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.

Using Experience Sampling Methodology Data to Characterize the Substance Use of Youth With or At-Risk of Psychosis.

Objectives: Psychotic-spectrum disorders emerge during adolescence and early adulthood, which corresponds with the peak period for substance use initiation. Clinical and epidemiological data provide support that substance use is associated with psychotic symptom onset and severity. Experience-sampling methodology (ESM) data may provide additional insight into dynamic associations between substance use and psychotic symptoms. This is one of the first efforts to characterize substance use frequency and dynamic associations with psychotic symptoms and negative affect from ESM data in both clinical high risk (CHR) and early psychosis (EP) individuals. Methods: Using ESM, 33 individuals, including 17 with CHR and 16 EP (age range: 15-24), provided information on substance use, negative affect, and psychotic symptoms 6 times a day across a 21-day data collection window. Psychotic symptoms and negative affect included multi-item variables rated on a seven-point Likert Scale. Participants reported recent substance use for 4 drug classes (nicotine, cannabis, depressants, stimulants) via a yes/no item. Descriptive information included data on substance use frequency, and momentary negative affect and psychotic symptoms. Exploratory analyses included multi-level and person-level dynamic structural equation models, which assessed contemporaneous and lagged associations between substance use and symptoms. Results: Twenty-seven individuals (82%) reported recurrent substance use including stimulants (n = 12, 46%), nicotine (n = 9, 27%), cannabis (n = 6, 18%), and depressants (n = 4, 12%). Individuals with any recurrent substance use indicated usage at 47.7% of answered prompts; stimulants at 23.6%; nicotine at 74.2%; cannabis at 39.1%; and depressants at 20.1%. A multi-level dynamic structural equation model reflected that substance use (any class) was associated with lagged negative affect (ß = -0.02, CI: -0.06, < -0.00) but no significant contemporaneous or lagged associations between substance use and psychotic symptoms. Person-level models suggest potentially meaningful inter-individual variability. Conclusions: CHR and EP individuals use a range of substances that may both reflect and influence other experiences in daily life experiences. Data reflected moderate to high rates of recurrent substance use with more consistent use within nicotine and cannabis classes. ESM data have the potential to increase our understanding of the dynamic relationships between substance use and symptoms and to inform treatment for individuals in early course psychosis.

Social motivation and behavior in first-episode psychosis: Unique contributions to social quality of life and social functioning.

Social functioning is diminished among people early in the course of psychotic illnesses, and is likely influenced by the negative symptoms that accompany these disorders, including changes in motivation and experience of pleasure. Though social impairments have a deleterious impact on functioning, socialization is a multifaceted behavior and little is known about how the various aspects may influence social functioning and social quality of life among people with first-episode psychosis. In the present study, we investigated the associations of specific aspects of social motivation and behavior with social functioning and social quality of life in a group of 54 young people (aged 15 to 35) with first-episode psychosis. Though different aspects of social motivation and behavior correlated positively with one another, social motivation for peer interactions was uniquely associated with social functioning and social quality of life - including when a broad measure of negative symptoms was considered within the same model. When these same associations were examined longitudinally, social motivation for peer interactions again emerged as a unique predictor of change in social functioning over 6 months. Our results suggest that the unique contribution of aspects of social motivation has implications for treatment, including the importance of developmentally-informed interventions to improve peer socialization in youth and young adults with psychosis.

A pilot study of a brief inpatient social-skills training for young adults with psychosis.

Objective: Psychotic disorders are serious illnesses that are most amenable to early intervention. Though inpatient units are typically the first care setting for young people with psychosis, almost all early intervention work has been limited to outpatient settings. Social difficulties are a core feature of psychotic illnesses, and despite need for empirically supported social-skills treatments there are few interventions intended specifically for the developmental phase during which psychosis manifests (i.e., late teenage to early adult years). Method: Our group implemented an adapted social-skills training intervention (SST) designed for young adults on a psychiatric inpatient unit. Nineteen young adult inpatients (aged 18-35) with psychosis participated. Psychiatric symptoms and aspects of social functioning, including reported social self-efficacy and performance on social skills role-plays, were assessed before and after SST participation. Results: Preliminary data demonstrate improvements in both self-report and performance-based measures of social functioning after SST participation. Conclusions and Implications for Practice: These findings, though preliminary, support additional, larger-scale investigations of this SST among young adults with psychosis. Further, multidisciplinary collaborations are valuable in providing specialized care for young adults with psychosis who are receiving inpatient psychiatric care. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Phase II Study of Combination Obinutuzumab, Ibrutinib, and Venetoclax in Treatment-Naïve and Relapsed or Refractory Chronic Lymphocytic Leukemia.

