Contact information
Type
Scientific
Primary contact
Dr Manon J B Vincken
ORCID ID
Contact details
University Maastricht
Department of Medical
Clinical and Experimental Psychology
P.O. Box 616
Maastricht
6200 MD
Netherlands
+31 (0)43 388 1047
m.vincken@dmkep.unimaas.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Risk of chronic Post-Traumatic Stress Disorder (PTSD) after Acute Stress Disorder (ASD) diminishes with an early intervention (Cognitive Behavioural Therapy [CBT]) that attempts to modify cognitive appraisals.
Ethics approval
Approval received from the Medical Ethics Commission academic hospital of Maastricht/Maastricht University (Medisch Ethische Commissie azM/UM) on the 11th OCtober 2006 (ref: 06-3-045).
Study design
Randomised, crossover, single blind multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Post-Traumatic Stress Disorder (PTSD)
Intervention
Brief trauma-focused cognitive behavioral therapy intervention or control-condition (wait-list-controls).
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Presence versus absence of PTSD
2. PTSD-symptom-severity, assessed with:
a. structured interview (Anxiety Disorders Interview Schedule for Children [ADIS-C])
b. self-completed questionnaires (Child Post-traumatic Stress Scale [CPSS])
Secondary outcome measures
Symptoms of anxiety and/or depression according to questionnaires (Revised Children's Anxiety and Depression Scale [RCADS]) and quality of life.
Overall trial start date
01/12/2006
Overall trial end date
01/01/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Children (aged seven to 17)
2. Had contact with Victim Assistance experiencing a traumatic event less than two weeks ago
3. Meet the Diagnostic and Statistical Manual of mental disorders (DSM) criteria for Acute Stress Disorder
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
80
Participant exclusion criteria
1. Brain injury
2. Psychotic or organic mental disorder
3. Current suicidal ideation
4. Intelligence Quotient (IQ) less than 80
5. Low proficiency in Dutch
6. No parent willing to participate in the study
Recruitment start date
01/12/2006
Recruitment end date
01/01/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Maastricht
Maastricht
6200 MD
Netherlands
Sponsor information
Organisation
University Maastricht (UM) (The Netherlands)
Sponsor details
P.O. Box 616
Maastricht
6200 MD
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Alternative name(s)
Netherlands Organisation for Health Research and Development
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Netherlands
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary