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Showing 1-17 of 17 trials
NCT05380440
Young parents aged 16 to 30, involved in the DHS system for child welfare or self-sufficiency needs are at risk for opioid use disorder and/or methamphetamine use disorder (OUD; MUD). Those identified as engaging in opioid or methamphetamine misuse are at high risk for escalation. Children of parents with OUD and MUD are at-risk for entering into foster care. Oregon is one state particularly affected by this challenge. The proposed research offers one potential solution by adapting and evaluating a recently developed treatment for parental OUD and MUD, for prevention. This study seeks to collaborate with Oregon Department of Humans Services (DHS) leadership to deliver a new outpatient prevention program to high-risk, young, parents. The Prevention Adaptation of Families Actively Improving Relationships (PRE-FAIR) program will include community-based mental health, parent management, and ancillary needs treatment, and ongoing monitoring and prevention services for opioid and methamphetamine use. This study will randomize 240 parents, aged 16 to 30, to receive PRE-FAIR or standard case management and referral, in two counties in Oregon. Outcomes will include an evaluation of the effectiveness of PRE-FAIR in addressing risk factors associated with substance use disorders in DHS-involved populations, OUD and MUD outcomes, and implementation outcomes including implementation process and milestones, and program delivery outcomes. Intervention and Implementation costs will be assessed, and the benefit of PRE-FAIR will be evaluated in relation to standard services, but also in relation to capacity and population needs. Study hypotheses are: (1) Parents randomized to PRE-FAIR will be less likely to escalate opioid and/or methamphetamine use, and to receive a diagnosis of OUD and/or MUD; (2) Parents randomized to PRE-FAIR will experience significant reductions in mental health, parent skills, and ancillary needs compared to those receiving standard services; (3) Counties will follow the implementation plan developed in collaboration between study team members and state leadership, and that doing so will yield successful implementation of PRE-FAIR; and (4) Implementation and intervention costs for PRE-FAIR will demonstrate a benefit for offering PRE-FAIR compared to standard services, particularly in rural communities where capacity influences service delivery decisions.
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.
NCT05021224
The investigators will identify characteristics of suicidal patients who do or do not attend a first mental health visit following referral using administrative data. Then, the investigators will apply established approaches to contextual inquiry to identify barriers and facilitators to mental health treatment attendance for individuals at risk of suicide. Using established procedures from implementation science and behavioral economics, the investigators will then leverage the insights gleaned from Aims 1 and 2, relevant theories and frameworks, and the extant literature to develop preliminary strategies to support attendance at first mental health visit. Strategies will be developed in collaboration with a team of experts in suicide, implementation science, and behavioral economics. These preliminary strategies will then be iteratively tested and refined. The investigators also will assess putative mechanism using behavioral tasks and self-report tools.
NCT05231018
This study presents a digital mental-health protocol designed to offer remote, personalized support to former or current COVID-19 patients. A total of 100 subjects will be enrolled. Participation is voluntary, and an extended informed-consent form is signed before any evaluation, assessment or voice/video call. Consent forms are collected remotely for those who have been discharged and are currently in remission and in-person for subjects hospitalized in a COVID-19-ward of either pneumology, internal medicine or infectious disease departments. Efforts will be made to assess all participants who have completed the minimum required intervention activities: for DigiCOVID, minimum required intervention activities include attending psychotherapy sessions at least 4 times. As the main goal of this project is to evaluate the feasibility, acceptability and usability of DigiCOVID, the investigators will conduct an analysis of the following primary outcome measures in all ITT participants: 1. Assessment of completion rate. Based on our previous studies, the investigators expect that ≥80% of participants will complete the battery of online self-reports: 2. Usability ratings obtained post-DigiCOVID via a 7-point Likert-scale questionnaire (mean rating of all responses). This is a brief and embedded post-study questionnaire on program satisfaction, clarity, and perceived benefits. Participants will rate each sentence on the following 7-point Likert scale: 1 = Completely Agree; 2 = Mostly Agree; 3 = Somewhat Agree; 4 = Undecided; 5 = Somewhat Disagree; 6 = Mostly Disagree; 7 = Completely Disagree. Based on our previous studies, the investigators hypothesize exit survey ratings of at least ≥4.5 ±1.5 on the 7-point Likert scale items; 3. Reported side effects (raw score). Based on our previous findings, the investigators expect 0 adverse events due to program use; 4. Overall program completion rate. Based on previous findings, the investigators hypothesize full program completion in ≥70% study participants. The secondary outcome measures will be collected at baseline and immediately after the treatment for all participants. The investigators designed DigiCOVID to improve mental wellbeing. Therefore, the investigators will measure the impact of the intervention by looking at pre-post changes in the following outcome measures: the General Health Questionnaire (GHQ-12) (Goldberg, 1988) , the Impact of Event Scale-Revised (IES-R) (Weiss \& Marmar, 1997), the General Anxiety Disorder-7 (GAD-7) (Robert L Spitzer et al., 2006), the Insomnia Severity Index (ISI) (Morin et al., 2011), and the Patient Health Questionnaire (PHQ-9) (Kroenke et al., 2001). The investigators expect to observe a significant improvement across all these secondary outcome measures in COVID-19 patients. To verify these experimental hypotheses, the investigators will conduct the analysis based on the pre-intervention (baseline) and post-intervention data using parametric and non parametric statistical tests. The criterion for statistical significance is p \< 0.05. Results with p \< 0.1 will be described as trends.
