: 18 Years - Any
Updated: 2026-02-04
2 states
NCT06248203
Teachers Leading the Front Lines - Adolescent
Purpose: The purpose of this research is to pilot test a novel, alternative, potentially sustainable system of teacher-delivered, task-shifted adolescent mental health care. Participants: Principals of 60 rural, low-cost private secondary schools of the Darjeeling Himalayas will be invited to participate as a school and an individual. Teachers will be approached individually. Two students per teacher who meet inclusion criteria will be randomly chosen for enrollment. Procedures: This is a RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) guided, mixed methods CRCT, clustered at schools, of Tealeaf-A's Reach, Adoption \& Implementation (Primary Outcomes, implementation-based), as well as evaluating for preliminary indicators of Effectiveness \& Maintenance (Secondary Outcomes, clinically-based).
Gender: All
Ages: 13 Years - Any
Updated: 2025-12-18
1 state
NCT07283744
A Mindfulness-Based Intervention to Reduce Stress Through the Cultivation of Loving-Kindness, Compassion, Joy, and Equanimity in Healthcare Professionals
Nearly 50% of the adult workforce experience adverse psychological symptoms (e.g., stress, depression, burnout, etc.) stemming from workplace stressors, with healthcare workers experiencing rates as high as 80%. Some common complaints and downstream consequences of working in high-stress healthcare occupations are elevated levels of perceived stress, depression, and burnout. These conditions have been associated with unfavorable occupational (e.g., increased medical errors), patient (e.g., increased mortality rates), and provider-related outcomes (e.g., increased rates of cardiovascular disease), imposing a heavy burden on an already stretched system. Given the impact of perceived stress, depression, and burnout on employee and patient health, a clear need exists to develop effective interventions to reduce distress and promote well-being among healthcare professionals. In particular, interventions that target processes particularly vulnerable to provider stress (e.g., compassion) are needed. The present study will evaluate the feasibility and efficacy of a mindfulness-based intervention inspired by the Buddhist Four Immeasurables practice on reducing perceived stress (primary outcome), depressive symptoms, burnout, and biological markers of inflammation, and enhancing psychological well-being and sleep quality (secondary outcomes) in 80 healthcare workers. Additionally, we will investigate several mediators (compassion, positive emotions, equanimity, and mindfulness) of intervention effects. Participants will be healthcare employees of UCLA Health. They will be enrolled in a six-week, two-arm randomized controlled trial. Participants will complete self-report questionnaires at baseline, mid-course, and post-intervention to assess study outcomes and mediators. We aim to advance the study of interventions that reduce distress and promote well-being using practices that cultivate kind feelings toward oneself and others.
Gender: All
Ages: 18 Years - Any
Updated: 2025-12-16
1 state
NCT05962879
Development of a Transdiagnostic Intervention for Adolescents at Risk for Serious Mental Illness
This research study aims to develop a brief group-based treatment called Resilience Training for Teens, then to test how well it protects high school students with mild symptoms of depression, anxiety, or having unusual feelings from developing mental illnesses.
Gender: All
Ages: 14 Years - 19 Years
Updated: 2025-12-09
1 state
NCT05974553
Dialectical Behavior Therapy for Justice-Involved Veterans
Dialectical Behavior Therapy for Justice-Involved Veterans (DBT-J) is a comprehensive, integrative program distinctively designed to address the range of mental health, substance use, case management, and legal needs of Veterans with current or ongoing criminal justice involvement. Data from two prior clinical trials attest to the program's feasibility and acceptability and preliminarily suggest participation in the program may yield meaningful improvements in risk for criminal behavior and resolution of high-priority case management needs. However, continued research is needed to further investigate the program's efficacy. This Phase III clinical trial aims to investigate the superiority of DBT-J over a supportive group therapy treatment in decreasing risk of future criminal behavior and increasing psychosocial functioning. Secondary and exploratory aims will also investigate superiority of DBT-J in improving secondary treatment targets, potential differential efficacy across special-interest Veteran subgroups, and long-term consequences of program participation.
