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.

REACH Study (Recovery Environments: Assessing Cognitive & Brain Health in Community Mental Health)

The purpose of this study is to understand how different types of community-based mental health care affect thinking abilities, daily functioning, and brain activity in adults with schizophrenia and related conditions. The investigators are especially interested in learning whether the Clubhouse Model-a structured, supportive community for individuals with mental illness-has unique benefits compared to standard outpatient mental health services. If participants decide to join, they will be asked to complete a total of six study visits with the research team over the course of your participation. Three of these study visits are at the beginning (baseline) and the remaining three are six months later. Two of the three visits will includes interviews, questionnaires, and thinking and memory tasks (cognitive testing) and one session will be an MRI brain scan, which is a safe and non-invasive imaging procedure. The total time required for each visit will be approximately 90 minutes to two hours. Participants may take breaks as needed.

REWRITALIZE Your Recovery - Evaluation of a Creative Writing Group Intervention

Health institutes call for psychosocial interventions and recovery-oriented approaches as supplement to pharmacological treatment for mental health disorders. Participatory art interventions have been suggested to be promising in promoting recovery by stimulating connectedness, hope, renegotiation of identity, participatory meaning-making and empowerment. Moreover, cognitive literature studies suggest there might be potential benefits of engaging with literature in terms of improved cognition and social cognition. In spite of promising findings, the evidence base is still thin. We have developed REWRITALIZE (REWR), a manualised, recovery-oriented fifteen-session participatory creative writing group intervention, led by a professional author and attended by a mental health professional. The intervention comprises introduction to literary forms, spontaneous writing on those forms, sharing texts and engaging in reflective discussions about them. It is designed to provide a holding and non-stigmatising environment. The aim of the present study is to evaluate REWR for persons with severe mental illness. This study is a randomised controlled clinical trial (RCT) with an embedded pilot RCT focusing on clinical and personal recovery. This study is an investigator-initiated, randomised, two-arm, single-blinded, multi-center, waiting list trial. Participants (n=266) with severe mental illness (\>18 yrs.) will be recruited at six psychiatric centres in region Zealand and randomised to active (creative writing group + treatment as usual) or control (waiting list + treatment as usual) condition. Assessments will be collected pre- and post-intervention and six months after end of intervention. The primary outcome measure will be the questionnaire of the process of recovery administered at the end of the intervention. Secondary outcome measures comprise measures of recovery, self-efficacy and mentalising assessed at the end of the intervention and six months after the intervention ends. The post-intervention measures will be compared between active and control groups by means of independent sample t-tests. The pilot RCT will focus on a subset of participants (n=70) with schizophrenia spectrum disorders (18-35 yrs), evaluating exploratory outcome measures related perspective-taking, social cognition, cognitive function, psychosocial functioning, and symptom level.

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.

EPI-MINN: Targeting Cognition and Motivation - National

The purpose of this study is to perform a practice-based research project designed to assess whether cognition and motivated behavior in early psychosis can be addressed as key treatment goals within real-world settings by using a 12-week mobile intervention program. We will recruit participants who are receiving care for early psychosis from clinics across the United States. We will compare outcomes from participants who receive treatment at coordinated specialty care (CSC) early psychosis clinics to those that receive standard community care. A qualifying CSC program will provide comprehensive clinical services such as psychotherapy, medication management, psychoeducation, and work or education support. This study will be conducted remotely, and participants can participate at home with their own electronic devices. The aim of this study is to investigate a well-defined 12-week mobile intervention program specifically designed to target cognitive functioning and motivated behavior for individuals with early psychosis. Participants will complete a screening interview which will include diagnosis and symptom ratings, neurocognitive assessment, and self-reports of symptoms, behavior, and functioning. Then participants will be randomized to receive the 12-week mobile intervention, or an active control of treatment as usual. The investigators will test for differences in the clinical trajectories after training, and at two follow up appointments at 6 and 12 months post-training.

iTBS to Enhance Social Cognition in People With Psychosis

The goal of this clinical trial is to examine if iTBS applied to the DMPFC improves social cognitive performance compared to sham stimulation in people diagnosed with schizophrenia, schizoaffective disorder, schizophreniform disorder, or psychotic disorder not otherwise specified. The main objectives of this trial are: * Compare changes in social cognitive performance between the active vs. sham treatment groups * Compare changes in social cognitive network functional connectivity between the active vs. sham treatment groups Each participant will receive iTBS (active or sham) five days per week for four consecutive weeks. Functional magnetic resonance imaging (fMRI) scans, clinical assessments, and cognitive tests will be performed at pre-treatment, post-treatment, and 6 months after the completion of treatment.

Investigating the Muscarinic System in Schizophrenia Using Positron Emission Tomography

Within the schizophrenia population, there are individuals that respond to first-line antipsychotic treatments while others do not. The availability of muscarinic M4 subtype receptors (M4R) may play a role as to whether a person with schizophrenia is responsive to first-line antipsychotics or not. The goal of this observational study is to compare the availability of M4R in antipsychotic-free patients with schizophrenia and matched healthy controls. In addition, M4R availability in schizophrenia patients will be examined in relation to response to first line antipsychotics and clinical and cognitive measures. This study may help better understand antipsychotic resistance in schizophrenia and lead to the development of new treatment options, particularly for cognitive deficits and negative symptoms.

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.

Individual Placement and Support and/or Cognitive Remediation Therapy Added to TAU in Patients With Early Schizophrenia

This study aims to test the hypothesis that addition of Individual Placement and Support (IPS) and/or Cognitive Remediation Therapy (CRT) in addition to treatment as usual in patients with early psychosis will be feasible and acceptable in patients with early schizophrenia.