Accelerating Medicines Partnership® Schizophrenia (AMP® SCZ): Rationale and Study Design of the Largest Global Prospective Cohort Study of Clinical High Risk for Psychosis.

This article describes the rationale, aims, and methodology of the Accelerating Medicines Partnership® Schizophrenia (AMP® SCZ). This is the largest international collaboration to date that will develop algorithms to predict trajectories and outcomes of individuals at clinical high risk (CHR) for psychosis and to advance the development and use of novel pharmacological interventions for CHR individuals. We present a description of the participating research networks and the data processing analysis and coordination center, their processes for data harmonization across 43 sites from 13 participating countries (recruitment across North America, Australia, Europe, Asia, and South America), data flow and quality assessment processes, data analyses, and the transfer of data to the National Institute of Mental Health (NIMH) Data Archive (NDA) for use by the research community.

Outcomes During and After Early Intervention Services for First-Episode Psychosis: Results Over 5 Years From the RAISE-ETP Site-Randomized Trial.

To examine long-term effects of early intervention services (EIS) for first-episode psychosis, we compared Heinrichs-Carpenter Quality of Life (QLS) and Positive and Negative Syndrome Scale (PANSS) scores and inpatient hospitalization days over 5 years with data from the site-randomized RAISE-ETP trial that compared the EIS NAVIGATE (17 sites; 223 participants) and community care (CC) (17 sites; 181 participants). Inclusion criteria were: age 15-40 years; DSM-IV diagnoses of schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, or psychotic disorder not otherwise specified; first psychotic episode; antipsychotic medication taken for ≤6 months. NAVIGATE-randomized participants could receive NAVIGATE from their study entry date until NAVIGATE ended when the last-enrolled NAVIGATE participant completed 2 years of treatment.

Relapse prevention through health technology program reduces hospitalization in schizophrenia.

Background: Psychiatric hospitalization is a major driver of cost in the treatment of schizophrenia. Here, we asked whether a technology-enhanced approach to relapse prevention could reduce days spent in a hospital after discharge.

Methods: The Improving Care and Reducing Cost (ICRC) study was a quasi-experimental clinical trial in outpatients with schizophrenia conducted between 26 February 2013 and 17 April 2015 at 10 different sites in the USA in an outpatient setting.

Post-acute college student satisfaction with telepsychiatry during the COVID-19 pandemic.

Objectives: Patient satisfaction with telepsychiatry during the COVID-19 pandemic has generally been positive, but few studies have compared patient experiences across settings, and no study to date has investigated the experience of college students receiving post-acute mental health treatment in an outpatient setting.

Participants: The current study surveyed college student outpatients (n = 101) to understand their experiences using telehealth during the COVID-19 pandemic.

Methods: An anonymous survey was delivered electronically and included questions regarding patients' age, treatment length, telehealth use, and their experience and satisfaction with telepsychiatry.

Mental Health Care Providers' Attitudes Toward Telepsychiatry: A Systemwide, Multisite Survey During the COVID-19 Pandemic.

Objectives: The COVID-19 pandemic has forced a rapid transition to telepsychiatry. This study examined the experience and attitudes of mental health care providers toward telehealth.

Methods: At 18 centers across the United States, 819 mental health care providers completed an electronic survey about telepsychiatry use and satisfaction.

Patient Attitudes Toward Telepsychiatry During the COVID-19 Pandemic: A Nationwide, Multisite Survey.

Background: The COVID-19 pandemic and its associated movement restrictions forced a rapid and massive transition to telepsychiatry to successfully maintain care continuity.

Objective: The aim of this study is to examine a large number of patients' experiences of, use of, and attitudes toward telepsychiatry.

Methods: An anonymous 11-question survey was delivered electronically to 14,000 patients receiving telepsychiatry care at 18 participating centers across 11 US states between the months of April and June 2020, including questions about their age and length of service use, as well as experience and satisfaction with telepsychiatry on a 5-point Likert scale.

Effect of Long-Acting Injectable Antipsychotics vs Usual Care on Time to First Hospitalization in Early-Phase Schizophrenia: A Randomized Clinical Trial.

Importance: Long-acting injectable antipsychotics (LAIs) can potentially reduce hospitalization risk by enhancing medication adherence but are rarely considered for early-phase schizophrenia treatment.

Objective: To determine whether encouraging use of a LAI compared with usual care delays the time to first hospitalization with patients with early-phase illness.

Design, Setting, And Participants: The Prevention of Relapse in Schizophrenia (PRELAPSE) trial was cluster randomized with a follow-up duration of 2 years.

