Contact information
Type
Scientific
Primary contact
Prof Alain Brunet
ORCID ID
Contact details
Douglas Hospital Research Center
Perry Building (E 4129)
6875
LaSalle Boulevard
Montréal
H4H 1R3
Canada
+1 514 761 6131 x 4348
alain.brunet@douglas.mcgill.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SR-4370
Study information
Scientific title
A brief and early psychological intervention for individuals exposed to psychological trauma
Acronym
Study hypothesis
A time by group interaction is expected whereby self-reported symptoms of posttraumatic stress disorder (PTSD) will be less severe in the intervention group than in the no intervention control group at the post-test, but not at the pre-test or at mid-treatment.
Ethics approval
McGill's Research and Ethic Board. Date of approval: 09/09/2002 (protocol number: A01-B03-02A)
Study design
Single-blind randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Posttraumatic stress disorder
Intervention
This is a single-blind, randomised controlled trial with a treated group and another group on a waiting list completing the periodic assessments only.
This two-session dyadic intervention includes elements of psychoeducation and motivational interviewing, and targets communication between the patient and significant other, aiming to facilitate support, promote bi-directional disclosure, reduce disclosure-constraining behaviours, and improve coping. It promotes the disclosure of thoughts and emotions about the trauma in the natural environment of the dyad while attempting to reduce social constraints on disclosure and negative social support interactions. The intervention is led by a social worker or a nurse trained and supervised every second week by a clinical psychologist. The initial 90-minute session takes place within the first few weeks after the traumatic event. A 75-minute follow-up meeting is scheduled two weeks later.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
PTSD self-reported symptoms as measured by the Impact of Event Scale Revised. We measured PTSD symptoms on average 26 days after trauma exposure (baseline, before treatment), then on average 40 days post-trauma at mid-treatment (after one treatment session), and 90 days after trauma exposure (a time when one can diagnose chronic PTSD), and then again 2 years after trauma exposure.
Secondary outcome measures
Negative social support. (It was hypothesised that the treatment would decrease the provision of negative social support from the significant other toward the trauma victim.). This was assessed using the Social Constraints Scale (SCS). Timepoints: 26 days (on average) after trauma exposure (baseline, before treatment), 40 days post-trauma at mid-treatment (after one treatment session), 90 days and 2 years after trauma exposure.
Overall trial start date
09/09/2002
Overall trial end date
14/03/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Both males and females, adults aged 18-65
2. Patients who present to the emergency room because of trauma exposure (in the last 10 days). Trauma is defined as an event eliciting a peritraumatic reaction of fear, helplessness, or horror.
3. Patients who speak either French or English
4. Medication free at trial onset
5. Patients who are in a medically stable condition
6. Patients who live in the Montreal metropolitan area
7. Patients who have a significant other whom they can bring to the therapy session
8. Patients who succeed at making an appointment with the therapist in a timely manner
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
66
Total final enrolment
74
Participant exclusion criteria
1. Patients who have a suspected or confirmed traumatic brain injury
2. Patients who have a lifetime diagnosis of psychosis, substance/alcohol dependence, bipolar disorder, or mental retardation
3. Patients who have been clinically depressed in the last 2 years
Recruitment start date
09/09/2002
Recruitment end date
14/03/2008
Locations
Countries of recruitment
Canada
Trial participating centre
Douglas Hospital Research Center
Montréal
H4H 1R3
Canada
Sponsor information
Organisation
Québec Fund for Research on Society and Culture (FQRSC) (Canada)
Sponsor details
140
Grande Allée Est
Bureau 470
Québec
G1R 5M8
Canada
+1 418 643 7582
fqrsc@fqrsc.gouv.qc.ca
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Québec Fund for Research on Society and Culture (Fonds Québécois de la Recherche sur la Société et la Culture) (FQRSC), formerly known as Québec Council for Social Research (Conseil Québécois de la Recherche Sociale) (CQRS) (Canada) (ref: SR-4370)
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
Basic results (scientific)
Publication list
2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/23986816 (added 28/06/2019)