Clinical Research Directory

Shared Decision Making for Antipsychotic Medications

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.

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

The Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services (BICEPS) study aims to understand the early stages of psychotic disorders like Schizophrenia, Schizoaffective Disorder, and Bipolar I Disorder. It involves gathering mental health information, brain scans (MRI), eye movement patterns (Eye-Tracking), and brain electrical waves (EEG) data from individuals who have experienced these disorders in recent years. Participants will be involved for about a year, with four visits over this period. Screening procedures, lasting approximately 3 hours, include tests for drug use, a pregnancy test for eligible women, clinical interviews about feelings and experiences, psychiatric and family history interviews, and a medical history review. Research procedures for eligible participants include DNA collection, a neuropsychological test battery, EEG, eye-tracking, and MRI. These procedures will help researchers understand brain function, genetics, and cognitive abilities related to psychotic disorders. Follow-up visits at 1-month, 6-month, and 12-month intervals involve modified clinical interviews and repeating neuropsychological tests to track changes over time. Participants may opt to provide DNA samples for genetic analysis, undergo various cognitive tests, EEG to record brain waves, eye-tracking to monitor eye movements, and MRI scans to visualize brain structure. Follow-up visits at regular intervals will help researchers track changes in symptoms and cognitive function. This study provides comprehensive insight into the onset and progression of psychotic disorders and offers valuable information for patients, families, and healthcare providers involved in managing these conditions. Our goal is to better understand whether a combination of biological markers and different types of people (BT1, BT2, BT3) can help us predict how well individuals with early psychosis respond to specialized care. We expect that those in BT3 will have the best outcomes, BT2 will have intermediate outcomes, and BT1 will have the poorest outcomes. Even though BT1 and BT2 might start with similar cognitive issues, their biology might lead to different responses to treatment. This research can help us understand which treatments work best for different people with early psychosis.

Enhancing Veteran-Clinical Collaboration in VA PRRCs

Over 60% of Veterans with serious mental illness have a service-connected disability that impairs their ability to work, go to school, and/or have successful personal lives. Although traditional treatments tend to focus on symptom remission, Veterans prioritize a range of treatment goals, including personal empowerment and gaining personally meaningful skills. Increasing Veteran-clinician collaboration can help effectively align care with each Veteran's goals and support an empowering therapeutic experience. This project will evaluate the effectiveness of a group-based intervention intended to increase Veterans' comfort, confidence, knowledge, and skills to collaborate with their treatment teams. Findings from this study will contribute important knowledge about this intervention's effectiveness and how to enhance its effectiveness, especially for Veterans from minoritized groups. If the decision-making intervention is effective, it would help Veterans with serious mental illness, and might also help Veterans with other chronic health conditions, like PTSD and chronic pain.

Young Adults With Violent Behavior During Early Psychosis (Aim 2)

This study aims to provide an evidence-based behavioral intervention to reduce violent behavior for individuals experiencing early psychosis.

The OPUS YOUNG Trial. Early Intervention Versus Treatment as Usual for Adolescents With First-episode Psychosis

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 290 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.

Rituximab Treatment for Psychosis And/or Obsessive Compulsive Disorder with Probable Immune System Involvement

The primary objective for this study is to evaluate whether Rituximab as compared to placebo is a clinically effective treatment for a subgroup of patients suffering from psychosis and/or obsessive-compulsive disorder (OCD) or -behavior (OCB) where there is an indication of immune system involvement. The secondary objectives of this study are 1. To assess whether Rituximab treatment (with the doses and timing described below) as compared to placebo is associated with amelioration in psychiatric symptomatology 2. To assess whether Rituximab treatment as compared to placebo is associated with improvement in executive functions 3. To assess whether Rituximab treatment as compared to placebo is associated with amelioration in neurological symptoms 4. To evaluate the longevity of psychiatric, neurological and executive improvements associated with Rituximab treatment for up to 16 months after the first infusion (i.e. 12 months after the last infusion) 5. To evaluate whether Rituximab treatment as described is safe for these patients. The exploratory objectives of this study are 1. To assess changes in blood and cerebrospinal fluid (CSF) markers for immune activity associated with Rituximab treatment compared to placebo 2. To assess statistical associations between biological markers in blood or CSF and clinical response 3. To describe changes in somatic symptoms associated with treatment with Rituximab vs placebo for patients with initial symptoms in the questionnaires 4. To describe changes on MR and EEG associated with treatment with Rituximab vs placebo for patients with initial pathology in these examination 5. To study immune mechanisms coupled with psychiatric symptoms, possibly identifying novel biomarkers with potential for subtyping encephalopathies with immune engagement, using biobank cells, blood and CSF samples collected from the participants.

Benefits of Combining MCT With CR in the Recovery of Patients With Psychotic Spectrum Disorders

The goal of this clinical trial is to compare the efficacy of combined REHACOP + MCT alone in persons with nonaffective psychotic disorder in terms of recovery. The main questions it aims to answer are: * Does combined REHACOP + MCT therapy increase the clinical recovery in persons with nonaffective psychotic disorder (compared to MCT alone)? * What is the impact of combined REHACOP + MCT therapy compared to MCT therapy alone on personal/psychological recovery, cognitive biases, and social cognition, taking gender differences into account? * What is the durability of the effects of combined REHACOP + MCT therapy compared to MCT therapy alone on clinical recovery, personal recovery, cognitive biases, and social cognition in the long term? Researchers will compare REHACOP+MCT therapy to MCT alone to see if there are differences in personal/psychological recovery. Participants will: * Participate in Metacognitive Training or in combined REHACOP + Metacognitive training therapy. * Do 8 weekly sessions of 45-60 minutes (MCT group). * Do 12 weekly sessions of 45-60 minutes (RECHACOP+MCT group). * Visit the clinic for checkups and tests. * Answer self-administered tests.

The Efficacy of Metacognitive Skills Training in the Context of Forensic Psychiatric Care

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.