Study of a PST-trained voice-enabled artificial intelligence counselor for adults with emotional distress (SPEAC-2): Design and methods.

BACKGROUND: Novel and scalable psychotherapies are urgently needed to address the depression and anxiety epidemic. Leveraging artificial intelligence (AI), a voice-based virtual coach named Lumen was developed to deliver problem solving treatment (PST). The first pilot trial showed promising changes in cognitive control measured by functional neuroimaging and improvements in depression and anxiety symptoms. METHODS: To further validate Lumen in a 3-arm randomized clinical trial, 200 participants with mild-to-moderate depression and/or anxiety will be randomly assigned in a 2:1:1 ratio to receive Lumen-coached PST, human-coached PST as active treatment comparison, or a waitlist control condition where participants can receive Lumen after the trial period. Participants will be assessed at baseline and 18 weeks. The primary aim is to confirm neural target engagement by testing whether compared with waitlist controls, Lumen participants will show significantly greater improvements from baseline to 18 weeks in the a priori neural target for cognitive control, right dorsal lateral prefrontal cortex engaged by the go/nogo task (primary superiority hypothesis). A secondary hypothesis will test whether compared with human-coached PST participants, Lumen participants will show equivalent improvements (i.e., noninferiority) in the same neural target from baseline to 18 weeks. The second aim is to examine (1) treatment effects on depression and anxiety symptoms, psychosocial functioning, and quality of life outcomes, and (2) relationships of neural target engagement to these patient-reported outcomes. CONCLUSIONS: This study offers potential to improve the reach and impact of psychotherapy, mitigating access, cost, and stigma barriers for people with depression and/or anxiety. CLINICALTRIALS: gov #: NCT05603923.

Association Between User Interaction and Treatment Response of a Voice-Based Coach for Treating Depression and Anxiety: Secondary Analysis of a Pilot Randomized Controlled Trial.

BACKGROUND: The quality of user interaction with therapeutic tools has been positively associated with treatment response; however, no studies have investigated these relationships for voice-based digital tools. OBJECTIVE: This study evaluated the relationships between objective and subjective user interaction measures as well as treatment response on Lumen, a novel voice-based coach, delivering problem-solving treatment to patients with mild to moderate depression or anxiety or both. METHODS: In a pilot trial, 42 adults with clinically significant depression (Patient Health Questionnaire-9 [PHQ-9]) or anxiety (7-item Generalized Anxiety Disorder Scale [GAD-7]) symptoms or both received Lumen, a voice-based coach delivering 8 problem-solving treatment sessions. Objective (number of conversational breakdowns, ie, instances where a participant's voice input could not be interpreted by Lumen) and subjective user interaction measures (task-related workload, user experience, and treatment alliance) were obtained for each session. Changes in PHQ-9 and GAD-7 scores at each ensuing session after session 1 measured the treatment response. RESULTS: Participants were 38.9 (SD 12.9) years old, 28 (67%) were women, 8 (19%) were Black, 12 (29%) were Latino, 5 (12%) were Asian, and 28 (67%) had a high school or college education. Mean (SD) across sessions showed breakdowns (mean 6.5, SD 4.4 to mean 2.3, SD 1.8) decreasing over sessions, favorable task-related workload (mean 14.5, SD 5.6 to mean 17.6, SD 5.6) decreasing over sessions, neutral-to-positive user experience (mean 0.5, SD 1.4 to mean 1.1, SD 1.3), and high treatment alliance (mean 5.0, SD 1.4 to mean 5.3, SD 0.9). PHQ-9 (Ptrend=.001) and GAD-7 scores (Ptrend=.01) improved significantly over sessions. Treatment alliance correlated with improvements in PHQ-9 (Pearson r=-0.02 to -0.46) and GAD-7 (r=0.03 to -0.57) scores across sessions, whereas breakdowns and task-related workload did not. Mixed models showed that participants with higher individual mean treatment alliance had greater improvements in PHQ-9 (ß=-1.13, 95% CI -2.16 to -0.10) and GAD-7 (ß=-1.17, 95% CI -2.13 to -0.20) scores. CONCLUSIONS: The participants had fewer conversational breakdowns and largely favorable user interactions with Lumen across sessions. Conversational breakdowns were not associated with subjective user interaction measures or treatment responses, highlighting how participants adapted and effectively used Lumen. Individuals experiencing higher treatment alliance had greater improvements in depression and anxiety. Understanding treatment alliance can provide insights on improving treatment response for this new delivery modality, which provides accessibility, flexibility, comfort with disclosure, and cost-related advantages compared to conventional psychotherapy. TRIAL REGISTRATION: ClinicalTrials.gov NCT04524104; https://clinicaltrials.gov/study/NCT04524104.