Gender: All
Ages: 18 Years - Any
Updated: 2025-11-19
2 states
NCT05576090
UCLA REST Study (REsearch on Sleep Techniques)
Sleep disturbance has a range of negative effects on psychosocial and biological processes important for academic and social success as well as mental and physical health among adolescents and young adults. Limited, inconsistent, and poor quality sleep lead to anxiety, depressive feelings, loneliness, and fatigue over time. These symptoms, in turn, interfere with the ability to get a good night's rest. Sleep disruption can also upregulate inflammatory processes during the years of adolescence and young adulthood in ways that can create risk for the development of chronic health conditions (e.g., diabetes, depression, cardiovascular disease) in later adulthood. Sleep, however, is also a modifiable health behavior, leading many institutions to embark upon efforts to improve the sleep of their students. The challenge is to identify programs and interventions that can simultaneously improve sleep, be delivered at scale, and be easily completed by students. UCLA has developed and validated a group-based mindfulness intervention, Mindful Awareness Practices (MAPs), that has demonstrated beneficial effects on sleep in adults and may offer a promising, scalable approach for reducing sleep disturbance and improving associated psychological and biological outcomes in college students. However, this approach requires validation in this population relative to sleep education programs, which increasingly dominate the college landscape. To address this important public health problem, the investigators propose to conduct a single site, two-arm, parallel group randomized controlled trial to test the efficacy of the validated, group-based, six-week MAPs intervention vs. sleep education, an active time and attention matched control condition, for first and second year undergraduate students who report poor sleep at this critical transition year. The investigators are aiming to enroll approximately 240 participants. Participants will complete questionnaires, provide blood samples for immune analysis and will be provided with wrist actigraphs to wear for 7 days, in order to collect objective measurements of sleep at pre- and post-intervention visits, and at a 3-month follow-up visit. Additional follow-up assessments will take place at 6-month, and 12-month post-intervention to evaluate persistence of effects.
Gender: All
Ages: 18 Years - 22 Years
Updated: 2025-11-10
1 state
NCT06689787
A Mobile Health Intervention to Improve Psychosocial Functioning in Veterans With Posttraumatic Stress Disorder and Depression Symptoms
Posttraumatic stress disorder (PTSD) and depression are the two most common mental health conditions among Veterans. When Veterans experience both, there is a negative impact on their functioning, making it difficult to function at work or at home and socially with other people. Although talk therapies can result in improvements in functioning, they are difficult to access because there are limited clinicians who can provide them. As most US adults now own a smartphone, mobile apps are a way for Veterans to access content traditionally delivered through talk therapies at their own pace. This study will test a mobile app based on a trauma-informed talk therapy that has helped Veterans with PTSD and depression make large improvements in functioning, through learning skills to navigate emotions and relationships. Additionally, through answering brief surveys and enabling passive tracking on their smartphones, Veterans will see real-time information on their functioning and mental health and on potential benefits from using these skills.
Gender: All
Ages: 18 Years - Any
Updated: 2025-10-29
1 state
NCT06580847
Benefits of Choir for Older Adults With Unaddressed Hearing Loss (WP2)
Unaddressed age-related hearing loss is highly prevalent among older adults, typified by negative consequences for speech-in-noise perception and psychosocial wellbeing. There is promising evidence that group singing may enhance speech-in-noise perception and psychosocial wellbeing. However, there is a lack of robust evidence, primarily due to the literature being based on small sample sizes, single site studies, and a lack of randomized controlled trials. Hence, to address these concerns, this SingWell Project study utilizes an appropriate sample size, multisite, randomized controlled trial approach, with a robust preplanned statistical analysis. The objective of the study is to explore if group singing may improve speech-in-noise perception and psychosocial wellbeing for older adults with unaddressed hearing loss. The investigators designed an international, multisite, randomized controlled trial to explore the benefits of group singing for adults aged 60 years and older with unaddressed hearing loss. After undergoing an eligibility screening process and completing an information and consent form, the investigators intend to recruit 210 participants that will be randomly assigned to either group singing or an audiobook club (control group) intervention for a training period of 12-weeks. The study has multiple timepoints for testing, that are broadly categorized as macro (i.e., pre- and post-measures across the 12-weeks), or micro timepoints (i.e., pre- and post-measures across a weekly training session). Macro measures include behavioural measures of speech and music perception, and psychosocial questionnaires. Micro measures include psychosocial questionnaires and heart-rate variability. The investigators hypothesize that group singing may be effective at improving speech perception and psychosocial outcomes for older adults with unaddressed hearing loss-more so than participants in the control group.
