Susan Gingerich

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 United States. The National Institute of Mental Healths Recovery After an Initial Schizophrenia Episode (RAISE) initiative focused on the development and evaluation of first-episode treatment programs designed for the U.S. health care system. This article describes the background, rationale, and nature of the intervention developed by the RAISE Early Treatment Program project-known as the NAVIGATE program-with a particular focus on its psychosocial components. NAVIGATE is a team-based, multicomponent 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) toward psychological and functional health. The core services provided in the NAVIGATE program include the family education program (FEP), individual resiliency training (IRT), supported employment and education (SEE), and individualized medication treatment. NAVIGATE embraces a shared decision-making approach with a focus on strengths and resiliency and on 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. health care system by providing a comprehensive intervention specially designed to meet the unique treatment needs of persons recovering from a first episode of psychosis. A cluster-randomized controlled trial comparing NAVIGATE with usual community care has recently been completed.

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. 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.

Treatment of co-occurring psychotic and substance use disorders.

People with psychotic disorders and other serious mental illnesses, such as schizophrenia, bipolar disorder, and severe major depression, have high rates of co-occurring substance use disorder, which can wreak havoc in their lives. In this article the authors describe strategies for assessing substance use problems in people with serious mental illnesses, and then address the treatment of these co-occurring disorders. The authors review principles of treatment of co-occurring disorders, including integration of mental health and substance abuse services, adopting a low-stress and harm-reduction approach, enhancing motivation, using cognitive-behavioral therapy strategies to teach more effective interpersonal and coping skills, supporting functional recovery, and engaging the social network. The authors include a section on how social workers may play a key role in assessment, treatment, or referral for co-occurring disorders in a variety of settings. Throughout the article the authors emphasize that belief in the possibility of recovery from co-occurring disorders and instilling hope in clients, their family members, and other treatment providers, are vital to the effective treatment of co-occurring disorders.

Coordinated Technology-Delivered Treatment to Prevent Rehospitalization in Schizophrenia: A Novel Model of Care

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.

Individual Resiliency Training: An Early Intervention Approach to Enhance Well-Being in People with First-Episode Psychosis

Early intervention treatment programs have begun to play an increasingly important role in improving long-term outcomes for people with psychosis. These programs focus on helping people achieve recovery through reducing the risk of relapse, improving illness self-management skills, and making progress toward a meaningful life. This article describes Individual Resiliency Training (IRT), the individual therapy component of the Recovery After Initial Schizophrenia Episode Early Treatment Program (RAISE-ETP). As part of a comprehensive specialty care program for people with first-episode psychosis (FEP), IRT uses a strengths-based approach that focuses on progress toward individual recovery goals, as well as improving social functioning and overall well-being. IRT addresses recovery by engaging in illness self-management, Cognitive Behavior Therapy for Psychosis, and psychiatric rehabilitation skills. Two illustrative cases show how people can use information and skills within the IRT modules to make progress toward recovery and learn individualized skills to address common challenges. Within a coordinated specialty care program, IRT provides strategies and skills that promote recovery and resiliency, and shows promise toward improved illness outcomes for people with FEP. [Psychiatr Ann. 2015;45(11):554560.] Piper S. Meyer, PhD, is the Center Director, Minnesota Center for Chemical and Mental Health, University of Minnesota School of Social Work. Jennifer D. Gottlieb, PhD, is a Research Assistant Professor, Center for Psychiatric Rehabilitation, Departments of Occupational Therapy, Psychiatry, and Psychology, Boston University. David Penn, PhD, is the Linda-Wagner Martin Distinguished Professor, Department of Psychology, University of North Carolina. Kim Mueser, PhD, is the Executive Director, Center for Psychiatric Rehabilitation, Department of Occupational Therapy, Boston University. Susan Gingerich, MSW, is an Independent Trainer and Consultant. Address correspondence to Piper S. Meyer, PhD, Minnesota Center for Chemical and Mental Health, 1404 Gortner Avenue, 170 Peters Hall, St. Paul, MN 55108; email: psmeyer@umn.edu. Disclosure: The authors have no relevant financial relationships to disclose. 10.3928/00485713-20151103-06

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. 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.

T255. WHO PARTICIPATED IN FAMILY WORK IN THE US RAISE-ETP FIRST EPISODE SAMPLE?

