View clinical trials related to Schizophrenia, Paranoid.
Filter by:Hallucinations or delusions that occur for the first time in older people with no acute medical problems or mood symptoms may be related to impending dementia. This study aims to confirm this hypothesis using novel blood biomarkers and Positron Emission Tomography (PET) imaging tracers, as well as non-invasive testing.
Although psychotic disorders typically affect less than 1% of the population, they are a significant cause of disability worldwide. Psychotic symptoms such as hallucinations, delusions and suicidal ideation can be profoundly disturbing, and negatively impact daily living. However, the social consequences of psychosis are often even more troubling than the symptoms. For example, people with psychosis have a high risk of experiencing violence, poverty, homelessness, incarceration, and unemployment, among other adverse outcomes. There is a need for a range of accessible, appropriate interventions for people with psychosis to be delivered to those in the most vulnerable situations, including in low-resource settings in sub-Saharan Africa. A systematic review recently carried out as part of the formative research for SUCCEED identified 10 studies evaluating the impact of interventions for people with psychosis in Africa, most of which had a strongly clinical focus. The review concluded that there was a need for further research involving people with lived experience of psychosis in designing and evaluating holistic interventions that meet their diverse needs, within and beyond the health sector. SUCCEED Africa is a six-year Health Research Programme Consortium (RPC) that has brought together people with lived experience of psychosis and people with professional experience (researchers, clinicians) from four African countries (Malawi, Nigeria, Sierra Leone, Zimbabwe) to co-produce a community-based intervention for psychosis, using a Theory of Change-driven approach. The SUCCEED intervention takes the World Health Organisation's (WHO's) CBR Matrix as a point of departure to consider the multifaceted needs of people living with psychosis and other psychosocial disabilities, and how best to meet these needs by mobilising the resources of individuals and families affected, as well as their broader communities. This protocol describes a pilot study in which the SUCCEED intervention will be delivered and evaluated on a small scale, in preparation for a larger multi-country research evaluation using more rigorous methods, including randomised controlled trials in Nigeria and Zimbabwe and observational studies in Malawi and Sierra Leone, respectively. The main outcome of interest is change in subjective quality of life among participants with lived experience of psychosis who are offered the intervention over a four-month follow up period.
Deficiencies in social cognition are part of the core symptomatology of psychotic disorders. And deficiencies in social cognition, the closely related concept of metacognition, and, for example, paranoid attitudes are all associated with violence. The link between social cognition and violence is also observed through rehabilitation, as both group-based Social Cognition Interaction Training (SCIT) and group-based Metacognitive Skills Training (MCT) have reduced violent behavior in patients with psychotic disorders. Thus, a better knowledge of social cognition and its rehabilitation in psychotic disorders can help to reduce risky behavior and to rehabilitate the significant social difficulties often found in psychotic disorders. This research study aims to examine factors underlying the efficacy of group-based MCT. The goal of the metacognitive skills training group developed by Moritz and partners is to strengthen the social and metacognitive skills of the patients participating in the group. The group consists of 10 sessions during which exercises and discussion are emphasized. The themes of the group sessions are, for example, jumping to conclusions -bias, empathy, and memory. Detailed information is available from the MCT website (https://clinical-neuropsychology.de/metacognitive_training-psychosis/). Overall there is meta-analysis-level evidence for the moderate effectiveness of MCT on positive symptoms of psychotic illnesses, such as delusions. Prior studies have argued that the unique factor underpinning MCT's efficacy is its impact on various cognitive biases, and that participating in the group especially reduces patients' tendency to jump to conclusions, which is a cognitive style associated with delusions and deficits in social perception and reasoning. As delusionality is related to the risk of violence, these results form a logical link between jumping to conclusions, delusionality, and violence. But the results regarding the effectiveness of MCT are still somewhat conflicting, and studies seem to be of varying quality. Additional longitudinal research and research related to the jumping to conclusion bias are also needed. The hypothesis regarding this study is that the MCT group reduces patients' tendency to jump to conclusions. These reductions are presumed to be associated in one-year follow-up with fewer mood symptoms, delusions, paranoia, and more psychological flexibility.
