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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.The current study surveyed college student outpatients (n = 101) to understand their experiences using telehealth during the COVID-19 pandemic.An anonymous survey was delivered electronically and included questions regarding patients' age, treatment length, telehealth use, and their experience and satisfaction with telepsychiatry. A mixed-methods approach was used to analyze responses between groups through Chi-Square, Kruskal-Wallis, or Mann-Whitney tests, and qualitatively to understand themes across items related to the benefits and challenges of telehealth.College students were more likely to utilize video-based telehealth and preferred video-based care. College students receiving medication management were much more likely to endorse telehealth being as helpful as in-person treatment. Several challenges associated with telehealth were raised in both groups.Understanding the benefits and challenges of telepsychiatry in this high-risk college population may help enhance access to care during a critical period of development in which most psychopathology emerges.

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. Assessments occurred every 6 months. 61% of participants had assessments conducted ≥2 years; 31% at 5 years. Median follow-up length was CC 30 months and NAVIGATE 38 months. Primary analyses assumed data were not-missing-at-random (NMAR); sensitivity analyses assumed data were missing-at-random (MAR). MAR analyses found no significant treatment-by-time interactions for QLS or PANSS. NMAR analyses revealed that NAVIGATE was associated with a 13.14 (95%CI:6.92,19.37) unit QLS and 7.73 (95%CI:2.98,12.47) unit PANSS better improvement and 2.53 (95%CI:0.59,4.47) fewer inpatient days than CC (all comparisons significant). QLS and PANSS effect sizes were 0.856 and 0.70. NAVIGATE opportunity length (mean 33.8 (SD = 5.1) months) was not associated (P = .72) with QLS outcome; duration of untreated psychosis did not moderate (P = .32) differential QLS outcome. While conclusions are limited by the low rate of five-year follow-up, the data support long-term benefit of NAVIGATE compared to community care.

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.At 18 centers across the United States, 819 mental health care providers completed an electronic survey about telepsychiatry use and satisfaction.Overall, 73% of providers using videoconferencing and 66% using the telephone rated their experience as excellent or good. Flexible scheduling or rescheduling (77%) and timely start (69%) were frequently reported advantages for both modalities. Challenges were related to patients' inability to use conferencing devices (52%), lack of sense of closeness or connection (46%), and technical problems (39%). After the pandemic resolves, 64% of respondents would want to continue using telepsychiatry in at least 25% of their caseload.Telepsychiatry was very well perceived among mental health care providers, and many would like to continue using it. Access to technology and training raises concerns.

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. Methods We conducted a large, prospective, ten-site, longitudinal study of four technology-assisted interventions for patients with schizophrenia spectrum disorders within 60 days of psychiatric hospital discharge, a high risk period. One tool employed was a smartphone intervention called ‘FOCUS,’ which could be used by patients as needed, providing help in five content areas: medications, mood, social, sleep and voices. Each login was date- and time-stamped as occurring during normal clinic hours, or ‘off-hours,’ and the pattern of use described. Results 347 of 368 patients utilized FOCUS during the 6-month study. There were a total of 75,447 FOCUS logins; 35,739 (47.4%) were self-initiated and 38,139 (50.6%) were off-hours. 18,450 of the logins during off-hours were self-initiated (24.5%). No differences in average usage per month were found based on race/ethnicity. A subset of ‘high utilizers’ (n = 152, 43.8%) self-initiated use of all five FOCUS modules both on- and off-hours. They tended to be women, >35 years old, and had a high school diploma or greater. Conclusion Most patients with schizophrenia spectrum disorders recently discharged from the hospital utilized a smartphone intervention targeted to address troublesome residual symptoms. One quarter of the total smartphone utilization was self-initiated off-hours, indicating the potential utility of this tool to extend support for patients during periods of elevated risk.

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. The components included four interventions (Individualized Resiliency Training, Family Education Program, Supported Employment and Education, Personalized Medication Management) and the overall organization (staffing and structure) of the NAVIGATE team. Most of the sites demonstrated acceptable or higher levels of fidelity in their implementation of the four interventions and the organization of the program, with all 17 sites demonstrating at least acceptable overall fidelity to the NAVIGATE program. The results indicate that the NAVIGATE program can be implemented with good fidelity to the treatment model in a diverse array of community mental health care settings serving persons with a 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. This study used pattern mixture mixed model (PMMM) in the analysis of outcomes of a two-year cluster-randomized trial, the Recovery after an Initial Schizophrenia Episode-Early Treatment Program, which compared a coordinated specialty care intervention called NAVIGATE to usual community care (CC). PMM-adjusted outcome differences between NAVIGATE and CC were estimated by the weighted-average of effects across the retention patterns. Results Compared to the original analysis, PMMM improved model fit and the estimated effectiveness of NAVIGATE as compared to CC. On the Quality of Life Scale NAVIGATE effectiveness increased by 1.50 points (25.4%); on the Positive and Negative Syndrome Scale, by 1.72 points (39.8%), and on the Calgary Depression Scale by 0.49 points (62.1%). PMMM did not improve model fit for employment days, substance use days, or hospital days. Conclusion Use of PMMM improved model fit and increased the estimated differences between NAVIGATE and CC for major outcomes. Patients with differential retention patterns may have different outcome trajectories. PMMM is a useful tool for addressing potential biases arising from these differences.