Lifestyle Intervention and Excess Weight in Chronic Obstructive Pulmonary Disease (COPD): INSIGHT COPD Randomized Clinical Trial.

Rationale: Being overweight or obese is common among patients with chronic obstructive pulmonary disease (COPD), but whether interventions targeted at weight loss improve functional impairments is unknown. Objectives: INSIGHT (Intervention Study in Overweight Patients with COPD) tested whether a pragmatic low-intensity lifestyle intervention would lead to better physical functional status among overweight or obese participants with COPD. Methods: The trial was a 12-month, multicenter, patient-level pragmatic clinical trial. Participants were recruited from April 2017 to August 2019 from 38 sites across the United States and randomized to receive usual care or usual care plus lifestyle intervention. The intervention was a self-directed video program delivering the Diabetes Prevention Program's Group Lifestyle Balance curriculum. Results: The primary outcome was 6-minute-walk test distance at 12 months. Priority secondary outcomes were postwalk modified Borg dyspnea at 12 months and weight at 12 months. Participants (N = 684; mean age, 67.0 ± 8.0 yr [standard deviation]; 41.2% female) on average were obese (body mass index, 33.0 ± 4.6 kg/m2) with moderate COPD (forced expiratory volume in 1 second % predicted, 58.1 ± 15.7%). At 12 months, participants randomized to the intervention arm walked farther (adjusted difference, 42.3 ft [95% confidence interval (CI), 7.9-76.7 ft]; P = 0.02), had less dyspnea at the end of the 6-minute-walk test (adjusted difference, -0.36 [95% CI, -0.63 to -0.09]; P = 0.008), and had greater weight loss (adjusted difference, -1.34 kg [95% CI, -2.33 to -0.34 kg]; P = 0.008) than control participants. The intervention did not improve the odds of achieving clinically meaningful thresholds of walk distance (98.4 ft) or dyspnea (1 unit) but did achieve meaningful thresholds of weight loss (3% and 5%). Conclusions: Among participants with COPD who were overweight or obese, a self-guided low-intensity video-based lifestyle intervention led to modest weight loss but did not lead to clinically important improvements in physical functional status and dyspnea. Clinical trial registered with www.clinicaltrials.gov (NCT02634268).

Mediating Effects of Neural Targets on Depression, Weight, and Anxiety Outcomes of an Integrated Collaborative Care Intervention: The ENGAGE-2 Mechanistic Pilot Randomized Clinical Trial.

Background: Integrated treatments for comorbid depression (often with anxiety) and obesity are lacking; mechanisms are poorly investigated. Methods: In a mechanistic pilot trial, adults with body mass index ≥30 and Patient Health Questionnaire-9 scores ≥10 were randomized to usual care (n = 35) or an integrated behavioral intervention (n = 71). Changes at 6 months in body mass index and Depression Symptom Checklist-20 scores were co-primary outcomes, and Generalized Anxiety Disorder Scale-7 score was a secondary outcome. Changes at 2 months in the activation and functional connectivity of regions of interest in the negative affect circuit were primary neural targets, and secondary targets were in the cognitive control, default mode, and positive affect circuits. Results: Participants were 47.0 years (SD = 11.9 years), 76% women, 55% Black, and 20% Latino. Depression Symptom Checklist-20 (between-group difference, -0.3 [95% CI: -0.6 to -0.1]) and Generalized Anxiety Disorder Scale-7 (-2.9 [-4.7 to -1.1]) scores, but not body mass index, decreased significantly at 6 months in the intervention versus usual care groups. Only Generalized Anxiety Disorder Scale-7 score changes at 6 months significantly correlated with neural target changes at 2 months in the negative affect (anterior insula, subgenual/pregenual anterior cingulate cortex, amygdala) and cognitive control circuits (dorsal lateral prefrontal cortex, dorsal anterior cingulate cortex). Effects were medium to large (0.41-1.18 SDs). Neural target changes at 2 months in the cognitive control circuit only differed by treatment group. Effects were medium (0.58-0.79 SDs). Conclusions: Compared with usual care, the study intervention led to significantly improved depression but not weight loss, and the results on neural targets were null for both outcomes. The significant intervention effect on anxiety might be mediated through changes in the cognitive control circuit, but this warrants replication.

