Workshop on the Development and Evaluation of Digital Therapeutics for Health Behavior Change: Science, Methods, and Projects

The health care field has integrated advances into digital technology at an accelerating pace to improve health behavior, health care delivery, and cost-effectiveness of care. The realm of behavioral science has embraced this evolution of digital health, allowing for an exciting roadmap for advancing care by addressing the many challenges to the field via technological innovations. Digital therapeutics offer the potential to extend the reach of effective interventions at reduced cost and patient burden and to increase the potency of existing interventions. Intervention models have included the use of digital tools as supplements to standard care models, as tools that can replace a portion of treatment as usual, or as stand-alone tools accessed outside of care settings or direct to the consumer. To advance the potential public health impact of this promising line of research, multiple areas warrant further development and investigation. The Center for Technology and Behavioral Health (CTBH), a P30 Center of Excellence supported by the National Institute on Drug Abuse at the National Institutes of Health, is an interdisciplinary research center at Dartmouth College focused on the goal of harnessing existing and emerging technologies to effectively develop and deliver evidence-based interventions for substance use and co-occurring disorders. The CTBH launched a series of workshops to encourage and expand multidisciplinary collaborations among Dartmouth scientists and international CTBH affiliates engaged in research related to digital technology and behavioral health (eg, addiction science, behavioral health intervention, technology development, computer science and engineering, digital security, health economics, and implementation science). This paper summarizes a workshop conducted on the Development and Evaluation of Digital Therapeutics for Behavior Change, which addressed (1) principles of behavior change, (2) methods of identifying and testing the underlying mechanisms of behavior change, (3) conceptual frameworks for optimizing applications for mental health and addictive behavior, and (4) the diversity of experimental methods and designs that are essential to the successful development and testing of digital therapeutics. Examples were presented of ongoing CTBH projects focused on identifying and improving the measurement of health behavior change mechanisms and the development and evaluation of digital therapeutics. In summary, the workshop showcased the myriad research targets that will be instrumental in promoting and accelerating progress in the field of digital health and health behavior change and illustrated how the CTBH provides a model of multidisciplinary leadership and collaboration that can facilitate innovative, science-based efforts to address the health behavior challenges afflicting our communities

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

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

Comprehensive Versus Usual Community Care for First-Episode Psychosis: 2-Year Outcomes From the NIMH RAISE Early Treatment Program

The primary aim 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. healthcare system, to Community Care on quality of life

Cardiometabolic Risk in Patients With First-Episode Schizophrenia Spectrum Disorders: Baseline Results From the RAISE-ETP Study

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 A1c based, 15.4%) and diabetes (glucose based, 3.0%; hemoglobin A1c 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<.01) but not elevated metabolic parameters (except triglycerides to HDL-C ratio [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

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

Prescription Practices in the Treatment of First-Episode Schizophrenia Spectrum Disorders: Data From the National RAISE-ETP Study

Treatment guidelines suggest distinctive medication strategies for first episode and multi-episode patients with schizophrenia. How much community clinicians adjust their usual treatment regimens for first episode patients is unknown. We examined prescription patterns and factors associated with prescription choice within a national cohort of early phase patients

Treatment Interruptions and Telemedicine Utilization In Serious Mental Illness: A Retrospective, Longitudinal Claims Analysis

