Background Digital mental health interventions (DMHIs) may reduce treatment access issues for those experiencing depressive and/or anxiety symptoms. DMHIs that incorporate relational agents may offer unique ways to engage and respond to users and to potentially help reduce provider burden. This study tested WB-LIFE, a DMHI that employs Woebot, a relational agent that delivers evidence-based psychotherapies, among those with baseline clinical levels of depressive or anxiety symptoms. Self-reported depressive and anxiety symptom changes between baseline and end of 8-week intervention, as well as the association between demographic and clinical characteristics and each outcome, were measured Methods This exploratory, single-arm, 8-week study of 256 adults yielded non-mutually exclusive subsamples with either clinical levels of depressive or anxiety symptoms at baseline. Week 8 Patient Health Questionnaire-8 (PHQ-8) changes were measured in the depressive subsample (PHQ-8≥10). Week 8 Generalized Anxiety Disorder-7 (GAD-7) changes were measured in the anxiety subsample(GAD-7≥10). Demographic and clinical characteristics were examined in association with symptom changes via bivariate and multiple regression models adjusted for WB-LIFE utilization. Characteristics included age, sex at birth, race/ethnicity, marital status, education, sexual orientation, employment status, health insurance, baseline levels of depressive and anxiety symptoms, and concurrent psychotherapeutic or psychotropic medication treatments during the study. Results Both the depressive and anxiety subsamples were predominantly female, educated, non-Hispanic white, and averaged 38 and 37 years of age, respectively. The depressive subsample had significant reductions in depressive symptoms at Week 8 (mean change= - 7.28, p<0.01); the anxiety subsample had significant reductions in anxiety symptoms at Week 8 (mean change= -7.45, p<0.01). No significant associations were found between sex at birth, age, employment status, educational background and Week 8 symptom changes. Significant associations between depressive and anxiety symptom outcomes and sexual orientation, marital status, concurrent mental health treatment, and baseline symptom severity were found. Conclusions The present study suggests early promise for WB-LIFE as an intervention for depression and/or anxiety symptoms. Although exploratory in nature, this study revealed potential user characteristics associated with outcomes that can be investigated in future studies. Trial Registration This study was retrospectively registered on ClinicalTrials.gov (#NCT05672745) on 05/01/2023.

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BACKGROUND With the proliferation of digital mental health interventions (DMHIs) guided by relational agents, little is known about the behavioral, cognitive and affective engagement components associated with symptom improvement over time. Obtaining a better understanding could lend clues about recommended use for particular subgroups of the population, the potency of different intervention components, and the mechanisms underlying the intervention’s success. OBJECTIVE This exploratory study applied clustering techniques to a range of engagement indicators mapped to the intervention’s active components and the Connect, Attend, Participate, and Enact (CAPE) model to examine the prevalence and characterization of each identified cluster among users of a relational agent-guided DMHI. METHODS Adults aged 18 or older were invited via social media to participate in an 8-week intervention of a DMHI guided by the natural language processing (NLP)-supported relational agent, Woebot. Users completed assessments of affective and cognitive engagement: working alliance as measured by Goal and Task working alliance subscale scores and enactment (i.e., application of therapeutic recommendations in real-world settings). The app collected behavioral engagement (i.e., utilization). We applied agglomerative hierarchical clustering analysis to the engagement indicators to identify the number of clusters best fit to the data collected, characterized them, and then examined associations with baseline demographic and clinical characteristics as well as mental health outcomes at Week 8. RESULTS Analyses (n=202) supported 3 clusters: 1) “Typical Utilizers” (n=81, 40%), who had intermediate levels of behavioral engagement; 2) “Early Utilizers” (n=58, 29%), who had the highest levels of behavioral engagement in week 1; and 3) “Efficient Engagers” (n=63, 31%)., who had significantly higher levels of affective and cognitive engagement, but the lowest level of behavioral engagement. With respect to mental health baseline and outcomes measures, “Efficient Engagers” had significantly higher levels of baseline resilience (p=.0004) and greater declines in depressive symptoms (p=.01) and stress (p=.01) from baseline to Week 8 compared to Typical Utilizers. Significant differences across clusters were found by age, gender identity, race/ethnicity, sexual orientation, education, and insurance coverage. The main analytic findings remained robust in sensitivity analyses. CONCLUSIONS Three distinct, robust engagement clusters were identified, which were characterized by varying baseline demographic and clinical characteristics and differing mental health outcomes. Additional research is needed to inform fine-grained recommendations regarding optimal engagement and to determine the best sequence of particular intervention components with known potency. The findings represent an important first step in disentangling the complex interplay between different affective, cognitive, and behavioral engagement indicators and outcomes associated with use of a DMHI incorporating an NLP-supported relational agent. CLINICALTRIAL This study was retrospectively registered on ClinicalTrials.gov (#NCT05672745).

