Culturally tailored digital therapeutic for substance use disorders with urban Indigenous people in the United States: A randomized controlled study.

INTRODUCTION: Indigenous people experience health disparities, including higher rates of substance use disorders (SUDs). Digital therapeutics are a growing platform for treatment services and have the potential to expand access to culturally responsive interventions for Indigenous people. As one of the first randomized controlled trials for SUDs for American Indian and Alaska Native (AI/AN) adults, the aim of this study was to pilot test the efficacy of a culturally tailored intervention among urban Indigenous adults. METHODS: The study used a randomized controlled parallel design of 12 weeks of treatment-as-usual (TAU) (n = 26) versus TAU + Therapeutic Education System-Native Version (TES-NAV) (n = 27) with follow-up assessments at end of treatment and week 24 in an urban outpatient addiction treatment program for Native American adults. TAU consisted of individual/group counseling and cultural activities. The TES-NAV arm comprised TAU + 26 self-directed culturally tailored digital skills-based modules grounded in the community reinforcement approach with contingency management for abstinence and module completion. Primary outcome was longest consecutive weeks of abstinence from drugs and heavy drinking measured using self-report (Timeline Followback) and urine alcohol and drug toxicology screen during 12 weeks of treatment. Secondary outcomes were percent days abstinence during and posttreatment, coping strategies, social connectedness, and substance use and sexual risk behaviors. RESULTS: The study enrolled fifty-three (52.8 % male) AI/AN adults seeking treatment for a SUD. Although the study did not detect a benefit of TAU+TES-NAV over TAU on the primary outcome (Median = 2 consecutive weeks of abstinence for both arms) at end of treatment (treatment effect: Z = -0.78, p = 0.437), TAU+TES-NAV participants did demonstrate significantly greater percent days of abstinence at the week 24 follow-up (69.3 % versus 49.0 % for TAU; t = 2.08, p = 0.045) and significantly greater change in social connectedness mean score, baseline to week 12 (Z = -2.66, p = 0.011), compared to TAU. The study detected no differences between treatment arms for coping strategies or risk behaviors. CONCLUSION: The addition of TES-NAV to TAU did not significantly improve consecutive weeks of abstinence from drugs or heavy drinking; however, several secondary findings suggest promise for a culturally tailored digital therapeutic SUD intervention among urban Indigenous people. CLINICAL TRIALS: GOV REGISTRATION: #NCT03363256.

Patient Engagement in a Multimodal Digital Phenotyping Study of Opioid Use Disorder.

BACKGROUND: Multiple digital data sources can capture moment-to-moment information to advance a robust understanding of opioid use disorder (OUD) behavior, ultimately creating a digital phenotype for each patient. This information can lead to individualized interventions to improve treatment for OUD. OBJECTIVE: The aim is to examine patient engagement with multiple digital phenotyping methods among patients receiving buprenorphine medication for OUD. METHODS: The study enrolled 65 patients receiving buprenorphine for OUD between June 2020 and January 2021 from 4 addiction medicine programs in an integrated health care delivery system in Northern California. Ecological momentary assessment (EMA), sensor data, and social media data were collected by smartphone, smartwatch, and social media platforms over a 12-week period. Primary engagement outcomes were meeting measures of minimum phone carry (≥8 hours per day) and watch wear (≥18 hours per day) criteria, EMA response rates, social media consent rate, and data sparsity. Descriptive analyses, bivariate, and trend tests were performed. RESULTS: The participants' average age was 37 years, 47% of them were female, and 71% of them were White. On average, participants met phone carrying criteria on 94% of study days, met watch wearing criteria on 74% of days, and wore the watch to sleep on 77% of days. The mean EMA response rate was 70%, declining from 83% to 56% from week 1 to week 12. Among participants with social media accounts, 88% of them consented to providing data; of them, 55% of Facebook, 54% of Instagram, and 57% of Twitter participants provided data. The amount of social media data available varied widely across participants. No differences by age, sex, race, or ethnicity were observed for any outcomes. CONCLUSIONS: To our knowledge, this is the first study to capture these 3 digital data sources in this clinical population. Our findings demonstrate that patients receiving buprenorphine treatment for OUD had generally high engagement with multiple digital phenotyping data sources, but this was more limited for the social media data. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.3389/fpsyt.2022.871916.