Abstract Background The Recovery After an Initial Schizophrenia Episode Early Treatment Program (RAISE-ETP) is a US NIMH-funded 34 site cluster randomized controlled trial which evaluated the benefits of participation in a multicomponent intervention, entitled NAVIGATE, for first episode psychosis (FEP). Previously, participation in NAVIGATE was reported to yield significant participant benefits, compared to customary care (Kane et al, 2016). NAVIGATE included tailored medication, individual resiliency training, family education, and supported education and employment. Here we examine the absolute rate of family engagement in professional support services in the intent to treat sample, as well identify predictors of participation. Methods A total of 404 individuals between ages 15 and 40 were enrolled. DSM-IV diagnoses of non-affective psychosis were included. All participants had experienced only one episode of psychosis, had been prescribed less than 6 months of lifetime psychotic medication, spoke English, and provided informed consent. Participants were offered a minimum of two years of NAVIGATE or customary care (CC). At baseline, participants provided demographic and clinical history information; they were administered the Heinrichs-Carpenter Quality of Life Scale (QOL) and the Positive and Negative Symptom Scale (PANSS). Site research assistants interviewed participants monthly to capture participation in the four types of NAVIGATE interventions, allowing treatment groups to be compared on receipt of key services. Results One hundred nineteen of the 404 participants (29.4%) reported their relatives attending five or more family sessions within the first year of randomization (102 families (45.74%) in NAVIGATE; 17 (9.39%) in CC). In a simultaneous logistic regression analysis predicting meeting this five family sessions threshold or not, significant independent predictors (all p <. 05) included treatment group, consumer negative symptoms, consumer self-reported quality of family relationship, race, and consumer residence. Relatives were more likely to attend family sessions if their loved one was 1) randomized to NAVIGATE, 2) had greater negative symptoms on the PANSS, 3) self-reported as emotionally closer to the family, 4) was Caucasian, and 5) lived with family. Other consumer PANSS and QOL scores, consumer age, ethnicity, health insurance status, cigarette smoking status, and consumers’ mother education were not significant independent predictors. Discussion Although the benefits of family support and education have been highlighted for persons with a recent onset of psychosis, the results here suggest that engaging relatives in these services, at least in the US, can be challenging. Even given a relatively low threshold of attendance at least 5 family sessions in the first year of treatment, the majority of this sample did not meet the criterion, although participation rates were significantly higher in NAVIGATE. This increase likely reflects the effort NAVIGATE teams expended to engage relatives. It is perhaps not surprising that families of consumers who live with them and/or report feeling closer to them are more likely to attend clinic sessions. Interestingly, higher levels of consumer negative, but not positive symptoms, were also associated with greater attendance at family sessions; this finding suggests that living with a consumer who appears unmotivated and withdrawn may be particularly challenging and prompt relatives to seek more assistance. Finally, our data on race suggest, as other have noted, that greater outreach may be needed to engage non-Caucasian families in services.

