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Mental Disorder clinical trials

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NCT ID: NCT03611998 Completed - Mental Disorder Clinical Trials

Survivors of Sex Trafficking: Occupation-Based Interventions for Executive Functioning

Start date: September 1, 2016
Phase: N/A
Study type: Interventional

Persons traumatized through sex trafficking can demonstrate similar neurobehavioral and executive function (EF) deficits as persons with cortical injuries. In this pilot study, occupation-based activity (OBA) programming was implemented at a residence for females who had been trafficked. The study hypothesis was that OBA would facilitate development of EF skills in these clients, enabling more successful occupational performance. Method: Eight women engaged in OBA sessions over the course of eight months. Session objectives were to maximize independence in daily life skills and to foster EF component skills such as problem-solving, decision-making, cooperation, direction following and appropriate self-expression. Outcome measures used were the Executive Function Performance Test (EFPT), the Canadian Occupational Performance Measure (COPM) and the Occupational Therapy Task Observation Scale (OTTOS). Results: Gains were seen from baseline to final session in COPM score changes meeting minimally clinical difference, and OTTOS scores showing significant improvement: t(7)= -2.49, p=.04. Preliminary findings suggest that occupation-based programming may facilitate development of EF skills in sex-trafficked women.

NCT ID: NCT03485391 Completed - Anxiety Disorders Clinical Trials

Peer Social Support During In Vivo Exposure for PTSD

PEP
Start date: May 1, 2018
Phase: N/A
Study type: Interventional

Veterans who have prematurely dropped out of exposure therapy for PTSD will be contacted and offered the opportunity to return to treatment, this time with the assistance of an in vivo exposure therapy 'workout buddy'. This peer will meet them at the in vivo exposure therapy location and offer support an encouragement while the patient remains in that location. As the PTSD treatment standards in Charleston and other VA sites across the country increasingly include telemedicine delivered care, both in person and telemedicine based exposure therapy recipients will be included. There will be no randomization; all participants will receive the peer support 'workout buddy' for exposure therapy assignments.

NCT ID: NCT03460756 Completed - Depression Clinical Trials

A Clinical Trial of Oral Ganaxolone in Women With Postpartum Depression

Start date: December 28, 2017
Phase: Phase 2
Study type: Interventional

A clinical study to evaluate safety, tolerability and efficacy of oral administration of ganaxolone in women with postpartum depression

NCT ID: NCT03382782 Completed - Obesity Clinical Trials

Peer Navigators to Address Obesity-Related Concerns for African Americans With Serious Mental Illness

Start date: December 12, 2017
Phase: N/A
Study type: Interventional

People with serious mental illness such as schizophrenia and bipolar disorder experience high rates of physical illness and die earlier than people without serious mental illness (WHO, 2005). Health differences seem to be worse among African Americans (Weber, Cowan, Millikan & Niebuhr, 2009). High rates of obesity among this group contribute to health and wellness concerns (de Hert et al., 2011), with African American women at higher risk of obesity than men. Behavioral weight loss interventions (BWLIs) may promote diet and physical activity that lead to weight loss, but healthy food and safe physical activity options are less available in low-income neighborhoods. Peer navigators have been found to be effective in addressing health differences, and may help people living in low-income communities find healthy food and activity resources (Fischer, Sauaia, & Kutner, 2007). In addition, traumatic experiences are common among persons with serious mental illness as well as African Americans, and may impact weight. Through this project, investigators will test two interventions designed to address overweight and obesity among African Americans with serious mental illness. The first is a BWLI designed for persons with serious mental illness and adapted to meet the needs of African Americans. This program has 8-month intervention phase and 4-month maintenance phase. The intervention includes group weight management classes, group physical activity, individual visits to address barriers to meeting weight goals, and weigh-ins. The second intervention is a peer navigator program that assists people with serious mental illness in meeting their health needs in the community. Two-hundred and seventy (270) research participants will be recruited and randomly assigned to one of three conditions: BWLI program, BWLI program plus peer navigator, and treatment as usual (integrated physical and mental health care). Investigators will evaluate these interventions over a 12-month period, and will track weight change, health behaviors, physical and mental health, recovery, and quality of life. Investigators also seek to understand the impact of gender and trauma on outcomes. Investigators hypothesize that peer navigators will improve outcomes over the BWLI program alone. Findings will advance knowledge and services to reduce racial disparities in obesity and comorbid health conditions for African Americans with serious mental illnesses.

NCT ID: NCT03348813 Completed - HIV Clinical Trials

HIV/STI Prevention Among Black Adolescents With Mental Illnesses (Project GOLD)

Start date: August 1, 2014
Phase: N/A
Study type: Interventional

Despite advances in HIV/sexually transmitted infection (STI) prevention, Black youth account for the largest number of new HIV infections among heterosexual youth. Having a mental illness contributes to HIV/STI risk among heterosexually active Black youth, as some use sex as a means to manage psychological distress, regulate emotions and receive validation or acceptance. Current intervention models focus on cognitive-behavioral strategies to reduce risk among adolescents; however, these approaches in isolation do not address the psychopathology that further potentiates risk behaviors among adolescents with mental illnesses. This randomized controlled trial evaluated the effects of "Project GOLD", a theoretically-driven, gender and culturally relevant, developmentally and psychologically appropriate HIV/STI risk reduction intervention on the sexual behaviors of Black male and female adolescents in Philadelphia (aged 14-17). In addition to evidence-based HIV/STI preventions strategies (e.g., role playing), Project GOLD includes unique emotion regulation content to address the relationship between psychological distress and HIV/STI risk behaviors. The research team approached and screened 704 adolescents. Eighty-two participated in the elicitation research activities (e.g., focus groups, intervention dress rehearsal). Another 173 underwent a structured demographic and mental health diagnostic interview to determine RCT eligibility. Project GOLD was then tested with 108 Black youth in comparison to a general health promotion control condition (intervention n = 52; control n = 56). Youth who were not in psychiatric treatment were also included, as the investigators hypothesized that they would also benefit from the targeted psychoeducational content; post-hoc analyses examined differences in the intervention effects based on whether or not youth were in psychiatric treatment. The intervention had high feasibility and acceptability. These findings underscore the need to encourage HIV/STI testing and risk reduction efforts among Black youth, including those with mental illnesses.

