Active clinical trials for "Mental Disorders"

This research project aims at early detection, early intervention, and recovery of individuals with psychosis and prevention of their family members who are at high risk of having developmental problems and developing psychosis episode in later stages of their life. It consists of two major parts with the following study designs & aims: Part I : Developing a comprehensive and integrative psychosocial and community skills training programme (IPCST) and conducing a pilot randomised controlled trial to compare the study outcomes between the two settings in Hong Kong and Beijing. To develop IPCST as an innovative intervention model targeting individuals with first or recent onset of psychosis to reduce their stay in mental hospital and bridges them to independent living in the community with optimal social and professional support; To evaluate IPCST in terms of the clinical, vocational, and psychosocial outcomes of participants using a randomized controlled trial design and compare these outcomes between Hong Kong and Beijing; To examine the cost-effectiveness of IPCST in the two cities; and To train professionals and research personnel in Hong Kong and mainland for implementation Part II: Exploring the health needs of younger family members of individuals with early psychosis and the strategies in preventing this clinical high risk group from developing psychotic episode and developmental problems in later stages of their lives. To identify the potential developmental problems or sufferings of theses younger family members living with patients with mental illness; To provide baseline assessment of their psychosocial stress, mental health, and quality of life; To identify interventions that may prevent them from developing psychosis and other developmental problems and improve their mental health.

This study aims to investigate the clinical efficacy of continuous theta burst stimulation (cTBS) on the right DLPFC as an add-on treatment in bipolar depression. The study consists of three phases. Phase 1: Bipolar depressed patients will be selected by a certified psychiatrist, who will administer (semi-)structured clinical interviews (M.I.N.I.-Plus 5.0.0, HRSD-17). The presence of exclusion criteria will be evaluated. Eligible patients will undergo MRI brain imaging for TMS neuronavigation Phase 2: Baseline clinical, cognitive and psychomotor assessments will take place. Patients will also undergo blood samples for laboratory and research assessments. TBS involves applying triple-pulse 50 Hz bursts given at a rate of 5 Hz uninterrupted trains (1). Patients will be treated with in total 20 continuous Theta Burst Stimulation (cTBS) session (900 pulses per session) over the right dorsolateral prefrontal cortex, which will be spread over 4 days. A stimulation intensity of 100% of the subject's resting motor threshold (rMT) of the right abductor pollicis brevis muscle will used. Patients will be randomized to receive either the real cTBS or sham treatment. Sham stimulation will be applied with a sham coil. The sham coil produces identical sounds but is not associated with a stimulus sensation compared to the coil delivering real stimulation cTBS. The investigators expect that real cTBS treatment and not sham will result in a significant and clinical meaningful response. Phase 3: Two post-treatment assessment moments will take place respectively 3 (max. 4) days and 10 (max. 11) days after the last treatment day. The assessments are the same clinical, cognitive and psychomotor assessments as in phase 2.

Social cognition dysfunction (including emotional perception, theory of mind, and attribution bias) is a common dysfunction in serious mental illness, which may influence their life roles and daily functions. The social cognition and interaction training (SCIT) is a manual-guide group intervention that can apply to people with serious mental illness.Thus this study aims to conduct SCIT groups in Taiwan to investigate its feasibility and effectiveness. This study will include 30 clients. Investigators will randomly allot participants into two group, and conduct a crossover design. The experimental group will receive a 60-minutes manual-guide SCIT session each week for 20 times, which will be leaded by 2 licensed occupational therapists. After the intervention, investigators will analyze demographic data and compare the difference between experimental group and control group on the social cognition performance.

The study consists in a pragmatic superiority randomized controlled trial comparing different strategies of psychotherapy for professionals and students from essential services with high levels of emotional distress during the COVID-19 pandemic in Brazil. Therapeutic strategies to be evaluated are Brief Cognitive Behavioral Telepsychotherapy, Brief Interpersonal Telepsychotherapy and Telepsychoeducation, as an active control. Note: This study was approved by the Ethics and Research Committee of the Hospital de Clínicas de Porto Alegre and is originally registered at Plataforma Brasil, a Brazilian study registration platform (under CAAE: 30608420.5.0000.5327). Recruitment began in May 28th 2020.

Current Canadian Clinical Practice guidelines emphasize the need for effective psychosocial adjuncts to pharmacotherapy for schizophrenia (Canadian Psychiatric Association 2005). This randomized control trial seeks to contribute to the body of evidence supporting psychosocial treatments by assessing the effectiveness of metacognitive training (MCT) and cognitive remediation (CR) at treating the persistent positive and cognitive symptoms of schizophrenia. MCT is a therapy designed to improve patient awareness and insight into the cognitive biases that are frequently seen in schizophrenia; it has been associated with decreased psychopathology (specifically decreased positive symptoms) and improved psychosocial function. CR is a therapy designed to improve performance in a variety of neurocognitive functions such as attention, memory, and executive functioning; it has been associated with improved cognitive and psychosocial functioning. Both MCT and CR will be compared to treatment as usual (TAU) as done previously (Kumar er al., 2010; Moritz et al., 2011). Hypotheses: MCT will produce greater change in delusions (severity and conviction) than CR and TAU. CR and MCT will produce greater change in social/everyday functioning than TAU. CR will produce greater improvement in basic attention and memory measures relative to MCT and TAU. MCT will produce greater reduction on tasks measuring targeted reasoning biases relative to CR and TAU. CR will increase efficiency of functional networks on a working memory task relative to MCT and TAU. MCT will lead to a greater decrease in the neural response to evidence matches relative to CR and TAU.

