Objective Despite steady increases in the prevalence of depression and anxiety, many adolescents remain undertreated. Digital mental health interventions (DMHI) may address some barriers to care. This study is the first to examine the prospective noninferiority of a smartphone-based, self-guided relational agent (W-GenZD) DMHI to address adolescent depressive symptoms compared to group-based telehealth cognitive-behavioral therapy (CBT). Method Adolescents 13 to 17 years of age who were seeking treatment for depression and/or anxiety at a children's hospital outpatient mental health program and who met study inclusion criteria were randomized to either W-GenZD (n = 71) or CBT Group (n = 70). The primary aim was to examine feasibility and acceptability. The secondary aim was to test the noninferiority of W-GenZD compared to CBT Group on the 8-item Patient Health Questionnaire (PHQ-8) at 4 weeks (end of treatment [EOT]). The study also examined the trajectory of working alliance, anxiety, general mood, and safety in each intervention group. Results W-GenZD was noninferior to CBT Group in reducing depressive symptoms, with a mean between-group PHQ-8 EOT score difference of −0.67, 95% CI=− 2.30, 0.82 in intent-to-treat analysis (N = 141) using multiple imputation for missing values. Four different sensitivity analyses confirmed noninferiority, including per protocol analysis (−1.38, −3.61, 0.86, n=82). Feasibility, acceptability, and tertiary aims were similar in both groups, and data support the safety of W-GenZD in a mental health outpatient setting. Conclusion Results suggest that W-GenZD is a feasible and efficacious intervention for adolescents presenting with depression and/or anxiety in a real-world setting. W-GenZD could help expand the capacity of mental health clinicians to support the many youth and families in need of mental health care. Plain language summary Many adolescents with depression and anxiety can't access professional help. Digital tools, including apps, may help address barriers to care. This is the first study to compare an interactive chat-based app (W-GenZD) with active therapy—in telehealth-delivered group-based cognitive-behavioral therapy (CBT Group)—among adolescents with symptoms of depression and/or anxiety in a real-world children's hospital outpatient setting. Results suggest that W-GenZD was noninferior to CBT Group in reducing depressive symptoms at 4 weeks or end of treatment. Feasibility and acceptability of the interventions were similar in both groups and data support the safety of W-GenZD in a mental health outpatient setting. Clinical trial registration information Feasibility and Acceptability of W-GenZD vs CBT-light Teletherapy for Adolescents Seeking Mental Health Services; https://clinicaltrials.gov/study/NCT05372913
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