Condition category
Mental and Behavioural Disorders
Date applied
27/03/2006
Date assigned
31/03/2006
Last edited
22/04/2008
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

Prof Andreas Maercker

ORCID ID

Contact details

University of Zurich
Department of Abnormal Psychology
Scheuchzerstr. 21
Zurich
8006
Switzerland
maercker@psychologie.unizh.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

KA 1476/3-1

Study information

Scientific title

Acronym

Study hypothesis

Cognitive-behavioral intervention for patients with post-traumatic stress disorder (PTSD) improves their health in comparison to wait-list control condition

Ethics approval

Approved by the University Ethics Committee, Dresden University in September 2001 (ref: 33 02 2001)

Study design

Interventional, randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Condition

Post-traumatic stress disorder

Intervention

Cognitive-behavioral treatment (psychotherapy) versus wait-list control

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Clinical interview for PTSD (CAPS)

Secondary outcome measures

1. Questionnaires
2. Electroencephalogram (EEG) parameters
3. Peripheral electrophysiology

Overall trial start date

01/04/2002

Overall trial end date

31/08/2003

Reason abandoned

Eligibility

Participant inclusion criteria

1. Positive diagnosis (above the threshold of standardized clinical assessment according to clinical interview - clinician-administered PTSD scale [CAPS])
2. Age 18-65 years
3. German language competency

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

42

Participant exclusion criteria

Co-morbid diagnoses (e.g. bipolar disorder, current alcohol or drug abuse and cognitive impairment)

Recruitment start date

01/04/2002

Recruitment end date

31/08/2003

Locations

Countries of recruitment

Germany

Trial participating centre

University of Zurich
Zurich
8006
Switzerland

Sponsor information

Organisation

German Research Foundation (Deutsche Forschungsgemeinsschaft) (DFG)

Sponsor details

Kennedyallee 40
Bonn
53170
Germany
+49 (0)228 8851
postmaster@dfg.de

Sponsor type

Research organisation

Website

http://www.dfg.de

Funders

Funder type

Research organisation

Funder name

German Research Foundation (Deutsche Forschungsgemeinsschaft) (DFG) KA 1476/3-1 to /3-3

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results in http://www.ncbi.nlm.nih.gov/pubmed/16824221

Publication citations

  1. Results

    Maercker A, Zöllner T, Menning H, Rabe S, Karl A, Dresden PTSD treatment study: randomized controlled trial of motor vehicle accident survivors., BMC Psychiatry, 2006, 6, 29, doi: 10.1186/1471-244X-6-29.

Additional files

Editorial Notes