|- candidate number||2571|
|- NTR Number||NTR965|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||3-mei-2007|
|- Secondary IDs||METC2006.005 |
|- Public Title||Prevention of Adolescent Social and Test Anxiety.|
|- Scientific Title||Fear of negative evaluation in social and test anxiety, a RCT testing two easily accessible interventions.|
|- hypothesis||1. Cognitive behavioural group therapy is more effective than no intervention in prevention of social anxiety and related psychological problems;|
2. Computer-based BiasRetraining is more effective than no intervention in prevention of social anxiety and related psychological problems;
3. Cognitive behavioural group therapy and BiasRetraining are equally effective in preventing social anxiety and related psychological problems.
|- Healt Condition(s) or Problem(s) studied||Cognitive behavioural group therapy, Computer-based BiasRetraining|
|- Inclusion criteria||1. Scholars in first and second grade of high school (age 13-15);|
2. VMBO-T, HAVO and VWO (Atheneum and Gymnasium) with elevated symptoms of social and test anxiety as measured with RCADS and ETAV.
|- Exclusion criteria||1. PDD;|
2. Other mental disorders based on the ADIS interview C/P;
3. Severe social and/or test anxiety.
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||10-apr-2007|
|- planned closingdate||31-mei-2011|
|- Target number of participants||2300|
|- Interventions||1. Cognitive behavioural group therapy (appr. 8 participants per group): 12 1,5-hour sessions. Psycho-education, cognitive therapy, exposure, task concentration training;|
2. Bias Retraining: internet-based training consisting of 21 45-minute sessions using Interpretational bias retraining, attentional bias retraining and self-esteem conditioning tasks.
|- Primary outcome||1. Revised Child Anxiety and Depression Scale (RCADS, Chorpita et al.,
2. Spielberger Test Anxiety Inventory (Spielberger et al., 1980);
3. the interference of mental disorders by the semi-structured Anxiety;
4. Disorder Interview Schedule (ADIS, Silverman and Albano, 1996).
|- Secondary outcome||1. Fear of negative evaluation (FNE, Watson & Friend, 1969; Leary, 1983);|
2. Rosenberg self-esteem scale (RSES, Rosenberg, 1965);
3. Matson Evaluation of Social Skills with Youngsters (MESSY, Matson,
Rotatori & Helsel, 1983);
4. Implicit Association Test (IAT, Greenwald et al., 1998).
|- Timepoints||Assessments take place at pretest, posttest, and at 6, 12, and 24 months
The ADIS will only be included in the pretest, posttest and
12 months follow-up assessment, whereas the self report questionnaires
will be included in all assessments.
|- Trial web site||http://www.projectpasta.nl|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||dr. M.H. Nauta|
|- CONTACT for SCIENTIFIC QUERIES||dr. M.H. Nauta|
|- Sponsor/Initiator ||Accare, Division University Center for Child and Adolescent Psychiatry, University Medical Center Groningen (UMCG), University of Groningen (RuG), department of Clinical and Developmental Psychology |
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||In this study the effectiveness of two easiliy accessible interventions is tested. Participants (2300) are recruited on high schools. They are screened on symptoms of social and test anxiety. Participants with elevated scores are interviewed (ADIS C/P). After the interview they are randomly assigned to one of three conditions (assignment takes place on school level). Participants are measured immediately before the intervention/control, immediately after intervention/control and there is a follow-up at 6, 12 and 24 months. At 24 months all 2300 participants will be screened again.|
|- Main changes (audit trail)|
|- RECORD||3-mei-2007 - 2-jun-2012|