Abstract
BackgroundUniversity students are vulnerable to poor mental health, psychological distress, and loneliness relative to nonuniversity student peers. However, the rate of seeking mental health treatment among university students is low. Web-based psychological interventions may provide an opportunity for supporting vulnerable university students who are unlikely to otherwise seek support.ObjectiveThe aim of this study is to examine the feasibility, acceptability, safety, and efficacy of an existing web-based transdiagnostic cognitive behavioral therapy (CBT) mental health program for use among Australian university students.MethodsThis is a pilot randomized controlled trial comparing a self-directed web-based CBT mental health program with a waitlist control. The self-directed modules will be augmented with optional webchat or telephone coaching with a therapist. The recruitment target is 70 university students who do not present with a clinical mental health disorder. Allocation will be made in a 1:1 ratio and will occur after the initial baseline assessment. Assessments will be completed at baseline, upon completion of a 4-week waitlist (waitlist group only), upon completion of the program, and at 3 months after completion of the program.ResultsThe trial was funded in June 2018, and the protocol was approved by the Swinburne University Human Research Ethics Committee in September 2018. Recruitment commenced in October 2018, with the first participant allocated in November 2018. A total of 70 participants were recruited to the trial. The trial recruitment ceased in June 2019, and data collection was finalized in December 2019. We expect the final data analysis to be completed by November 2020 and results to be published early in 2021. The primary outcomes are feasibility, acceptability, safety, and symptoms of depression, anxiety, and stress. The secondary outcomes are psychological wellbeing, quality of life, loneliness, self-reported physical health status, emotion regulation, and cognitive and mindfulness processes.ConclusionsThe acceptability, feasibility, safety, and efficacy of a web-based mental health program in university students will be evaluated. Web-based mental health programs offer the opportunity to engage university students who may be reluctant to seek support through traditional face-to-face mental health services, and the transdiagnostic approach of the program has the potential to address the breadth of mental health concerns of university students.Trial RegistrationAustralian New Zealand Clinical Trial Registry ACTRN12618001604291; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12618001604291International Registered Report Identifier (IRRID)DERR1-10.2196/21307
Highlights
Bug fixes, Downtimes, Content Changes: ehealth systems are often dynamic systems
"The aim of the current study is to examine the feasibility, acceptability, safety, and e cacy of an existing online trans-diagnostic cognitive behavioural therapy (CBT) mental health program for use with Australian university students." "This is a pilot randomized control trial comparing a self-directed web-based CBT mental health program with a waitlist control."
A description of changes to methods includes important changes made on the intervention or comparator during the trial (5-iii) and other “unexpected events” that may have influenced study design such as staff changes, system failures/downtimes, etc. [2]
Summary
Downtimes, Content Changes: ehealth systems are often dynamic systems. A description of changes to methods includes important changes made on the intervention or comparator during the trial (e.g., major bug fixes or changes in the functionality or content) (5-iii) and other “unexpected events” that may have influenced study design such as staff changes, system failures/downtimes, etc. "Participants meeting the following criteria will be eligible for the study: (1) aged 17-26 years old; (2) currently enrolled as a student at an Australian university; (3) competent in English reading and comprehension; (4) able to receive phone or video conference call or attend the research centre for assessments. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email confirmation, phone calls) were used to detect/prevent these
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
