Effectiveness of a transdiagnostic individually tailored Internet-based and mobile-supported intervention for the indicated prevention of depression and anxiety (ICare Prevent) in Dutch college students: Study protocol for a randomised controlled trial

Felix Bolinski, Annet Kleiboer, Eirini Karyotaki, Judith E. Bosmans, Anna-Carlotta Zarski, Kiona K. Weisel, David D. Ebert, Corinna Jacobi, Pim Cuijpers, Heleen Riper

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Abstract

Background
Depression and anxiety are common and co-morbid disorders that affect a significant proportion of students. Innovative prevention strategies targeting both conditions are needed to reduce their health burden and costs. ICare Prevent is such an innovative strategy and contains a transdiagnostic individually tailored Internet-based and mobile-supported intervention. It addresses common risk factors of depression and anxiety as part of a large EU-funded multi-country project* (ICare). Little is known about the clinical and cost-effectiveness of this type of intervention compared to care as usual (CAU) for college students. We hypothesize that ICare Prevent will be more (cost-)effective than CAU in the reduction of symptoms of depression and anxiety.

Methods
A three-arm, parallel, randomized controlled superiority trial will be conducted comparing a guided and an unguided version of ICare Prevent with a control group receiving CAU. The trial will be open-label but outcome assessors will be blinded. A total of 252 college students (age ≥ 16 years) with subclinical symptoms of depression defined as a score ≥ 16 on the Center for Epidemiological Studies Depression Scale (CES-D), and/or anxiety, defined as a score ≥ 5 on the Generalized Anxiety Disorder scale (GAD-7), will be included. Those meeting diagnostic criteria for a depressive or anxiety disorder will be excluded. The primary outcome is change in disorder specific symptom severity from baseline to post-intervention. Secondary endpoints include self-reported depression and anxiety symptoms as well as time to onset of a mood or anxiety disorder until 12-month follow-up. Societal costs and quality of life will be assessed to estimate the intervention’s cost-effectiveness compared to CAU.

Discussion
Transdiagnostic individually tailored Internet-based prevention could be a (cost-)effective approach to tackle the disease burden of depression and anxiety among college students.

Trial registration
Dutch trial register, NTR 6562. Registered on 6 July 2017.
Original languageEnglish
Article number118
Pages (from-to)1-13
Number of pages13
JournalTrials
Volume19
DOIs
Publication statusPublished - 20 Feb 2018

Funding

This trial is funded as part of the larger project (ICare) by the European Commission Horizon 2020 Research and Innovation Action.

FundersFunder number
European Commission Horizon 2020 Research and Innovation Action
Horizon 2020 Framework Programme634757

    Keywords

    • Anxiety
    • Cognitive behavioral therapy
    • Depression
    • Internet-based intervention
    • Prevention
    • Randomized controlled trial
    • Students

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