Background: Avoiding interruptions and dropout in outpatient care can prevent mental illness symptom exacerbation and costly crisis services, such as emergency room visits and inpatient psychiatric hospitalization. During the COVID-19 pandemic, to attempt to maintain care continuity, telemedicine services were increasingly utilized, despite the lack of data on efficacy in patients with serious mental illness. Patients with serious mental illness are challenging to enroll and sustain in randomized controlled trials over time due to fluctuations in disease exacerbation. However, capturing and examining utilization and efficacy data in community mental health center (CMHC) patients with serious mental illness during the pandemic is a unique opportunity to inform future clinical and policy decision-making. Objective: We aimed to identify and describe the characteristics of CMHC patients with serious mental illness who experienced treatment interruptions and who utilized telemedicine during the pandemic. Methods: We conducted a retrospective observational study of treatment interruptions and telemedicine use during the period from December 2019 to June 2020 (compared to the period from December 2018 to June 2019) in New Hampshire CMHC patients. The study population included all Medicaid beneficiaries with serious mental illness engaged in treatment 3 months prior to the declaration of a state of emergency in response to the COVID-19 pandemic. We used chi-square tests of independence and logistic regression to explore associations between treatment interruptions and variables (gender, age, rurality, and diagnosis). Telemedicine utilization was categorized as low (\u3c25%), medium (25%-75%), or high (\u3e75%) use. Results: A total of 16,030 patients were identified. New Hampshire CMHCs demonstrated only a 4.9% increase in treatment interruptions compared with the year prior. Patients who were male (odds ratio [OR] 1.27, 95% CI 1.17-1.38; P\u3c.001), under the age of 18 years (ages 0-12 years: OR 1.37, 95% CI 0.62-0.86, P\u3c.001; aged 13-17 years: OR 1.49, 95% CI 0.57-0.79, P\u3c.001), or among milder diagnostic categories, such as anxiety disorders (OR 3.77, 95% CI 3.04-4.68; P\u3c.001) and posttraumatic stress disorder (OR 3.69, 95% CI 2.96-4.61; P\u3c.001), were most likely to experience treatment interruptions. Patients who were female (OR 0.89, CI 0.65-0.74), 18 to 34 years old (OR 0.74, CI 0.70-0.79), or among milder diagnostic categories, such as anxiety disorder (OR 0.69, CI 0.65-0.74) or posttraumatic stress disorder (OR 0.77, CI 0.72-0.83), and with major depressive disorder (OR 0.73, CI 0.68-0.78) were less likely to be in the low telemedicine utilization group. Conclusions: The integration of telemedicine supported care continuity for most CMHC patients; yet, retention varied by subpopulation, as did telemedicine utilization. The development of policies and clinical practice guidelines requires empirical evidence on the effectiveness and limitations of telemedicine in patients with serious mental illness

Benzodiazepine prescription practices and substance abuse in persons with severe mental illness

BACKGROUND: Benzodiazepines have many benefits for persons with severe mental disorders, but they may also lead to or exacerbate substance abuse. An American Psychiatric Association taskforce established practice guidelines in 1990 to assist physicians in managing these and other potential side effects of benzodiazepine use. The objectives of this study were to determine the prevalence of benzodiazepine use among persons with psychiatric disorders and to evaluate compliance with published prescribing guidelines. METHOD: We studied benzodiazepine use among New Hampshire Medicaid beneficiaries aged 18 to 64 years with ICD-9 diagnoses that were grouped under the headings schizophrenia, bipolar disorder, major depression, and other psychiatric disorders from Jan. 1995 through Dec. 1999. Rates and length of use, frequency of high-potency/fast-acting prescriptions, and diazepam-equivalent dosages were compared for those with and without retrospectively determined evidence of substance abuse, substance dependence, or a procedure code indicating treatment for a substance use disorder (SUD). RESULTS: Five-year prevalence of benzodiazepine use for persons with and without SUD was 63% versus 54% for schizophrenia, 75% versus 58% for bipolar disorder, 66% versus 49% for major depression, and 48% versus 40% for other psychiatric disorders. Differences were statistically significant over 5 years and in 1999 (p \u3c.0001). Among persons with major depression or other psychiatric disorders, those with comorbid SUD were more likely to use fast-acting/high-potency benzodiazepines; there were no such differences for those with schizophrenia or bipolar disorder. Persons with bipolar disorder or other psychiatric disorders and SUD received significantly higher diazepam-equivalent dosages than did those without SUD. CONCLUSION: Contrary to published guidelines, rates of benzodiazepine use are higher among Medicaid beneficiaries with severe mental illness and co-occurring SUD than among persons with severe mental illness alone. Additional research and possibly a reassessment of prescribing guidelines are recommended