This trial is a preliminary study to determine the use of far infrared radiation for the treatment of dementia and other mental sickness.

Studies have shown that people with certain disorders have an increased risk of developing a condition called Metabolic Syndrome (MS). In this study, the investigators want to learn more about MS among people staying in the hospital for treatment of Major Depressive Disorder (MDD) and also Major Depressive Disorder with Psychotic Features (MDpsy). The investigators also want to learn more about a stress hormone called cortisol that is made in the body. Those who take part in this study will answer some questionnaires, be given some psychiatric interviews, and have some blood taken along with a urine sample. The investigators believe that patients in the hospital with MDpsy will have higher baseline rates of MS factors, cortisol levels, dexamethasone non-suppression, and insulin resistance, compared with MDD alone.

Participants with recent onset psychosis (ROP) experience delusions, hallucinations, and impairment in social, cognitive and emotional functioning. Although symptoms often improve following pharmacological intervention, the marked cognitive deficits, that often precede the onset of symptoms, continue to persist despite current treatment methods. Computerized neurocognitive interventions (NCI) are a promising therapeutic approach in participants with chronic schizophrenia and individuals at risk for psychosis. Specifically, focus has shifted to social cognitive training (SCT) as treating social cognition have been shown to provide improvements not only in general cognitive deficits but is also related to improvements in functional outcome (occupational and social). NCIs include non-invasive computerized tasks that are done on a tablet. This intervention can be conducted in a clinical setting, as well as out of the comfort of one's home. Additionally, research has shown that NCIs have the potential to elicit neuroplastic effects on the brain. The purpose of this study is to explore the efficacy of a 10-hour SCT in improving the primary outcome measure, global cognition, and secondary outcome measure, global functioning, in ROP participants. It is hypothesized that participants receiving the intervention will show gains in global cognition, as well as the subdomains of social cognition, processing speed, and working memory. Additionally, participants undergoing active intervention are expected to show gains in functional connectivity primarily between the prefrontal cortex and amygdala and other brain areas, that are engaged in social cognition. Furthermore, machine learning approach will be used(support vector classification) to investigate how the decision scores of the resting state classifier, indicating health vs. disease proneness, change in response to the training. In this randomized controlled trial, participants with a ROP receive a 4-6-week treatment with 10 hours of SCT, with 30-minute sessions 4-5 times per week or treatment as usual (TAU) control condition. Baseline and follow-up (6 weeks after the baseline assessment) assessments include clinical diagnostic and symptom assessment, standard neuropsychological testing, and structural and functional imaging. The already recruited part of the ROP sample counts 27 participants in SCT and 27 in the TAU arm. The power analysis recommends to recruit at least 6 more participants in both study arms. For the purpose of machine learning part of the analysis an independent psychosis (ROP)-healthy population (HC) classifier will be used, which takes the data from the naturalistic multi-center european study, Personalized Prognostic Tools for Early Psychosis Management, in order to be able to track the decision scores of the intervention SCT sample without risk of overfitting.

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 and risperidone in first-episode psychosis at 3 years.

Intranasal administration of Oxytocin (OT) has been found to improve social communication skills and encoding of social cues. Studies indicate that the provision of OT enhances the ability to develop trust 1, to improve the benefits of social support during social stress induction tasks 2 and to increase positive communication during couples' conflict discussions 3. These studies, and many others, point to the potential beneficial effects of OT as a facilitator of relationship-focused processes such as psychotherapy. Studies assessing the effect of OT as a possible outcome enhancer in psychotherapy for clinical populations are scarce, and their findings are largely inconsistent 4. Reasons for this state of affairs include the complexity of recruitment in this population; the provision of single-dose OT, which tends to cause a lower and insufficient effect 5; and methodological constraints, such as the lack of a control group 6 or insufficient probing of interpersonal factors 7. In this study we intend to overcome these constraints by evaluating the impact of intranasal administration of OT in patients suffering from acute stages of anxiety and depression disorders and undergoing intensive, relationship-focused psychotherapy during psychiatric hospitalization. One-hundred-and-twenty admitted patients with anxiety and depression disorders will be randomized and double-blindly allocated to two groups: (a) psychotherapy + OT (n=60), and (b) psychotherapy + placebo (n=60). Patients will be followed for three weeks, beginning at the start of their hospitalization, and will be assessed for the severity of their anxiety and depression symptoms; their working alliance with their therapist; and their treatment outcome after each session. Psychotherapy will be delivered twice a week. Intranasal OT will be administered twice a day. This study can provide insights regarding the potential involvement of OT in the trajectories leading to the production of detectable changes in brain activity following psychotherapy. Additionally, it can support the development of an integrating model combining recent findings in psychotherapy research pertaining to the significant role of therapeutic alliance in psychotherapy outcome, and findings from neuroimaging studies. Finally, provision of OT as a psychotherapy enhancer can facilitate a rapid therapeutic response and subsequently replace aggressive psychiatric medication usage, needed to create a rapid decrease of distress during psychiatric admissions.