Psychotic Disorders clinical trials at UC Health
11 in progress, 7 open to eligible people
open to eligible people ages 18-60
Primary study: This study is a single-site, double-blind, randomized, controlled clinical trial to compare an evidence-based structured program of 30-35 hours of on-line cognitive and social cognitive training exercises performed over 16 weeks (~2 hours per week), delivered with an innovative digital app which provides users with a motivation coach to set personalized goals and with secure social networking for peer support, "PRIME" ; vs. 2) A control condition of computer games, encouraged at ~2 hours per week over 16 weeks, delivered with "PRIME". Unblinded Cognitive Training Sub-Study: Participants who were randomized to the computer games arm of the trial may be offered access to the active cognitive training at the end of their 6 month follow up appointments, if they still meet inclusion criteria. PRIME Super Users Sub-Study: Participants who have provided all follow up data to the initial study, including those who are currently enrolled in the Unblinded Cognitive Training sub-study, may be offered continued participation in the PRIME community as super-users.
open to eligible people ages 18-45
This is a confirmatory randomized controlled trial of the efficacy of a novel intervention combining neuroplasticity-based cognitive training with aerobic exercise, compared to the same systematic cognitive training alone. Treatment occurs for 6 months after randomization, with a followup assessment at 12 months. The investigators hypothesize that combining neuroplasticity-based computerized cognitive training and neurotrophin-enhancing physical exercise will produce neurotrophin increases and cognitive and functional improvements, even relative to cognitive training alone. The investigators target the period shortly after a first episode of schizophrenia to maximize the generalization of cognitive improvement to functional outcome, before chronic disability is established.
open to eligible people ages 18-50
This application seeks to determine if neurophysiological metrics of memantine (MEM)-enhanced early auditory information processing (EAIP) in schizophrenia (SZ) mediate gains in auditory processing fidelity (APF) and auditory learning.
open to eligible people ages 18-60
This randomized controlled clinical trial will test a combined group contact plus mobile CBT-informed skills training intervention targeting defeatist attitudes in consumers with schizophrenia in comparison to a supportive contact control group in order to change motivational negative symptoms linked to defeatist attitudes.
open to eligible people ages 18-70
Approximately 60 chronic smokers with bipolar disorder, schizophrenia or schizoaffective disorder who are motivated to try to quit smoking will be randomized to receive smoking cessation treatment with the FDA-approved medication, varenicline, delivered either a) at its standard dose and titration schedule (half of the participants) versus b) at a lower dose and slower titration schedule (the other half), for 12 weeks. All smokers will choose a target quit date sometime between 8 to 35 days after starting the medication. All participants will receive ten 30-minute sessions of a behavioral treatment called Acceptance and Commitment Therapy (ACT). Participants will be followed for an additional 12 weeks off study medication. The major endpoint is the feasibility of combining ACT with the different dosing strategies. Investigators will also conduct a blood test that measures the breakdown of nicotine in the body to explore whether that measure influences treatment response and side effects.
open to eligible people ages 18-55
These studies look to conduct efficient pilot testing of a novel intervention strategy for chronic psychotic disorders - Pharmacologic Augmentation of Cognitive Therapy (PACT) - via an experimental medicine approach. Antipsychotics are the major therapeutic tool for chronic psychotic disorders, including schizophrenia, but do not significantly alter their course or real-life impact. Specific cognitive therapies achieve modest symptom reduction and improved function and cognition in psychosis patients, including "bottom-up" sensory-based targeted cognitive training (TCT). While benefits of TCT are evident at the group level, almost half of all patients demonstrate little or no cognitive gains after 30-40 hours (h) of TCT. For patients and clinicians, the costs and logistical complexities associated with these time- and resource-intensive interventions can be prohibitive. We propose and will test a novel "augmentation strategy" for using medications to specifically enhance the benefits of TCT in schizophrenia.
“Comparison of standard targeted provider education with/without novel technology-enhanced screening to identify patients earlier”
open to eligible people ages 12-30
Reducing Duration of Untreated Psychosis (DUP) is a primary goal for improving long-term outcomes in young people with a first episode of psychosis (FEP). The "standard of FEP care" within the US focuses on targeted provider education regarding signs and symptoms of early psychosis to motivate patient referrals to FEP services, followed by initiation of services within largely clinic-based settings Experience at the Early Diagnosis and Preventive Treatment (EDAPT) FEP specialty program at U.C. Davis in Sacramento has identified two important bottlenecks to reducing DUP, consistent with reports in the literature from other FEP clinics. These are 1) delays in the identification of psychotic symptoms by referral sources, and 2) delays or disruptions of patient engagement in specialty FEP care. Building upon a comprehensive and established referral network of 20 sites across the Sacramento area (schools/universities, ER/inpatient hospitals, outpatient mental health, primary care), the investigators will address delays in patient identification and engagement using a two-phase, cluster randomized design. The investigators will consecutively test the impact of two interventions to reduce DUP, defined in this RFA as time from first onset of psychotic symptoms to engagement in FEP specialty care. To address identification delays, the investigators will examine the use of standard targeted provider education plus novel technology-enhanced screening compared to standard targeted provider education alone, testing the hypothesis that the education plus technology-enhanced screening will identify more patients, earlier in their illness. To address engagement delays, the investigators will compare the use of a mobile community-based, telepsychiatry-enhanced engagement team to standard clinic-based procedures for intake, engagement and initiation of treatment, to test the hypothesis that the mobile approach facilitates earlier and more stable engagement, thereby reducing DUP. The proposed work will provide new specific evidence-based practices for reducing DUP and improving outcomes through specialty care of individuals with a first episode of psychosis.
at UC Davis
Adapting and Examining Collaborative Decision Skills Training Among Veterans With Serious Mental Illness
Sorry, not yet accepting patients
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.
Sorry, in progress, not accepting new patients
This is a randomized study to compare Compensatory Cognitive Training (CCT) versus Recreational Therapy (RT) in Latino clinical high risk individuals in the US and Mexico. Study hypotheses: Compared to those who receive RT, study participants receiving CCT will show significant improvement in neurocognition, functional capacity, self-rated functioning and clinical measures.
Family-Focused Therapy for Individuals at High Clinical Risk for Psychosis: A Confirmatory Efficacy Trial
Sorry, not yet accepting patients
The present study is a confirmatory efficacy trial of Family Focused Therapy for youth at clinical high risk for psychosis (FFT-CHR). This trial is sponsored by seven mature CHR clinical research programs from the North American Prodrome Longitudinal Study (NAPLS). The young clinical high risk sample (N = 220 youth ages 13-25) is to be followed at 6-month intervals for 18 months.
This Study Tests Whether BI 409306 Prevents Patients With a Specific Type of Mental Illness (Attenuated Psychosis Syndrome) From Becoming Worse. This Study Looks at How Well Patients Tolerate the Medicine and How Effective it is Over 1 Year
Sorry, not currently recruiting here
This is a study in people between 16 and 30 years of age who have a specific type of mental illness called attenuated psychosis syndrome (APS). The purpose of this study is to find out whether BI 409306 helps reduce the symptoms of APS. Participants are in the study for 1 year and 2 months. During this time, they visit the study site about 15 times and get about 10 phone calls. Participants are put into 2 groups by chance. They get either BI 409306 or placebo. Placebo tablets look like BI 409306 tablets but do not contain any medicine. Participants take a BI 409306 or placebo tablet two times a day. During the study, participants answer questions in interviews and complete questionnaires so the doctors can check whether the APS symptoms change. The doctors also check the general health of the participants.