Gender: All
Ages: 60 Years - Any
Updated: 2025-09-18
5 states
NCT06454903
Developing a Smartphone Application to Support Veteran Opioid Use Disorder Treatment
Opioid Use Disorder (OUD) is a complex, chronic condition affecting nearly 70,000 Veterans who can experience significantly reduced quality of life (e.g., poorer social, occupational, and health-related functioning). VA clinics providing Medication treatment for OUD (MOUD; e.g., buprenorphine, methadone), the 1st-line treatment for OUD, often face challenges in also attempting to treat Veteran functional needs, which may require them to extend beyond their available resources to provide support. There is an urgent need for functionally impactful and accessible treatments for Veterans in MOUD. Acceptance and Commitment Therapy (ACT) is a well-suited framework to support the functioning of Veterans in MOUD with over 20 years of research support. However, the traditional practice ACT requires a trained clinician to provide weekly, hour-long therapy sessions (typically for 12-16 weeks) and may be too burdensome for MOUD clinics to use alongside standard care. Fortunately, emerging research suggests that mobile health interventions (MHIs; e.g., smartphone apps) can overcome many of these pragmatic barriers. MHIs can efficiently deliver functionally-focused treatments focused on Veteran functioning in "real-world" settings, through minimally burdensome and accessible formats. Currently however, no MHI's targeting functioning exist for Veterans in MOUD. The proposed study will address this gap by developing and evaluating an early prototype of a targeted smartphone app designed to enhance the functional outcomes of Veterans receiving MOUD called "ACT to RECOVER" (Acceptance and Commitment Therapy to Reach Empowerment through Commitment, Openness, and Valuing Experiences in Recovery). The study will occur in 3 phases: Phase 1: Development. Develop content for ACT to RECOVER using Veteran (n=10) and provider feedback (n=10). Phase 2: Iterative Usability Assessment. Conduct field testing (3 rounds, n=4-5 per round) to refine ACT to RECOVER format, acceptability, and usability. Phase 3: Pilot ACT to RECOVER in a Stage 1b Randomized Controlled Trial (RCT). Conduct a pilot trial to compare ACT to RECOVER (n=20) to a smartphone-based symptom monitoring control group (n=20). * (3a) Evaluate the acceptability and feasibility of each condition's app and study procedures. * (3b) Explore changes in functional (e.g., values-based living, quality of life) and clinical outcomes (e.g., illicit opioid use) which will be key outcomes in future efficacy testing.
Gender: All
Ages: 18 Years - Any
Updated: 2025-08-27
1 state
NCT07130981
Body Composition and Psychosocial Factors in ICI-Treated Cancer Patients
Evaluation of the effects of body composition, psychosocial factors, and drug-related problems on clinical progression (such as toxicity, treatment response, and quality of life) in cancer patients treated with immune checkpoint inhibitors
Gender: All
Ages: 18 Years - Any
Updated: 2025-08-24
1 state
NCT06587230
Teachers Leading the Front Lines - North Carolina (Tealeaf-NC)
Purpose: The purpose of this research is to pilot test a novel, alternative, potentially sustainable system of teacher-delivered, task-shifted child mental health care. Participants: \~300 estimated Procedures: This is a RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) guided, mixed methods, clustered evaluation of Tealeaf-NC's Reach, Adoption \& Implementation (Primary Outcomes, implementation-based), as well as evaluating for preliminary indicators of Effectiveness \& Maintenance (Secondary Outcomes, clinically-based).
Gender: All
Ages: 5 Years - 99 Years
Updated: 2025-06-27
1 state
NCT06174701
Building Resilience for Surgical Recovery
The goal of this clinical trial is to test problem solving therapy (PST) in older adults who are undergoing major surgery. The main question it aims to answer is: What is the feasibility and acceptability of delivering PST to older surgical patients with depressive symptoms or report lacking social support in the pre-operative and post-operative setting?