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. Results Approximately one-third of participants reported recent alcohol use (36.6%) and cannabis use (30.7%), and one half (51.7%) met criteria for any lifetime alcohol or drug use disorder. Lifetime substance use disorders were associated with male gender, White race, higher excited (hyperactivity, mood lability, impulsivity, hostility, and uncooperativeness), psychotic and depressive symptoms, less impaired cognition, and greater perceived stigma. Gender, race, and excited symptoms were the most consistent unique predictors of lifetime substance use disorders found in multivariate analyses. Conclusions Half of first episode psychosis patients have co-occurring substance use disorders, which are associated with both more severe symptoms and greater perceptions of stigma. Programs aiming to serve these patients must have the skills and clinical strategies to help people with these unique characteristics.

Study ObjectivesCoordinated specialty care (CSC) is widely accepted as an evidence-based treatment for first episode psychosis (FEP). The NAVIGATE intervention from the Recovery After an Initial Schizophrenia Episode Early Treatment Program (RAISE-ETP) study is a CSC intervention which offers a suite of evidence-based treatments shown to improve engagement and clinical outcomes, especially in those with shorter duration of untreated psychosis (DUP). Coincident with the publication of this study, legislation was passed by the United States Congress in 2014–15 to fund CSC for FEP via a Substance Abuse and Mental Health Services Administration (SAMHSA) block grant set-aside for each state. In Michigan (MI) the management of this grant was delegated to Network180, the community mental health authority in Kent County, with the goal of making CSC more widely available to the 10 million people in MI. Limited research describes the outcomes of implementation of CSC into community practices with no published accounts evaluating the use of the NAVIGATE intervention in a naturalistic setting. We describe the outcomes of NAVIGATE implementation in the state of MI.MethodsIn 2014, 3 centers in MI were selected and trained to provide NAVIGATE CSC for FEP. In 2016 a 4th center was added, and 2 existing centers were expanded to provide additional access to NAVIGATE. Inclusion: age 18–31, served in 1 of 4 FEP centers in MI. Data collection began in 2015 for basic demographics, global illness (CGI q3 mo), hospital/ED use and work/school (SURF q3 mo) and was expanded in 2016 to include further demographics, diagnosis, DUP, vital signs; and in 2018 for clinical symptoms with the modified Colorado Symptom Inventory (mCSI q6 mo), reported via an online portal. This analysis used data until 12/31/19. Mixed effects models adjusted by age, sex and race were used to account for correlated data within patients.ResultsN=283 had useable demographic information and were included in the analysis. Age at enrollment was 21.6 ± 3.0 yrs; 74.2% male; 53.4% Caucasian, 34.6% African American; 12.9 ± 1.7 yrs of education (N=195). 18 mo retention was 67% with no difference by sex or race. CGI scores decreased 20% from baseline (BL) to 18 mo (BL=3.5, N=134; 15–18 mo=2.8, N=60). Service utilization via the SURF was measured at BL (N=172) and 18 mo (N=72): psychiatric hospitalizations occurred in 37% at BL and 6% at 18 mo (pConclusionThe implementation of the NAVIGATE CSC program for FEP in MI resulted in meaningful clinical improvement for enrollees. Further support could make this evidence-based intervention available to more people with FEP.FundingSupported by funds from the SAMHSA Medicaid State Block Grant set-aside awarded to Network180 (Achtyes, Kempema). The funders had no role in the design of the study, the analysis or the decision to publish the results.

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. Receipt of SSA benefits and clinical outcomes were assessed at program entry and every 6 months for 2 years. Piecewise regression analysis was used to identify relative change in outcome trajectories after receipt of disability benefits.Results:Among 399 RAISE-ETP participants, 36 (9%) were receiving SSA disability benefits at baseline; of the remainder, 124 (34.1%) obtained benefits during the 2-year study period. The NAVIGATE inte...

