The NAVIGATE Program for First-Episode Psychosis: Rationale, Overview, and Description of Psychosocial Components

Comprehensive coordinated specialty care programs for first episode psychosis have been widely implemented in other countries, but not in the U.S. The National Institute of Mental Health’s (NIMH) Recovery After Initial Schizophrenia Episode (RAISE) initiative focused on the development and evaluation of first episode treatment programs designed for the U.S. healthcare system. This paper describes the background, rationale, and nature of the intervention developed by the Early Treatment Program project, the NAVIGATE program, with a particular focus on its psychosocial components. NAVIGATE is a team-based, multi-component treatment program designed to be implemented in routine mental health treatment settings and aimed at guiding people with a first episode of psychosis (and their families) towards psychological and functional health. The core services provided in the NAVIGATE program include the Family Education Program, Individual Resiliency Training, Supported Employment and Education, and Individualized Medication Treatment. NAVIGATE embraces a shared decision-making approach with a focus on strengths and resiliency, and collaboration with clients and family members in treatment planning and reviews. The NAVIGATE program has the potential to fill an important gap in the U.S. healthcare system by providing a comprehensive intervention specially designed to meet the unique treatment needs of persons recovering from a first episode of psychosis. The program is currently being evaluated in cluster randomized controlled trial comparing NAVIGATE to usual community care

Need for Cardiovascular Risk Reduction in Persons With Serious Mental Illness: Design of a Comprehensive Intervention

Persons with serious mental illness (SMI) comprise a high-risk group for cardiovascular disease (CVD)-related mortality with rates at least twice those of the overall US. Potentially modifiable CVD risk behaviors (tobacco smoking, obesity, physical inactivity, unhealthy diet) and risk factors (hypertension, diabetes, dyslipidemia) are all markedly elevated in persons with SMI. Evaluations of programs implementing integrated medical care into specialty mental health settings have not shown meaningful effects on CVD risk factor reduction. Rigorously tested, innovative interventions are needed to address the large burden of CVD risk in populations with SMI. In this article, we describe the design of a comprehensive 18-month intervention to decrease CVD risk that we are studying in a randomized clinical trial in a community mental health organization with psychiatric rehabilitation programs. The individual-level intervention incorporated health behavior coaching and care coordination/care management to address all seven CVD risk behaviors and risk factors, and is delivered by a health coach and nurse. If successful, the intervention could be adopted within current integrated care models and significantly improve the physical health of persons with SMI

A randomized controlled trial of varenicline and brief behavioral counseling delivered by lay counselors for adolescent vaping cessation: Study protocol

BackgroundApproximately one-fifth of high-school seniors and college students currently vape nicotine. Adolescents express a desire to quit vaping, and case reports have shown promise for e-cigarette tapering with dual behavioral and pharmacologic therapies. However, there are no published clinical trials to date that test these intervention approaches for adolescent nicotine vaping cessation. In this three-arm randomized, placebo-controlled, parallel-group study, we aim to assess the efficacy of varenicline in combination with brief behavioral counseling and texting support on vaping cessation in adolescents dependent on vaped nicotine.MethodsThe study will enroll 300 individuals between the ages of 16–25 with daily or near-daily nicotine vaping who reside in the Greater Boston area. Participants will be randomly assigned in a 1:1:1 ratio in blocks of six to one of the three arms: (1) a 12-week course of varenicline titrated to 1 mg bid, brief behavioral counseling delivered by a lay counselor, and an introduction to This is Quitting (TIQ) texting support created by the Truth Initiative; (2) a 12-week course of placebo, brief behavioral counseling, and TIQ; and (3) 12 weeks of enhanced usual care, consisting of advice to quit and an introduction to TIQ. The primary outcome will be biochemically verified continuous vaping abstinence at the end of the treatment (week 12). Secondary outcomes include continuous abstinence at follow-up (week 24), 7-day point prevalence abstinence at weeks 12 and 24, safety and tolerability of varenicline in an adolescent vaping population, as well as change in mood and nicotine withdrawal symptoms across the intervention period. Exploratory outcomes include change in comorbid substance use behaviors and nicotine dependence. Analysis will be intent-to-treat, with multiple imputation sensitivity analyses for participants with missing or incomplete outcome data.DiscussionThis is the first study to evaluate varenicline in combination with a novel, brief, lay counselor delivered vaping cessation program for adolescents who vape nicotine. Results will inform clinicians on the effectiveness and acceptability of this promising, but not yet tested intervention.Clinical trial registration: ClinicalTrials.gov, identifier NCT05367492

