53 Clinical Trials for Various Conditions
This study will compare a 12-session behavioral activation (BA) intervention modified for first-episode psychosis (FEP) to usual community mental health care (i.e., treatment-as-usual; TAU) delivered over 6 months with a sample of Latinos with FEP and their families. Comparable family group sessions will also be delivered to participants in both conditions. It is expected that BA participants will show better engagement than TAU participants.
Severe mental illnesses (SMI), such as schizophrenia, are associated with increased morbidity and mortality in large part due to obesity and concomitant metabolic disorders. People with SMI have twice the risk of becoming obese, driven by the use of antipsychotic medications. These antipsychotic medications are dopamine antagonists, which reduce brain dopamine levels, leading to an increase in food reinforcement, which leads to weight gain. This weight gain occurs very rapidly with the initiation of these medications, as do increases in LDL cholesterol, insulin, and leptin. While there have been attempts to develop weight loss programs, a recent meta-analysis concluded that these interventions led to statistically significant weight loss that was of no clinical significance and did not last beyond the intervention. Given the rapid weight gain/metabolic changes and the findings that it is easier to prevent weight gain than to lose weight, interventions targeting the early phases of a first episode of psychosis (FEP) are critical. However, the very few attempts have failed to address two key aspects of first episode psychosis. First, antipsychotic medications increase the reinforcing value of food and interventions have not included strategies to provide alternative reinforcements. Second, most patients experiencing FEP live with and are dependent on their parents, but existing interventions have not utilized parents in support of exercise and dietary changes. The purpose of this project is to assess the feasibility and acceptability of, and to provide preliminary evidence for the efficacy of a Family-Based Treatment (FBT) that includes both the patient and the parent in the intervention and provides structured help in developing alternative reinforcements that support exercise and dietary changes. The specific aims of this project are: 1. Recruit and provide FBT to 12 FEP patients and their parents using a multiple baseline single case experimental design; 2. Evaluate participation, attrition, and satisfaction of the patients and their families across the three month treatment period; 3. Examine the hypothesis that weight and food reinforcement will be significantly reduced during the treatment and follow-up phases in contrast to the baseline period.
The overall purpose of the proposed exploratory intervention development application, is to conduct research that will inform the adaptation and preliminary testing of NECT modified for youth (aged 15-24) with first episode psychosis (FEP), targeting self-concept and illness conceptions to increase treatment engagement. The specific aims of the project are to: 1) adapt NECT to be responsive to the needs and preferences of youth with FEP, and 2) Assess the feasibility, acceptability and preliminary effectiveness of the modified intervention (NECT-YA) combined with coordinated specialty care (CSC) services, compared to CSC services alone, in a small (n = 40) RCT.
The purpose of this study is to evaluate the impact of an antipsychotic medication decision aid and interpersonal and cognitive factors, such as attachment style and motivation, on emerging adults' ability to engage in shared decision making regarding their medications.
The project will evaluate thermoregulatory processes among individuals with and without first-episode psychosis.
Single-blind, randomized controlled trial of normobaric oxygen therapy among individuals with first-episode psychosis: Effects on symptomatology and cognition.
Investigators aim to develop and evaluate a culturally informed family motivational engagement strategy (FAMES) and implementation toolkit for coordinated specialty care (CSC) programs for first episode psychosis. First, 5 family member participants will be recruited into a three-month trial of FAMES and implementation toolkit. The investigators will then conduct a 16-month non-randomized, stepped-wedge trial with 50 family members from 5 CSC programs in community-based mental health clinics.
The research team will develop and test a prototype version of OnTrack\>An Online Role-Playing Game (OnTrack\>The Game or OTG), an online role-playing game designed for youth and young adults experiencing First Episode Psychosis (FEP). Phase I showed positive changes in quantitative measures of hope and recovery, as well as an enthusiastic response to the prototype as evidenced by qualitative interviews. In Phase II, the research team will refine, expand and finalize OTG and evaluate the effectiveness of OTG.