Implementing Technology-Supported Care for Depression and Alcohol Use Disorder in Primary Care in Colombia: Preliminary Findings.

OBJECTIVE: Depression and alcohol use disorder are among the most common causes of disability and death worldwide. Health care systems are seeking ways to leverage technology to screen, evaluate, and treat these conditions, because workforce interventions alone, particularly in low- and middle-income countries, are insufficient. This article reports data from the first year of implementation of a technology-supported, systematic approach to identify and care for persons with these disorders in primary care in Colombia. METHODS: A care process that includes waiting room kiosks to screen primary care patients, decision support tablets to guide doctors in diagnosis and treatment, and access to digital therapeutics as a treatment option was implemented in two primary care clinics, one urban and one in a small town. The project collected data on the number of people screened, diagnosed, and engaged in the research and their demographic characteristics. RESULTS: In the first year, 2,656 individuals were screened for depression and unhealthy alcohol use in the two clinics. Primary care doctors increased the percentage of patients diagnosed as having depression and alcohol use disorder from next to 0% to 17% and 2%, respectively. CONCLUSIONS: Early experience with implementing technology-supported screening and decision support for depression and alcohol use disorder into the workflow of busy primary care clinics in Colombia indicates that this care model is feasible and leads to dramatically higher rates of diagnoses of these conditions. Diagnosis in these settings appeared to be easier for depression than for alcohol use disorder.

Assessing the Integration of Behavioral Health Services in Primary Care in Colombia.

Integration of behavioral health care into primary care can improve health and economic outcomes. This study adapted the Behavioral Health Integration in Medical Care (BHIMC) index to the Colombian context and assessed the baseline level of behavioral health integration in a sample of primary care organizations. The BHIMC was able to detect the capacity to provide integrated behavioral care in Colombian settings. Results indicate a minimal to partial integration level across all sites, and that it is possible to measure the degree of integrated care capacity and identify improvement areas for better behavioral health care provision.

Item Response Theory Analysis of the Five Facet Mindfulness Questionnaire and its Short Forms.

OBJECTIVES: The Five Facet Mindfulness Questionnaire (FFMQ) is a self-report measure of mindfulness with forms of several different lengths, including the FFMQ-39, FFMQ-24, and FFMQ-15. We use item response theory analysis to directly compare the functioning of these three forms. METHODS: Data were drawn from a non-clinical Amazon Mechanical Turk study (N = 522) and studies of aftercare treatment of individuals with substance use disorders (combined N = 454). The item and test functioning of the three FFMQ forms were studied and compared. RESULTS: All 39 items were strongly related to the facet latent variables, and the items discriminated over a similar range of the latent mindfulness constructs. Items provided more information in the low to medium range of latent mindfulness than in the high range. Scores in three of the five FFMQ-39 facets were unreliable when measuring individuals in the high range of latent mindfulness, resulting from ceiling effects in item responses. Reliability in the high range of mindfulness was further reduced in the FFMQ-24 and FFMQ-15, such that short forms may be ill-suited for applications that require reliable measurement in the high range. CONCLUSIONS: Results suggest the existing FFMQ item pool cannot be reduced without negatively affecting either overall reliability or the span of mindfulness over which reliability is assessed. Conditional test reliability curves and item functioning parameters can aid investigators in tailoring their choice of FFMQ form to the reliability they hope to achieve and to the range of latent mindfulness over which they must reliably measure.

Evaluating the Factor Structure of Each Facet of the Five Facet Mindfulness Questionnaire.

