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

BackgroundAdjustment problems and disorders are highly prevalent among university students worldwide. These problems can cause significant interference in academic and social functioning and increase vulnerability to other mental health disorders. Unfortunately, only half of students in need receive psychological help. Furthermore, few studies have evaluated psychological interventions for adjustment disorders in students. New, more scalable forms of treatment for students with an adjustment disorder need to be developed, evaluated, and implemented. The study aims to determine the effectiveness of an online transdiagnostic cognitive behavioural intervention for students experiencing adjustment disorder and to assess mediators of change.Method/designIn this three-arm randomized controlled trial, we plan to recruit 214 Polish students diagnosed with an adjustment disorder. Participants who meet initial eligibility criteria will be randomly assigned to one of three 6-week conditions: (1) online cognitive behavioural therapy intervention based on an existing, empirically supported transdiagnostic protocol, the unified protocol; (2) online progressive muscle relaxation training as an active control group; or (3) waiting-list control group. Both interventions are asynchronous, interactive, and include minimal amount of therapist support. Assessments will consist of self-report questionnaires, daily diary measures, and neurocognitive tasks for evaluating cognitive functioning. These will be conducted at baseline, post-treatment, and 1-month follow-up. Daily diary measures will be taken during the first and last week of treatment (or waitlist period). Primary outcome measures will include adjustment disorder severity; secondary outcome measures will consist of other negative (psychopathology: depression, anxiety, and stress) and positive (life satisfaction) indexes of mental health as well as process measures (e.g. mindfulness, experiential avoidance, cognitive fusion).DiscussionTo our knowledge, the current study is the first to evaluate the effectiveness of a psychological intervention for students with adjustment disorder. Therefore, it may have important practical implications for students with this disorder. It can potentially guide the development of a scalable, validated treatment option.Trial registrationClinical Trials, NCT05768308, registered 14 March 2023, https://www.clinicaltrials.gov/ct2/show/NCT05768308