Effects of a virtual voice-based coach delivering problem-solving treatment on emotional distress and brain function: a pilot RCT in depression and anxiety.

Consumer-based voice assistants have the ability to deliver evidence-based treatment, but their therapeutic potential is largely unknown. In a pilot trial of a virtual voice-based coach, Lumen, delivering problem-solving treatment, adults with mild-to-moderate depression and/or anxiety were randomized to the Lumen intervention (n = 42) or waitlist control (n = 21). The main outcomes included changes in neural measures of emotional reactivity and cognitive control, and Hospital Anxiety and Depression Scale [HADS] symptom scores over 16 weeks. Participants were 37.8 years (SD = 12.4), 68% women, 25% Black, 24% Latino, and 11% Asian. Activation of the right dlPFC (neural region of interest in cognitive control) decreased in the intervention group but increased in the control group, with an effect size meeting the prespecified threshold for a meaningful effect (Cohen's d = 0.3). Between-group differences in the change in activation of the left dlPFC and bilateral amygdala were observed, but were of smaller magnitude (d = 0.2). Change in right dlPFC activation was also meaningfully associated (r ≥ 0.4) with changes in self-reported problem-solving ability and avoidance in the intervention. Lumen intervention also led to decreased HADS depression, anxiety, and overall psychological distress scores, with medium effect sizes (Cohen's d = 0.49, 0.51, and 0.55, respectively), compared with the waitlist control group. This pilot trial showed promising effects of a novel digital mental health intervention on cognitive control using neuroimaging and depression and anxiety symptoms, providing foundational evidence for a future confirmatory study.

Design and Formative Evaluation of a Virtual Voice-Based Coach for Problem-solving Treatment: Observational Study.

BACKGROUND: Artificial intelligence has provided new opportunities for human interactions with technology for the practice of medicine. Among the recent artificial intelligence innovations, personal voice assistants have been broadly adopted. This highlights their potential for health care-related applications such as behavioral counseling to promote healthy lifestyle habits and emotional well-being. However, the use of voice-based applications for behavioral therapy has not been previously evaluated. OBJECTIVE: This study aimed to conduct a formative user evaluation of Lumen, a virtual voice-based coach developed as an Alexa skill that delivers evidence-based, problem-solving treatment for patients with mild to moderate depression and/or anxiety. METHODS: A total of 26 participants completed 2 therapy sessions-an introductory (session 1) and a problem-solving (session 2)-with Lumen. Following each session with Lumen, participants completed user experience, task-related workload, and work alliance surveys. They also participated in semistructured interviews addressing the benefits, challenges and barriers to Lumen use, and design recommendations. We evaluated the differences in user experience, task load, and work alliance between sessions using 2-tailed paired t tests. Interview transcripts were coded using an inductive thematic analysis to characterize the participants' perspectives regarding Lumen use. RESULTS: Participants found Lumen to provide high pragmatic usability and favorable user experience, with marginal task load during interactions for both Lumen sessions. However, participants experienced a higher temporal workload during the problem-solving session, suggesting a feeling of being rushed during their communicative interactions. On the basis of the qualitative analysis, the following themes were identified: Lumen's on-demand accessibility and the delivery of a complex problem-solving treatment task with a simplistic structure for achieving therapy goals; themes related to Lumen improvements included streamlining and improved personalization of conversations, slower pacing of conversations, and providing additional context during therapy sessions. CONCLUSIONS: On the basis of an in-depth formative evaluation, we found that Lumen supported the ability to conduct cognitively plausible interactions for the delivery of behavioral therapy. Several design suggestions identified from the study including reducing temporal and cognitive load during conversational interactions, developing more natural conversations, and expanding privacy and security features were incorporated in the revised version of Lumen. Although further research is needed, the promising findings from this study highlight the potential for using Lumen to deliver personalized and accessible mental health care, filling a gap in traditional mental health services.