NCT06659913
The association between adequate amount of physical activity and good health is well established and for children and young people, and sufficient physical activity is an important factor for normal growth and development. Contrary, physical inactivity is associated with higher symptom pressure of mental disorders. Adolescents with mental disorders report to be less active compare the general population, with potentially increased risk of health and lifestyle diseases. This project aims to provide new knowledge on the degree of physical activity, motivation for physical activity and subjective perception of health in adolescents in need of mental health care. Further, this project aim to provide possible solution on how to increase physical activity in this patient group. Thus, this project has the potential to impact future guidelines for mental health services for adolescents in need of mental health care.
NCT06423092
The mental health of parents of preterm newborns (PTNB) is negatively affected by prolonged hospitalization of the PTNB in the intensive care unit. This produces changes in the role of the parents and the bond with the newborn, leading to states of depression, anxiety, and stress. Several strategies, including music therapy, have been implemented to mitigate the negative impact on the parents' mental health. The main objectives of the proposed trial are to determine whether Music Therapy (MT) songwriting combined with standard care (SC) during NICU stay is superior to SC alone in reducing the risk of postpartum depression in at-risk parents of preterm children at the end of treatment, and understand the lived experiences of participating parents who received music therapy for their mental health.
NCT04797364
Implementation of pharmacogenetic testing for children and adolescents aged 6-24 who are starting or changing psychiatric medication.
NCT04652154
The project aims to transition the approach used to care for children with complex conditions and care pathways into a more holistic and coordinated model. The traditional model where specialists independently treat single diseases, makes joint and coordinated decisions about patients with multiple and unclear conditions difficult. In particular there is a gap between mental and somatic services. In preparation for re-designing the care model, several pre-studies are conducted, both a register study and a collection of user reported experiences. Built on the results, we have invented multi-disciplinary teams of complementary competences including paediatricians, psychologists, and physiotherapists to meet the patient and family. The study includes: * To implement the new team intervention in a clinical case-control study * To scientifically evaluate the intervention * To systematise lessons learned in regard to potential spread across systems and patient groups Children 6-16 years together with family and professionals will constitute the team. The assessment aims to clarify the patient's condition through shared decision making and to develop a treatment plan for the child. It is a clinical randomised controlled trial where TpT children will be compared to children following treatment as usual. It includes a one year follow-up regarding a set of evaluation domains: provider perspectives, user-centred experiences and outcomes, as well as health care outcomes.
NCT04704635
Stroke is thought to cause disability immediately after stroke followed by a 3-to-6-month recovery period, after which disability levels are supposed to stabilize unless recurrent events occur. However, studies showed that post-stroke recovery is heterogeneous. While some stroke survivors quickly recover, others may show an accelerated accumulation of disability over time. The current prospective observational study will investigate trajectories of multidimensional functioning and self-rated health in the year after stroke. Particularly, the study aims to explore the relationship between trajectories of disability and self-rated health. Moreover, the study will focus on potential predictors of changes in disability and self-rated health, i.e., views on aging and psychological resilience. Patients will be recruited during their stay at the stroke unit and participate in a face-to-face interview and four follow-up telephone interviews in the post-stroke year.
NCT05377008
Children with neurofibromatosis are more likely to have difficulties related to their psychological and neurocognitive functioning (e.g., more likely to have depression, have social difficulties, be diagnosed with ADHD). The purpose of this randomized control study is to determine how effective and useful this study's single session intervention can be in improving psychological and neurocognitive functioning. Enrolled families will consist of one parent/guardian and child. Parents and patients will complete questionnaires and objective tests at baseline, 3 months, and 6 months. Families randomized to the intervention arm will be provided with one single session intervention at Month 1 to learn about their child's testing results and receive psychoeducation and recommendations related to psychological and neurocognitive functioning.
NCT04426305
Randomized controlled trial among patients from family practices at risk of psychosocial suffering due to social distancing measures. Patients from the intervention group receive support from community health workers. contacted at least 8 times by community health workers. Evolution of psychosocial wellbeing is evaluated by questionnaires at time 0 and after 6 weeks of intervention. Psychosocial outcomes are compared between control and intervention groups. Process evaluation will be done through in-depth interviews.
