Clinical Trials Logo

Mental Health Impairment clinical trials

View clinical trials related to Mental Health Impairment.

Filter by:

NCT ID: NCT03742128 Enrolling by invitation - Depression Clinical Trials

Health and Quality of Life Among Resettled Syrians in Norway

REFUGE-I
Start date: November 27, 2018
Phase:
Study type: Observational

Brief summary The civil war in Syria has taken a severe toll on the Syrian population, with over 350 000 dead and more than 10 million Syrians forced to leave their home since 2011. The majority of the estimated 5.6 million Syrians who have left the country as refugees currently reside in Syria's neighboring countries (Turkey, Jordan and Lebanon), while about 1 million have fled to Europe. In the peak year of 2015, a little over 10500 Syrians applied for asylum in Norway and an estimated 26 000 lived in the country at the start of 2018 according to statistics from the Norwegian Directorate of Immigration. Being a refugee or resettled refugee is psychologically stressful and increases the risk of ill mental health. Prior research has demonstrated high to very high levels of posttraumatic stress disorder (PTSD), depression and anxiety in refugees compared to normal populations. As highlighted in prior review articles on the subject, there is a lack of studies on refugees originating from the Middle Eastern countries, and there is a need for future studies on refugee mental health to move beyond the focus on PTSD, depression and anxiety in order to capture the wider psychological consequences associated with being a refugee or resettled refugee. With the current number of displaced people globally approaching an unprecedented 70 million, including more than 25 million refugees, the need to understand and address the health challenges in this population is more pressing than ever. The present study, REFUGE-I, constitutes the first phase of a planned longitudinal cohort study (REFUGE-study) on health and quality of life among resettled Syrian refugees in Norway. The overarching aims of REFUGE-I are to recruit a representative sample of Syrian adults who are willing to participate in the longitudinal cohort study and to obtain baseline information on health-related topics as well as demographics for this recruited sample. REFUGE-I will use a cross-sectional survey design. The study population will be a random and representative sample of 10 000 Syrians over 18 years who arrived in Norway between 2015 and 2017, and who currently live and have a registered residential address in Norway. The sampled group will be contacted and informed about the study through postal mail. Information about the study will also be distributed through other channels: regular media (e.g. television and newspapers), social media (e.g. Facebook), District Medical Doctors/Public Health Officers, and a study web-page with more detailed information on the study including instructive animation videos in Arabic. Those consenting to participate will be asked to fill out and return a postal survey questionnaire on demographics and health-related topics focusing on: Symptoms of posttraumatic stress, anxiety and depression Quality of life Self-reported physical health (focusing on subjective pain) Sleep difficulties and alcohol consumption patterns Social support Potentially traumatic experiences before or during the flight from Syria Stress experienced after arrival in Norway (post-migratory stress) Participants will also be asked whether the research group can contact them again for the second and third phase of the longitudinal study, and informed that consent to participation entails consent that survey data will be linked to Norwegian registry data on education, work participation and sick-leave, drug prescriptions and utilization of the health-care system. The registry data will be linked to survey data in the later phases of the larger longitudinal study. The main objective of the REFUGE-I study is to obtain and publish a thorough cohort profile that includes descriptive statistics for the final sample on the above-listed health-related topics, as well as information and statistics on potential selection bias issues that might affect the generalizability of findings. The study is a collaborative effort between five research institutions and universities in Norway and Sweden. One of the collaborating partners, The Swedish Red Cross University College, has already conducted a similar study on 1215 resettled adult Syrian refugees in Sweden, and results from REFUGE-I will be compared to the findings from the Swedish study. Moreover, an important long-term goal for the larger REFUGE-study is to help advance research on refugees by making resources from the study available online, and through the creation of a large database containing pooled data from the REFUGE-study and studies done through the Swedish Red Cross University College and potentially other national and international research groups.