Recovery-oriented practices that promote client-centered care, collaboration, and functional outcome have been recommended to improve treatment engagement, especially for individuals with serious mental illness (SMI). Psychological well-being (PWB) is related to recovery and refers to experiencing purpose and meaning in life through realizing one's potential. The recently completed Recovery After an Initial Schizophrenia Episode Early Treatment Program (RAISE ETP) study sought to improve quality of life, functional outcome, and well-being in individuals with first episode psychosis (FEP). Therefore, the primary aims of the present analysis were: 1) to examine the impact of treatment on PWB and mental health recovery trajectories, 2) to examine the impact of duration of untreated psychosis (DUP) on these outcomes, and 3) to examine the relationships among these outcomes and quality of life. Multilevel modeling was used given the nested data structure. Results revealed that PWB and mental health recovery improved over the course of the 2-year treatment; there were no significant treatment differences. In addition, DUP was associated with the Positive Relationships and Environmental Mastery dimensions of PWB. Finally, PWB, mental health recovery, and quality of life were all significantly correlated at baseline while controlling for depressive symptoms. Overall, the findings indicate that PWB and mental health recovery can improve in FEP, are related to yet distinct from quality of life, and that DUP may play a role in certain facets of these constructs.

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 ≥ 5 h 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. All study participants were offered SEE regardless of their initial interest in work or school. Monthly assessments over 24 months recorded days of employment and attendance at school, days of participation in SEE, and both employment and public support income (including disability income). General Estimation Equation models were used to compare CC and NAVIGATE on work and school participation, employment and public support income, and the mediating effect of receiving ≥ 3 SEE visits on these outcomes. Results NAVIGATE treatment was associated with a greater increase in participation in work or school (p = 0.0486) and this difference appeared to be mediated by SEE. No group differences were observed in earnings or public support payments. Conclusion A comprehensive, team-based FEP treatment approach was associated with greater improvement in work or school participation, and this effect appears to be mediated, in part, by participation in SEE.

Background Psychiatric hospitalization is a major driver of cost in the treatment of schizophrenia. During the first six months after a hospitalization, patients are at increased risk for return to the hospital. Targeting treatment during this period may be especially valuable. Mobilizing a range of treatment enhancements using both smart phones and computers to support patients by individualizing treatment to specific needs may be especially beneficial. The Improving Care Reducing Cost (ICRC) program sought to determine whether a novel, multicomponent, and technology-enhanced approach to relapse prevention in outpatients following a psychiatric hospitalization could reduce days spent in a hospital after discharge. Methods The ICRC study was a quasi-experimental clinical trial in outpatients with schizophrenia conducted between February 2013 and April 2015 at 10 sites in the US that provide both in and outpatient. Data were obtained from 89 participants who received usual relapse prevention services, followed by a second cohort of 349 participants who received technology-enhanced relapse prevention program. Both groups were followed for 6 months. Patients were between 18 and 60 years old; had a diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder not otherwise specified; and were currently hospitalized or had been hospitalized within the past 30 days at consent. The first cohort received usual care; the second cohort received the Health Technology Program (HTP) a technology-enhanced relapse prevention program. HTP included medication treatment guided by a computer decision support system for the prescriber, a smartphone application for patients that supported medication adherence and other coping strategies, a web-based patient and family psycho-educational intervention, and web-accessed cognitive behavioral therapy for paranoia and hallucinations. A mental health technology coach provided technical support, and developed a personalized, structured, relapse prevention plan with each participant that identified individual relapse precipitants and determined which HTP components should be employed to address them. All patients received computers and Android smartphones to insure access to the interventions. Days spent in a psychiatric hospital during 6 months after discharge was assessed. The Heinrichs Carpenter Quality of Life Scale was completed at baseline and six months. Results The study included 438 patients. Control participants (N = 89; 37 females) were enrolled first and received usual care for relapse prevention, and followed by 349 participants (128 females) who received the HTP. Days of hospitalization were reduced by 4 days (Mean days: b = -4.25, 95% CI: -8.29; -0.21, P = 0.039) during follow-up in the intervention condition compared to control. Finally, using Heinrichs Carpenter Quality of Life total score at month 6 as an outcome, we found no significant effect of HTP (β = 0.02, t (345) = 0.43, P = 0.668). Discussion Recently hospitalized patients with schizophrenia who received an integrated technology informed relapse prevention program (HTP) experienced fewer days in the hospital compared to those who received usual care in the six months following their discharge. Given the high patient burden and costs of even a single day spent in a psychiatric hospital, estimated at $1358 per day based on inflation adjusted results from a recent study, our findings imply total savings in psychiatric inpatient expenditures of $5772 during the first 6 months after discharge on average. However, reduction in hospitalization days did not result in a parallel improvement in functioning as assessed by the Quality of Life Scale. Although the control and experimental cohorts were comparable in many characteristics, the quasi–experimental design represented by sequential cohorts rather than a true concurrent randomized controlled trial represents a limitation. The results of the study suggest that technology enhanced treatments that are tailored to patient needs can be implemented in a range of clinical settings in the US to patients at high risk of hospitalization and that the intervention can reduce subsequent hospitalization days. Future research should address limitations in the current study design and will benefit from the development of technology applications that can be available on a single flexible platform.