Psychotic disorders often develop a chronic course with devastating consequences for individuals, families, and societies usually with first onset during adolescence and early adulthood. Early intervention programs, which provide intensive, phase specific, psychosocial, and pharmacological treatment for people in the first five years after the initial psychotic episode (early psychosis) can significantly improve the outcome and are therefore strongly recommended in national and international guidelines. However, most early intervention programs in people with early psychosis still focus on improving symptoms and relapse prevention, rather than targeting educational and vocational recovery, although engagement in work and education is a high priority for young people with early psychosis and reduces the social disability associated with the disorder. The aim of the present study is to explore the effects of Supported Employment and Education (SEE) following the Individual Placement and Support (IPS) model in people with early psychosis. The investigators compare treatment as usual (TAU) in an outpatient psychiatric setting to TAU plus SEE.
This study aims to provide an evidence-based behavioral intervention to reduce violent behavior for individuals experiencing early psychosis.
This study aims to provide an evidence-based shared decision making intervention for antipsychotic medications, the Antipsychotic Medication Decision Aid (APM-DA), for individuals experiencing early psychosis and provide, for the first time, an understanding of the shared decision making mechanism of action.
The OPUS YOUNG (OY) study investigates the efficacy of early intervention service versus treatment as usual (TAU) for adolescents aged 12-17 years with a first-episode psychosis. In Denmark, the yearly incidence of schizophrenia in youth below the age of 18 years has increased from 137 in 2000 to 477 in 2016. Outcomes in people with schizophrenia spectrum disorders are suboptimal with low quality of life, low rates of recovery, substance misuse, higher rates of suicide, violence and legal problems, low educational and vocational attainment, and a significantly reduced life-expectancy of 15-20 year. Schizophrenia imply a large burden of disease with severe impact on patients, their families, the service system and a large economic societal burden. The investigators will include 284 participants age 12-17 years with an early onset psychosis within the following diagnostic classes: schizophrenia spectrum, psychotic depression or drug-induced psychosis. The design is an independent, investigator initiated, pragmatic, randomized clinical trial, with blinded outcome assessment. Participants are randomized 1:1 to OY or TAU. Participants in OY are offered 2 years of specialized intervention (OY) regardless of age, while participants in TAU are switched to adult psychiatry at the age of 18 years. OY builds on the Danish evidenced based intervention for young adults, OPUS, adjusted to meet the specific needs of adolescents: intensified support for caretakers and relatives including siblings; social cognition and interaction treatment; and individual cognitive behavioral case management. OY addresses the specific challenges of psychopharmacologic treatment in youth; supported transition to adult care after OY; school or educational support; and prevention and treatment of substance misuse. The primary endpoint is improved functioning in daily and social life after 24 months. Secondary outcome measures are psychopathology, quality of life, family stress, and retention in treatment and school/employment, and healthcare consumption. The clinical and societal perspective of a large scale implementation is improved prevention of the negative consequences of early-onset psychosis and a reduced burden of severe mental illness.
The study is a randomised, assessor-blinded parallel-groups superiority clinical trial fulfilling the CONSORT criteria for non-pharmacological treatment. A total of 256 patients will be allocated to either Cognitive Behavioural Virtual Reality Therapy plus treatment as usual, versus traditional CBT for psychosis plus treatment as usual. All participants will be assessed at baseline and 3- and 9 months post baseline. A stratified block-randomisation with concealed randomisation sequence will be conducted. Independent assessors blinded to the treatment will evaluate outcome. Analysis of outcome will be carried out with the intention to treat principles.
The purpose of this single-arm feasibility study is to develop and pilot test a novel process-based and modular group therapy approach for patients with acute psychotic symptoms in an inpatient setting.
The aim of this study is to test the effect of cognitive stimulation (CS), applied individually and at home, on the overall cognitive functioning, emotional state, functionality, and quality of life (QoL) in adults with psychotic disorders. To this end, a randomised controlled clinical trial will be conducted in which selected participants will be randomly assigned to an individual intervention group using CS or a control group. The CS program is adapted from other existing protocol, composed of 32 sessions. Each session will last 45 minutes and will be held twice weekly. There will be four evaluation points (baseline, intra-evaluation - after 8 weeks of intervention, post-evaluation - after 16 weeks of intervention, follow-up - after 8 weeks of the end of intervention).