A brief and early psychological intervention for individuals exposed to psychological trauma

ISRCTN	ISRCTN97075515
DOI	https://doi.org/10.1186/ISRCTN97075515
Secondary identifying numbers	SR-4370

Submission date: 27/08/2008
Registration date: 06/10/2008
Last edited: 28/06/2019

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

Prof Alain Brunet
Scientific

Douglas Hospital Research Center
Perry Building (E 4129)
6875
LaSalle Boulevard
Montréal
H4H 1R3
Canada

Phone	+1 514 761 6131 x 4348
Email	alain.brunet@douglas.mcgill.ca

Study information

Study design	Single-blind randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	A brief and early psychological intervention for individuals exposed to psychological trauma
Study objectives	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(s)	McGill's Research and Ethic Board. Date of approval: 09/09/2002 (protocol number: A01-B03-02A)
Health condition(s) or problem(s) studied	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
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 study start date	09/09/2002
Completion date	14/03/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	Both
Target number of participants	66
Total final enrolment	74
Key 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
Key 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
Date of first enrolment	09/09/2002
Date of final enrolment	14/03/2008

Locations

Countries of recruitment

Canada

Study participating centre

Douglas Hospital Research Center

Montréal
H4H 1R3
Canada

Sponsor information

Québec Fund for Research on Society and Culture (FQRSC) (Canada)
Government

140, Grande Allée Est
Bureau 470
Québec
G1R 5M8
Canada

Phone	+1 418 643 7582
Email	fqrsc@fqrsc.gouv.qc.ca
Website	http://www.fqrsc.gouv.qc.ca
"ROR"	https://ror.org/00shpc021

Funders

Funder type

Government

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)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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	26/08/2013	28/06/2019	Yes	No

Editorial Notes

28/06/2019: Publication reference and total final enrolment added.