This study proposes to examine the application of rTMS for the treatment of cognitive dysfunction in FEP. This is an important population for study because if effective, rTMS may represent a preventative treatment for the development of social and vocational impairment that is associated with cognitive dysfunction in schizophrenia. This study will also seek to refine the understanding of the brain circuitry that mediates the potential pro-cognitive effects of rTMS through the use of functional magnetic resonance imaging (fMRI) at baseline and following the course of rTMS administration.
Insight, or lack of illness awareness, is a prominent and pressing clinical concern in the treatment and recovery of patients with psychotic disorders. Impaired insight results in poor treatment engagement and adherence, more frequent hospitalizations, greater positive and negative symptoms, and poor psychosocial functioning. Addressing these complications early in the disease process may lead to altered illness course with better outcomes. To date, only a small number of nonpharmacological interventions have been developed, none of which adequately address poor insight during the first few years of psychotic illness. Further, presently available therapeutic interventions do not attend to difficulties associated with improved insight, such as depression. The purpose of this investigation is to implement a novel intervention designed to improve insight, metacognition, neurocognition, symptoms, and ultimately overall functioning in persons with early psychosis. The novel intervention will integrate a number of previously established therapeutic approaches, such as metacognitive, narrative, cognitive behavioral and motivational interviewing, and hence be labeled Integrated Metacognitive Therapy (IMT). In order to measure the efficacy of IMT, all subjects will undergo a battery of assessments in each of these domains prior to and following either a novel intervention (N = 10) or treatment as usual (N = 10) for a period of approximately six months. Throughout the study, each IMT session (N = 10, 24 sessions each) will be audio recorded, transcribed, and de-identified to allow for careful ongoing qualitative analyses of potential active and inert ingredients of the approach and ultimately the development of an IMT manual which can then be tested in a larger, more rigorous randomized control trial. This investigation will play an important role in advancing current knowledge about treating insight in early psychosis. Further, it will serve to expand upon the intervention tools available by producing a much needed treatment manual designed specifically to target insight during an illness phase crucial for positive long term outcomes in psychosis.
The purpose of this study is to investigate the structural, functional and chemical brain abnormalities in patients with first episode psychosis and assess the evolution of these abnormalities during the course of the disease.
This 52 week long study evaluates the effectiveness of aripiprazole versus risperidone in treating people with first-episode schizophrenia. Patients who do not improve with these medications receive clozapine as their third medication trial.
Assured treatment with Risperal CONSTA will provide first-episode patients, who have a greater potential for therapeutic response, with their best opportunity for continued improvement in cognitive function beyond three months of treatment.
This study will determine the effectiveness of the Graduated Recovery Intervention Program, a manual-based individual therapy program, in enhancing the clinical benefit of routine treatment for individuals recovering from their first episodes of psychosis.
Individuals with first-episode psychosis (FEP) are at high-risk for several poor functional and clinical outcomes, including suicide. Coordinated Specialty Care (CSC) is a multidisciplinary, team-based intervention known to improve such outcomes, including suicide risk. However, 30-50% of patients disengage from CSC, thereby limiting its impact. This pilot study will develop and test feasibility of a behavioral change program that uses moderate financial incentives to encourage treatment engagement in 2 CSC programs. A single-arm of 80 patient-participants at these two clinics will be recruited to assess feasibility and acceptability from patient perspectives. Additionally,15 clinicians at these two clinics will be recruited to assess feasibility and acceptability from clinician perspectives, and 50 clinicians from peer clinics not involved in the intervention will be recruited to assess scalability of the intervention. The trial will feature an three-month period for recruitment and baseline data collection and will subsequently feature three intervention periods (3 months each) where modifications to the interventions will be tested (each informed by the feasibility and acceptability findings of the prior period) with the aim of sequentially improving it.
The goal of this project is to investigate whether a systematic screening approach enhanced by an innovative model of communicating information about psychosis and treatment options to patients and families (ComPsych) can reduce Duration of Untreated Psychosis (DUP) by facilitating early identification of first episode psychosis (FEP) cases, rapid referral to specialty care and engagement in treatment. The study team will use a stepped-wedge cluster randomized controlled trial design to compare a systematic screening and communication method (SCM) to systematic screening method (SM) to evaluate whether SCM substantially reduces DUP. The study team hypothesize that: (1) SCM will result in a higher number of individuals initiating specialty services compared to SM; (2) The mean DUP of FEP individuals in SCM condition will be lower than the mean DUP of FEP individuals in SM condition, due to the reduced time to initiate FEP services. We will also conduct a qualitative study to examine implementation barriers and facilitators of SCM.
