No registrations found.
ID
Source
Brief title
Health condition
Depression, Anxiety, Prevention
Depressie, Angst, Preventie
Sponsors and support
Intervention
Outcome measures
Primary outcome
Disorder specific symptom severity at post-intervention (Quick Inventory for Depression Scale + Hamilton Anxiety Rating Scale)
Secondary outcome
Time 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 intervention’s cost-effectiveness.
Background summary
A 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).
Study objective
ICare Prevent is more effective than care as usual in preventing episodes of depression and/or anxiety.
Study design
T0 - screening
T1 - baseline
T2 - mid-intervention
T3 - post-intervention
T4 - 6 months follow-up
T5 - 12 months follow-up
Intervention
Acces 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.
Felix Bolinski
Van der Boechorstraat 1
Amsterdam 1081 BT
The Netherlands
+31 (0)20 59 85204
f.bolinski@vu.nl
Felix Bolinski
Van der Boechorstraat 1
Amsterdam 1081 BT
The Netherlands
+31 (0)20 59 85204
f.bolinski@vu.nl
Inclusion criteria
Age > 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 criteria
being 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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6378 |
| NTR-old | NTR6562 |
| CCMO | NL60705.029.17 |
| OMON | NL-OMON47514 |