P3A005: A Randomized Controlled Feasibility Study of CBT Skills Group and W-genzd, a Relational Agent-guided Digital Intervention, Among Adolescents Seeking Outpatient Care for Anxiety And/or Depression

Background: Dramatic escalations of depression and anxiety among adolescents further exacerbate unmet mental health care needs as healthcare systems cannot meet demand. Digital mental health interventions (DMHIs) provide promise as first line interventions, such as within stepped care paradigms, but require feasibility and efficacy testing. Research reported preliminary efficacy of Woebot for Adolescents (W-GenZD), a mobile application DMHI featuring Woebot, a relational agent that delivers guided cognitive behavioral therapy (CBT). Further evaluation of W-GenZD among adolescents with symptoms of depression and/or anxiety is warranted. This randomized controlled trial’s (RCT) main objective was to determine the feasibility and satisfaction associated with W-GenZD and telehealth-delivered CBT skills group, among a sample of adolescents seeking care for depression and/or anxiety from a children's hospital outpatient mental health clinic that uses a stepped care approach to triage patients depending on presenting level of need.

Methods: The study (Copernicus IRB Protocol #20221397, ClinicalTrials.gov NCT05372913) randomized 141 adolescents aged 13-17 years to either W-GenZD or telehealth CBT skills group. Adolescents presented seeking care for depression and/or anxiety and were deemed appropriate for step one of the hospital’s established stepped care model. Analyses in the intent-to-treat population were conducted, yielding group estimates for (1) feasibility, measured by the Usage Rating Profile-Intervention, Revised (URP-IR; range 0-36) at 4 weeks end of treatment (EOT) and (2) intervention satisfaction, measured by the Client Satisfaction Questionnaire (CSQ-8; range 0-32) at EOT.

Results: The sample (n= 71 in W-GenZD; n=70 in CBT skills group) was 14 years old (SD = 1.21) on average, 78% self-identified as female, 92% non-Hispanic, 49% white, 34% African American, and 60% heterosexual. At EOT the W-GenZD and CBT skills group participants had mean (SD) feasibility scores of 29.17(4.55) and 29.29(4.46), respectively. Both groups had satisfaction scores in the measure’s “good” range (W–GenZD=23.08(5.51); CBT skills group=22.49(5.54)).

Conclusion: This RCT, the first of its kind to investigate W-GenZD, a relational agent-delivered DMHI, and telehealth delivered CBT skills group in an outpatient children’s hospital setting. Findings support the feasibility of integration of the DMHI into this ecosystem’s established stepped care paradigm, as well as satisfaction of W-GenZD among this sample of adolescents seeking care for depression and/or anxiety. Findings have important implications for adolescents, parents, and providers seeking additional outpatient MH support options for youth.

Disclaimer: W-GenZD is not yet available and has not yet been cleared/approved or evaluated by FDA.