F249. FAMILY BURDEN IN THE US RAISE-ETP PROGRAM: TREATMENT EFFECTS AND PREDICTORS

Abstract Background The Recovery After an Initial Schizophrenia Episode Early Treatment Program (RAISE-ETP) is a US NIMH-funded 34 site cluster randomized controlled trial evaluating the benefits of participation in a multicomponent intervention for first episode psychosis (FEP). Previously, participation in the RAISE-ETP comprehensive specialty care (CSC) program, entitled NAVIGATE, was reported to yield significant participant clinical and functional improvements, compared to customary care (Kane et al, 2016). NAVIGATE included tailored medication, individual resiliency training, family education, and supported education and employment. Family burden has been identified as a key factor in FEP, with high levels of distress often found in relatives. Here, we look at the presence and predictors of family burden in relatives in the RAISE-ETP sample over the two years of study participation. Methods A total of 404 individuals between ages 15 and 40 were enrolled. DSM-IV diagnoses of non-affective psychosis were included. All participants had experienced only one episode of psychosis, had been prescribed less than 6 months of lifetime psychotic medication, spoke English, and provided informed consent. Participants were offered a minimum of two years of CSC or customary care. At baseline, participants provided demographic and clinical history information; they were administered the Heinrichs-Carpenter Quality of Life Scale (QOL) and the Positive and Negative Symptom Scale (PANSS) regularly throughout the study. Each participant was asked to nominate a family member for administration of the Burden Assessment Scale (BAS) throughout the study. The BAS yields a total score, as well as subscales assessing disrupted activities, personal distress, guilt, time perspective, and worry. Results Fifty-seven percent of the participants nominated a relative who was assessed with the BAS. Interestingly, the only statistically significant independent predictors of baseline family burden were relatives’ reports of their loved ones’ dependence and lack of help with chores; no consumer demographic, PANSS, or QOL variables were identified. BAS total scores improved significantly in both conditions, but significantly more in NAVIGATE. Consumer report of better family relationship quality on the QOL was associated with significantly less family burden on the BAS over time, but neither PANSS positive, negative or symptom total, total QOL, nor participation in specific CSC psychosocial components mediated the observed BAS total burden reductions. With regard to the BAS burden components, there was a main effect of improvement over time on family disrupted activities, guilt, time perspective, and worry, with disrupted activities, personal distress, and guilt all evidencing a time by group interaction favoring greater reductions in NAVIGATE. Discussion As anticipated, family burden is widely evidenced in the relatives of US FEP consumers who are new to treatment. This burden does not appear to reflect unique consumer characteristics. There appears to be a reduction in family burden during the loved one’s FEP treatment, with that reduction enhanced when the consumer is participating in a more intensive CSC program. Interestingly, while many potential intervening variables were tested as mediators of the CSC impact on family burden, none were identified. The overall pattern of results suggests that it maybe the very fact of a loved one being enrolled in a treatment program, especially if it is a comprehensive FEP intervention, rather than engagement in specific program components or consumer improvements, that are associated with reductions in family burden over the first year of treatment.

F254. EXPANDING THE REACH OF NAVIGATE CSC PROGRAMS ACROSS THE U.S.: WHAT DO WE KNOW?

Abstract Background The Recovery After Initial Schizophrenia Episode-Early Treatment Program (RAISE-ETP) study was a landmark investigation whose positive results led to increased funding and support to build first episode psychosis programs across the US. Every state in the country received dedicated funding to implement a coordinated specialty care (CSC) program designed to identify and treat persons with first episode psychosis within the context of the nation’s multi-payer health system. Since the funding began in 2014, numerous CSC programs have been developed but little is known about which models of treatment providers are implementing and the success of these programs. The research here presents data from a survey focusing on providing feedback from the first episode psychosis programs in the US implementing NAVIGATE, the CSC program utilized in RAISE-ETP. The survey targets the program directors in the NAVIGATE programs; the aims of the survey include 1) to describe the program characteristics of NAVIGATE teams in the US and 2) to better understand how NAVIGATE programs are identifying and enrolling people into their services. Capturing local data on CSC team composition and case identification strategies is particularly critical in multi-payer systems lacking guidance and oversight from a national health system. Methods An online survey is being conducted to assess the implementation of NAVIGATE programs in the US and evaluate the procedures that the program director utilizes to identify and enroll NAVIGATE participants in services. Program directors from NAVIGATE programs are being identified and contacted to participate by national trainers to join a national database of first episode programs. Program data collected includes information about the location of the program, staff in the different NAVIGATE team roles (prescriber, individual clinician, family clinician, and employment/education specialists, as well as optional roles such as peer advocate and case manager), program enrollment criteria, number of participants screened and enrolled, and rates of planned and unplanned discharge. In addition, program directors are asked questions to report community based strategies to identify participants and screening procedures to enroll participants. Data analysis will focus on presenting the demographic and clinical characteristics of the programs. Common themes will be ascertained, including barriers and facilitators to identifying and enrolling participants with first episode psychosis. Helpful recommendations provided by the project directors on identifying and screening participants will be synthesized and reported. Results There are approximately 30 NAVIGATE programs in 14 states in the US. Results will highlight the dissemination of NAVIGATE in the US and implementation of these programs across a wide range of different communities. We will describe the dissemination of NAVIGATE across the US and similarities and differences across NAVIGATE programs. Results also will provide feedback on the challenges and helpful strategies that program directors have used to engage people in treatment. Discussion The findings from this survey will be the first to provide an overview of the implementation of the NAVIGATE program in the US. The results will provide an overview of the dissemination of the NAVIGATE program, the only CSC program evaluated in a national US trial. Recommendations could help inform the ongoing development and dissemination of coordinated specialty care programs.

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). 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.