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.Univariate and multivariate baseline and time-varying covariate analyses were conducted to identify predictors of hospitalization in the Recovery After an Initial Schizophrenia Episode-Early Treatment Program (RAISE-ETP) study, a 2-year cluster randomized trial for participants experiencing a first episode of psychosis who were outpatients at study entry. The trial compared an early intervention treatment model (NAVIGATE) with usual community care at 34 clinics across the United States.RAISE-ETP enrolled 404 participants of whom 382 had one or more postbaseline assessments that included hospitalization data. Thirty-four percent of NAVIGATE and 37% of usual-care participants were hospitalized during the trial. Risk analyses revealed significant predictors of hospitalization to be the number of hospitalizations before study entry; duration of untreated psychosis; and time-varying days of substance misuse, presence of positive symptoms, and beliefs about the value of medication.These results indicate that hospital use may be decreased by reducing the duration of untreated psychosis and prior hospitalizations, minimizing residual symptoms, preventing substance misuse, and facilitating adherence to medication taking. Addressing these factors could enhance the impact of first-episode early intervention treatment models and also enhance outcomes of people with first-episode psychosis treated using other models.

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. Study prescribers also received training on prescribing guidelines. Results At the 19 US outpatient clinics randomized to provide LAI antipsychotic treatment, 576 potential participants were identified who met inclusion criteria based on a screening interview. Of these, 83 (14.4%) declined participation because they would not consider LAI antipsychotic treatment and 165 (28.6%) declined for other reasons, resulting in 328 providing written study consent. The first post-consent visit included detailed evaluations to confirm inclusion/exclusion criteria. Thirty-nine participants who consented did not complete this evaluation and 55 were found to not meet criteria, resulting in a final sample of 234 participants. Two hundred thirteen (91.0%) accepted at least one LAI antipsychotic injection during their first 3 months of study participation. Conclusions Large numbers of early-phase patients with schizophrenia were willing to participate in an LAI antipsychotic trial and by inference in non-study LAI antipsychotic treatment. LAI antipsychotic-focused staff training has the potential to substantially enhance the use of LAI antipsychotics. Trial registration ClinicalTrials.gov identifier: NCT02360319.

Objective:The primary aim of this study was to compare the impact of NAVIGATE, a comprehensive, multidisciplinary, team-based treatment approach for first-episode psychosis designed for implementation in the U.S. health care system, with community care on quality of life.Method:Thirty-four clinics in 21 states were randomly assigned to NAVIGATE or community care. Diagnosis, duration of untreated psychosis, and clinical outcomes were assessed via live, two-way video by remote, centralized raters masked to study design and treatment. Participants (mean age, 23) with schizophrenia and related disorders and ≤6 months of antipsychotic treatment (N=404) were enrolled and followed for ≥2 years. The primary outcome was the total score of the Heinrichs-Carpenter Quality of Life Scale, a measure that includes sense of purpose, motivation, emotional and social interactions, role functioning, and engagement in regular activities.Results:The 223 recipients of NAVIGATE remained in treatment longer, experienced greater ...

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. Descriptive statistics were used to analyze and report data. Results In total, 3070 patients with different age ranges participated. The overall experience using telepsychiatry was either excellent or good for 1189 (82.2%) participants using video and 2312 (81.5%) using telephone. In addition, 1922 (63.6%) patients either agreed or strongly agreed that remote treatment sessions (telephone or video) have been just as helpful as in-person treatment. Lack of commute (n=1406, 46.1%) and flexible scheduling/rescheduling (n=1389, 45.5%) were frequently reported advantages of telepsychiatry, whereas missing the clinic/hospital (n=936, 30.7%) and not feeling as connected to their doctor/nurse/therapist (n=752, 24.6%) were the most frequently reported challenges. After the current pandemic resolves, 1937 (64.2%) respondents either agreed or strongly agreed that they would consider using remote treatment sessions in the future. Conclusions Telepsychiatry is very well perceived among a large sample of patients. After the current pandemic resolves, some patients may benefit from continued telepsychiatry, but longitudinal studies are needed to assess impact on clinical outcomes and determine whether patients’ perceptions change over time.

