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Background: University students experience elevated psychological distress, with limited access to mental health services. While cognitive behavioral therapy (CBT) demonstrates efficacy for anxiety and depression, treatment gaps persist due to access barriers and insufficient between-session support. Large language model (LLM) chatbots could improve and scale CBT delivery. However, the scientific evaluation of chatbot-enhanced protocols is just emerging. Objective: This pilot study aimed to assess the feasibility, acceptability, and preliminary efficacy of an LLM-based ChatBot as an adjunct to group Unified Protocol (UP) therapy for between-session support in university students with subclinical anxiety and depression symptoms. Methods: A single-arm feasibility trial recruited university students aged 18 years and older with moderate subclinical symptoms (Social Phobia Inventory: 21-40, Patient Health Questionnaire-9: 5-14, or Generalized Anxiety Disorder-7: 5-14), excluding those with current psychiatric disorders, suicidal ideation, or psychotropic medication use. The intervention comprised 4 weekly group UP counseling sessions complemented by an adjunctive Claude 3.7-Sonnet LLM ChatBot programmed with UP-based therapeutic prompts for between-session support rather than a stand-alone therapeutic agent. Primary feasibility outcomes included treatment adherence, chatbot engagement metrics, and system usability (System Usability Scale). Secondary outcomes assessed changes in generalized anxiety (Generalized Anxiety Disorder-7 Scale), social anxiety (Social Phobia Inventory), depression (Patient Health Questionnaire-9), and well-being (Short Warwick-Edinburgh Mental Wellbeing Scale) using paired t tests. Qualitative feedback was collected through focus group interviews and analyzed using thematic analysis. Results: Of 72 screened participants, 37 met eligibility criteria and 19 initiated treatment (mean age 22.06, SD 1.78 years; 70.6% female). Retention was high with 17 completers (10.5% dropout rate). Among completers, 94.1% (16/17) attended ≥3 group sessions. The engagement with the CBT ChatBot was substantial: participants were active on a median of 23 days during the 34-day study period and exchanged a median of 15 messages in total. System usability was rated as excellent (mean 84.94, SD 10.98 out of 100). Pre-to-post comparisons revealed significant improvements in generalized anxiety (mean change -3.00, SD 3.46; t16=3.01, P=.004; Cohen d=0.71) and mental well-being (mean change +2.29, SD 3.65; t16=-2.17, P=.02; Cohen d=0.69). Social anxiety and depression showed nonsignificant trends toward improvement. Qualitative feedback highlighted the CBT ChatBot's accessibility and nonjudgmental support while noting limitations in personalization. No adverse events or inappropriate chatbot interactions occurred. Conclusions: Augmenting a group UP therapy with an LLM ChatBot demonstrated high feasibility, acceptability, and preliminary efficacy signals for university students with subclinical symptoms. The hybrid intervention package achieved strong retention and engagement while maintaining safety. These findings support progression to a randomized controlled trial to definitively evaluate this technology-enhanced approach for expanding access to evidence-based mental health interventions.
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