NCT ID: NCT03707366 Active, not recruiting - Substance Use Clinical Trials

Fostering Healthy Futures for Teens: An RCT

FHF-T
Start date: June 2015
Phase: N/A
Study type: Interventional

This study will implement and evaluate a mentoring program designed to promote positive youth development and reduce adverse outcomes among maltreated adolescents with open child welfare cases. Teenagers who have been maltreated are at heightened risk for involvement in delinquency, substance use, and educational failure as a result of disrupted attachments with caregivers and exposure to violence within their homes and communities. Although youth mentoring is a widely used prevention approach nationally, it has not been rigorously studied for its effects in preventing these adverse outcomes among maltreated youth involved in the child welfare system. This randomized controlled trial will permit us to implement and evaluate the Fostering Healthy Futures for Teens (FHF-T) program, which will use mentoring and skills training within an innovative positive youth development (PYD) framework to promote adaptive functioning and prevent adverse outcomes. Graduate student mentors will deliver 9 months of prevention programming in teenagers' homes and communities. Mentors will focus on helping youth set and reach goals that will improve their functioning in five targeted "REACH" domains: Relationships, Education, Activities, Career, and Health. In reaching those goals, mentors will help youth build social-emotional skills associated with preventing adverse outcomes (e.g., emotion regulation, communication, problem solving). The randomized controlled trial will enroll 234 racially and ethnically diverse 8th and 9th grade youth (117 intervention, 117 control), who will provide data at baseline prior to randomization, immediately post-program and 15 months post program follow-up. The aims of the study include testing the efficacy of FHF-T for high-risk 8th and 9th graders in preventing adverse outcomes and examining whether better functioning in positive youth development domains mediates intervention effects. It is hypothesized that youth randomly assigned to the FHF-T prevention condition, relative to youth assigned to the control condition, will evidence better functioning on indices of positive youth development in the REACH domains leading to better long-term outcomes, including adaptive functioning, high school graduation, career attainment/employment, healthy relationships, and quality of life.

NCT ID: NCT03603613 Completed - Clinical trials for Mental Health Disorder

Youth FORWARD Phase 1 YRI and EPP Study

Start date: July 31, 2018
Phase: N/A
Study type: Interventional

Objectives: The objectives of this research proposal are to study the delivery of an evidence-based mental health intervention in the alternate setting of youth employment programs tied to regional economic development and to examine the use of an Interagency Collaborative Team Approach (ICTA) as an implementation scale-up strategy that addresses the human resource shortage and related access to care and capacity challenges in low- and middle-income countries (LMICs). Specifically, this study aims to examine the incorporation of the evidence-based Youth Readiness Intervention (YRI) into a program that promotes employment among youth through a pilot study and scale-up intervention study in Sierra Leone. Study population: The study population includes youth participants, ages 18-26, with elevated t-scores on assessments of functional impairment and emotional dysregulation, who live in the Kailhun District of Sierra Leone. Pilot study design: A cluster randomized three-arm trial will be employed in the pilot phase in the same districts as the scale-up study. Youth participants (N=180, 18-26 years old, 50% female), stratified by gender, will be randomized into the three study arms. Once youth participants are enrolled into the study, they will be assigned to community level sites based on geographical location. Each of these community level sites will make up one cluster. The clusters will then be randomly assigned into the three study arms so that sixty youth participants will be randomized into the youth entrepreneurship training (EPP) arm, sixty youth participants will be randomized into the YRI+EPP arm, and sixty youth participants will be randomized into the control arm . The pilot study will last approximately 12 weeks and data will be collected at baseline and post-intervention. Further, investigators will survey 120 third-party reporters for a total pilot study sample size of 300 participants. Pilot study primary outcomes: The primary outcomes of the pilot study are to assess implementation science aspects related to a new partnership with the Deutsche Gesellschaft für Internationale Zusammenarbeit's (GIZ), who will fund and deliver the entrepreneurship training. This will include pretesting the measures battery, assessing the logistics of integrating the YRI into the entrepreneurship training, and testing use of the Interagency Collaborative Team Approach to training, supervision, and fidelity monitoring.

NCT ID: NCT03542500 Completed - Clinical trials for Mental Health Disorder

Youth FORWARD Phase 2 YRI and EPP Study

Start date: July 19, 2019
Phase: N/A
Study type: Interventional

Objectives: The objectives of this research proposal are to study the delivery of an evidence-based mental health intervention in the alternate setting of youth employment programs tied to regional economic development and to examine the use of a Collaborative Team Approach (CTA) as an implementation scale-up strategy that addresses the human resource shortage and related access to care and capacity challenges in low- and middle-income countries (LMICs). Specifically, this study aims to examine the incorporation of the evidence-based Youth Readiness Intervention (YRI) into a program that promotes employment among youth (EPP/Entrepreneurship Training program) through a pilot study and scale-up intervention study in Sierra Leone. Study population: The study population includes youth, ages 18-30, with elevated t-scores on assessments of functional impairment and emotional dysregulation, who live in the Kono, Koinadugu and Kailhun districts of Sierra Leone. Scale-up study design: For the scale-up study, a Hybrid Type 2 Effectiveness-Implementation Cluster Randomized Three-arm trial will be employed. We estimate the entire sample size for the scale-up study to be 3,630 participants, including 1200 youth, 10 agency heads, 20 intervention facilitators, and 2400 third-party informants. Upon enrollment into the study, youth will be assigned to community level sites based on geographical location. Each of these community level sites will make up one cluster. These clusters will be randomized into the three study conditions: the control condition - where youth do not receive the YRI or the EPP but are able to utilize as available resources in the community - the EPP-only condition, and the YRI+EPP condition. Data will be collected at baseline, post-YRI, post-EPP, and 12-months follow-up. Scale-up study outcomes: Implementation outcomes of the Hybrid Type II study are focused on process and implementation aspects including a costing analysis, measures of fidelity and the sustainment and quality of delivering YRI within a Collaborative Team Approach to support intervention delivery, training and supervision. Effectiveness outcomes of the Hybrid Type II study are development of emotion regulation, mental health assessed as anxiety and depression, and interpersonal functioning, including self report and by third-party reporters for assessment of the YRI's ability to improve youth's interpersonal skills and functioning in the community and the entrepreneurship training program. In a Hybrid Type II study implementation and effectiveness aims are dual and equally important aspects of the study. (Curran et al., 2015) Outcomes associated with both aims are considered primary outcomes in this study.

