Personalized Transdiagnostic Cognitive Behavior Therapy With Midtreatment Stepped Care to Improve Mental Health Among University Students in Sweden: Feasibility Study for a Randomized Controlled Trial

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Abstract
Background: University students show a high prevalence of diverse mental health problems, requiring adaptable interventions to assist them in improving their mental health. Objective: This study aimed to evaluate the feasibility of transdiagnostic internet-delivered cognitive behavioral therapy (ICBT) for anxiety and depression in preparation for a randomized controlled trial. ICBT incorporated 2 innovative approaches to increase precision: user-steered content personalization and within-treatment adaptive modification based on early symptom trajectory. Methods: This single-group, open-label study was conducted online in Sweden in the autumn of 2021, recruiting from students who had completed the World Health Organization (WHO) World Mental Health International College Student (WMH-ICS) mental health survey. Participants were eligible if they scored 5-19 on the Patient Health Questionnaire-9 (PHQ-9), or ≥5 on the Generalized Anxiety Disorder-7 (GAD-7), or both. Participants completed an 8-week ICBT program with therapist support. They initially personalized their program by selecting a primary problem orientation, anxiety or depression, and choosing additional elective modules, and could consult their therapist regarding these choices. At midtreatment, stepped care was piloted, in which participants without symptom improvement were randomized to adaptive enhancement of therapist support or to continue treatment as before. The main feasibility outcomes included data on reach and uptake, intervention acceptability, stepped care procedures, and assessment retention up to 6 months. The GAD-7 and PHQ-9 were the primary outcome measures, with changes in scores calculated using mixed effects models. Results: Of 749 invited students, 55 (7%) completed the study screening, and 28 (4%) were included. The GAD-7 baseline score was 9.5 (SD 4.4), and the PHQ-9 baseline score was 11.2 (SD 5.2). Participants opened 6.2 (SD 2.2) out of the 8 treatment modules. The user-directed personalization yielded 27 unique treatment configurations across 28 participants. At week 4, 16/27 (59%) participants remaining in treatment were randomized in the stepped care procedure. Ratings on self-report measures showed acceptable to good therapeutic alliance and treatment satisfaction. Eleven participants reported increased stress associated with the treatment. Reductions in depression and anxiety symptoms were observed at postmeasurement and 6 months follow-up, with 43% attrition at those times. Conclusions: This pioneering study of personalized ICBT with adaptive change among university students demonstrated the overall feasibility of the treatment. To enhance the design of a future definitive trial, modifications are necessary to mitigate assessment attrition and reduce treatment-related stress. Trial Registration: ClinicalTrials.gov NCT05509660; https://clinicaltrials.gov/study/NCT05509660

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