JMIR Publications

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 evaluated the feasibility of a randomized controlled trial of transdiagnostic cognitive behavioral therapy (ICBT) for anxiety and depression, where treatment was adapted to individual needs via user-steered decisions on personalized content and stepped care, responsively implemented at mid-treatment.

Methods:

This single-group, open-label study took place in Sweden in the autumn of 2021 and recruited among students who participated in the WHO World Mental Health International College Student (WMH‐ICS) mental health survey. Eligibility criteria were a score of 5-19 on the PHQ-9 and/or a score of ≥5 on the GAD-7. During the eight-week treatment period, participants initially personalized their treatment by choosing problem orientation (anxiety or depression) and additional elective content, with the possibility of consulting a therapist about their choices. At mid-treatment, a stepped-care procedure was piloted, where participants who did not show symptom improvements were randomized to receive adapted treatment involving increased therapist support or to continue treatment as before. The study objective was to collect feasibility data on reach and uptake, intervention acceptability, stepped care procedures, and assessment adherence up to six months. 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. GAD-7 baseline score was M=9.5 (SD=4.4) and PHQ-9 baseline score was M=11.2 (SD=5.2). On average, participants opened 6.2 (SD=2.2) out of eight treatment modules. The possibility of content personalization yielded 27 unique treatment configurations across 28 participants. At mid-treatment, 16 out of 27 (59%) participants who remained in treatment were randomized to stepped care. Ratings on self-report measures showed acceptable to good therapeutic alliance and treatment satisfaction, but eleven participants reported increased stress associated with the treatment. Reductions in depression and anxiety symptoms were observed at post-measurement and follow-up, although there was a 43% attrition rate for assessments at those times.

Conclusions:

The study identified areas for improvement but no major unexpected barriers to disseminating personalized transdiagnostic ICBT with university students. Pending changes to improve assessment attrition and reduce stress levels in treatment, a full-scale trial is considered feasible. Clinical Trial: ClinicalTrials.gov NCT05509660