Active clinical trials for "Mental Disorders"

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 study aims to examine the effectiveness of cognitive behavior therapy for psychosis in first episode patients and see the outcome of CBT on psychotic symptoms. Because cognitive behavior therapy mostly use in depressive patient to treat the negative thinking pattern Cognitive behavioral approaches in the treatment of psychosis have become more prevalent in recent years for a number of reasons. Evidence has been available for the past two or three decades regarding the success of these techniques with other forms of psychopathology such as depression, anxiety disorders, and medical problems. Anxiety, depression and low self-esteem have been cited as the most common consequences of psychotic disorders. The observation has also emerged that many patients develop their own coping strategies for reducing the frequency, severity, and disruptiveness of their symptoms. There has also been increasing evidence regarding the influence of social environmental factors on the course of psychosis and the development of stress-vulnerability models to explain these relationships. Research suggests that 20 to 50 percent of persons with psychosis who receive neuroleptics continue to experience difficulties related to their psychotic symptoms.

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.

Obstructive sleep-disordered breathing (SDB) affects 2-3% of children and may lead to problems with nighttime sleep and daytime behavior, learning, sleepiness, and mood. Adenotonsillectomy (AT) is the second most common surgical procedure in children. It is now performed more often for suspected SDB than for any other indication. However, recent studies indicate that many if not most children still have SDB after AT, and many still have learning or behavioral problems associated with SDB. The goals of this study are: (1) to assess the extent that behavior, cognition, and sleepiness in children can improve with Continuous positive airway pressure (CPAP) treatment after AT, and (2) to identify which patients stand to gain most from post-operative assessment and treatment.

There is increasing recognition of the need to stabilize sleep-wake cycles in individuals with major mental disorders. As such, clinicians and researchers advocate for the use of interventions targeted at sleep and circadian dysrhythmias as an adjunct to the standard treatments offered for acute illness episodes of a broad range of diagnoses. To determine the trans-diagnostic generalizability of chronotherapy, the investigators will explore the benefits of admitting individuals with major mental disorders to an acute psychiatric inpatient unit where changes in light exposure are integrated into the therapeutic environment. A two-arm pragmatic effectiveness randomized controlled treatment trial, where individuals admitted for inpatient psychiatric care will be allocated to a ward with blue depleted evening light or to a ward with the same layout and facilities but lacking the new lighting technology. The trial will test whether the experimental lighting conditions offer any additional benefits beyond those associated with usual treatment in an acute psychiatric inpatient unit. The main objectives are to examine any differences between groups in the mean duration of hospitalization in days. Additional analyses will compare groups differences in sleep, functioning, symptoms, medication usage, and side-effects and whether length of stay is associated with stability of sleep-wake cycles and circadian rhythms. Given this unique research opportunity, ancillary investigations will determine any benefits according to diagnostic subgroups and potential drawbacks such as any adverse effects on the well-being of professionals working across both wards.

Cognitive impairments are a core and enduring feature of first-episode psychosis and schizophrenia, and are associated with significant functional impairment. Cognitive remediation (CR) is a behavioural intervention that has been found to have a small to moderate effect on cognition in individuals with schizophrenia, and recent studies suggests that it leads to improved cognition in persons with first-episode psychosis. Results from a CR feasibility project that was conducted through the Winnipeg Regional Health Authority's Early Psychosis Prevention and Intervention Service (EPPIS) showed promising findings. Specifically, large effect sizes were found in the areas of verbal learning and self-esteem. Moreover, the intervention was found to be acceptable to the participants. However, the findings are limited by the sample size and lack of control group. In this proposed study, the investigators seek to expand the scientific support for treating neurocognitive impairments in order to increase functional productivity associated with first-episode psychosis. A novel group CR program, action-based cognitive remediation (ABCR), has been developed by Dr. C. Bowie (co-investigator) to promote the generalization of cognitive skills to real-world activities. ABCR has been found to improve both cognition and functional competence in persons with schizophrenia. The primary outcome measure will examine whether ABCR results in improved executive functioning in persons with first-episode psychosis compared to psychiatric rehabilitation alone. Secondary outcome measures (e.g., memory, processing speed, self-esteem, emotional functioning, adaptive functioning) will also be analyzed.

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 determine vitamin C and vitamin E in combination are effective in the treatment of cognitive and behavior disorder in children with fragile X syndrome.

This is a randomised controlled trial which investigates the effectiveness of CARMS (Cognitive AppRoaches to coMbatting Suicidality) therapy in reducing suicidal thoughts and how well CARMS works in practice within the NHS. The trial will compare two groups of people with psychosis who are using NHS mental health services. One group will carry on with their usual treatment. The other group will be offered 24 weekly sessions of CARMS therapy, plus their usual treatment.