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. The study began in December 2014, was completed in March 2019, and was conducted in 39 mental health centers in 19 US states. Site randomization assigned 19 clinics to encourage treatment with long-acting aripiprazole monohydrate (aripiprazole once monthly [AOM] condition) and 20 to provide treatment as usual (clinician’s choice [CC] condition). Participant eligibility criteria included (1) schizophrenia diagnosis confirmed by a structured clinical interview, (2) fewer than 5 years of lifetime antipsychotic use, and (3) age 18 to 35 years. The AOM sites identified 576 potentially eligible participants, of whom 234 (40.6%) enrolled; CC sites identified 685 potentially eligible participants, of whom 255 (37.2%) enrolled. Interventions There were no restrictions on treatment at CC sites (including using LAIs) or at AOM sites with the exception that aripiprazole monohydrate had to be prescribed within US Food and Drug Administration–approved guidelines. Main Outcomes and Measures The primary outcome was time to first psychiatric hospitalization based on participant interviews every 2 months, the service use resource form administered every 4 months, and other sources (eg, health records) as available. Potential events were adjudicated by an independent committee masked to treatment assignment. Results The 489 participants (368 men [75.3%]) had a mean (SD) age of 25.2 (4.2) years and 225 (46.0%) had 1 year or less lifetime antipsychotic use. Fifty-two AOM (22%) and 91 CC participants (36%) had at least 1 hospitalization. The mean survival time until first hospitalization was 613.7 days (95% CI, 582.3-645.1 days) for AOM participants and 530.6 days (95% CI, 497.3-563.9 days) for CC participants. For time to first hospitalization, the hazard ratio was 0.56 (95% CI, 0.34- 0.92;P = .02), favoring AOM. Survival probabilities were 0.73 (95% CI, 0.65-0.83) for AOM participants and 0.58 (95% CI, 0.50-0.67) for CC participants. The number needed to treat to prevent 1 additional hospitalization was 7 participants treated with AOM compared with CC. Conclusions and Relevance Long-acting injectable antipsychotic use by patients with early-phase schizophrenia can significantly delay time to hospitalization, a personally and economically important outcome. Clinicians should more broadly consider LAI treatment for patients with early-phase illness. Trial Registration ClinicalTrials.gov Identifier:NCT02360319

Background Even with early intervention services, a third or more of first-episode patients are hospitalized over the first 2 yrs. of treatment. Non-adherence is a major factor in increasing risk of hospitalization. Long-acting injectable antipsychotics (LAI’s) have shown effectiveness in addressing this concern in both mirror image and cohort studies. However, randomized controlled trials (RCT’s) have reported mixed results. RCT’s can change the ecology of care and do not reflect “real world” conditions, particularly when adherence is a focus of study. The large simple trial (LST) is a design intended to address such concerns. Methods The PRELAPSE trial was a LST involving cluster randomization of 39 clinics. 19 sites were randomized to provide LAI treatment-the Aripiprazole Once Monthly (AOM) condition and 20 sites to treatment as usual-Clinician’s Choice (CC). The primary hypothesis was that the opportunity for treatment with AOM would significantly delay time to first hospitalization. Inclusion criteria were: 1) schizophrenia diagnosis confirmed by a Structured Clinical Interview for DSM-5, Research Version (SCID-5); 2) A key challenge in conducting this study was facilitating the acceptance of LAI’s among early phase patients at the experimental sites. AOM-specific training included information on the role of non-adherence in relapse/hospitalization, the effectiveness of LAIs in this context, the rationale for LAI use and selection of aripiprazole; shared decision-making principles; discussing LAIs with patients/ families; discussion of transition to LAI’s and prescribing guidelines consistent with the package insert for AOM. Training included providing suggested “scripts,” frequently asked questions, role-playing and overcoming logistical barriers to the use of LAIs across different healthcare settings. Results The 489 participating subjects had a mean age of 25, 75% were male, 44% African-American and 35% Caucasian. 46.0% had There were 489 subjects (234 AOM and 255 CC). A total of 52 AOM subjects had at least one hospitalization (22.2%) and 90 CC subjects had a least one (35.3%). For time to first hospitalization, under the proportional hazards assumption, the hazard ratio was HR=0.56 (95% CI = 0.34, 0.92), p=0.02.The estimated survival probabilities and 95% CI’s from the Cox model were 0.73 (0.65, 0.83) for AOM subjects and 0.58 (0.50, 0.67) for CC subjects. This translates to a number needed to treat (NNT) for prevention of one additional hospitalization for every 6.67 subjects treated with AOM relative to CC. Discussion This study demonstrates the feasibility of engaging the overwhelming majority of early phase patients in the use of LAI’s if clinical staff are well trained. The use of LAI’s in this population produced a significant delay in time to hospitalization and a NNT of 7 for the prevention of hospitalization.

