Active clinical trials for "Depression"

The primary intervention offered through this study is a manualized and culturally adapted CBT intervention combined with an exercise intervention, administered by trained Community Health Workers and exercise trainers to ethnic minority elders with moderate to severe mood symptoms and at risk of disability. In addition to the intervention implementation, the study examines how to successfully build collaborative research for the provision of evidence-based mental health and disability prevention treatments for ethnic minority elders in community-based settings. Thus, the study will evaluate the three components necessary for a successful intervention: efficacy, since the intervention must work, acceptability among clients and partnering agencies, and feasibility and sustainability within the organization.

In recent years it has become evident that some types of antidepressants are associated both with an increased risk of falling and decreased bone mineral density. These factors predispose patients for serious fractures such as hip fractures with substantial morbidity and mortality. The specific mechanisms involved in this negative impact on bone and postural control have not been fully elucidated. It is well known that Vitamin D plays an important role for bone health as well as muscle function and thus indirectly postural control. Furthermore, vitamin D deficiency has been observed among depressed patients. To our knowledge no study has investigated the involvement of Vitamin D in relation to the increased risk of fractures associated with antidepressants. Therefore, this project will investigate the underlying mechanisms leading to skeletal impairment and musculoskeletal symptoms in patients receiving different types of antidepressants. Moreover, the effect of vitamin D supplementation will be investigated among patients taking these antidepressants. 150 subjects will participate in this study: 50 of which is diagnosed with depression and receive Citalopram (SSRIs); 50 depressed subjects receiving Mirtazapine(NaSRI); and 50 controls. Through randomisation half of the subjects in each group will receive daily Vitamin D supplementation for a period of one year. Through this period all 150 subjects will be followed through different measurements including bone density, muscle function and balance, nociception, quality of life and depression severity. It is expected that results from this study will provide increasing awareness and knowledge of the side effect profile of antidepressants on bone metabolism. This may prompt clinicians to screen patients at high risk of drug-induced osteopenia or osteoporosis and accordingly provide treatment, which may reduce the incidence of potentially avoidable fractures. Moreover, some types of antidepressants may show to produce a minimal or even no effect on bone turnover, and should be considered as first line treatment in the group of patients at risk of fractures.

This is an open label, randomized, add-on, 8 weeks multicentre study to evaluate the efficacy and safety of paroxetine Controlled Release (CR) in patients with Major Depressive Disorder (MDD) comorbid Irritable Bowel Syndrome (IBS). Subjects will be patients who are referred to the outpatient or inpatient clinic of gastroenterology departments of province level general hospitals in China. All subjects present with irritable bowel syndrome according to ROME III, and also are diagnosed with MDD by Mini-International Neuropsychiatric Interview (MINI). All subjects will provide written informed consent prior to participating in the study. Subjects will be assessed for eligibility at a screening visit, with eligible patients returning for a assessment within 1 week, at which time they will randomly enter into paroxetine CR (12.5mg/d, flexible dose: 12.5-50mg/d) plus IBS regular treatment or IBS regular treatment only. Subjects will be evaluated at weeks 2 (Day 14), 4 (Day 28), 6 (Day 42) and 8 (Day 56), for a total of 5 study treatment visits.

To compare e-screening versus usual screening on: 1) women's and healthcare providers' views on feasibility and acceptability; 2) rates of detection of prenatal and postpartum depression and anxiety; 3) perceived risk and benefit of disclosure; 4) cost-effectiveness; 5) psychometric properties. We also aim to identify factors associated with feasibility of e-screening.Compared to usual screening:1) e-screening is as feasible; 2) e-screening yields similar rates of prenatal and postpartum depression and anxiety; 3) the mean score for risk of disclosure is significantly lower and benefit of disclosure is significantly higher in the e-screening group; 4) e-screening is as or more cost effective in detecting prenatal and postpartum depression and anxiety; 5) features of e-screening are significantly associated with feasibility and acceptability, whereas demographic factors are not; and 6) reliability and validity indices of ALPHA and EPDS are strongly correlated for both administration modes.

This study is a pilot to assess feasibility of the protocol in patients and controls across six participating sites. The goal is to identify biological markers (biomarkers)that can be measured at baseline or early in treatment to predict treatment outcome in individual patients with Major Depressive Disorder (MDD). Biomarkers of interest will be clinical (using interview and self-report measures), molecular (from blood samples) and neurobiological (using neuroimaging and EEG).

In the U.S., rates of preterm birth and low birth weight have increased over the past 30 years. Poor birth outcomes are especially high among racial/ethnic minority populations. Maternal stress is an important factor that can lead to negative birth outcomes. Thus, programs that reduce stress during pregnancy could improve birth outcomes. Initial pilot work tested a mindfulness-based approach to stress reduction during pregnancy. Women in the pilot study had lower stress and improved coping after the program. For the current study, mindfulness is added to an existing prenatal healthcare program called CenteringPregnancy (CP). CP provides prenatal care through 10 group sessions. This study compares CP with a version of CP infused with mindfulness skills training. Effects of the two versions of CP on psychological stress and coping, stress hormones, and birth outcomes will be tested. Data will be collected from participants three times: twice during pregnancy and once after birth. Medical records will provide data on birth outcomes and other health factors. The study will provide initial information about a mind-body program to reduce stress and improve birth outcomes. Data from the study will inform the development of an R01 proposal for a larger study. The study will also help advance the long term goal of reducing health disparities.

The purpose of this study is to build a scientific evidence base for the training and delivery of a depressive symptoms education program, developed by local community members, called a Resiliency Class (RC). The RC has strong elements of Cognitive Behavioral Therapy and is designed to be delivered as a psycho-educational class by non-professionals to improve mood. Depressive symptoms are common, especially in low-income, minority communities. Depressive symptoms that don't meet DSM-IV criteria for Major Depression still carry a significant amount of disability. Interventions that address sub-threshold depressive symptoms have been noted to result in a decreased likelihood of depression and diminished use of mental health services. Few interventions using a health education / health promotion focus are designed to be delivered by non-professionals to address individuals with mild to moderate depressive symptoms in low income, minority communities. This project will take place in the Centinela Valley, which roughly corresponds to Service Planning Area (SPA) 6 or South Los Angeles (SLA). This single-blind, randomized trial will utilize a wait-list control design where half of the participants enrolled in the study will be randomized to the Resiliency Class (7 sessions) and half will go to a wait-list control condition where they will receive 2 case management calls and referrals to social services. We propose to screen 1500 clients to detect about 450 participants with depressive symptoms (endorsed one item on the PHQ-2). We plan to enroll 400 participants, 200 in the resiliency class and 200 in the wait-list control condition. Primary outcomes measures will include depressive symptoms, function, and measures of resiliency. We will assess these measures at baseline and at 3 months after completion of the Resiliency Class or wait-list condition. After the completion of the first round of classes, we will conduct a preliminary analysis of the impact of the resiliency classes versus the wait-list control case management calls on depressive symptoms. If the resiliency classes improve depressive symptoms more than the wait-list control, we will offer wait-list controls access to the resiliency classes and then disseminate the resiliency class through trainings. We hypothesize that the resiliency classes will lead to greater reductions in client depressive symptoms than the wait-list case management calls in the randomized trial of this project.

The Danish regions aim to implement antenatal education in small groups for all expectant parents. The effects of general antenatal education for childbirth or parenthood, or both, remain largely unknown. Also it is unknown if antenatal education in small groups is superior to antenatal lectures which is currently standard care. The aim of the trial is to evaluate if antenatal birth and parent preparation in small groups can increase parenting resources thereby easing birth and creating a smoother and less stressful transition to parenthood among the participants, compared to those allocated to standard care. This in turn is hypothesized to improve health and thriving among newborn families and affect their use of healthcare services. A thorough process evaluation will be conducted highlighting enabling factors and barriers to the implementation. Finally cost-effectiveness analysis will be conducted. Individually randomised trial sited at Hvidovre Hospital, a large birth clinic in the Copenhagen Capital Region of Denmark. Participants: 1756 pregnant women ≥ 18 years old, recruited before 20+0 weeks gestation, due to give birth at Hvidovre Hospital. Being legally able and willing to provide signed consent, and being fluent in Danish. Women are randomised to receive: A research-based birth and parenting program. The intervention consists of 4 sessions in small groups that last for 2,5 hours per session at 25, 33 and 35 weeks of gestation, and a post-natal session 5 weeks after expected due date. Standard care (control group). The pregnant woman and her partner are offered two antenatal lectures in an auditorium. The allocation of participants to the intervention will be 1:1 to the intervention and the control group. Data will be collected via questionnaires at baseline, 37 weeks gestation, 9 weeks post-partum, 6 months post-partum and 1 year post-partum, via the hospital obstetric database, and via the national registers. Analyses will be intention to treat. Subgroup analysis will be conducted in relation to personal and demographic characteristics. Process evaluation will be conducted using questionnaires and qualitative interviews. The incremental societal cost of the intervention will be computed and compared to the measured outcomes in a cost-effectiveness analysis. Outcomes: Stress, parenting alliance, depressive symptoms, wellbeing obstetric intervention, use of health care services, self-efficacy, divorce.

The primary objective of this study is to evaluate the safety and efficacy of an electronic cognitive behavioral therapy application (eCBT Mood) compared to a control group consisting of a mood monitoring handheld computer application in the treatment of patients with mild to moderate major depressive disorder.

The purpose of this study is to examine the efficacy of the active interventions (exercise or wellness/support intervention) compared to usual care on the prevention of postpartum depression among women at risk for depression. The investigators will also examine the efficacy of an exercise intervention compared to a wellness/support intervention on postpartum depressive symptoms among women at risk for depression.