Gender: All
Ages: 65 Years - Any
Updated: 2025-05-01
1 state
NCT06854822
Siblings to a Child with Cancer: Needs and Pre-loss Grief
Background and Aim: Siblings to a brother or sister with cancer have reported difficulties dealing with such things as their parents' suffering, loneliness in relation to their own feelings as well as uncertainty regarding their brother's/sister's treatment, prognosis and survival. Siblings also struggle with fear of death and dying, and unresolved grief. Unfortunately, siblings are a forgotten group both in society, within the family, in health care, in school, and in research even if there has been a huge improvement the last 10 years. These children's needs must be identified and handled during the illness trajectory as a way of supporting their challenging situation and prevent avoidable psychological distress. Nevertheless, there exists no validated standardized assessment instrument in Swedish that measure the needs of these children even if it is well known that it is beneficial for emotional and psychological well-being to use assessment instrument. Moreover, no instrument in Swedish exists that identify children with prolonged pre-death grief despite that prolonged grief during illness is associated with psychological distress. This study therefore aim to translate, culturally adapt, and evaluate the psychometric properties of the Swedish version of the Sibling Cancer Needs Instrument (SCNI) and Prolonged Grief Disorder (PG-12) among children and youths who have a brother or sister with cancer. Material and Methods: Present instruments will be translated and culturally adapted according to the World Health Organization's (WHO) guidelines. After that, the psychometric properties of the Swedish version of SCNI and PG-12 will be examined. The Swedish version of the SCNI and PG-12 will be revised by a group of several experts in psychology, paediatric oncology, and family health, for its face and content validity. In addition, pre-test respondents will include approx. 10 siblings. They will be recruited from one of the six pediatric oncology centers in Sweden, the home care for children at the same hospital, and at the hospice for children and youths in Sweden (Lilla Erstagården) where established collaborations with clinicians exists today with sibling supporters. Information about the study will be given by the researchers who also ask for informed consent. Children aged 15 years and older consent themselves while those between 12-14 years have to have consent from their guardian(s)/parent(s). Pre-test respondents will be administered SCNI and PG-12 and be systematically debriefed. During debriefing, siblings will be asked what they thought the question was asking, whether they could repeat the question in their own words, what came to their mind when they heard a particular phrase or term. They will also be asked to explain how they choose their answer. These questions will be repeated for each item. The answers to these questions should be compared to the respondent's actual responses to the instrument for consistency. Respondents will also be asked about any word they did not understand as well as any word or expression that they found unacceptable or offensive. Finally, when alternative words or expressions exist for one item or expression, the pre-test respondent should be asked to choose which of the alternatives conforms better to their usual language. After that, siblings will be asked to participate in a web-survey. They will be recruited from: 1) the six pediatric oncology centers in Sweden, 2) the hospice for children and youths in Sweden (Lilla Erstagården), and 3) via advertisement on social media, e.g. on Instagram at "Nära Cancer" and the Childhood Cancer Fund. The siblings will also be identified by a sibling supporter at the six pediatric oncology centers and Lilla Erstagården. The sibling supporters will invite the siblings to the study by giving them a web address to a website where they will find information about the study. On the website, the siblings could either go directly to the web-survey (if the sibling is 15 years or older) or register their interest to participate in the web-survey (if the sibling is between 12-14 years). Parents of siblings who register their interest to participate in the web-survey on the website (siblings aged 12-14 years), will be contacted by a researcher via email or phone (depending on how they wish to be contacted), and the parents/guardians and the sibling will be informed about the study, and informed consent will be granted from both guardians/parents. Advertisement on social media will take the siblings or parents/guardians to the same web-page/web-survey as previously described. Analysis: Descriptive statistics will be used to present demographic data and study variables, including means and standard deviations, medians and quartiles, and frequencies. We will use factor analysis in order to evaluate the fit of the models. A sample size of 200 will be acceptable if the models are not too complex.
Gender: All
Ages: 12 Years - 24 Years
Updated: 2025-03-05
NCT06019377
Intervention to Enhance Coping and Help-seeking Among Youth in Foster Care
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.
Gender: All
Ages: 16 Years - 20 Years
Updated: 2025-02-28
1 state
NCT06412679
RESETTLE-IDPs: Life-Skills Education and Psychosocial Resilience Building for Displaced Nigerians
The RESETTLE-IDPs study aims to address the urgent mental health needs of internally displaced youth and women in Nigeria, who face high rates of depression, anxiety, and post-traumatic stress due to exposure to conflict, violence, and loss. Despite the immense needs, there is a severe lack of culturally appropriate, evidence-based interventions to support the resilience and well-being of these vulnerable populations. To fill this gap, the study will evaluate the effectiveness and implementation of a novel life skills education (LSE) program delivered through two innovative approaches: in-person peer support groups and WhatsApp-based virtual support groups. The LSE curriculum, developed through extensive community engagement, covers topics such as stress management, communication, problem-solving, health, safety, and advocacy, all tailored to the unique challenges of displacement. In the in-person arm, trained IDP peers and local providers will facilitate weekly group sessions over 12 weeks, providing a safe space for participants to learn, practice, and apply new skills while building social connections and support networks. In the WhatsApp arm, participants will receive weekly messages with educational content, reflection prompts, and exercises, moderated by trained facilitators to foster dialogue and peer support. By comparing these two delivery methods, the study aims to identify the most feasible, acceptable, and effective strategies for rolling out psychosocial support interventions in humanitarian settings, particularly those with limited resources and access. The study will also assess the interventions' impact on key mental health outcomes, including depression, anxiety, PTSD, and well-being, as well as life skills, functioning, and implementation metrics such as reach, adoption, and sustainability. Ultimately, the RESETTLE-IDPs study seeks to generate actionable evidence to inform the development and scale-up of culturally responsive, community-driven interventions that can promote the mental health and resilience of conflict-affected populations in Nigeria and beyond. By empowering IDP youth and women with the knowledge, skills, and support to navigate the challenges of displacement, the study aims to contribute to a brighter, more hopeful future for these resilient communities
Gender: All
Ages: 13 Years - Any
Updated: 2025-02-10
1 state
NCT06596551
Aspirational Rehabilitation Coaching for Holistic Health (ARCH): A Pilot Pre-Post Experimental Study
The ARCH programme is a novel, strength-based, dyadic, multicomponent psychosocial intervention that blends together psychoeducation, psychosocial support and self-compassion practices to aid first-time stroke survivors and their family caregivers with their psycho-socio-emotional and spiritual challenges following discharge from in-patient care. A pre-post experimental design with a feasibility and acceptability assessment is adopted to evaluate and refine the ARCH intervention in promoting wellbeing, self-compassion, independence, quality of life, hope, resilience, self-efficacy and dyadic mutuality.