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.gov without language restrictions through June 6, 2017. Study Selection: Randomized trials comparing EIS vs TAU in first-episode psychosis or early-phase schizophrenia spectrum disorders. Data Extraction and Synthesis: This systematic review was conducted according to PRISMA guidelines. Three independent investigators extracted data for a random-effects meta-analysis and prespecified subgroup and meta-regression analyses. Main Outcomes and Measures: The coprimary outcomes were all-cause treatment discontinuation and at least 1 psychiatric hospitalization during the treatment period. Results Across 10 randomized clinical trials (mean [SD] trial duration, 16.2 [7.4] months; range, 9-24 months) among 2176 patients (mean [SD] age, 27.5 [4.6] years; 1355 [62.3%] male), EIS was associated with better outcomes than TAU at the end of treatment for all 13 meta-analyzable outcomes. These outcomes included the following: all-cause treatment discontinuation (risk ratio [RR], 0.70; 95% CI, 0.61-0.80; P

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. The survey included self-reported gender, age, weight, and height, and questions about the importance of efficacy and side effects on the decision to take a prescribed antipsychotic medication. Results Patients rated efficacy and side effects as important attributes of antipsychotic treatment, with 93.6% and 83.6% of patients listing these as “very” or the “most” important factors in taking prescribed medication. A total of 87.6% of respondents identified the ability to think more clearly as an important property of their medication. Patients identified weight gain, physical restlessness, and somnolence as important side effects of current treatments (“very” or “most” important by 61.6%, 60.8%, and 58.8%, respectively). When asked about willingness to change antipsychotic medication, anticipated weight gain had a negative influence on willingness to try the new treatment, with 22.0% declining to try a medication that would lead to weight gain of 2.7–4.5 kg (6–10 lb), 34.0% declining for anticipated weight gain of 5.0–9.1 kg (11–20 lb), and 52.4% declining for anticipated weight gain greater than 9 kg (20 lbs). Conclusion Patients living with schizophrenia spectrum disorders are influenced by many factors when considering whether to take their medication, including efficacy and side effects. It is important for clinicians to assess specific patient concerns to develop a comprehensive treatment plan that maximizes adherence to the prescribed therapy.

Objective The premise of the National Institute of Mental Health Recovery After an Initial Schizophrenia Episode Early Treatment Program (RAISE-ETP) is to combine state-of-the-art pharmacologic and psychosocial treatments delivered by a well-trained, multidisciplinary team in order to significantly improve the functional outcome and quality of life for first-episode psychosis patients. The study is being conducted in non-academic (ie, real-world) treatment settings, using primarily extant reimbursement mechanisms. Method We developed a treatment model and training program based on extensive literature review and expert consultation. Our primary aim is to compare the experimental intervention to "usual care" on quality of life. Secondary aims include comparisons on remission, recovery, and cost-effectiveness. Patients 15-40 years old with a first episode of schizophrenia, schizoaffective disorder, schizophreniform disorder, psychotic disorder not otherwise specified, or brief psychotic disorder according to DSM-IV and no more than 6 months of treatment with antipsychotic medications were eligible. Patients are followed for a minimum of 2 years, with major assessments conducted by blinded, centralized raters using live, 2-way video. We selected 34 clinical sites in 21 states and utilized cluster randomization to assign 17 sites to the experimental treatment and 17 to usual care. Enrollment began in July 2010 and ended in July 2012 with 404 subjects. The results of the trial will be published separately. The goal of the article is to present both the overall development of the intervention and the design of the clinical trial to evaluate its effectiveness. Conclusions We believe that we have succeeded in both designing a multimodal treatment intervention that can be delivered in real-world clinical settings and implementing a controlled clinical trial that can provide the necessary outcome data to determine its impact on the trajectory of early phase schizophrenia. Trial registration ClinicalTrials.gov identifier: NCT01321177.

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). Three-level conditional linear growth modeling was used given the nested data structure. Results: The results indicated that perceived autonomy support increased significantly over time for those in NAVIGATE but not in community care. Once treatment began, higher perceived autonomy support was related to higher quality of life at six, 12, and 18 months in NAVIGATE and at 12, 18, and 24 months in community care. Higher perceived autonomy support was related to improved scores on total symptoms and on excited symptoms regardless of treatment group and time. Conclusions: Overall, perceived autonomy support increased in NAVIGATE but not for those in community care and was related to improved quality of life and symptoms across both treatment groups. Future research should examine the impact of perceived autonomy support on a wider array of outcomes, including engagement, medication adherence, and functioning.

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. Black Americans were also less likely to have private insurance, more likely to be homeless or transient, had significantly poorer quality of life, more severe disorganized symptoms, worse neurocognition, and were less likely to abuse alcohol than Caucasians. The implications of these findings are discussed, and suggestions are provided for future avenues of treatment and research on racial disparities in first-episode psychosis.

