Active clinical trials for "Psychotic Disorders"

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 overall aim of this randomized controlled trial is to evaluate the effectiveness of a problem-solving intervention for the prevention of sick leave among employees with early signs of CMDs. The intervention is delivered by first-line managers and a 30% reduction in sick leave days is expected in the experimental condition compared to treatment-as-usual, during the 12- months follow-up.

The current study examines the efficacy of a cognitive training intervention for improving emotion regulation in psychotic disorders. it is hypothesized that the cognitive training program will enhance prefrontal activation, leading to enhanced emotion regulation.

Recovery-oriented care is an imperative for the VA, particularly in mental health programming for Veterans with serious mental illness (SMI). Collaborative decision-making (CDM) is a recovery-oriented approach to treatment decision-making that assigns equal participation and obligation to patients and providers across all aspects of decision-making, thereby empowering patients and facilitating better decision-making based on patient values and preferences. CDM is associated with several important outcomes including improved treatment engagement, treatment satisfaction, and social functioning. However, current levels of CDM among Veterans with SMI are low, and there is not yet an evidence-based method to improve CDM. Improving Veteran skill sets associated with engaging in CDM is a potential intervention strategy. Collaborative Decision Skills Training (CDST) is a promising new intervention that was previously developed by the applicant for use in adult civilians with SMI and found to improve relevant skills and improve sense of personal recovery. The proposed study has two primary stages. First, a small, one-armed, open label trial will establish CDST's feasibility will evaluate CDST among 12 Veterans with SMI receiving services at the VA San Diego Psychosocial Rehabilitation and Recovery Center (PRRC) and identify and complete any needed adaptations to CDST. Stakeholder feedback from Veterans, VA clinicians, and VA administrators will be collected to assess Veteran needs and service context to identify any needed adaptations to the CDST manual or the delivery of CDST to maximize its impact and feasibility. The developers of CDST will review all feedback and make final decisions about adaptations to ensure that CDST retains its essential components to protect against loss of efficacy. For example, a recommendation to adjust role-play topics to better reflect the needs of Veterans would be accepted because it would increase CDST's relevance without impairing its integrity, but a recommendation to remove all role-plays would not be accepted because it would cause loss of a key component. Second, CDST will be compared to active control (AC) using a randomized clinical trial of 72 Veterans. The primary outcome measure will be functioning within the rehabilitation context, operationalized as frequency of Veteran CDM behaviors during Veteran-provider interactions. Secondary outcomes are treatment attendance, engagement, satisfaction, and motivation, along with treatment outcomes (i.e., rehabilitation goal attainment, sense of personal recovery, symptom severity, and social functioning). Three exploratory outcomes will be assessed: Veteran-initiated collaborative behaviors, acute service use and provider attitudes and behavior. Veterans will be randomly assigned to CDST or AC conditions. Veterans in the both groups will attend eight hour-long group sessions held over eight weeks. All Veterans will complete an assessment battery at baseline, post-intervention, and at three-month post-intervention follow-up. Following the trial and adaptation phase, the findings will be used to develop a CDST service delivery manual and design a logical subsequent study. The results of the proposed study will inform the potential for larger trials of CDST and the utility of providing CDST broadly to Veterans with SMI. The results of this study will expand current understanding of CDM among Veterans with SMI by providing data that will: 1) identify adaptations needed to optimize CDST for Veterans receiving services in PRRCs; 2) identify possible benefits of CDST; 3) inform development of alternate interventions or methods to improve CDM; and 4) further elucidate CDM and associated treatment processes among Veterans with SMI receiving VA rehabilitation services.

Single-blind, randomized controlled trial of normobaric oxygen therapy among individuals with first-episode psychosis: Effects on symptomatology and cognition.

The goal of this clinical trial is to conduct a single-blind randomized controlled trial to verify whether the Avatar Intervention has greater efficacy over supportive intervention to reduce cannabis use in patients with psychotic disorders.

The participants in the study will receive psychiatric treatment at the UCLA Aftercare Research Program. All participants in this 12-month RCT will receive cognitive training. Half of the patients will also be randomly assigned to the aerobic exercise and strength training condition, and the other half will be randomly assigned to the Healthy Living Group condition. The primary outcome measures are improvement in cognition and level of engagement in the in-group and at-home exercise sessions. Increases in the level of the patient's serum brain-derived neurotropic factor (specifically Mature BDNF) which causes greater brain neuroplasticity and is indicator of engagement in aerobic exercise, will be measured early in the treatment phase in order to confirm engagement of this target. In order to demonstrate the feasibility and portability of this intervention outside of academic research programs, the interventions will be provided via videoconferencing. The proposed study will incorporate additional methods to maximize participation in the exercise condition, including the use of the Moderated Online Social Therapy (MOST) platform to enhance motivation for treatment based on Self-Determination Theory principles, and a "bridging" group to help the participants generalize gains to everyday functioning. In addition, the exercise group participants will receive personally tailored text reminders to exercise.

The goal of this clinical intervention study is to investigate the effects of exergaming on cognition and other clinical symptoms in outpatient individuals with schizophrenia. The main questions it aims to answer are: Will an exergaming intervention contribute to improved cognition and reduced clinical symptoms, as well as enhanced physical health/self-efficacy/quality of life, in individuals with schizophrenia? Will the gaming component strengthen motivation for a physically more intensive component, so that attendance will be at least as high as in comparable exercise studies despite the current study being implemented in a resource-limited, regular clinical outpatient setting? Participants will be asked to engage in two 45 minutes exergaming sessions with a designated personal trainer for 12 weeks. Results pre- and post intervention will be compared, and comparisons will also be made with a former randomized controlled trial conducted at the same site, in which the currently combined activities were investigated separately (high-intensity interval training and low-intensity video gaming), both yielding positive but different effects.

In this randomized double-blind trial, the investigators aim to investigate whether online high definition transcranial direct current stimulation (HD-tDCS) over the left dorsolateral prefrontal cortex (DLPFC) during a working memory task improves the severity of negative symptoms in schizophrenia patients with predominant negative symptoms.

The purpose of this study is to examine state representation in individuals aged 15-40 who have been diagnosed with a psychotic illness, as well as young adults who do not have a psychiatric diagnosis. State Representation is our ability to process information about our surroundings. The investigators will complete some observational tests as well as a cognitive training clinical trial.