PURPOSE: The development of highly effective targeted agents for chronic lymphocytic leukemia offers the potential for fixed-duration combinations that achieve deep remissions without cytotoxic chemotherapy. PATIENTS AND METHODS: This phase II study tested a combination regimen of obinutuzumab, ibrutinib, and venetoclax for a total of 14 cycles in both patients with treatment-naïve (n = 25) and relapsed or refractory (n = 25) chronic lymphocytic leukemia to determine the response to therapy and safety. RESULTS: The primary end point was the rate of complete remission with undetectable minimal residual disease by flow cytometry in both the blood and bone marrow 2 months after completion of treatment, which was 28% in both groups. The overall response rate at that time was 84% in treatment-naïve patients and 88% in relapsed or refractory patients. At that time, 67% of treatment-naïve patients and 50% of relapsed or refractory patients had undetectable minimal residual disease in both the blood and marrow. At a median follow-up of 24.2 months in treatment-naïve patients and 21.5 months in relapsed or refractory patients, the median progression-free and overall survival times were not yet reached, with only 1 patient experiencing progression and 1 death. Neutropenia and thrombocytopenia were the most frequent adverse events, followed by hypertension. Grade 3 or 4 neutropenia was experienced by 66% of patients, with more events in the relapsed or refractory cohort. There was only 1 episode of neutropenic fever. A favorable impact on both perceived and objective cognitive performance during treatment was observed. CONCLUSION: The combination regimen of obinutuzumab, ibrutinib, and venetoclax offers time-limited treatment that results in deep remissions and is now being studied in phase III cooperative group trials.

Acalabrutinib plus Obinutuzumab in Treatment-Naïve and Relapsed/Refractory Chronic Lymphocytic Leukemia.

Acalabrutinib is a selective irreversible Bruton tyrosine kinase (BTK) inhibitor that does not affect IL2-associated tyrosine kinase or antibody-dependent cellular cytotoxicity, making it an attractive candidate for combination therapy with anti-CD20 antibodies. We investigated acalabrutinib plus obinutuzumab in a phase Ib/II study (NCT02296918) of patients with treatment-naïve or relapsed/refractory chronic lymphocytic leukemia (CLL). Nineteen treatment-naïve and 26 relapsed/refractory patients were treated with acalabrutinib (100 mg twice daily) until progression and obinutuzumab (cycle 1: 100 mg day 1, 900 mg day 2, 1000 mg days 8 and 15; cycles 2-6: 1,000 mg day 1). Grade 3/4 adverse events occurred in 71% of patients. Overall response rates were 95% (treatment-naïve) and 92% (relapsed/refractory). Thirty-two percent of treatment-naïve and 8% of relapsed/refractory patients achieved complete remission. At 36 months, 94% (treatment-naïve) and 88% (relapsed/refractory) were progression free. Acalabrutinib plus obinutuzumab was well tolerated, producing high and durable responses in treatment-naïve and relapsed/refractory CLL. SIGNIFICANCE: Rituximab plus the less selective BTK inhibitor ibrutinib has not shown benefit in CLL; however, the selective BTK inhibitor acalabrutinib plus the antibody-dependent cellular cytotoxicity-enhanced antibody obinutuzumab yielded durable responses that deepened over time in treatment-naïve and relapsed/refractory CLL, supporting the evaluation of this approach in larger, comparative studies in CLL.This article is highlighted in the In This Issue feature, p. 327.

Identifying risk factors for depression and anxiety symptoms in patients with chronic lymphocytic leukemia.

PURPOSE: This study assessed whether empirically supported risk factors can identify future depression and anxiety symptoms in a specific cancer type, chronic lymphocytic leukemia (CLL). METHODS: Patients enrolled in a CLL treatment clinical trial (N = 106) participated at baseline following informed consent and prior to treatment initiation. Risk factors with empirical support (personal or family psychiatric history, recurrent, advanced or progressive disease, low socioeconomic status, gender, medical comorbidities, and single marital status) and additional risk factors (cancer-specific stress, social contacts, negative life events, absolute lymphocyte counts, treatment group, and fatigue) were measured at baseline to predict depression and anxiety symptoms at 12 months. RESULTS: Data show 14% (n = 15) and 12% (n = 13) of patients experienced moderate-severe depression and anxiety symptoms, respectively. Multiple linear regression analyses found medical comorbidities predicted 12-month anxiety symptoms (p < 0.05). Also, negative life events predicted depression and anxiety symptoms and fatigue predicted depression symptoms (p < 0.05). CONCLUSION: Empirically supported risk factors associated with depression and anxiety symptoms are limited in predicting future depression and anxiety symptoms beyond initial screening in patients with CLL. In addition to levels of depression and anxiety symptoms at baseline, negative life events, higher levels of fatigue, and greater medical comorbidities were associated with future depression or anxiety symptoms in patients with CLL.