NCT04725578
Stony Brook University is home to several mental health clinics, that all work towards achieving overall wellness of their clients. The goals of Stony Brook University are met with the help of associated clinics that strive to improve wellness of individuals and their communities by helping to treat both mental and physical health impairments. One of these many clinics is the Krasner Psychological Center (KPC). At present, the KPC faces a challenge common to virtually all mental health clinics across the United States: the demand for psychological services far outpaces the number of available providers. Indeed, in the US, approximately 70% of those in need of mental health services do not receive them. As such, wait-lists at mental health clinics like the KPC are increasingly long, and longer wait-times for psychotherapy have predicted worse clinical outcomes once treatment is accessed (i.e., a 'nocebo' effect). Thus, there is a pressing need for effective, sustainable service delivery models that may facilitate more rapid access to care-for instance, providing a low-intensity service rapidly after an individual decides to seek treatment, capitalizing on client motivation. This sort of rapidly-provided, low-intensity service might have the added benefit of reducing overall waitlist lengths--e.g., if some subset of clients find the low-intensity service to be sufficient, a single session might be sufficient (in some cases) to spur positive behavioral and emotional change. One solution to this problem is the integration of single-session services into mental health clinics. Extensive research suggests that both youths and adults can benefit from just one session of goal-directed counseling, and these clinical benefits have been observed for a wide array of problems-including anxiety, depression, self-harm, and interpersonal conflicts. This research suggests the possibility that, for some subset of clients, a single session of counseling may be helpful, or even sufficient, in reducing clinical distress. Further, offering such service in a telehealth format will alleviate frequently cited barriers to care like transportation, geographic constraints, and limited time. Therefore, the objective of this study is to examine the feasibility, acceptability, and short-term effects of the new telehealth-Single-Session Consultation (SSC) service, which is presently being provided to clients on the waiting list for psychotherapeutic services at the Krasner Psychological Center. The telehealth-SSC offers clients the opportunity to participate in a single, goal-directed consultation session based on Solution-Focused Brief Therapy (SFBT) within two weeks of inquiring about services at the KPC (typically, clients wait 2-6 months prior to their initial clinic appointment). SFBT is an evidence-based therapy approach that guides services offered by existing single-session therapy clinics internationally. Clients who participate in the telehealth-SSC at any of these clinics may find the session helpful; two weeks after participating in the session, they receive the option to remain on the waitlist for long-term psychotherapy or remove themselves from the waitlist for psychotherapy, depending on whether they feel their clinical needs have been successfully addressed.
NCT04138459
In Norway, official guidelines and policies state that recovery oriented services in the field of mental health and substance abuse services is a desirable goal. This collaborative research project aims to provide in-depth knowledge of how recovery oriented practices and collaboration in the mental health and substance abuse services in the municipality of New Drammen develop over a three-year period. Using qualitative methods, the main aim of the study is to explore what recovery orientation of services in mental health and substance abuse presupposes and involves related to roles, collaboration and knowledge. To explore these issues, service users will be interviewed together with their primary mental health professional. The study will also apply observational fieldwork in order to observe recovery oriented practices between service users and professionals and between professionals. An advisory group consisting of people with background as service users, mental health clinicians and service leaders will contribute throughout the project. .
NCT02790827
This study evaluates the effectiveness of a multi-pronged intervention in reducing and preventing violence against women and children compared to a treatment as usual control group among families living in Lusaka, Zambia.
NCT03067207
This study will seek to compare the effect of a mindfulness meditation program for adolescents with chronic illness delivered either in person or via an online platform. The 8-week program will combine meditation practices, breathing exercises and group discussions. Participants will be recruited from different general and specialized clinics at the Hospital for Sick Children and will be allocated to either an in-person or the online group through a random process (like tossing a coin). The study will aim to recruit 60 participants ages 13-18. Each participant will provide data through research questionnaires, recorded interviews and saliva samples.
NCT02680899
The study herein seeks to determine whether students undergoing InSciEd Out curriculum in mental health and addiction (called My Mind, My Body) experience changes in their mental health-related knowledge, attitudes, and help-seeking behavioral intentions. The research group hypothesizes that students undergoing InSciEd Out mental health and addiction curriculum will exhibit pre-post increases in mental health literacy, decreases in mental health stigmatization, and increases in mental health help-seeking behavioral intentions.
NCT02158871
The purpose of this study is to compare the impact of a new workplace-based mental health peer education program with standardized mental health literacy training on early intervention and support for healthcare employees with mental health issues. Participants are healthcare workers who volunteer to participate in one of the two twelve-hour group education programs. It is hypothesized that the customized "Beyond Silence" peer education program led by trained staff members with personal experience of mental ill-health will be more effective in reducing the stigma associated with help-seeking and help-outreach regarding mental ill-health in the workplace. The comparison group is a standardized mental health literacy training program that has been widely implemented in both Canada and around the world. Change in help-seeking/help-outreach behavior, mental health knowledge and beliefs of participants will be assessed at three-month intervals; before, after and three months following the educational intervention.