Study objectivePatient-reported outcomes and preferences rely on reports of the status of a patient’s health condition that comes directly from the patient, without interpretation or qualification by clinicians or investigators. Patient-reported outcomes and preferences have become an accepted approach in drug development. As part of this effort, we assessed the relative importance to patients with schizophrenia of trying a new antipsychotic that might improve symptoms in the context of common antipsychotic side effects, especially weight gain. Information from surveys such as this one can provide pilot guidance about what might be acceptable versus unacceptable trade-offs when considering new therapies for schizophrenia.MethodsWe prospectively administered a cross-sectional survey to 250 patients with clinical diagnoses of schizophrenia or schizoaffective disorder, aged ≥18 years, from five US outpatient community clinics, regarding the importance of efficacy and side effects on treatment decisions involving medications. Sixty-four percent (n=160) of the patients were male; mean age was 43 years (range: 18–72 years); mean weight was 91 kg (range: 49–182 kg); and mean body mass index was 30.3 kg/m2 (range: 15.3–63.3 kg/m2).ResultsPatients rated both efficacy and side effects as important attributes of medication for schizophrenia treatment, with 88.5% identifying the ability to think more clearly as an important property of their medication. Patients identified efficacy and side effects as important drivers to take their prescribed medicine (endorsed as very or most important by 94.3% and 84.0% of patients, respectively). Patients identified weight gain, physical restlessness and somnolence as significant side effects of current treatments for schizophrenia (very/most important by 61.5%, 60.4%, and 58.9%, respectively). When asked about willingness to change antipsychotics, anticipated weight gain had a strong negative influence on willingness to try a new antipsychotic, with 44.9% of patients declining to try a medication that would lead to a weight gain of 3–5 kg, and 70.8% of patients declining for an anticipated weight gain of 5–9kg.ConclusionPatients living with schizophrenia or schizoaffective disorder are influenced by many factors when considering whether to take their prescribed medication, including efficacy and side effects. It is important for clinicians to assess patient-specific concerns and develop a comprehensive treatment plan to maximize adherence to prescribed therapies.Funding Acknowledgements: This study was funded by Alkermes, Inc.

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. Objective Our aim was to evaluate the viability of extended mHealth interventions for people with schizophrenia-spectrum disorders following hospital discharge. Specifically, we set out to examine the following: (1) Can individuals be engaged with a mobile phone intervention program during this high-risk period?, (2) Are age, gender, racial background, or hospitalization history associated with their engagement or persistence in using a mobile phone intervention over time?, and (3) Does engagement differ by characteristics of the mHealth intervention itself (ie, pre-programmed vs on-demand functions)? Methods We examined mHealth intervention use and demographic and clinical predictors of engagement in 342 individuals with schizophrenia-spectrum disorders who were given the FOCUS mobile phone intervention as part of a technology-assisted relapse prevention program during the 6-month high-risk period following hospitalization. Results On average, participants engaged with FOCUS for 82% of the weeks they had the mobile phone. People who used FOCUS more often continued using it over longer periods: 44% used the intervention over 5-6 months, on average 4.3 days a week. Gender, race, age, and number of past psychiatric hospitalizations were associated with engagement. Females used FOCUS on average 0.4 more days a week than males. White participants engaged on average 0.7 days more a week than African-Americans and responded to prompts on 0.7 days more a week than Hispanic participants. Younger participants (age 18-29) had 0.4 fewer days of on-demand use a week than individuals who were 30-45 years old and 0.5 fewer days a week than older participants (age 46-60). Participants with fewer past hospitalizations (1-6) engaged on average 0.2 more days a week than those with seven or more. mHealth program functions were associated with engagement. Participants responded to prompts more often than they self-initiated on-demand tools, but both FOCUS functions were used regularly. Both types of intervention use declined over time (on-demand use had a steeper decline). Although mHealth use declined, the majority of individuals used both on-demand and system-prompted functions regularly throughout their participation. Therefore, neither function is extraneous. Conclusions The findings demonstrated that individuals with schizophrenia-spectrum disorders can actively engage with a clinically supported mobile phone intervention for up to 6 months following hospital discharge. mHealth may be useful in reaching a clinical population that is typically difficult to engage during high-risk periods.

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).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.A total of 200 patients (mean±SD age=34.6±10.6 years) had 28.2±2.0 contacts with the MHTC that lasted 38.3±14.2 minutes. The most discussed topic was case management (52%), and digital tools were discussed in 45% of meetings. Altogether, 87% of patients used at least one of the digital tools, with 96% of patients rating the HTP as satisfying to at least some extent.These data suggest very high acceptance of the HTP, a program that integrates available human support with digital tools.

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). Incremental cost effectiveness ratios were evaluated with bootstrap distributions. The Net Health Benefits Approach was used to evaluate the probability that the value of NAV benefits exceeded its costs relative to CC from the perspective of the health care system. The NAV group improved significantly more on the QLS and had higher outpatient mental health and antipsychotic medication costs. The incremental cost-effectiveness ratio was $12 081/QLS-SD, with a .94 probability that NAV was more cost-effective than CC at $40 000/QLS-SD. When converted to monetized Quality Adjusted Life Years, NAV benefits exceeded costs, especially at future generic drug prices.

