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Effectiveness of an Internet-based prevention intervention for depression and anxiety


- candidate number27509
- NTR NumberNTR6562
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-jul-2017
- Secondary IDsNL60705.029.17 ToetsingOnline
- Public TitleEffectiveness of an Internet-based prevention intervention for depression and anxiety
- Scientific Title(Cost-) Effectiveness of a Transdiagnostic Internet-based Intervention (ICare Prevent) for the Prevention of Depression and Anxiety
- ACRONYMICare Prevent
- hypothesisICare Prevent is more effective than care as usual in preventing episodes of depression and/or anxiety.
- Healt Condition(s) or Problem(s) studiedDepression, Anxiety
- Inclusion criteriaAge > 16;
subclinical symptoms of depression (Center for Epidemiologic Studies Depression Scale ≥ 16) and/or anxiety (7-item Generalized Anxiety Disorder scale ≥ 5);
not meeting criteria for a full syndrome presentation of any common mental health disorder within the past six months, in the absence of cardinal symptoms during the past three weeks (assessed by the MINI International Neuropsychiatric Interview)
- Exclusion criteriabeing on a waitlist for, currently receiving or having received psychotherapy within the past 12 months for any mental condition;
having a lifetime bipolar or psychiatric disorder (assessed by the MINI International Neuropsychiatric Interview);
being at moderate to severe risk for suicide (assessed by the MINI International Neuropsychiatric Interview);
self-reported inability to read or write Dutch;
no access to a computer or the Internet;
participation in similar studies at time of inclusion
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-aug-2017
- planned closingdate31-aug-2019
- Target number of participants252
- InterventionsAcces to ICare Prevent, a transdiagnostic Internet-based intervention. The intervention is based on CBT principles. One arm of the RCT is self-guided, the other arm receives feedback on exercises by a trained eCoach. All three groups in the RCT have access to usual care.
- Primary outcomeDisorder specific symptom severity at post-intervention (Quick Inventory for Depression Scale + Hamilton Anxiety Rating Scale)
- Secondary outcomeTime to mental health disorder onset within 6 and 12 months follow-up as well as moderators and mediators of intervention outcome and adherence. In addition, societal costs and healthcare utilization are investigated to estimate the interventionís cost-effectiveness.
- TimepointsT0 - screening
T1 - baseline
T2 - mid-intervention
T3 - post-intervention
T4 - 6 months follow-up
T5 - 12 months follow-up
- Trial web sitewww.icare-online.eu/nl
- statusplanned
- CONTACT FOR PUBLIC QUERIES Felix Bolinski
- CONTACT for SCIENTIFIC QUERIESDr Annet Kleiboer
- Sponsor/Initiator Vrije Universiteit Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
European Unionís Horizon 2020 research and innovation programme, grant agreement No 634757
- Publications
- Brief summaryA three-arm randomized controlled trial is conducted comparing the (cost-)effectiveness of a) a guided version of ICare Prevent, b) an unguided version of ICare Prevent, to c) care as usual for the prevention of depression and anxiety. A specific focus is put on student populations. 252 participants will be randomized into either of the three groups, resulting in 84 participants per condition. This study is part of a large European project (ICare); www.icare-online.eu/nl).
- Main changes (audit trail)
- RECORD6-jul-2017 - 30-jul-2017


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