Brunet 2013.
Methods | Design: RCT | |
Participants |
Setting: emergency departments of 2 public hospitals Type of trauma exposure: exposure to a life‐threatening event Inclusion criteria: experienced a life‐threatening event in the last 10 days that elicited a peritraumatic reaction of fear, helplessness or horror. Exclusion criteria: did not speak either French or English; had or were suspected of having a traumatic brain injury; had a lifetime diagnosis of psychosis, substance or alcohol dependence, bipolar disorder or mental retardation; had been clinically depressed in the last 2 years; were taking psychotropic medication at the onset of the study; were injured to the extent that they could not participate in the study; lived outside the Montreal metropolitan area; did not have a significant other (a friend, spouse or another family member) to bring to the therapy session; or did not succeed in making an appointment with the therapist within 30 days after trauma exposure. Sample size: 90 people eligible to take part; 83 randomised; 74 completed baseline measures and were identified as the ITT sample; 5 individuals were subsequently withdrawn for protocol violation. Mean age: 36.29 (SD 11.05) years Gender: 40 (54.1%) men; 34 (45.9%) women Ethnicity: 85.1% white; 14.9% other Country: Canada |
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Interventions |
Group 1: brief dyadic CBT intervention: n = 37 2‐session dyadic intervention included elements of psychoeducation and motivational interviewing, and targeted communication between the patient and significant other, aiming to facilitate support, promote bidirectional disclosure, reduce disclosure constraining behaviours and improve coping. It promoted 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. Group 2: waiting list: n = 37 Waiting list group filled out and returned the questionnaires. |
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Outcomes |
PTSD: IES‐R; CAPS Other: SCS; SAS‐SR Follow‐up: postintervention |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Allocation undertaken through randomly permuted blocks. |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | IES‐R (self‐report measure) was the primary outcome. We judged the risk of detection bias to be low using this measure. PTSD diagnosis was made using the CAPS. It was unclear whether assessor were blind to allocation. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Analysis undertaken using ITT principles. 4 (5.4%) individuals were removed from the study for protocol violation and not included in follow‐up analyses. A further 3 (4.1%) participants did not complete outcomes. |
Selective reporting (reporting bias) | Unclear risk | No study protocol identified. |
Other bias | High risk | Authors affiliated with experimental intervention. |