Construct validity of PROMIS® Cognitive Function in cancer patients and noncancer controls.

OBJECTIVE: The Patient-Reported Outcomes Measurement Information System Cognitive Function-Concerns® (PROMIS®-CF-Concerns) assesses self-reported cognitive complaints. Construct validity data for the CF-Concerns are few. To add to the literature, an analysis of criterion validity for cognitive complaints (European Organisation for Research and Treatment of Cancer-Cognitive Functioning subscale [EORTC-CF]) and cognitive performance (neuropsychological tests of memory [NIH Toolbox Auditory Verbal Learning Test] and verbal fluency [Controlled Oral Word Association Test]) and discriminant validity (self-reports of negative emotions of anxiety, depression, negative mood) are provided. A two-group comparison design was used. METHOD: Forty-four patients with chronic lymphocytic leukemia (CLL) and 44 age- and gender-matched noncancer controls completed self-report measures and neuropsychological tests. Spearman's rank correlations (rs) and independent-samples t tests were used. RESULTS: Regarding criterion validity, PROMIS®-CF-Concerns significantly correlated with the EORTC-CF (rs = 0.77, p < .001), although not with tests of memory (-0.19) or verbal fluency (0.16). As expected, patients with CLL performed lower than did controls on neuropsychological tests (ps < .05) yet did not differ from controls on PROMIS®-CF-Concerns. PROMIS®-CF-Concerns was reliably and significantly correlated with negative emotions, with rs ranges across measures of -0.42 to -0.69 for the CLL group and -0.53 to -0.78 for controls. CONCLUSIONS: PROMIS®-CF-Concerns exhibited high internal consistency. Criterion validity was evidenced for cognitive complaints though not for cognitive performance as assessed here. In summary, the analysis supports the criterion validity of PROMIS®-CF-Concerns for cognitive complaints. It also covaries with self-reports of co-occurring anxiety, depression, and negative mood. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Improving access to specialized care for first-episode psychosis: an ecological model.

Psychotic spectrum disorders are serious illnesses with symptoms that significantly impact functioning and quality of life. An accumulating body of literature has demonstrated that specialized treatments that are offered early after symptom onset are disproportionately more effective in managing symptoms and improving outcomes than when these same treatments are provided later in the course of illness. Specialized, multicomponent treatment packages are of particular importance, which are comprised of services offered as soon as possible after the onset of psychosis with the goal of addressing multiple care needs within a single care setting. As specialized programs continue to develop worldwide, it is crucial to consider how to increase access to such specialized services. In the current review, we utilize an ecological model of understanding barriers to care, with emphasis on understanding how individuals with first-episode psychosis interact with and are influenced by a variety of systemic factors that impact help-seeking behaviors and engagement with treatment. Future work in this area will be important in understanding how to most effectively design and implement specialized care for individuals early in the course of a psychotic disorder.

Cells, cytokines, chemokines, and cancer stress: A biobehavioral study of patients with chronic lymphocytic leukemia.

BACKGROUND: Chronic lymphocytic leukemia (CLL) is the most prevalent adult leukemia, with profound disease-related cellular, humoral, and innate immune suppression. The objective of this study was to study the correlations between stress and disease-specific, negative prognostic cellular, cytokine, and chemokine markers in patients with CLL. METHODS: A single-group, observational design was used. Patients with relapsed/refractory CLL (N = 96) who were entering a phase 2 trial of an experimental therapy (ibrutinib) were studied. Before the first dose, a validated self-report measure of stress (the Impact of Event Scale) was completed, and blood was drawn for absolute lymphocyte counts (ALCs) and for cytokine and chemokine enzyme-linked immunosorbent assays. Multiple linear regression models tested stress as a concurrent predictor of ALCs; of cytokines (tumor necrosis factor α [TNFα], a proliferation-inducing ligand [APRIL], B-cell activating factor [BAFF], interleukin 6 [IL-6], IL-10, IL-16, and vascular endothelial growth factor [VEGF]); and of the chemokine (C-C motif) ligand 3 (CCL3). RESULTS: Controlling for relevant demographic variables, comorbidities, CLL genetic risk (deletion of the short arm of chromosome 17 [del17p]), and correlates of inflammation, stress predicted higher ALCs (P < .05), and higher levels of TNFα (P < .05), IL-16 (P < .01), and CCL3 (P < .05). Stress was not associated with APRIL, BAFF, IL-6, IL-10, or VEGF. CONCLUSIONS: Novel biobehavioral data from patients with relapsed/refractory CLL demonstrate that stress is related to heightened levels of cellular, cytokine, and chemokine markers associated previously with progressive disease in CLL. The current results indicate that stress is related to immune and inflammatory processes that contribute to cancer cell proliferation and survival. These data provide a first look into these processes. Cancer 2018. © 2018 American Cancer Society.

