Active clinical trials for "Mental Disorders"

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

Patients with psychoses are randomized either to group treatment (ACT) or individual CBT for 18 sessions.

The purpose of this study is to assess the effectiveness of Meta-Cognitive Training (EMC) in people with a brief psychotic disorder, especially positive symptoms. The secondary objectives would be to assess the effect of EMC on metacognition (cognitive distortions and deficits in theory of mind), psychosocial functioning and quality of life, neuropsychological functioning and gender, as well as determine the changes produced by EMC in the insight of each session and the maintenance of the effects of EMC program at six months of treatment.

Obesity occurs at 2-3 times the general population rate in persons living with a psychotic illness. The risk of obesity-related serious medical conditions like diabetes and heart disease are also two to three times higher in this population. Traditional behavioral weight management approaches help more than half of these individuals to lose weight, but a significant proportion are not helped. This pilot study is intended to determine the feasibility, efficacy, acceptability, and potential clinical utility of an intervention that integrates mindfulness, acceptance, distress tolerance, and motivation and commitment combined with traditional behavioral strategies for weight loss. This is the first study to investigate such an acceptance-based behavioral intervention for weight loss in psychotic illness. The results from this study will help to determine whether future research in this area is warranted with a larger sample, over a longer period of time. Primary hypothesis: Weight loss will be greater in individuals who receive the acceptance based behavioral intervention, relative to those who receive nutritional counseling.

The purpose of this study is to determine whether a scientifically validated treatment for Posttraumatic Stress Disorder (PTSD) called Prolonged Exposure (PE) can be delivered effectively to Veterans with Military Sexual Trauma (MST) related PTSD using videoconferencing technology, which allows a therapist and patient who are not in the same room as one another to communicate. The investigators are interested in learning if this form of mental health service delivery is an acceptable alternative to traditional face-to-face therapy delivered with the therapist in the same room as the patient. This study is being conducted at the Charleston VA Medical Center and surrounding Community-Based Outpatient Clinics (CBOCs), and will involve approximately 100 female participants.

The purpose of this study is to assess the effectiveness and implementability of ICT for co-occurring alcohol use and mental health disorders within community addiction treatment, as delivered by routine community addiction clinicians.

This is a RCT study, aiming at evaluating the effectiveness of the Everyday Life in Balance (BEL) intervention. The intervention: The BEL was developed on the basis of previous research on lifestyle interventions made by the current research group and other researchers . It is a group-based programme (5-8 participants) with 12 sessions, one session a week, and 2 booster sessions with two-week intervals. The themes for the group sessions are, e.g., activity balance, healthy living, work-related activities, and social activities. Each session contains a main group activity and a home assignment to be completed between sessions. The main group activity starts with analysing the present situation and proceeds with identifying desired goals and finding strategies for how to reach them. The home assignment is aimed at testing one of the proposed strategies. Self-analysis, setting goals, finding strategies and evaluating the outcome of tested strategies form a process for each session, but also for the BEL intervention as a whole. After completed BEL, the participants will have developed an ability to reflect on their own situation and have strategies for changing their everyday life in a desired direction, such that they feel their everyday life has a satisfactory balance between rest and work, secluded and social activities, etc. The BEL intervention is led by occupational therapists. They take part in a specifically developed two-day education and follow the BEL manual [7]. They also participate in a web-based discussion forum where they can seek support from the researchers and/ or other BEL occupational therapists. Selection of units and participants: On the basis of blocks of four units, two are randomized to the BEL and two to the control condition, which is care as usual (CAU) and generally means standard occupational therapy. Occupational therapists in the units select participants based on the patients' needs for a lifestyle intervention and being likely to benefit from a group intervention. The same criteria are applied in the BEL units and the CAU units. Power analysis: The investigators desire 120 participants from each group. This will also allow for analysis of subgroups. Instruments: A number of self-report instruments tapping satisfaction with daily occupations, well-being, perceived worker role, social interaction, recovery etc., will be used, supplemented with qualitative interviews. Procedure: As the intervention starts, the attendees answer questionnaires about their personal situation regarding. Subsequently, the BEL is implemented in the units randomised to that condition. After 16 weeks of intervention (including the booster sessions), the measurements are repeated. A follow-up is then made after another six months. The same data collection is made at corresponding time points in the comparison units. Additional qualitative interviews are made in the intervention units, with strategically selected participants (attendees and staff) to get a deeper picture of the intervention process and its implications. When the research project is finished, the comparison units will be given the opportunity to go through the intervention. Analyses: The primary analysis concerns differences in outcomes between the BEL group and the CAU group. Analyses of the qualitative interviews, by means of grounded theory, will yield a more detailed description of the BEL and its implications, as perceived by both attendees and staff. Current state of the study: The project is in the initial phase and the first units were recruited in late 2012. At present, 24 units have been randomized to either condition. The second measurements (after completed BEL) have just been completed and follow-ups will continue until mid-2016, as will qualitative interviews. Analysing data and reporting results will continue until late 2018. By including 60 participants in each group the studies will be able to detect a medium effect size (ES=0.4), which would be a difference of clinical and practical significance. Age, gender and being of foreign origin will be considered as covariates, along with other socioeconomic factors such as family situation, educational level and money at one's disposal. Other factors that should be considered are the participant's functional status and diagnoses. Research has not shown that diagnosis per se plays any substantial role in the outcome of psychiatric rehabilitation, for the course of a psychiatric disability or for how people perceive their everyday occupations, but this should be investigated further because the evidence is inconclusive. Level of functioning, level of psychopathology, and negative symptoms have indeed been shown to be of importance for outcomes of psychiatric rehabilitation. Therefore, this project will also control for factors related to diagnosis and functional status.