NCT ID: NCT03399500 Completed - Health Behavior Clinical Trials

Homeless Care Management App

Link2Care
Start date: April 27, 2018
Phase: Phase 3
Study type: Interventional

There is a significant revolving door of incarceration among homeless adults, a population with substantial health disparities. Homeless adults who receive the professional coordination of individualized care (i.e., case management) during the period following their release from jail experience fewer mental health and substance use problems, are more likely to obtain stable housing, and are less likely to be re-incarcerated. The proposed study will use mobile technology to address these barriers and fill gaps in the understanding of the causes of the revolving door of homeless incarceration. This research represents a step toward integrated service connection and healthcare service provision for one of the most underserved, high need, and understudied populations in the United States. Smart phone apps that increase the use of available healthcare services and identify predictors of key outcomes (e.g., homelessness, re-arrest, medication compliance) could be used to reach hard to reach populations with histories of significant and persistent health disparities (e.g., homeless adults).

NCT ID: NCT03336125 Completed - Clinical trials for Mental Health Impairment

Key Nutrients and Mental Health

Start date: November 17, 2017
Phase: N/A
Study type: Interventional

The purpose of the project is to investigate whether an intervention program with vitamin D supplementation is able to improve the biology of stress resilience as well as subjective well-being in individuals with antisocial behavior problems (forensic inpatients).

NCT ID: NCT03067207 Completed - Chronic Illness Clinical Trials

In-Person vs e-Health Mindfulness-Based Intervention for Adolescents With Chronic Illness

Start date: November 4, 2016
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03013595 Active, not recruiting - Clinical trials for Mental Health Disorder

The MILESTONE Study: Improving Transition From Child to Adult Mental Health Care

MILESTONE
Start date: October 2015
Phase: N/A
Study type: Interventional

This study evaluates the longitudinal health and social outcomes of adolescent mental health service users who are at the transition boundary of their child and adolescent mental health service, and whether the implementation of a model of managed transition at the service boundary benefits them, as compared to usual care.

NCT ID: NCT03012451 Completed - Clinical trials for Stress, Psychological

A Psychosocial Program Impact Evaluation in Jordan

Start date: April 2015
Phase: N/A
Study type: Interventional

The study aims to deliver a robust pre-post evaluation of the wellbeing impacts of an innovative, brief, and scalable psychosocial intervention, delivered to refugee youth living in urban settlements in Jordan. The study was conducted using two waves of data collection: the first featured an intervention and a matched control group, the second featured a full randomized control trial.

NCT ID: NCT03000153 Terminated - Clinical trials for Mental Health Impairment

Effectiveness of Tracking Goals in Counselling

Goals in MIND
Start date: October 19, 2017
Phase: N/A
Study type: Interventional

Recent evidence suggests that focusing on positive goals rather than problems to avoid, may be associated with better psychological health and attainment of goals. In addition, the advantages of using personalised measures have been highlighted in a number of studies. The Goals Form is a new measure that comprises both elements. It invites clients, in collaboration with their therapist, to identify up to seven goals for therapy typically at a first assessment session and then to rate them on a 1-7 Likert scale, with 1 being not at all achieved and 7 being completely achieved. This research is important for clinical practice as it provides the foundations to identify what might be a helpful factor in counselling and psychotherapy. The aim of the study is to test whether the use of the Goals Form leads to better clinical outcomes in counselling and psychotherapy. Participants in this study are counsellors and service users at Tower Hamlets Mind. The design of this study is a trial, which looks at comparing outcome measure scores in 'therapy as usual' and 'therapy using the Goals Form' when participants are randomly assigned to one of the two conditions. Interventions in this study involve using the Goals Form at the start of every session and taking part in a 30 minute interview once therapy has ended to give feedback about using the form in therapy . In addition to assessing outcome, the study also serves to compare satisfaction scores across the two conditions. It is a pilot to determine the feasibility of such trial including recruitment rates over a period of a year, adherence of counsellors and clients to the protocol, and the ethical issues raised.