NCT ID: NCT03330301 Completed - Obesity Clinical Trials

D-tecting Disease - From Exposure to Vitamin D During Critical Periods of Life

D-tect
Start date: April 1, 2012
Phase: N/A
Study type: Observational [Patient Registry]

Vitamin D deficiency is common among otherwise healthy pregnant women and may have consequences for them as well as the early development and long-term health of their children. However, the importance of maternal vitamin D status has not been widely studied. The present study is divided into a societal experiment (1) and a case-cohort study (2): 1. The present study includes an in-depth examination of the influence of exposure to vitamin D early in life and during critical periods of growth for development of type 1 diabetes (T1D), type 2 diabetes, gestational diabetes, pre-eclampsia, obesity, asthma, arthritis, cancer, mental and cognitive disorders, congenital disorders, dental caries and bone fractures during child- and adulthood. The study is based on the fact that mandatory fortification of margarine with vitamin D, which initiated in 1937, was terminated in 1985. Apart from determining the influences of exposure prior to conception and during pre- and postnatal life, the investigators examined the importance of vitamin D exposure during specific seasons and trimesters, by comparing disease incidence among individuals born before and after the fortification. 2. Additionally, a validated method was used to determine neonatal vitamin D status using stored dried blood spots (DBS) from individuals who develop the aforementioned disease entities as adults and their time and gender-matched controls. Unparalleled, the study will help determine the effects of vitamin D exposure during critical periods in life. There are a sufficient number of individuals to verify any effects during different gestation phases and seasons of the year. The results, which will change our current understanding of the significance of vitamin D, will enable new research in related fields, including interventional research designed to assess supplementation needs for different subgroups of pregnant women. Also, other health outcomes can subsequently be studied to generate multiple new interdisciplinary health research opportunities involving vitamin D.

NCT ID: NCT03328286 Completed - Mental Disorder Clinical Trials

Improving Integration of Mentally Burdened Young Adults in the Labour Market

inklusiv
Start date: August 15, 2017
Phase: N/A
Study type: Interventional

Young adults who do not successfully transition from compulsory education to upper secondary level are at increased risk of developing mental illness, as compared with their working peers. The causality is unclear: they are either unable to find a job due to a pre-existing mental illness, or their failure in finding a job has contributed to the mental illness. The Zurich University of Applied Sciences has developed an innovative intervention that includes psychotherapeutic support in a work integration programme. Recognising and treating mental illness early increases the chances of a successful transition to the labour market.

NCT ID: NCT03230955 Completed - Smoking Cessation Clinical Trials

Effectiveness of a Smoking Cessation Quit Line for Mental Health Patients

QUITMENTAL
Start date: May 2, 2017
Phase: N/A
Study type: Interventional

Pragmatic randomized clinical trial, single-blind, with allocation 2:1 [Intervention Group (IG) and control group (CG)] in 5 acute hospitals. The IG will receive telephone assistance to quit smoking (including psychological and psycho-educational support and pharmacological treatment advice, if required) proactively for 12 months, and the CG only brief counselling after discharge. To assess the effectiveness of a multicomponent and motivational intensive telephone-based intervention to stop smoking ("quit line") addressed to smokers with mental disorders discharged from hospitals.

NCT ID: NCT03118388 Completed - Mental Health Clinical Trials

Engaging Homeless Youth in Vocational Training to Meet Their Mental Health Needs

SEI
Start date: September 18, 2009
Phase: Phase 2
Study type: Interventional

This randomized controlled trial (RCT) compared the efficacy between the Social Enterprise Intervention (SEI) and Individual Placement and Support (IPS) with homeless youth with mental illness. Methods: Non-probability quota sampling sampling was used to recruit 72 homeless youth from one agency, who were randomized to the SEI (n=36) or IPS (n=36) conditions.

NCT ID: NCT02989805 Completed - Mental Disorder Clinical Trials

Engaging Patients With Mental Disorders From the ED in Outpatient Care

EPIC
Start date: April 3, 2017
Phase: N/A
Study type: Interventional

This study will compare the effectiveness of professional and peer care managers in improving linkage to and engagement in outpatient care after an emergency department (ED) discharge, as well as the mechanisms by which engagement occurs. The study will use a multi-site randomized trial study design across 8 EDs in South Carolina with telepsychiatry programs; each site will have one professional care manager (social worker or nurse) and one peer specialist care manager. Eligible subjects at each site will be randomized to a one-year treatment engagement intervention, the Coordination, Access, Referral and Evaluation (CARE) Program with either a peer or professional care manager, resulting in a total of 290 participants across sites. The CARE program will focus on shared decision-making between care managers and patients, and combines the traditional medical model of care management with a recovery-based approach.