JMIR Publications

ABSTRACT

Background:

Internet-based cognitive behavioral interventions (iCBT) are efficacious treatments of depression and anxiety. Yet, it is unknown whether adding human guidance is feasible and beneficial within a large educational setting.

Objective:

To potentially demonstrate: (1) the superiority of two variants of a transdiagnostic iCBT program (human-guided and computer-guided iCBT) over care as usual (CAU) in a large sample of university students, and (2) the superiority of human-guided iCBT over computer-guided iCBT.

Methods:

Participants were students with elevated levels of anxiety and/or depression from a large university in the Netherlands and were randomized to one of three conditions: (1) human-guided (HG) iCBT, (2) computer-guided (CG) iCBT, and (3) CAU. The primary outcome measures were depression (Patient Health Questionnaire, PHQ-9) and anxiety (Generalized Anxiety Disorder scale, GAD-7). Secondary outcomes included substance-related problems (AUDIT-C and DAST-10). Linear mixed models were used to estimate effects of time, treatment group, and their interactions (slopes). The primary research question was whether the three conditions differed in improvement over three time points (baseline, mid-treatment, posttreatment) in terms of depression and anxiety symptoms. Results were analyzed according to the intention-to-treat principle using multiple imputation. Patients were followed exploratively from baseline, to 6 and 12 months. We randomized 801 participants.

Results:

Both in short-term and long-term analyses, the slopes for the three conditions did not differ significantly in terms of depression and anxiety, although both online interventions were marginally more efficacious than CAU over 6 months (P’s between .023 and .034). All groups showed significant improvement over time (P’s < .001). For the secondary outcomes, only significant improvements over time (across, not between groups) were found for drug use. Significant differences were found in terms of adherence, indicating that participants in the HG condition did more sessions than in the CG condition (P = .002).

Conclusions:

The transdiagnostic iCBT program offers a practical, feasible and efficacious alternative to usual care to tackle mental health problems in a large university setting. There is no indication that human guidance should be preferred over technological guidance. The potential preference of human support also depends on scale of implementation and cost-effectiveness, which need to be addressed in future trials. Clinical Trial: NL7328/NTR7544 (ICTRP)