Transdiagnostic and tailored internet intervention to improve mental health among university students: Research protocol for a randomized controlled trial

Abstract

Background: Emerging adulthood is associated with mental health problems. About one in three university students shows symptoms of depression and anxiety that can negatively affect their developmental trajectory in work, intimate relationships and health, and interfere with academic performance. Mood and anxiety disorders are key predictors of dropout from higher education. A treatment gap exists, where a considerable proportion of students with such disorders do not seek help. Offering internet interventions to students with mental health problems could reduce the treatment gap, increase mental health and improve academic performance. Meta-analysis of internet interventions for university students has shown small effects for depression and none for anxiety. Larger trials are recommended to further explore effects of guidance, transdiagnostic approaches, and individual treatment components. Methods: This study offers 1200 university students in Sweden participation in a three-armed randomized controlled trial (RCT) evaluating a guided or unguided transdiagnostic internet intervention for mild to moderate depression and anxiety, where the waitlist control group accesses the intervention at 6-month follow-up. Students reporting suicidal ideation/behaviors are excluded and referred to treatment within the healthcare system. An embedded study within a trial (SWAT), aiming to minimize the risk of treatment failure, randomizes participants in the guided and unguided groups, identified at week 3 of 8 as being at higher risk of failing to benefit from treatment, to an adaptive treatment strategy, or to continue the treatment as originally randomized. Primary outcomes are symptoms of depression and anxiety. Follow-ups occur post-treatment and at 6-, 12- and 24-months post-randomization. Between-group outcome analyses and within-group analyses of clinically significant change will be reported. Qualitative interviews about treatment experiences are planned. Discussion: This study investigates the effects of a transdiagnostic internet intervention among university students in Sweden, with an adaptive treatment strategy employed during the course of treatment to minimize the risk of treatment failure. The study will contribute knowledge about longitudinal trajectories of mental health and well-being following treatment, taking into account possible gender differences in responsiveness to treatment. With time, effective internet interventions could make treatment for mental health issues more widely accessible to the student group. Trial registration: NCT05085756, October 20, 2021, https://classic.clinicaltrials.gov/ct2/show/NCT05085756, Prospectively registered Trial registration: NCT05085756, October20, 2021, https://classic.clinicaltrials.gov/ct2/show/NCT05085756, Prospectively registered