Gender: All
Ages: 21 Years - Any
Updated: 2024-09-19
NCT06242964
The PRISM-Social Needs (PRISM-SN) Intervention for Adolescents and Young Adults With Cancer
The goal of this study is to establish feasibility, acceptability, and proof-of-concept of an psychosocial intervention adapted to address social health needs of adolescents and young adults (AYAs) newly diagnosed with cancer. The aims of this study are to: 1. Determine if the Promoting Resilience in Stress Management - Social Needs (PRISM-SN) adapted intervention is feasible and acceptable, defined via program uptake and retention and patient-reported feedback. 2. Explore whether PRISM-SN improves social outcomes at 12-week follow-up compared to usual care. Participants will be randomized to receive usual psychosocial care or the PRISM-SN program. Participants on both arms will complete patient-reported outcome surveys at enrollment and 12-weeks later. Researchers will compare participants who received the PRISM-SN program to those who received usual care to see if the program improves psychosocial outcomes.
Gender: All
Ages: 12 Years - 25 Years
Updated: 2024-06-25
1 state
NCT05943600
An Assessment of Treatment Adherence of Osteoporosis Patients From a Biopsychosocial Perspective
This observational study aims to learn about the psychosocial risk factors of osteoporosis (OP) patients. The main question it aims to answer is: * Which biopsychosocial factors affect OP patients' fragility fracture risk regarding the health behaviour model? Participants will fulfil these forms below here; * Sociodemographic and Clinical Information Form, * Fragility Fracture Information Form * Medication Adherence Report Scale * Brief Illness Perception Scale * The Beliefs About the Medicines Scale-Specific * The Short Assessment of Patient Satisfaction * Perceived Stress Scale * Multidimensional Perceived Social Support Scale * Brief Symptom Inventory - Depression and Anxiety * Health Behavior Assessment Scale
Gender: All
Ages: 18 Years - Any
Updated: 2023-07-13
NCT05468684
PROCO Neck: The Course and Neuroplasticity in Neck Pain-Associated Disorders and Whiplash-Associated Disorders
Neck pain-associated disorders (NAD) and whiplash-associated disorders (WAD) are major health problems. NAD has a lifetime prevalence of 54%. Although the majority of patients recovers within the first three months, a minority develops persistent pain. WAD, in contrast, is reported less frequently, but patients are often suffering more badly. Patients with chronic symptoms represent a considerable burden in terms of pain, suffering, health care needs, and social costs. Findings on the natural course of NAD and WAD reflect the necessity to identify factors besides pain related to the persistence of symptoms. First, alterations of input and processing of multiple sensory modalities causing movement control impairment can result in persistent symptoms and affect the quality of life. Besides, findings of psychosocial factors predictive of pain outcomes support the growing body of research proposing a bidirectional relationship between somatic and psychosocial variables. In particular, there is a pressing need to investigate pain-related activity patterns, besides fear-avoidance behavior in NAD and WAD. Maladaptive activity pattern have an impact on on pain and disability in the long-term prognosis. Mt important, given the high prevalence of NAD and WAD, the cortical representation of the cervical spine has not yet been investigated and, reports on neuroplasticity remain scarce. These shortcomings should be addressed to provide evidence for the temporal aspect of neuroplasticity and its involvement in pain persistence. Hypotheses: We hypothesize I. that impaired sensorimotor abilities, mental health at baseline increase pain intensity and disability during measurement. II. that maladaptive pain-related activity patterns avoidance and overactivity at baseline are prognostic factors for pain persistence and disability. III. that the WAD cohort shows more depression, anxiety and stress compared to the NAD cohort.
Gender: All
Ages: 18 Years - 65 Years
Updated: 2022-07-21
1 state