Effectiveness and mediators of change of an online CBT intervention for students with adjustment disorder – study protocol for a randomized controlled trial

Abstract

Abstract Background Adjustment problems and disorders are highly prevalent among university students worldwide. Unfortunately, only half of students in need receive psychological help. Furthermore, there is a paucity of studies evaluating prevalence, predictors and interventions for adjustment disorders in students. For these reasons, new, more scalable forms of treatment for students with adjustment disorder must be developed, evaluated and implemented. The aim of the study is to determine the effectiveness of an online transdiagnostic cognitive behavioural intervention for students experiencing adjustment disorder and to evaluate mediators of change. Method/Design In this three-arm randomized controlled trial, we plan to recruit 214 Polish students diagnosed as having an adjustment disorder. Participants who meet initial eligibility criteria will be randomly assigned to one of three conditions: 1) 6-week online cognitive behavioural therapy intervention based on the Unified Protocol, 2) 6-week online progressive muscle relaxation training as an active control group, or 3) waiting-list control group. Both the internet and active interventions are asynchronous, unguided and interactive. Assessments will consist of self-report questionnaires, daily diary measures, neurocognitive tasks for the evaluation of cognitive functioning, and recently received grades at university. Measures will be taken at baseline, at post-treatment and at 1-month follow-up. Daily diary measures will be taken during the first and last week of the interventions. Primary outcome measures will include adjustment disorder severity; secondary outcome measures will include other negative (psychopathology: depression, anxiety and stress) and positive (life satisfaction and level of academic adjustment) indexes of mental health as well as and process measures (e.g., mindfulness, experiential avoidance, cognitive fusion). Discussion The current study, to our knowledge, is to be the first evaluating the effectiveness of a psychological intervention for students with adjustment disorder. Therefore, it may have important practical implications for students with this disorder. It has the potential to guide the development of a scalable, validated treatment option. Trial registration Clinical Trials, NCT05768308, registered 14 March 2023, https://www.clinicaltrials.gov/ct2/show/NCT05768308