Despite advances in schizophrenia treatment, symptom relapses and rehospitalizations impede recovery for many people and are a principal driver of the high cost of care. Technology-delivered or technology-enhanced treatment may be a cost-effective way to provide flexible, personalized evidence-based treatments directly to people in their homes and communities. However, evidence for the safety, acceptability, and efficacy of such interventions is only now being established. The authors of this Open Forum describe a novel, technology-based approach to prevent relapse after a hospitalization for psychosis, the Health Technology Program (HTP), which they developed. HTP provides in-person relapse prevention planning that directs use of tailored, technology-based treatment based on cognitive-behavioral therapy for psychosis, family psychoeducation for schizophrenia, and prescriber decision support through a Web-based program that solicits information from clients at every visit. Technology-based treatments are delivered through smartphones and computers.

Objective:This study is the first to examine duration of untreated psychosis (DUP) among persons receiving care in community mental health centers in the United States.Methods:Participants were 404 individuals (ages 15–40) who presented for treatment for first-episode psychosis at 34 nonacademic clinics in 21 states. DUP and individual- and site-level variables were measured.Results:Median DUP was 74 weeks (mean=193.5±262.2 weeks; 68% of participants had DUP of greater than six months). Correlates of longer DUP included earlier age at first psychotic symptoms, substance use disorder, positive and general symptom severity, poorer functioning, and referral from outpatient treatment settings.Conclusions:This study reported longer DUP than studies conducted in academic settings but found similar correlates of DUP. Reducing DUP in the United States will require examination of factors in treatment delay in local service settings and targeted strategies for closing gaps in pathways to specialty FEP care.

Objective:Treatment guidelines suggest distinctive medication strategies for first-episode and multiepisode patients with schizophrenia. To assess the extent to which community clinicians adjust their usual treatment regimens for first-episode patients, the authors examined prescription patterns and factors associated with prescription choice in a national cohort of early-phase patients.Method:Prescription data at study entry were obtained from 404 participants in the Recovery After an Initial Schizophrenia Episode Project’s Early Treatment Program (RAISE-ETP), a nationwide multisite effectiveness study for patients with first-episode schizophrenia spectrum disorders. Treatment with antipsychotics did not exceed 6 months at study entry.Results:The authors identified 159 patients (39.4% of the sample) who might benefit from changes in their psychotropic prescriptions. Of these, 8.8% received prescriptions for recommended antipsychotics at higher than recommended dosages; 32.1% received prescriptions for ol...

Importance The fact that individuals with schizophrenia have high cardiovascular morbidity and mortality is well established. However, risk status and moderators or mediators in the earliest stages of illness are less clear. Objective To assess cardiometabolic risk in first-episode schizophrenia spectrum disorders (FES) and its relationship to illness duration, antipsychotic treatment duration and type, sex, and race/ethnicity. Design, Setting, and Participants Baseline results of the Recovery After an Initial Schizophrenia Episode (RAISE) study, collected between July 22, 2010, and July 5, 2012, from 34 community mental health facilities without major research, teaching, or clinical FES programs. Patients were aged 15 to 40 years, had research-confirmed diagnoses of FES, and had less than 6 months of lifetime antipsychotic treatment. Exposure Prebaseline antipsychotic treatment was based on the community clinician’s and/or patient’s decision. Main Outcomes and Measures Body composition and fasting lipid, glucose, and insulin parameters. Results In 394 of 404 patients with cardiometabolic data (mean [SD] age, 23.6 [5.0] years; mean [SD] lifetime antipsychotic treatment, 47.3 [46.1] days), 48.3% were obese or overweight, 50.8% smoked, 56.5% had dyslipidemia, 39.9% had prehypertension, 10.0% had hypertension, and 13.2% had metabolic syndrome. Prediabetes (glucose based, 4.0%; hemoglobin A 1c based, 15.4%) and diabetes (glucose based, 3.0%; hemoglobin A 1c based, 2.9%) were less frequent. Total psychiatric illness duration correlated significantly with higher body mass index, fat mass, fat percentage, and waist circumference (all P P = .04]). Conversely, antipsychotic treatment duration correlated significantly with higher non–HDL-C, triglycerides, and triglycerides to HDL-C ratio and lower HDL-C and systolic blood pressure (all P ≤ .01). In multivariable analyses, olanzapine was significantly associated with higher triglycerides, insulin, and insulin resistance, whereas quetiapine fumarate was associated with significantly higher triglycerides to HDL-C ratio (all P ≤ .02). Conclusions and Relevance In patients with FES, cardiometabolic risk factors and abnormalities are present early in the illness and likely related to the underlying illness, unhealthy lifestyle, and antipsychotic medications, which interact with each other. Prevention of and early interventions for psychiatric illness and treatment with lower-risk agents, routine antipsychotic adverse effect monitoring, and smoking cessation interventions are needed from the earliest illness phases.