Brom 1993.
Methods | Design: RCT | |
Participants |
Setting: Participants were recruited from police records of MVA and seen on an outpatient basis. Type of trauma exposure: MVA Inclusion criteria: exposure to an MVAs of moderately serious‐to‐serious severity Exclusion criteria: not specified Sample size: 738 people randomised and written to by the police and invited to take part in study; 151 agreed to take part in the study; 83 (36%) agreed to take part in the monitoring group and 68 (13%) took up the offer of intervention. Mean age: 37.6 (SD 16.6) years Gender: 89 (58.9%) men; 62 (41.1%) women Ethnicity: not reported Country: Netherlands |
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Interventions |
Group 1: counselling intervention: n = 68 Counselling intervention lasted 3–6 sessions depending on need. Components of the intervention included: practical help and information on procedures following an MVA and general information about psychological reactions; support to recognise that the event was over, to explore the experience and related emotions and to mobilise support networks; reality testing and confronting emotional reactions; confronting the memory of the experience; ongoing contact at least 2–3 months after the accident; referral for psychotherapeutic treatment where indicated. Group 2: monitoring group: n = 83 Monitoring group were unaware that they were part of a comparison study and received assessments only. |
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Outcomes |
PTSD: IES Other: Trauma Symptom Inventory Follow‐up: 1 and 6 months |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Not reported but outcomes were likely to be measured by the therapists. |
Incomplete outcome data (attrition bias) All outcomes | High risk | The plan of analysis and management of dropout is not reported. |
Selective reporting (reporting bias) | Unclear risk | No study protocol identified. |
Other bias | High risk | Randomisation occurred prior to potential participants agreeing to take part in the study and participants were only aware that they were either invited to participate in a secondary prevention programme or that they were invited to participate in a research project. The response rate for the monitoring group was 36%, for the intervention group 13%. Symptom scores on the IES were not matched at baseline. Groups were not matched for marital status and income. Individuals in the monitoring group were more likely to be married and had a statistically significant higher level of income. |