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NCT07545239
Migrant populations experience elevated levels of psychological distress while facing barriers to accessing mental health care. Lifestyle factors such as physical activity, sleep, diet, and social engagement are closely linked to mental health and represent promising targets for preventive interventions. Digital delivery may increase accessibility and reduce structural barriers to care. The aim of this study is to evaluate the feasibility, acceptability, and efficacy of a culturally and linguistically adapted digital lifestyle intervention for migrants experiencing moderate psychological distress in Sweden. Participants (N = 240) will be randomized to an 8-week digital lifestyle intervention or to a wait-list control receiving a general lifestyle module. A nested pilot study (N = 30) will first assess feasibility and acceptability. Outcomes include general psychological health, quality of life, depression, anxiety, stress, and lifestyle behaviors. Assessments will be conducted at baseline, post-treatment (8 weeks), 2-month follow-up, and 6-month follow-up.
NCT05713695
This 3-year Hybrid Type 1 study will randomize 208 people with co-occurring substance use and mental health disorders (COD) referred from the Worcester Hub. This study seeks to evaluate the effectiveness of MISSION, a multi-component team approach, versus linkage with a Peer Specialist on improving outcomes among individuals with CODs. We expect that individuals receiving MISSION versus linkage only will show greater improvement in treatment engagement, substance use, and mental health outcomes. This study will also concurrently conduct a process evaluation to inform sustainability and future implementation of such interventions.
NCT07395700
This observational study evaluates the psychometric properties of the Behavioral Activation for Depression Scale (BADS) in individuals with substance use disorders. The study examines the scale's internal structure, reliability, and validity using data from 289 participants who completed the BADS. External and incremental validity analyses were conducted in a subsample of 127 participants for whom additional clinical measures were available, including assessments of symptom severity, anxiety, impulsivity, and anger expression. This approach reflects the availability of complete data for each analytic component and allows for a comprehensive evaluation of the BADS in a clinical population.
NCT04639167
The aim of this randomized, two-arm, investigator initiated, multi municipal, parallel-group superiority trial is to compare the effect on self-reported personal recovery of the following interventions: (1) 10-week group-based peer support intervention "Paths to everyday life" (PEER) added to service as usual (SAU); and (2) SAU alone. The primary outcome is self-reported personal recovery at end of intervention. Secondary and exploratory measures include empowerment, quality of life, functioning, hope, self-efficacy, self-advocacy and social network. The investigators, hypothesize that the superiority of the PEER intervention will be applicable for secondary outcomes and exploratory measures at end of intervention so that improvement in empowerment, hope, self-efficacy, self-advocacy, social network, quality of life and functioning will be improved among participants allocated to the PEER intervention.
NCT07364799
Emotional dysregulation in justice-involved youth (JIY) is a condition that significantly impacts young people, their families, and juvenile justice and public health systems. Affecting an estimated 60-70% of detained Attention deficit hyperactivity disorderadolescents, it is a major driver of aggression, substance use, school failure, and later recidivism. Despite available treatments, managing emotional dysregulation in custody remains challenging, with youth often enduring high arousal, anger, and anxiety that persist into adulthood. Current popular therapies, including Cognitive Behavioral Therapy (CBT) and Dialectic Behavioral Therapy (DBT), often fall short in detention because they rely on verbal processing, require multiple scheduled sessions, and/or need highly trained staff. Other technologies, like biofeedback and neurostimulation techniques, are still under scrutiny for adolescents, given their higher-than-usual Adverse Events (AEs). This SoundHeal study aims to evaluate a sensory intervention using the Healpod, a distraction-free physical space where a participant sits, delivering sound, music, gentle vibrations, and ambient light. Following this is a brief expressive journaling exercise to compare any before, during and after experience changes from the sensory immersion. This prospective, single-center cohort study hypothesizes that these sessions will improve juveniles' ability to emotionally regulate, improve therapeutic alliance, mental health outcomes and build coping skills that can potentially help in long-term mental health and substance abuse treatment in JIY and beyond.
NCT07299526
Police officers are subject to various occupational risk factors that can contribute to the development of mental health difficulties such as depression, anxiety, and post-traumatic stress disorder. A previous study observed a low rate of access to specialized care services. Furthermore, carrying a firearm can facilitate acts of self-harm.
NCT07098260
Appropriate training for perinatal mental health care is an important public health concern as mental health disorders are common pregnancy complications. Perinatal and mental health care providers report the difficulty of treating perinatal individuals due to insufficient information available regarding mental health treatment decisions, differences in beliefs and attitudes, and concerns about adverse effects on patients, such as self-harm and suicide. Effective shared decision-making skills can improve perinatal and mental health care providers' competencies to meet the unique decision needs of perinatal individuals, particularly those with mental health disorders. The proposed project titled "DECIDE to Improve Maternal Mental Health Care Delivery" aims to adapt the DECIDE Provider Training developed by Dr. Alegria and her team,1 to improve the rapid and wide dissemination and implementation of DECIDE in meeting the mental health needs of perinatal individuals. DECIDE stands for Decide the problem; Explore the questions; Closed or open-ended questions; Identify the who, why, or how of the problem; Direct questions to your health care professional; Enjoy a shared solution. The DECIDE provider training was developed based on theories of intergroup contact in social psychology and a patient-centered framework.28-30 DECIDE teaches mental health providers how to improve perspective-taking, reduce attributional errors, and increase receptivity to the client population.1,15-17 The proposed project will (1) make content adaptation (i.e., adding topical training content to fit perinatal mental health care) and process adaption (i.e., creating asynchronous training modules to reduce the burden for care providers) to the DECIDE Provider Training and (2) assess the acceptability, appropriateness, and usability of adapted DECIDE provider training for rapid and wide dissemination and implementation of DECIDE in maternal mental health care delivery.
NCT07150832
When presenting to an ED with suicide, self-harm or other mental health crises, youth may also experience "boarding", which is defined by the Joint Commission as "the practice of holding patients in the ED or another temporary location after the decision to admit or transfer has been made." A recent national survey of 88 US acute care hospitals conducted by our research team found that 98.9% of hospitals were boarding youth awaiting psychiatric hospitalization, for an average of 2-3 days. However, as illustrated in a systemic review, little research has focused on developing interventions to support youth during this highly vulnerable time. 3 I-CARE is a modular, blended digital health intervention facilitated by individuals who are not mental health clinical staff to teach youth evidence-based psychosocial skills during the boarding period. This study will evaluate I-CARE's efficacy using a patient-level randomized clinical trial (RCT), randomizing youth to receive standard safety supervision or I-CARE in addition to standard safety supervision. If found to the efficacious, I-CARE could be scaled-up in new settings with limited resources and has the potential to significantly improve the quality of care received by youth experiencing boarding.
NCT06702332
The purpose of this Phase 1 single ascending dose (SAD) study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamic profile of MSD-001 when administered orally to healthy adult participants.
NCT07054554
Most mental health (MH) disorders develop in early childhood but are not clinically identified or treated until later-delaying treatment services that could prevent the enduring effects of long-term MH problems. Moreover, low income, ethno-racial minoritized children who exhibit higher rates of persistent MH disorders, are at greater risk for lags in identification and treatment. Head Start (HStart) has shown early school success for low-income children, aged 3-5 years, who are disproportionately Black or Latinx. HStart monitors early childhood MH symptoms, yet studies have found that when detected, only those most impaired are referred for treatment. In our research, the investigators learned that system and individual level barriers preclude early treatment among HStart preschoolers with developmental concern. The investigators showed that caregivers encountered system barriers of HStart teachers and primary care providers (PCPs) falling behind in referrals for intervention, and caregiver beliefs about stigma, their limited knowledge and distrust of healthcare hindered early engagement in services. Studies on MH treatment obstacles for low-income, ethno-racial minoritized people illustrate similar barriers to those found among HStart preschoolers with developmental concern. We developed and tested an ethno-racially matched, peer-based family navigator program for HStart preschoolers with developmental concern. Navigators used trust and empowerment to increase caregiver advocacy thereby leading to improved professional alliances and treatment. A navigator program for those with primary MH concerns has not been trialed. For Aim 1, the investigators aim to tailor and trial in a case series the Navigate-Train-Referral-Intervention Mental Health (NTRI-MH) intervention to promote access, engagement, coordination, and optimization of services for preschoolers with MH symptoms. The investigators have used focus group feedback from caregiver, navigator, HStart teacher, and PCP stakeholders to adapt NTRI-MH and created a web-based dashboard to monitor outcomes (Phase 1). Then, for phase 2, the investigators will conduct a feasibility study for caregivers of HStart preschoolers with MH symptoms, guided by ethno-racially matched family navigators and referrals by HStart teachers and PCPs (n=20). Further, for Aim 2, the investigators will pilot test NTRI-MH for caregivers of preschoolers with MH symptoms compared to an active control group of caregivers who receive child behavior training (n=86). The investigators will trial the effectiveness of the NTRI-MH mechanisms of caregiver beliefs on MH, empowerment, and professional alliances on family functioning and child emotion regulation. If the aims of the project are achieved, this study would have a large impact on early MH service use for ethno-racial minoritized young children with the potential to improve child MH outcomes.
NCT05092542
This study tests the effectiveness of a community-based peer advocacy, mutual learning, and social support intervention (Refugee and Immigrant Well-being Project) to reduce several negative consequences of the COVID-19 pandemic that are disproportionately impacting Latinx and Black populations: psychological distress, financial problems, and daily stressors. In partnership with five community-based organizations that focus on mental health, legal, education, and youth issues with Latinx immigrants and African refugees, we will also be able to examine the effects of people's involvement with community-based organizations and local and state policy changes on their mental health, economic stability, stressors, and social support. This is important not only for Latinx and Black populations and the large number of immigrants and refugees in the United States and worldwide, but also because the intervention model and what we learn from this study have the potential to alleviate mental health disparities experienced by other marginalized populations who face unequal access to social and material resources, disproportionate exposure to trauma and stress, and worse consequences of the COVID-19 pandemic.
NCT05138614
This 4-year study will randomize 1,000 people with co-occurring opioid use and mental health disorders (COD) at medication for opioid use disorder (MOUD) clinics to evaluate the effectiveness of MISSION, a multi-component team approach, or its components with MOUD versus MOUD alone, as well as the incremental benefits of MISSION or its components for improving outcomes. We expect that individuals receiving MISSION or its parts + MOUD will show greater improvement over MOUD alone on: engagement, substance use, and mental health.
NCT06311084
This study aims to investigate acceptability and feasibility of a new version of the Imaginator intervention, Imaginator 2.0, targeting self-harm behaviour in young people aged 12-25 under mental health services in the UK. Following an initial proof-of-concept study of Imaginator (Di Simplicio et al., 2020), a new version of the app that supports consolidation and practice of the techniques learnt in therapy was co-designed, and the protocol was adapted to be extended to younger adolescents. Imaginator 2.0 uses 'functional imagery training', training in individuals to develop and use functional (that is, helpful) mental images to support an alternative behaviour instead of self-harm. Mental imagery is the process of picturing something in the mind, and mental images have strong emotional and motivational characteristics. Functional Imagery Training (FIT) within Imaginator helps young people imagine adaptive behaviours as an alternative to self-harm when dealing with distressing emotions.
NCT05335382
In this multicenter study, the investigators want to compare treatment outcomes for patients with mental and behavioral health problems in traditional primary care (Care As Usual, CAU) and primary care centres that work according to the Primary Care Behavioral Health (PCBH) model. In addition to this, the investigators want to study organisation-level outcomes, such as access to care, perceived teamwork and work environment. To achieve this, primary care centres that have expressed interest in implementing PCBH will be cluster randomised between implementing directly or waiting for implementation.