Integrated collaborative care intervention for depression and obesity in primary care: translation from research to practice.

The objective of this study was to present lessons learned about engagement, delivery modality and pandemic impact while delivering a collaborative care intervention with a socioeconomically, racially and ethnically diverse sample. Participants completed a post-intervention survey (n = 41) on experiences and preferred intervention delivery modality, coronavirus 2019 (COVID-19) Impact Survey (n = 50) and provided open-ended feedback about the intervention (n = 27). Intervention process data included attendance, modality, and withdrawals. Data were analyzed using descriptive statistics and inductive content analyses. Of 71 intervention participants, 6 (8%) withdrew before session 1. Completers adhered to intervention timeline better than withdrawals. Participants liked the in-person interaction, efficient coach support, accountability of in-person and Zoom vs. phone sessions and the flexibility and convenience of phone and Zoom vs. in-person sessions. A majority of participants reported experiencing pandemic impacts such as heightened emotional distress, decreased activity engagement, poorer eating behaviors and being unable to meet basic needs. Participants deviating from intervention timelines may be re-engaged by targeted outreach attempts. Videoconference has the potential for providing as-needed coaching. Future interventions may be optimized to account for and address areas impacted by the pandemic. Findings revealed specific strategies that can be implemented in future interventions to improve emotional and physical health among diverse populations.

Association of COVID-19 impact with outcomes of an integrated obesity and depression intervention: Posthoc analysis of an RCT.

OBJECTIVE: To examine the association between COVID-19 impact and clinical outcomes of an integrated collaborative care intervention for adults with obesity and comorbid depression. METHODS: Latent class analysis identified clusters of self-reported COVID-19 impact. Cluster characteristics were examined using Fishers' least significant difference method and canonical discriminant analysis. Intervention vs. usual care effects on primary (body mass index [BMI], depressive symptoms) and secondary (anxiety symptoms and other psychosocial) outcomes stratified by cluster were examined using linear mixed models. RESULTS: Three clusters were identified: mental health and sleep impact (cluster 1, n = 37), economic impact (cluster 2, n = 18), and less overall impact (cluster 3, n = 20). Clusters differed in age, income, diet, and baseline coping skills. The intervention led to improvements across several health outcomes compared with usual care, with medium to large effects on functional impairments (standardized mean difference, -0.7 [95% CI: -1.3, -0.1]) in cluster 1, depressive symptoms (-1.1 [95% CI: -2.0, -0.1]) and obesity-related problems (-1.6 [95% CI: -2.8, -0.4]) in cluster 2, and anxiety (-1.1 [95% CI: -1.9, -0.3]) in cluster 3. CONCLUSIONS: People with obesity and comorbid depression may have varied intervention responses based on COVID-19 impact. Interventions tailored to specific COVID-19 impact clusters may restore post-pandemic health.

The Effects of Religiosity on Depression Trajectories After Widowhood.

This longitudinal study analyzed data from the 2006-2016 waves of the nationally representative Health and Retirement Study (HRS). Trajectories of depression among older adults ≥ 50 years (N = 1254) were examined over time to explore patterns of depression among those entering widowhood and the potential impact of religiosity on depressive symptoms during various stages of widowhood. Ordinary least squares (OLS) regression analysis was used to examine the association between widowhood and depression and the role of religiosity as a moderator of this association. Older adults experienced a statistically significant increase in depressive symptomology after the onset of widowhood, and depressive symptomology decreased post widowhood, but did not return to pre-widowhood levels. Additionally, high religious service attendance and higher intrinsic religiosity were both associated with lower depressive symptomology. High religious service attendance moderated the relationship between widowhood and depression among widowed older adults living alone.

Sex Moderates Treatment Effects of Integrated Collaborative Care for Comorbid Obesity and Depression: The RAINBOW RCT.

BACKGROUND: Sex influences health and related behaviors due to biological and psychosocial/socioeconomic factors. Assessing sex-specific responses to integrated treatment for comorbid obesity and depression could inform intervention targeting. PURPOSE: To test (a) whether sex moderates the effects of integrated collaborative care on weight and depression outcomes through 24 months and (b) whether treatment response at 6 months predicts 12 and 24 month outcomes by sex. METHODS: Secondary data analyses on weight and depression severity (SCL-20) measured over 24 months among 409 adults with obesity and depression in the Research Aimed at Improving Both Mood and Weight trial. RESULTS: Men achieved significantly greater weight reductions in intervention versus usual care than women, whereas women achieved significantly greater percentage reductions in SCL-20 than men at both 12 and 24 months. In logistic models, at 80% specificity for correctly identifying participants not achieving clinically significant long-term outcomes, women who lost <3.0% weight and men who lost <4.1% weight at 6 months had ≥84% probability of not meeting 5% weight loss at 24 months. Similarly, at 80% specificity, women who reduced SCL-20 by <39.5% and men who reduced by <53.0% at 6 months had ≥82% probability of not meeting 50% decrease in SCL-20 at 24 months. CONCLUSIONS: Sex modified the integrated treatment effects for obesity and depression. Sex-specific responses at 6 months predicted clinically significant weight loss and depression outcomes through 24 months. Based on early responses, interventions may need to be tailored to address sex-specific barriers and facilitators to achieving healthy weight and depression outcomes at later time points. CLINICAL TRIAL REGISTRATION: NCT02246413 (https://clinicaltrials.gov/ct2/show/NCT02246413).

Weight loss effects in usual primary care: Findings from 5 behavioral weight loss RCTs.

Primary care is an important setting for obesity treatment and behavior therapy is considered the first line. However, current practice often does not meet clinical guidelines and, furthermore, effects of usual care (UC) on weight loss are unclear. This makes it difficult to design sufficiently powered weight loss trials in primary care. This study analyzed data from UC control participants across 5 primary care-based randomized clinical trials of behavioral weight loss interventions to assess UC effects for 4 weight outcomes: body mass index (BMI), weight change (kg and %), and percent of participants achieving clinically significant 5% weight loss. Results indicated modest UC effects, suggesting modest weight loss is possible in usual primary care.

The ENGAGE-2 study: Engaging self-regulation targets to understand the mechanisms of behavior change and improve mood and weight outcomes in a randomized controlled trial (Phase 2).

Despite evidence for effective integrated behavior therapy for treating comorbid obesity and depression, treatment response is highly variable and the underlying neurobiological mechanisms remain unknown. This hampers efforts to identify mechanistic targets in order to optimize treatment precision and potency. Funded within the NIH Science of Behavior Change (SOBC) Research Network, the 2-phased ENGAGE research project applies an experimental precision medicine approach to address this gap. The Phase 1 study focused on demonstrating technical feasibility, target engagement and potential neural mechanisms of responses to an integrated behavior therapy. This therapy combines a video-based behavioral weight loss program and problem-solving therapy for depression, with as-needed intensification of antidepressant medications, and its clinical effectiveness was demonstrated within a parent randomized clinical trial. Here, we describe the ENGAGE Phase 2 (ENGAGE-2) study protocol which builds on Phase 1 in 2 ways: (1) pilot testing of an motivational interviewing-enhanced, integrated behavior therapy in an independent, primarily minority patient sample, and (2) evaluation of a priori defined neural targets, specifically the negative affect (threat and sadness) circuits which demonstrated engagement and malleability in Phase 1, as mediators of therapeutic outcomes. Additionally, the Phase 2 study includes a conceptual and methodological extension to explore the role of microbiome-gut-brain and systemic immunological pathways in integrated behavioral treatment of obesity and depression. This protocol paper documents the conceptualization, design and the transdisciplinary methodologies in ENGAGE-2, which can inform future clinical and translational research in experimental precision medicine for behavior change and chronic disease management. Trial registration: ClinicalTrials.gov #NCT 03,841,682.

The state of aging policy and politics in the Trump era.