The alliance-outcome relationship in individual psychosocial treatment for schizophrenia and early psychosis : A meta-analysis

The therapeutic alliance, or client-provider relationship, has been associated with better treatment engagement and outcomes for persons with schizophrenia-spectrum disorders (SSDs) and early psychosis in some studies, but not others. We conducted a meta-analysis of the research on alliance in SSDs and early psychosis across a range of interventions and outcomes. Parallel literature searches were conducted in PubMed and PsycINFO databases for articles between inception and 6/11/2020. English-language studies were included if they evaluated the relationship between alliance and a prospective outcome (treatment engagement, medication adherence, functioning, or total, positive, negative, or depressive symptoms) in an individual clinical treatment for SSDs/early psychosis and contained analyzable data. Correlations and partial correlations were meta-analyzed with random effects models to calculate mean across-study correlations and to carry out subsequent homogeneity and moderator variable analyses. Fourteen studies consisting of 2968 participants that assessed six outcomes across six psychosocial treatments were included. Results indicated that better client-rated (r = 0.20) and other-rated (i.e., provider- or observer-rated; r = 0.25) alliance were associated with better treatment engagement. Treatment type and sample race/ethnicity, but not age, gender, or timing of alliance rating moderated the association between other-rated alliance and engagement. Further, better other-rated alliance was related to improvements in positive (r = −0.14) and negative (r = −0.22) symptoms. A strong therapeutic alliance is important for both engaging clients with SSDs and early psychosis in treatment and facilitating improvements in positive and negative symptoms. Delivery and monitoring of treatments for this population should include assessment of the therapeutic alliance from multiple perspectives

Clinical and psychosocial outcomes of Black Americans in the Recovery After an Initial Schizophrenia Episode Early Treatment Program (RAISE-ETP) study

PURPOSE: In the US, Black people diagnosed with schizophrenia experience worse psychosocial and clinical outcomes than their White counterparts. While racism-related factors contribute to these disparities, an additional understudied explanation may be that psychosocial treatments for psychotic disorders are less effective for Black than White individuals. The purpose of this study is to examine the extent to which best treatment practices for first-episode psychosis (FEP) are effective for Black and White participants. METHODS: We conducted a secondary data analysis of the Recovery After an Initial Schizophrenia Episode Early Treatment Program (RAISE-ETP), a two-year multisite trial that compared a coordinated specialty care intervention for FEP (NAVIGATE) to community care as usual (CC) in 34 sites across the US. Specifically, we compared interviewer-rated quality of life and symptoms, as well as self-reported mental health and stigma, between 139 Non-Latinx Black and 172 Non-Latinx White participants with FEP in NAVIGATE and CC. RESULTS: We found few differences between Black and White participants over two-year outcomes, either overall or in terms of benefit from NAVIGATE. Across both treatment conditions, Black participants improved less than White participants on positive symptoms, an effect driven primarily by suspiciousness/persecution. In NAVIGATE, self-reported mental health stigma decreased for both Black and White participants, while in CC stigma decreased for White participants but increased for Black participants. This effect was driven primarily by experienced stigma rather than self-stigma. CONCLUSION: NAVIGATE benefits both Black and White individuals diagnosed with FEP. Mental health stigma and positive symptoms may be particularly important aspects of treatment for Black individuals diagnosed with FEP