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.

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.

Associations between daily step count trajectories and clinical outcomes among adults with comorbid obesity and depression.

Purpose: To examine the relationship between features of daily measured step count trajectories and clinical outcomes among people with comorbid obesity and depression in the ENGAGE-2 Trial. Methods: This post hoc analysis used data from the ENGAGE-2 trial where adults (n=106) with comorbid obesity (BMI ≥30.0 or 27.0 if Asian) and depressive symptoms (Patient Health Questionnaire-9 score ≥10) were randomized (2:1) to receive the experimental intervention or usual care. Daily step count trajectories over the first 60 days (Fitbit Alta HR) were characterized using functional principal component analyses. 7-day and 30-day trajectories were also explored. Functional principal component scores that described features of step count trajectories were entered into linear mixed models to predict weight (kg), depression (Symptom Checklist-20), and anxiety (Generalized Anxiety Disorder Questionnaire-7) at 2-months (2M) and 6-months (6M). Results: Features of 60-day step count trajectories were interpreted as overall sustained high, continuous decline, and disrupted decline. Overall sustained high step count was associated with low anxiety (2M, ß=-0.78, p<.05; 6M, ß=-0.80, p<.05) and low depressive symptoms (6M, ß=-0.15, p<.05). Continuous decline in step count was associated with high weight (2M, ß=0.58, p<.05). Disrupted decline was not associated with clinical outcomes at 2M or 6M. Features of 30-day step count trajectories were also associated with weight (2M, 6M), depression (6M), and anxiety (2M, 6M); Features of 7-day step count trajectories were not associated with weight, depression, or anxiety at 2M or 6M. Conclusions: Features of step count trajectories identified using functional principal component analysis were associated with depression, anxiety, and weight outcomes among adults with comorbid obesity and depression. Functional principal component analysis may be a useful analytic method that leverages daily measured physical activity levels to allow for precise tailoring of future behavioral interventions.

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.

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.

Beyond the Liver, Hepatitis E Can Affect the Nerves, Pancreas, and Blood Vessels. Extrahepatic Manifestations of Hepatitis E: A Comprehensive Literature Review.

Extrahepatic manifestations of Hepatitis E, though rare, are being increasingly reported in the medical literature. In this review article, we will discuss the extrahepatic manifestations of hepatitis E, such as Guillain-Barre syndrome, pancreatitis, and cryoglobulinemia, their clinical association with hepatitis E, and their management.