Cost-Effectiveness of Behavior Activation Versus Supportive Therapy on Adherence to Eye Exams in Older African Americans With Diabetes.

Although the importance of ophthalmologic screening in diabetic patients is widely recognized by clinicians, the cost-effectiveness of strategies aimed at improving eye care utilization in this population is not well established. A cost-effectiveness analysis was performed comparing behavior activation (BA) to supportive therapy (ST) in activating patients to receive a dilated fundus exam (DFE) and promoting healthy management of diabetes. Two hundred six subjects were randomized to receive either BA or ST between 2009 and 2013. Cost-effectiveness was calculated as incremental cost-effectiveness ratio (ICER) of BA versus ST. Total costs for BA and ST per participant were $259.02 and $216.12, respectively. At the 6-month follow-up, 87.91% of BA subjects received a DFE compared to 34.48% of ST subjects. The ICER for BA versus ST was $80.29/percent increase in DFE rate. In terms of improving DFE rates, BA was found to be more cost-effective than ST.

Effect of Behavioral Intervention on Dilated Fundus Examination Rates in Older African American Individuals With Diabetes Mellitus: A Randomized Clinical Trial.

IMPORTANCE: African American individuals are at high risk of diabetes mellitus and diabetic retinopathy but have suboptimal rates of dilated fundus examinations (DFEs). Early intervention is crucial for the prevention of diabetic retinopathy in this high-risk population. OBJECTIVE: To test the efficacy of behavioral activation for diabetic retinopathy prevention on rates of DFEs in older African American individuals with diabetes mellitus. DESIGN, SETTING, AND PARTICIPANTS: Masked randomized clinical trial at 2 urban medical centers from October 1, 2010, to May 31, 2014. Participants included 206 African American individuals 65 years and older with diabetes mellitus who had not obtained a DFE in the preceding 12 months. INTERVENTIONS: Participants were randomized to either behavioral activation for diabetic retinopathy prevention, a behavioral intervention designed to provide education, facilitate identifying and addressing health care barriers, and promote goal setting to improve rates of DFEs, or supportive therapy, a control condition. MAIN OUTCOMES AND MEASURES: The primary outcome was medical documentation of a DFE at 6 months' follow-up. Secondary outcomes included the Risk Perceptions and Risk Knowledge Survey of Diabetes Mellitus, Diabetes Self-Care Inventory, Patient Health Questionnaire 9, and National Eye Institute Vision Function Questionnaire 25 scores and hemoglobin A1c levels. RESULTS: More participants in the behavioral activation for diabetic retinopathy prevention group (87.9%) obtained a DFE compared with those in the supportive therapy group (34.1%) by the 6-month follow-up assessment (P < .001). Overall, participants in the behavioral activation for diabetic retinopathy prevention group were 2.5 times more likely to obtain a DFE compared with those in the supportive therapy group (risk ratio = 2.58; 95% CI, 1.91-3.48; P < .001). The intervention had no short-term effect on secondary outcomes of hemoglobin A1c levels, depression, or the Risk Perceptions and Risk Knowledge Survey of Diabetes Mellitus or National Eye Institute Vision Function Questionnaire 25 composite scores; however, both groups had improved adherence to diabetes mellitus self-care behaviors from baseline to 6-month follow-up. CONCLUSIONS AND RELEVANCE: Behavioral activation for diabetic retinopathy prevention significantly increased rates of DFEs in older African American individuals with diabetes mellitus. Behavioral interventions may have the potential to positively affect screening for diabetic retinopathy in at-risk populations. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01179555.

Increasing access to health care: examination of hospital community benefits and free care programs.

The present study explored hospital community benefits and free care programs at seven hospitals in Nassau and Suffolk counties in Long Island, NewYork. There were two components to this project: (1) assessment of information regarding the availability of free care and (2) an analysis of the community benefits information filed with state regulatory offices. Results show that not one of the seven hospitals consistently informed surveyors that free care was available to low-income, uninsured people. Surveyors had difficulty obtaining written free care policies. The article concludes with suggestions for government agencies, hospital administrators, social workers, and other advocates on how to get involved in efforts to increase access to health care for the uninsured population.