The aims of this project is to use an artificial intelligence (AI) smartphone app to provide support for medication adherence by patients with first episode psychosis.
This application proposes OnTrackNY as a regional scientific hub for the Early Psychosis Intervention Network (EPINET) program as part of the National Institute of Mental Health (NIMH)'s creation of a national learning health care system (LHS) for early psychosis care. OnTrackNY has grown into a 22-site network, under the leadership of Lisa Dixon, MD, MPH. Created and supported by the New York State's Office of Mental Health (OMH), OnTrackNY is a nationally recognized model providing coordinated specialty care (CSC) for adolescents and young adults within two years of the onset of non-affective psychosis. OMH regulates and licenses all mental health programs in New York and is a direct-services provider via state-operated programs statewide. This makes OMH an ideal partner for establishing a statewide learning health care system for early psychosis care. Further, OnTrackNY's administration, OnTrackCentral, operates within the OMH-supported Center for Practice Innovations at Columbia Psychiatry. In this model, OnTrackCentral serves as the hub and the 22 OnTrackNY programs serve as the spokes. Since 2014, the still-growing OnTrackNY network has served over 1,600 individuals. From its inception, OnTrackNY has aimed to deliver high-quality, data-driven, accountable and culturally competent care consistent with an LHS. As a condition of funding, all OnTrackNY providers follow established protocols that require submission of patient- and site-level standard measures of early psychosis clinical features, services, and treatment outcomes. The proposed EPINET regional hub, the OnTrackNY LHS, will emphasize and enhance two critical foundational components - Aim 1: proactively engage stakeholders to optimize understanding of key problems and their solutions at every LHS phase; and Aim 2: develop data systems with enhanced standardized data collection, including post-discharge data and linkages to external data systems, and enhancing data analytics that will allow for client-level treatment planning and prospective analytics, delivering real time, dynamic and actionable information to stakeholders. These LHS components do not follow in a stepwise sequence but instead operate in parallel and interact to facilitate and enhance quality improvement processes. This backbone will support the development of practice-based research.
The proposed project seeks to create a California early psychosis network using a core assessment battery of valid, low burden measures and mHealth technology platform to collect client-level data, visualize data via clinician dashboard for treatment planning, and integrate across clinics to provide de-identified data to the national coordinating hub. Research capacity for the network will be tested via development and validation of a measure of the Duration of Untreated Psychosis (DUP) that is feasible for use in community settings. The proposed California network will contribute systematically collected outcomes data on over 100 FEP clients per year, from 12 community and university EP clinics, to enhance the development of a national EP network, supported by the NIMH EPINET program.
Maintaining treatment engagement is critical for first episode psychosis patients to experience gains possible with coordinated specialty care (CSC). This study is designed to identify CSC participants still receiving care but at high risk for disengagement and to intervene to prevent/delay disengagement.
The goal if the project is to develop a learning health network devoted to the treatment of first episode psychosis.
The investigators are studying a jail-based intervention to reduce the duration of untreated psychosis (DUP) among young adults with previously undetected first-episode psychosis who are detained in jail. Longer DUP (or treatment delay) is linked to poorer outcomes in first-episode psychosis and there is evidence that justice-involved young adults with first-episode psychosis have an alarmingly long DUP. Thus, despite the expansion of Coordinated Specialty Care (CSC) programs that improve outcomes through early, multi-component care, there is a need to establish early detection services in the criminal justice system and create pathways from justice involvement to CSC. This intervention offers a novel and potentially high impact approach for reducing DUP in jail settings: a jail-based Specialized Early Engagement Support Service that receives referrals, engages detainees, and serves as a bridge to community-based CSC. The study team will design and implement the intervention, thoroughly study its feasibility and acceptability, and prepare an intervention manual for broader use in diverse jails and future formal research.