Predictors of Hospitalization of Individuals With First-Episode Psychosis: Data From a 2-Year Follow-Up of the RAISE-ETP.

Objective: Despite treatment advances in other domains, inpatient psychiatric hospitalization rates for individuals with first-episode psychosis remain high. Even with early intervention services, a third or more of individuals are hospitalized over the first 2 years of treatment. Reducing hospitalization is desirable from the individual's perspective and for public health reasons because hospitalization costs are a major component of treatment costs.

Patients With Early-Phase Schizophrenia Will Accept Treatment With Sustained-Release Medication (Long-Acting Injectable Antipsychotics): Results From the Recruitment Phase of the PRELAPSE Trial.

Objective: To document the acceptability of treatment with long-acting injectable (LAI) antipsychotic medication to early-phase schizophrenia patients as demonstrated by enrollment in a cluster-randomized LAI clinical trial.

Methods: Eligible patients aged 18-35 years with a DSM-5 diagnosis of schizophrenia and less than 5 years of lifetime antipsychotic use were recruited between December 2014 and December 2016. Training for LAI antipsychotic site staff included education regarding the role of nonadherence in relapse/hospitalization and the rationale for LAI antipsychotic use with early-psychosis patients, training in shared decision-making and communication strategies, review of frequently asked questions about LAI antipsychotics, and role-playing to develop skills and solutions to overcoming LAI antipsychotic logistical barriers.

Off-hours use of a smartphone intervention to extend support for individuals with schizophrenia spectrum disorders recently discharged from a psychiatric hospital.

Introduction: Technology-delivered healthcare interventions may enhance dissemination of evidence-based treatments in low-resource areas. These interventions may be accessed 'on-demand,' including after hours. Patients with schizophrenia do engage with technological aids but when/how they would utilize these tools is not known.

Patient preferences concerning the efficacy and side-effect profile of schizophrenia medications: a survey of patients living with schizophrenia.

Background: Despite the availability of numerous antipsychotic medications, many patients with schizophrenia continue to experience side effects that contribute to the overall burden of the illness. The present survey of patients with schizophrenia and schizoaffective disorder aimed to assess patient attitudes toward antipsychotic treatment, and understand key factors about willingness to try a new medication.

Methods: A cross-sectional survey was administered to 250 patients with a primary clinical diagnosis of a schizophrenia spectrum disorder across five outpatient clinics in the United States.

Implementation and fidelity assessment of the NAVIGATE treatment program for first episode psychosis in a multi-site study.

The NAVIGATE program was developed for the Recovery After Initial Schizophrenia Episode-Early Treatment Program (RAISE-ETP) study, which compared NAVIGATE to usual Community Care in a cluster randomized design involving 34 sites and 404 patients. This article describes the approach to training and implementing the NAVIGATE program at the 17 sites (including 134 practitioners) randomized to provide it, and to evaluating the fidelity of service delivery to the NAVIGATE model. Fidelity was evaluated to five different components of the program, all of which were standardized in manuals in advance of implementation.

Comparison of Early Intervention Services vs Treatment as Usual for Early-Phase Psychosis: A Systematic Review, Meta-analysis, and Meta-regression.

Importance: The value of early intervention in psychosis and allocation of public resources has long been debated because outcomes in people with schizophrenia spectrum disorders have remained suboptimal.

Objective: To compare early intervention services (EIS) with treatment as usual (TAU) for early-phase psychosis.

Data Sources: Systematic literature search of PubMed, PsycINFO, EMBASE, and ClinicalTrials.

Psychopharmacological Treatment in the RAISE-ETP Study: Outcomes of a Manual and Computer Decision Support System Based Intervention.

Objective: The Recovery After an Initial Schizophrenia Episode-Early Treatment Program compared NAVIGATE, a comprehensive program for first-episode psychosis, to clinician-choice community care over 2 years. Quality of life and psychotic and depressive symptom outcomes were found to be better with NAVIGATE. Compared with previous comprehensive first-episode psychosis interventions, NAVIGATE medication treatment included unique elements of detailed first-episode-specific psychotropic medication guidelines and a computerized decision support system to facilitate shared decision making regarding prescriptions.

Accounting for group differences in study retention in a randomized trial of specialized treatment for first episode psychosis.

Background: Schizophrenia is a chronic disabling disorder for which current treatments are only partially effective. While the evaluation of novel interventions is a high priority, loss to follow-up is a major threat to validity.

Methods: Pattern mixture modeling is a statistical technique that incorporates information on patterns of retention that may bias comparisons between randomized treatment groups.

Demographic, psychosocial, clinical, and neurocognitive baseline characteristics of Black Americans in the RAISE-ETP study.