NCT05753423
Dental caries is a complex multifactorial disease that is strongly related to and influenced by the children's dietary habits, sugar intake, salivary flow, salivary fluoride level, and preventive behaviors. Based on the literature, other factors can affect child dental caries including the influence of social factors, such as the family environment. To avoid suffering from dental caries, preventive oral hygiene practices beginning in childhood are crucial. However, parents are the primary providers of oral health care for their children and they generally play a pivotal role in the overall health and oral health of both children and adolescents. Therefore, this study aims to investigate the impact of maternal mental health in the form of depression, anxiety, or stress and their perceived social support on the oral health status and OHRQoL of their children.
NCT06222528
Depression is a leading cause of illness and disability in teenagers. Longer duration of untreated depression (DUD) is associated with greater severity, poorer outcome, and cognitive impairment. Stigma toward people with depression has been identified as a barrier to seeking help; therefore, reducing stigma toward young people at depressive risk could enhance their receptivity to seeking treatment. Social contact is a form of interpersonal contact with members of the stigmatized group and the most effective type of intervention for improvement in stigma-related knowledge and attitudes. In a prior study, the investigators developed short video interventions to reduce stigma and increase treatment seeking among adolescents with depression. The videos feature adolescent protagonists varied by race/ethncitiy and gender (Black girl, Black boy, White girl, White boy, Hispanic girl, Hispanic boy, nonbinary or transgender adolescent) who will share their experiences with depression, challenges, and recovery process. The investigators would like to conduct a randomized controlled trial (RCT) to test the efficacy of these tailored videos as compared to a video control condition (which provides information about depression and how to seek help but does not include a personal story) on reducing self-stigma and increasing help-seeking intentions and behavior at baseline, post, 2 week follow-up, and 4 week follow-up among adolescents ages 14-18 recruited via Cloudresearch. The videos will be shown again at 2 week follow-up.
NCT06172075
Young people with depression, especially those of underserved minority groups, avoid treatment due to stigma and discrimination. Social contact is a form of interpersonal contact with members of the stigmatized group and the most effective type of intervention for improvement in stigma-related knowledge and attitudes. In a prior study, the investigators developed short video interventions to reduce stigma and increase treatment seeking among people with depression. The videos vary by protagonist race/ethnicity (Latinx, non-Latinx Black, non-Latinx White) who share their experiences with depression, challenges, and recovery process. The investigators would like to test the efficacy of these videos using Prolific (a crowdsourcing platform). Specifically, the investigators are interested in conducting a randomized controlled trial (RCT) to test the efficacy of these videos as compared to a vignette control condition on reducing self-stigma and increasing help-seeking intentions and behavior at baseline, post, and 30 day follow-up among youth with depressive symptom scores on the PHQ-9≥ 5.
NCT03922217
This pilot study will test whether depression symptoms and cognitive functioning are impacted by internet-delivered mindfulness training following the principles of mindfulness meditation. The population is adults ages 65+ experiencing a current major depressive episode. Participants will receive an approximate 10-week instruction in mindfulness meditation, provided remotely through internet. Outcomes are depressive symptoms, assessed via clinical interview and self-report, and cognitive function, assessed via smartphone-delivered cognitive tests and surveys. The total duration of participation is approximately 18 weeks.
NCT06489912
Assess the prevalence of various psychiatric disorders in adolescents aged 12 to 16 receiving support from therapeutic, educational and pedagogical institutes.
NCT04693052
The purpose of this study is to collect patients' experiences and feedback to better understand and improve mental health care using telehealth services. This is critically important as telehealth appointments, including both phone and video calls, continue to be offered for regular appointments to reduce in-person interaction as a preventive measure to help control the spread of COVID-19.