OBJECTIVE: Nearly all studies treat the Five Facet Mindfulness Questionnaire as five independent scales (one measuring each of the five facets), yet almost no methodological work has examined the psychometric structure of the facets independently. We address this gap using factor analytic methods. METHODS: Exploratory and confirmatory factor models were fit to item response data from a sample of 522 adults recruited online. Findings were replicated in a sample of 454 adults receiving aftercare for substance use disorder. RESULTS: Parallel analysis suggested multiple factors for all five facets, in both samples. Exploratory factor models suggested the presence of method factors on the acting with awareness (items using the term "distraction") and describing facets (items that were reverse-scored). Confirmatory factor models fit poorly for all facets, in both samples. In follow-up analyses, model fit improved substantially on the acting with awareness and describing facets when method factors were included in a bifactor model. Model fit was also better for the facets of FFMQ short forms than for the full-length facets. The short-form facets and original facets correlated similarly with external criteria in both samples. CONCLUSIONS: None of the FFMQ facets fit a unidimensional factor model; yet, follow-up analyses suggested each can be considered substantively unidimensional. Initial tests suggest the facets' multidimensionality did not materially impact their relation to other psychological constructs, suggesting multidimensionality can be ignored for some purposes. The use of short-form facets or latent variable models (e.g., bifactor specifications) are both viable solutions for addressing multidimensionality when desired.

Technology-Based Contingency Management in the Treatment of Substance-Use Disorders.

Contingency management is one of the most efficacious interventions to promote drug abstinence. Contingency management has traditionally been delivered in person so that clinicians could confirm drug abstinence and provide access to additional therapeutic services. Now, new technologies not only permit remote confirmation of abstinence, but also remote delivery of incentives. We discuss several technology-based tools to assess substance use, and new ways to deliver contingency management to promote tobacco, alcohol, and cannabis abstinence. These new tools have the potential to dramatically increase access while maintaining high levels of treatment fidelity. Technology-based methods also allow arranging group contingencies that harness online communities, and they permit targeting multiple health-risk behaviors with a combination of sensor-based technologies. Overall, there are unprecedented opportunities to link technology with contingency management to promote drug abstinence.

Applying novel technologies and methods to inform the ontology of self-regulation.

Self-regulation is a broad construct representing the general ability to recruit cognitive, motivational and emotional resources to achieve long-term goals. This construct has been implicated in a host of health-risk behaviors, and is a promising target for fostering beneficial behavior change. Despite its clear importance, the behavioral, psychological and neural components of self-regulation remain poorly understood, which contributes to theoretical inconsistencies and hinders maximally effective intervention development. We outline a research program that seeks to define a neuropsychological ontology of self-regulation, articulating the cognitive components that compose self-regulation, their relationships, and their associated measurements. The ontology will be informed by two large-scale approaches to assessing individual differences: first purely behaviorally using data collected via Amazon's Mechanical Turk, then coupled with neuroimaging data collected from a separate population. To validate the ontology and demonstrate its utility, we will then use it to contextualize health risk behaviors in two exemplar behavioral groups: overweight/obese adults who binge eat and smokers. After identifying ontological targets that precipitate maladaptive behavior, we will craft interventions that engage these targets. If successful, this work will provide a structured, holistic account of self-regulation in the form of an explicit ontology, which will better clarify the pattern of deficits related to maladaptive health behavior, and provide direction for more effective behavior change interventions.

Improvement in psychopathology among opioid-dependent adolescents during behavioral-pharmacological treatment.

OBJECTIVE: To examine changes in behavioral and emotional problems among opioid-dependent adolescents during a 4-week combined behavioral and pharmacological treatment. METHODS: We examined scales of behavioral and emotional problems in youth using the Youth Self-Report measure at the time of substance abuse treatment intake and changes in scale scores during treatment participants were 36 adolescents (aged 13-18 years, eligible) who met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria for opioid dependence. Participants received a 28-day outpatient, medication-assisted withdrawal with either buprenorphine, or clonidine, as part of a double-blind, double dummy comparison of these medications. All participants received a common behavioral intervention, composed of 3 individual counseling sessions per week, and incentives contingent on opioid-negative urine samples (collected 3 times/week) attendance and completion of weekly assessments. RESULTS: Although a markedly greater number of youth who received buprenorphine remained in treatment relative to those who received clonidine, youth who remained in treatment showed significant reductions during treatment on 2 Youth Self-Report grouping scales (internalizing problems and total problems) and 4 of the empirically based syndrome scales (somatic, social, attention, and thought). On Youth Self-Report competence and adaptive scales, no significant changes were observed. There was no evidence that changes in any scales differed across medication condition. CONCLUSIONS: Youth who were retained demonstrated substantive improvements in a number of clinically meaningful behavioral and emotional problems, irrespective of pharmacotherapy provided to them.