Condition category
Mental and Behavioural Disorders
Date applied
22/01/2007
Date assigned
22/01/2007
Last edited
24/01/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.unimaas.nl/default.asp?taal=en

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

Publication citations

Additional files

Editorial Notes