Background Unmet pediatric mental health (MH) needs are growing as rates of pediatric depression and anxiety dramatically increase. Access to care is limited by multiple factors, including a shortage of clinicians trained in developmentally specific, evidence-based services. Novel approaches to MH care delivery, including technology-leveraged and readily accessible options, need to be evaluated in service of expanding evidence-based services to youths and their families. Preliminary evidence supports the use of Woebot, a relational agent that digitally delivers guided cognitive behavioral therapy (CBT) through a mobile app, for adults with MH concerns. However, no studies have evaluated the feasibility and acceptability of such app-delivered relational agents specifically for adolescents with depression and/or anxiety within an outpatient MH clinic, nor compared them to other MH support services. Objective This paper describes the protocol for a randomized controlled trial evaluating the feasibility and acceptability of an investigational device, Woebot for Adolescents (W-GenZD), within an outpatient MH clinic for youths presenting with depression and/or anxiety. The study’s secondary aim will compare the clinical outcomes of self-reported depressive symptoms with W-GenZD and a telehealth-delivered CBT-based skills group (CBT-group). Tertiary aims will evaluate additional clinical outcomes and therapeutic alliance between adolescents in W-GenZD and the CBT-group. Methods Participants include youths aged 13-17 years with depression and/or anxiety seeking care from an outpatient MH clinic at a children’s hospital. Eligible youths will have no recent safety concerns or complex comorbid clinical diagnoses; have no concurrent individual therapy; and, if on medications, are on stable doses, based on clinical screening and as well as study-specific criteria. Results Recruitment began in May 2022. As of December 8, 2022, we have randomized 133 participants. Conclusions Establishing the feasibility and acceptability of W-GenZD within an outpatient MH clinical setting will add to the field’s current understanding of the utility and implementation considerations of this MH care service modality. The study will also evaluate the noninferiority of W-GenZD against the CBT-group. Findings may also have implications for patients, families, and providers looking for additional MH support options for adolescents seeking help for their depression and/or anxiety. Such options expand the menu of supports for youths with lower-intensity needs as well as possibly reduce waitlists and optimize clinician deployment toward more severe cases. Trial Registration ClinicalTrials.gov NCT05372913; https://clinicaltrials.gov/ct2/show/NCT05372913 International Registered Report Identifier (IRRID) DERR1-10.2196/44940

BACKGROUND Unmet pediatric mental health (MH) needs are growing as rates of pediatric depression and anxiety dramatically increase. Access to care is limited by multiple factors, including a shortage of clinicians trained in developmentally specific, evidence-based services. Novel approaches to MH care delivery, including technology-leveraged and readily accessible options, need to be evaluated in service of expanding evidence-based services to youth and their families. Preliminary evidence supports the use of Woebot, a relational agent that digitally delivers guided cognitive behavioral therapy (CBT) through a mobile application, for adults with MH concerns. However, no studies have evaluated the feasibility and acceptability of such app-delivered relational agents specifically for adolescents with depression and/or anxiety within an outpatient MH clinic, nor compared them to other mental health support services. OBJECTIVE This manuscript describes the protocol for a randomized controlled trial evaluating the feasibility and acceptability of an investigational device, Woebot for Adolescents (W-GenZD), within an outpatient MH clinic for youth presenting with depression and/or anxiety. The study’s secondary aim will compare clinical outcomes of self-reported depressive symptoms with W-GenZD and a telehealth-delivered CBT skills group (CBT-group). Tertiary aims will evaluate additional clinical outcomes and therapeutic alliance between adolescents in W-GenZD and CBT-group. METHODS Participants include youth aged 13-17 years with depression and/or anxiety seeking care from an outpatient MH clinic at a children’s hospital. Eligible youth will have no recent safety concerns or complex comorbid clinical diagnoses, have no concurrent individual therapy and, if on medications, are on stable doses, based on clinical screening and as well as study-specific criteria. RESULTS The protocol received Institutional Review Board (IRB) approval on 3/31/22 and recruitment began in May 2022. CONCLUSIONS Establishing the feasibility and acceptability of W-GenZD within an outpatient MH clinical setting will add to the field’s current understanding of the utility and implementation considerations of this MH care service modality. The study will also evaluate the non-inferiority of W-GenZD against CBT group. Findings may also have implications for patients, families, and providers looking for additional MH support options for adolescents seeking help for their depression and/or anxiety. Such options expand the menu of supports for youth with lower intensity needs as well as possibly reduce wait lists and optimize clinician deployment toward more severe cases. CLINICALTRIAL ClinicalTrials.gov NCT05372913