The Incidence of Post trauma Psychopathology Study (TRAUMA TIPS): efficacy of an innovative preventive multimedia-intervention.|
|- candidate number||1510|
|- NTR Number||NTR318|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||9-sep-2005|
|- Secondary IDs||N/A |
|- Public Title||The Incidence of Post trauma Psychopathology Study (TRAUMA TIPS): efficacy of an innovative preventive multimedia-intervention.|
|- Scientific Title||The Incidence of Post trauma Psychopathology Study (TRAUMA TIPS): efficacy of an innovative preventive multimedia-intervention.|
|- ACRONYM||Trauma Tips-Prevention|
|- hypothesis||Our primary hypothesis is whether a brief early multimedia intervention is effective in preventing symptoms of posttraumatic stress, anxiety and depression in injured trauma patients.|
|- Healt Condition(s) or Problem(s) studied||Post-Traumatic Stress Disorder (PTSD), Depression, Anxiety|
|- Inclusion criteria||1. Injured patients who entered the shockrooms of the Academic Medical Center (AMC) or the Medical Center of the Free University (VUMC) in Amsterdam, the Netherlands;|
2. Age 18 years and older;
3. Proficiency in Dutch.
|- Exclusion criteria||1. Mentally uncapable of participating in trial (i.e. Glasgow Coma Scale score < 13);|
2. Physically uncapable of participating in trial;
4. Fulfilling diagnostic criteria for a biplar disorder, depression with psychotic features, psychotic disorder or organic disorder according to DSM IV.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2006|
|- planned closingdate||1-sep-2007|
|- Target number of participants||180|
|- Interventions||1. The multimedia (MM) intervention group (n = 90) and |
2. The control / non-intervention group (n = 90).
|- Primary outcome||PTSD scores (Clinician-Administered PTSD Scale CAPS, Blake et al., 1995 and the revised Impact of Event Scale IES-R, Weiss et al., 1997). |
|- Secondary outcome||Other psychopathology (MINI-PLUS clinical interview); anxiety and depression (HADS questionnaire); quality of life (WHOQOL).|
|- Trial web site||http://www.traumatips.nl|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES|| J. Mouthaan|
|- CONTACT for SCIENTIFIC QUERIES|| M. Sijbrandij|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Department of Psychiatry|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC), Achmea Stichting Slachtoffer en samenleving (SASS), ZON-MW, The Netherlands Organization for Health Research and Development|
|- Publications||Mouthaan, J., Sijbrandij, M., Reitsma, J.B., Luitse, J.S.K., Goslings, J.C., & Olff, M. (2011). Trauma TIPS: an internet-based intervention to prevent posttraumatic stress disorder in injured trauma patients. Journal of Cybertherapy and Rehabilitation, 4(3), 331-340.
Mouthaan, J., Sijbrandij, M., Reitsma, Gersons, B.P.R., & Olff, M. (2011). Internet-based prevention of posttraumatic stress symptoms in injured trauma patients: design of a randomized controlled trial. European Journal of Psychotraumatology, 2: 8294 - DOI: 10.3402/ejpt.v2i0.8294.
|- Brief summary||Previous research has shown that individual, single-session intervention interviews (psychological debriefing) in the aftermath of a traumatic event are not effective in preventing posttraumatic stress disorder (PTSD). Little research has been done so far on alternatives to debriefing. In this study, we propose to test a brief multimedia intervention (MM intervention) and to test its efficacy in a randomised controlled trial (RCT). The trial will involve adults who have sustained injuries in accidents or crime, to be recruited at the Trauma Units of the Academic Medical Centre (AMC) and the VU University Medical Centre (VUMC), both in Amsterdam. The subjects’ informed consent will be obtained 1 to 7 days after the critical incident. The MM intervention session, lasting a maximum of 30 minutes, is an internet-based programme containing interactive elements and visual and auditory materials. Its aim is to reduce acute psychological stress in trauma victims. The following core and elective modules will be included: information about procedures in trauma units, information about commonly experienced reactions to accident injuries, an audio clip providing relaxation techniques, and tips for dealing with the initial period after the traumatic experience.
Subjects will be assessed at pre-intervention (1 to 7 days after the trauma and immediately preceding the intervention) and at post-intervention (immediately following the intervention and at 1 month and 6 months posttrauma). The primary outcome measures will be symptoms of acute distress and PTSD scores. Secondary measures will be anxiety and depression and quality of life. If efficacy is demonstrated, the intervention can be made available to patients at all Dutch trauma centres.
Randomised controlled trial
Stress disorders, posttraumatic
Preventive health services
|- Main changes (audit trail)|
|- RECORD||9-sep-2005 - 9-mrt-2012|
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