The surprise election of President Donald J. Trump to the presidency of the United States marks a singular turning point in the American republic-not only because of his idiosyncratic approach to the office, but also because the Republican Party now holds the presidency and both houses of Congress, presenting a historic opportunity for change. The role of older Americans has been critical in both shaping and reacting to this political moment. Their political orientations and behaviors have shaped it through their electoral support for Republican candidates, but they also stand as highly invested stakeholders in the policy decisions made by the very officials they elected and as beneficiaries of the programs that Republicans have targeted. This article draws on the content of this issue to explore the ways in which Trump administration policies are likely to significantly undermine the social safety net for near-elderly and older Americans with respect to long-term care, housing, health care, and retirement. It also draws on issue content to speculate on the ways that these policy changes might shape politics and political behavior. We conclude that the response of older voters in the 2018 midterm elections to efforts by the Trump administration and its Republican allies in Congress to draw back on the federal government's commitment to programs and policies affecting them will shape the direction of aging policy and politics in the years to come.

Media Portrayal of the Nursing Homes Sector: A Longitudinal Analysis of 51 U.S. Newspapers.

Purpose: Most Americans' low opinion of the nursing home (NH) sector could derive, in part, from the way in which it is portrayed in the media. This study furthers understanding of media portrayal of the NH sector by identifying how NHs were depicted in 51U.S. newspapers from 1999 to 2008. Design and methods: Keyword searches of the LexisNexis database were performed to identify 16,280 NH-related articles. Article content was analyzed, and tone, themes, prominence, and central actor were assessed. Basic frequencies and descriptive statistics were used to examine article content across regions, market type, and over time. Results: Findings reveal considerably less NH coverage in the Western United States and a steady decline in NH coverage nationally over time. Most articles were news stories; more than one third were located on the front page of the newspaper or section. Most articles focused on NH industry and government interests, very few on residents/family and community concerns. Most articles were neutral or negative in tone; very few were positive or mixed. Common themes included quality, financing, and legal concerns. Tone, themes, and other article attributes varied across region, market type, and over time. Implications: Overall, findings reveal changes in how newspapers framed NH coverage, not only with respect to tone but also with respect to what dimensions of this complex issue have been emphasized during the time period analyzed. Variation in media coverage may contribute to differences in government and public views toward the NH sector across regions and over time.

The Protective Effects of Religiosity on Depression: A 2-Year Prospective Study.

PURPOSE OF THE STUDY: Approximately 20% of older adults are diagnosed with depression in the United States. Extant research suggests that engagement in religious activity, or religiosity, may serve as a protective factor against depression. This prospective study examines whether religiosity protects against depression and/or aids in recovery. DESIGN AND METHODS: Study data are drawn from the 2006 and 2008 waves of the Health and Retirement Study. The sample consists of 1,992 depressed and 5,740 nondepressed older adults (mean age = 68.12 years), at baseline (2006), for an overall sample size of 7,732. Logistic regressions analyzed the relationship between organizational (service attendance), nonorganizational (private prayer), and intrinsic measures of religiosity and depression onset (in the baseline nondepressed group) and depression recovery (in the baseline depressed group) at follow-up (2008), controlling for other baseline factors. RESULTS: Religiosity was found to both protect against and help individuals recover from depression. Individuals not depressed at baseline remained nondepressed 2 years later if they frequently attended religious services, whereas those depressed at baseline were less likely to be depressed at follow-up if they more frequently engaged in private prayer. IMPLICATIONS: Findings suggest that both organizational and nonorganizational forms of religiosity affect depression outcomes in different circumstances (i.e., onset and recovery, respectively). Important strategies to prevent and relieve depression among older adults may include improving access and transportation to places of worship among those interested in attending services and facilitating discussions about religious activities and beliefs with clinicians.

Promoting collaboration between hospice and palliative care providers and adult day services for individuals with intellectual and developmental disabilities.

While end-of-life issues are increasingly gaining more attention, people with intellectual and developmental disabilities (IDD) continue to receive significantly less consideration in research, education, and clinical practice compared with the general population. This is a growing concern especially since the sheer number of persons aging with IDD is expected to double in the next 17 years. Furthermore, policies are shifting to reflect a preference for home and community-based services as an alternative to institutionalization, and it becomes evident that adult day services (ADS) may be ideal settings for receipt of end-of-life care, especially among individuals with IDD. However, end-of-life care and advance planning most commonly occur in long-term care settings for the general population and have historically been less of a priority in ADS and residential services for people with IDD. This article discusses the attitudes of, and collaboration between, ADS and end-of-life providers for aging adults including persons with IDD and explores how ADS may be a great pathway for delivering end-of-life care to the IDD population. Implications and recommendations will also be examined.