Many people with idiopathic rapid eye movement (REM) sleep behavior disorder (RBD) have an underlying synucleinopathy, the most common of which are Parkinson's disease (PD) and Lewy body disease. Identifying additional abnormal clinical features may help in identifying those at greater risk of evolving to a more severe syndrome. Because gait disorders are common in the synucleinopathies, early abnormalities in gait in those with RBD could help in identifying those at increased risk of developing overt parkinsonism and/or cognitive impairment. The investigators aim to identify subtle gait abnormalities in idiopathic RBD and to identify sensitive and early biomarkers: to detect subtle gait disorders in pre-symptomatic stage of synucleinopathy and to track their evolution in the parallel with the disease progression. Main objective: In comparison with age and gender matched-controls, to identify in patients with RBD a larger reduction of gait velocity (and other abnormalities of spatio-temporal characteristics of gait) between a single (gait) and a dual-task (gait+cognitive task). Secondary objective: In comparison with age and gender matched-PD patients, to identify in patients with RBD a smaller reduction of gait velocity (and other abnormalities of spatio-temporal characteristics of gait) between a single (gait) and a dual-task (gait+cognitive task). In patients with RBD to identify correlations between the spatio-temporal characteristics modifications of gait between a single (gait) and a dual-task (gait+cognitive task) and the percentage of REM without atonia - the dopamine transporter (DAT) density using FP-CIT single-photon emission computed tomography; the reduction of the olfactory discrimination and thresholds. In patients with RBD to track the spatio-temporal characteristics evolution of gait over time (every 6 months for 2 years)

Cognitive enhancement is a primary goal in treating individuals with schizophrenia. Cognitive deficits are already present at the first break of the illness, seem to remain stable during early phases and noticeably influence daily functioning. Differences among antipsychotics in terms of cognitive effectiveness have turned out to be a topic of increasing research interest. The initially postulated superior neurocognitive effectiveness of second-generation antipsychotics (SGAs) compared to first-generation antipsychotics (FGAs) is currently under debate. Long-term studies would be of great value to evaluate the differential benefits exerted by antipsychotic drugs on cognitive performance. The aim of this study is to investigate the cognitive effects of aripiprazole, quetiapine and ziprasidone in first-episode psychosis at 1 year.

The purpose of this study is to determine wether peer support is effective for the treatment of people with severe mental illness.