Early intervention programs for psychosis help improve short-term treatment and recovery outcomes for individuals experiencing psychosis. OnTrackNY is a coordinated specialty care (CSC) program, developed to treat young adults within two years of experiencing a non-affective episode of psychosis. This project aims to expand the role of family engagement and support within the OnTrackNY model. Borrowing from the Needs Adapted and Open Dialogue models, the study team created a family therapy service that includes the client and members of his/her social network to navigate crises and assist in treatment planning. This service, Social Network Meetings, will be offered to individuals enrolled in the OnTrackNY@MHA program as an additional, voluntary, service option. The study proposes that the introduction of Social Network meetings may improve treatment and recovery outcomes.
The goal of this project is to investigate whether a systematic screening approach for individuals with first episode psychosis (FEP) can substantially reduce Duration of Untreated Psychosis (DUP). The study team will evaluate the feasibility of screening a consecutive help-seeking population entering mental health services in order to facilitate early identification of FEP cases, rapid referral to specialty care and engagement in treatment.
The study examines the possible effect of a community campaign to decrease the duration of untreated psychosis in persons with their first episode of a psychotic disorder.
This proposal aims to establish a Digital Laboratory focused on advancing help-seeking and expediting treatment initiation in youth ages 12-29 who are at Clinical High-Risk (CHR) for developing psychosis. Leveraging the Health Action Process Approach (HAPA) model, this study will identify help-seeking subtypes in 25,000 youth who screen positive for psychosis-risk on Mental Health America's national online screening platform, iteratively develop and test theory and data-driven, personalized strategies to advance help-seeking using Micro-Randomized Trials and a Sequential Multiple Assignment Randomized Trial, identify the most accurate CHR screening threshold in an online environment, and link youth, when indicated, to local clinical care via Accelerating Medicines Partnership - Schizophrenia (AMP-SCZ), a NIH funded national network of CHR programs throughout the US. This academic-industry partnership aims to curate one of the largest datasets of youth with CHR, and to develop effective strategies to enhance early help-seeking, in a population where help-seeking is critical and a significant barrier to care.
This project will use a smartphone technology to improve medication prescribing for individuals with FEP. We will collect real-time symptom and functioning data via smartphones to provide prescribers and other clinical team members with clinically relevant and time-sensitive information that will inform and promote shared decision making (SDM) and personalized interventions. The result will be a time-sensitive, data-driven, collaborative process to optimize medication regimens in order to maximize benefits, minimize harms, and promote adherence.
The objective of the proposed study is to determine the feasibility of an Early Detection program that aims to: (i) identify college students at clinical high risk (CHR) of psychosis or with first episode psychosis (FEP), and (ii) efficiently link them to coordinated specialty care (CSC) services for a 2nd stage screen, a clinical assessment, and appropriate treatment. The study will also determine pathways to care and perceived barriers to care among those students enrolled in Coordinated Specialty Care.
There is compelling evidence that longer duration of untreated psychosis independently predicts negative outcomes. The proposal aims to explore whether targeted and proactive online outreach through search engine advertisements, coupled with engaging, informative, and interactive online resources, can effectively reduce the duration of untreated psychosis and facilitate earlier treatment initiation in New York State. Results from this initiative will be critical to informing the subsequent design and conduct of larger, focused, and proactive digital media campaigns targeting patient with First Episode Psychosis and their caregivers online, intended to accelerate linkage to care and reduce the duration of untreated psychosis throughout the U.S.
The objectives of this research is to (1) create a family intervention and provider manual to train family members of young people with psychosis (YP-P) who are heavy cannabis users new communication skills to motivate change in the YP-P's cannabis use, (2) pre-test the intervention with 10 family member participants and adapt the intervention based on their recommendations, and (3) evaluate the feasibility and acceptability of the intervention in a randomized pilot trial (n=40). The investigators anticipate that the intervention will improve family participants' communication skills, decrease expressed emotion and caregiver burden. The investigators anticipate that improvements in communication skills, expressed emotion and caregiver burden will lead to decreases in the cannabis use of their YP-P.