Condition category
Mental and Behavioural Disorders
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
02/10/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.traumatips.nl

Contact information

Type

Scientific

Primary contact

Dr J. Mouthaan

ORCID ID

Contact details

Academic Medical Centre
Department of Psychiatry
Center for Anxiety Disorders
Research Group Psychotrauma
Meibergdreef 5
1105 AZ
Netherlands
+31 (0) 20 891 3667
j.mouthaan@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR318

Study information

Scientific title

Acronym

Trauma Tips-Prevention

Study hypothesis

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

Received from the local medical ethics committee

Study design

Multicentre randomised single-blinded active-controlled parallel-group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

PTSD scores (Clinician-Administered PTSD Scale [CAPS] and the revised Impact of Event Scale [IES-R])

Secondary outcome measures

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])

Overall trial start date

01/09/2007

Overall trial end date

01/07/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant 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)

Recruitment start date

01/09/2007

Recruitment end date

01/07/2010

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Centre
Meibergdreef 5
1105 AZ
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (Netherlands)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

http://www.amcpsychiatrie.nl/

Funders

Funder type

Hospital/treatment centre

Funder name

Academic Medical Centre (AMC) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Achmea Victim and Society Foundation (Achmea Stichting Slachtoffer en Samenleving) (SASS) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Netherlands Organisation for Health Research and Development (ZonMW) (Grant no. 62300038)

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

1. 2011 protocol in: 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.
2. 2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22893814
3. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23942480

Publication citations

  1. Protocol

    Mouthaan J, Sijbrandij M, Reitsma JB, Gersons BP, Olff M, Internet-based prevention of posttraumatic stress symptoms in injured trauma patients: design of a randomized controlled trial., Eur J Psychotraumatol, 2011, 2, doi: 10.3402/ejpt.v2i0.8294.

  2. Results

    Mouthaan J, Sijbrandij M, de Vries GJ, Reitsma JB, van de Schoot R, Goslings JC, Luitse JS, Bakker FC, Gersons BP, Olff M, Internet-based early intervention to prevent posttraumatic stress disorder in injury patients: randomized controlled trial., J. Med. Internet Res., 2013, 15, 8, e165, doi: 10.2196/jmir.2460.

Additional files

Editorial Notes