This study compared baseline characteristics of Black Americans and Caucasians with first-episode psychosis in the Recovery After an Initial Schizophrenia Episode Early Treatment Program (RAISE-ETP). Black American (N=152) and Caucasian (N=218) participants were compared on demographic, psychosocial, clinical, and neurocognitive measures. Results indicated several notable racial differences in baseline characteristics: a greater proportion of Black Americans than Caucasians were female, and Black Americans reported less personal and parental education than Caucasians.

Demographic and clinical correlates of substance use disorders in first episode psychosis.

Background: We assessed the prevalence and correlates of lifetime substance use disorders in people with first episode psychosis using the baseline data from the Recovery After an Initial Schizophrenia Episode (RAISE) Early Treatment Program study.

Methods: Research staff assessed 404 first episode patients at 34 community mental health centers across the United States with the Structured Clinical Interview for DSM-IV for diagnoses of psychotic and substance use disorders. Logistic regression was used to evaluate the relationships between participant characteristics and lifetime substance use disorders, followed with generalized linear mixed-effects regression models to identify unique predictors of lifetime substance use disorders.

Perceived Autonomy Support in the NIMH RAISE Early Treatment Program.

Objective: This study examined perceived support for autonomy-the extent to which individuals feel empowered and supported to make informed choices-among participants in the Recovery After an Initial Schizophrenia Episode Early Treatment Program (RAISE ETP). The aims of this study were to evaluate whether NAVIGATE, the active treatment studied in RAISE ETP, was associated with greater improvements in perceived autonomy support over the two-year intervention, compared with community care, and to examine associations between perceived autonomy support and quality of life and symptoms over time and across treatment groups.

Methods: This study examined perceived autonomy support among the 404 individuals with first-episode psychosis who participated in the RAISE ETP trial (NAVIGATE, N=223; community care, N=181).

Incomes and Outcomes: Social Security Disability Benefits in First-Episode Psychosis.

Objective: Social Security Administration (SSA) disability benefits are an important source of income for people with psychoses and confer eligibility for health insurance. The authors examined the impact of coordinated specialty care on receipt of such benefits in first-episode psychosis, along with the correlates and consequences of receiving them.

Method: The Recovery After an Initial Schizophrenia Episode-Early Treatment Program (RAISE-ETP) study, a 34-site cluster-randomized trial, compared NAVIGATE, a coordinated specialty care program, to usual community care over 2 years.

Supported employment and education in comprehensive, integrated care for first episode psychosis: Effects on work, school, and disability income.

Background: Participation in work and school are central objectives for first episode psychosis (FEP) programs, but evidence effectiveness has been mixed in studies not focused exclusively on supported employment and education (SEE). Requirements for current motivation to work or go to school limit the generalizability of such studies.

Methods: FEP participants (N=404) at thirty-four community treatment clinics participated in a cluster randomized trial that compared usual Community Care (CC) to NAVIGATE, a comprehensive, team-based treatment program that included ≥5h of SEE services per week, , grounded in many of the principles of the Individual Placement and Support model of supported employment combined with supported education services.

mHealth for Schizophrenia: Patient Engagement With a Mobile Phone Intervention Following Hospital Discharge.

Background: mHealth interventions that use mobile phones as instruments for illness management are gaining popularity. Research examining mobile phone‒based mHealth programs for people with psychosis has shown that these approaches are feasible, acceptable, and clinically promising. However, most mHealth initiatives involving people with schizophrenia have spanned periods ranging from a few days to several weeks and have typically involved participants who were clinically stable.

Health Technology Intervention After Hospitalization for Schizophrenia: Service Utilization and User Satisfaction.

Objective: The authors examined patients' acceptance of the Health Technology Program (HTP), an integrative approach to relapse prevention after hospitalization of adults with schizophrenia or related disorders. The program combines use of digital tools with support from a mental health technology coach (MHTC).

Methods: Patients with schizophrenia spectrum disorders received six months of treatment that began within 60 days of a psychiatric hospitalization and included the development of a personalized relapse prevention plan, three digital tools, and contacts with MHTCs.

Cost-Effectiveness of Comprehensive, Integrated Care for First Episode Psychosis in the NIMH RAISE Early Treatment Program.

This study compares the cost-effectiveness of Navigate (NAV), a comprehensive, multidisciplinary, team-based treatment approach for first episode psychosis (FEP) and usual Community Care (CC) in a cluster randomization trial. Patients at 34 community treatment clinics were randomly assigned to either NAV (N = 223) or CC (N = 181) for 2 years. Effectiveness was measured as a one standard deviation change on the Quality of Life Scale (QLS-SD).