Condition category
Mental and Behavioural Disorders
Date applied
27/08/2008
Date assigned
06/10/2008
Last edited
06/10/2008
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 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

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 measures

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

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

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

http://www.fqrsc.gouv.qc.ca

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes