The incidence of post-trauma psychopathology study (TRAUMA TIPS): efficacy of an innovative preventive multimedia intervention

ISRCTN	ISRCTN57754429
DOI	https://doi.org/10.1186/ISRCTN57754429
Protocol serial number	NTR318
Sponsor	Academic Medical Centre (AMC) (Netherlands)
Funders	Academic Medical Centre (AMC) (Netherlands), Achmea Victim and Society Foundation (Achmea Stichting Slachtoffer en Samenleving) (SASS) (Netherlands), Netherlands Organisation for Health Research and Development (ZonMW) (Grant no. 62300038)

Submission date: 20/12/2005
Registration date: 20/12/2005
Last edited: 02/10/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr J. Mouthaan
Scientific

Academic Medical Centre
Department of Psychiatry
Center for Anxiety Disorders, Research Group Psychotrauma
Meibergdreef 5
1105 AZ
Netherlands

Phone	+31 (0) 20 891 3667
Email	j.mouthaan@amc.uva.nl

Study information

Primary study design	Interventional
Study design	Multicentre randomised single-blinded active-controlled parallel-group trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	Trauma Tips-Prevention
Study objectives	Our primary hypothesis is whether a brief early multimedia intervention is effective in preventing symptoms of post-traumatic stress, anxiety and depression in injured trauma patients. On 21/03/2012, the following changes were made to the trial record: 1. The anticipated start date was changed from 01/09/2006 to 01/09/2007. 2. The anticipated end date was changed from 01/09/2007 to 01/07/2010. 3. The target number of participants was changed from 180 to 300. 4. 'Netherlands Organisation for Health Research and Development (ZonMW) (Grant no. 62300038)' was added to the sources of funding field.
Ethics approval(s)	Received from the local medical ethics committee
Health condition(s) or problem(s) studied	Depression, post-traumatic stress disorder (PTSD), anxiety
Intervention	Current interventions as of 21/03/2012: The multimedia (MM) intervention group (n = 151) versus the the control/non-intervention group (n = 149). 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: 1. Information about procedures in trauma units 2. Information about commonly experienced reactions to accident injuries 3. An audio clip providing relaxation techniques 4. 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, 3, 6 and 12 months post-trauma). Previous interventions: The multimedia (MM) intervention group (n = 90) versus the the control/non-intervention group (n = 90). 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: 1. Information about procedures in trauma units 2. Information about commonly experienced reactions to accident injuries 3. An audio clip providing relaxation techniques 4. 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 post-trauma).
Intervention type	Other
Primary outcome measure(s)	PTSD scores (Clinician-Administered PTSD Scale [CAPS] and the revised Impact of Event Scale [IES-R])
Key secondary outcome measure(s)	1. Other psychopathology (Mini International Neuropsychiatry Interview Plus [MINI-PLUS] clinical interview) 2. Anxiety and depression (Hospital Anxiety and Depression Score [HADS] questionnaire) 3. Quality of life (World Health Organization Quality of Life Assessment [WHOQOL])
Completion date	01/07/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	300
Key inclusion criteria	1. Injured patients who entered the shockrooms of the Academic Medical Centre (AMC) or the Vrije University Medical Centre (VUMC) in Amsterdam, Netherlands 2. Aged 18 years and older 3. Proficiency in Dutch
Key exclusion criteria	1. Mentally incapable of participating in trial (i.e., Glasgow Coma Scale score less than 13) 2. Physically incapable of participating in trial 3. Suicidality 4. Fulfilling diagnostic criteria for a bipolar disorder, depression with psychotic features, psychotic disorder or organic disorder according to Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM IV)
Date of first enrolment	01/09/2007
Date of final enrolment	01/07/2010

Locations

Countries of recruitment

Netherlands

Study participating centre

Academic Medical Centre

Meibergdreef 5
1105 AZ
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	13/08/2013		Yes	No
Protocol article	protocol	01/03/2011		Yes	No
Protocol article	protocol	01/09/2011		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes