Table 3.
Primary, secondary and other pre-specified outcome measures by condition.
| Continuous outcome | Intervention (total n = 22) | Control (total n = 19) | Effect size | |||||
|---|---|---|---|---|---|---|---|---|
| n | Mean | SD | n | Mean | SD | d | 95% CI for d | |
| Primary outcome, Week 1 | ||||||||
| Number of intrusive memories (diary) | 20 | 3.85a | 8.57 | 19 | 7.37 | 7.88 | 0.43 | −0.23, 1.08 |
| Secondary outcome, Week 5 | ||||||||
| Number of intrusive memories (diary) | 18 | 0.28 | 0.57 | 18 | 2.89 | 6.43 | 0.57 | −0.12, 1.26 |
| Secondary outcomes, 1 week | ||||||||
| IES-R | ||||||||
| Intrusion subscale | 16 | 4.12 | 4.13 | 17 | 8.53 | 6.23 | 0.83 | 0.09, 1.57 |
| Avoidance subscale | 16 | 2.38 | 2.42 | 17 | 8.06 | 7.85 | 0.97 | 0.22, 1.72 |
| HADS | ||||||||
| Anxiety subscale | 16 | 3.25 | 2.89 | 17 | 4.71 | 3.64 | 0.44 | −0.28, 1.16 |
| Depression subscale | 16 | 1.62 | 1.89 | 17 | 3.06 | 3.36 | 0.52 | −0.20, 1.24 |
| Total | 16 | 4.88 | 4.62 | 17 | 7.76 | 6.81 | 0.49 | −0.23, 1.22 |
| Other outcomes, 1 week | ||||||||
| SRHR | 16 | 5.62 | 1.36 | 16 | 5.12 | 1.54 | −0.34 | −1.07, 0.38 |
| SRSR | 16 | 5.81 | 2.17 | 16 | 4.88 | 2.53 | −0.40 | −1.13, 0.33 |
| Intrusion-related distress | 13 | 2.00 | 2.55 | 16 | 3.38 | 3.42 | 0.45 | −0.33, 1.22 |
| Intrusion vividness | 13 | 2.85 | 3.44 | 16 | 4.50 | 3.46 | 0.48 | −0.30, 1.26 |
| Concentration disruption | 16 | 1.38 | 0.72 | 16 | 2.39 | 1.65 | 0.80 | 0.05, 1.55 |
| Secondary outcomes, 1 month | ||||||||
| IES-R | ||||||||
| Intrusion subscale | 16 | 1.88 | 2.39 | 18 | 3.78 | 3.72 | 0.60 | −0.11, 1.32 |
| Avoidance subscale | 16 | 1.94 | 4.55 | 18 | 3.39 | 4.27 | 0.33 | −0.38, 1.03 |
| HADS | ||||||||
| Anxiety subscale | 16 | 3.19 | 3.02 | 18 | 3.83 | 3.07 | 0.21 | −0.49, 0.91 |
| Depression subscale | 16 | 2.12 | 3.24 | 18 | 2.72 | 3.63 | 0.17 | −0.53, 0.87 |
| Total | 16 | 5.31 | 5.76 | 18 | 6.56 | 6.06 | 0.21 | −0.49, 0.91 |
| Other outcomes, 1 month | ||||||||
| SRHR | 16 | 5.06 | 1.84 | 18 | 5.00 | 1.28 | −0.04 | −0.74, 0.66 |
| SRSR | 16 | 6.69 | 1.40 | 18 | 5.67 | 2.68 | −0.47 | −1.18, 0.24 |
| Intrusion-related distress | 13 | 1.69 | 3.45 | 16 | 1.25 | 2.24 | −0.16 | −0.92, 0.61 |
| Intrusion vividness | 13 | 1.08 | 2.29 | 16 | 1.88 | 2.53 | 0.33 | −0.44, 1.10 |
| Concentration disruption | 15 | 1.27 | 1.03 | 18 | 1.83 | 1.50 | 0.43 | −0.29, 1.15 |
| Secondary outcomes, 3 months | ||||||||
| IES-R | ||||||||
| Intrusion subscale | 15 | 1.33 | 2.13 | 18 | 2.33 | 2.83 | 0.39 | −0.33,1.11 |
| Avoidance subscale | 15 | 0.80 | 1.26 | 18 | 1.61 | 2.85 | 0.36 | −0.36,1.07 |
| HADS | ||||||||
| Anxiety subscale | 14 | 2.36 | 2.90 | 18 | 3.22 | 3.15 | 0.28 | −0.45,1.02 |
| Depression subscale | 14 | 1.43 | 1.91 | 18 | 2.17 | 2.50 | 0.33 | −0.41,1.06 |
| Total | 14 | 3.79 | 4.66 | 18 | 5.39 | 5.40 | 0.31 | −0.42,1.05 |
| Other outcomes, 3 months | ||||||||
| SRHR | 14 | 5.57 | 1.34 | 18 | 5.44 | 0.86 | −0.12 | −0.84,0.61 |
| SRSR | 14 | 7.21 | 1.19 | 18 | 6.28 | 2.27 | −0.50 | −1.24,0.24 |
| Concentration disruption | 14 | 1.43 | 1.60 | 18 | 1.56 | 1.15 | 0.09 | −0.64,0.82 |
| Secondary outcomes, 6 months | ||||||||
| IES-R | ||||||||
| Intrusion subscale | 12 | 1.33 | 3.47 | 16 | 0.75 | 1.13 | −0.24 | −1.03,0.55 |
| Avoidance subscale | 12 | 0.42 | 0.90 | 15 | 0.93 | 1.33 | 0.44 | −0.36,1.25 |
| HADS | ||||||||
| Anxiety subscale | 12 | 2.08 | 2.50 | 16 | 3.44 | 3.22 | 0.46 | −0.33,1.26 |
| Depression subscale | 12 | 1.08 | 1.68 | 15 | 1.87 | 1.81 | 0.45 | −0.36,1.25 |
| Total | 12 | 3.17 | 4.02 | 15 | 5.53 | 4.66 | 0.54 | −0.27,1.35 |
| Other outcomes, 6 months | ||||||||
| SRHR | 12 | 5.83 | 1.34 | 16 | 5.38 | 1.36 | −0.34 | −1.13,0.45 |
| SRSR | 12 | 7.25 | 0.87 | 16 | 5.12 | 2.66 | −1.01 | −1.85,−0.18 |
| Concentration disruption | 12 | 1.58 | 1.73 | 15 | 1.27 | 0.70 | −0.25 | −1.05,0.55 |
CI confidence interval, HADS Hospital Anxiety and Depression Scale, IES-R Impact of Event Scale–Revised, SRHR Self Rated Health Rating, SRSR Self Rated Sleep Rating.
aTable 3 reports the analysis including all participants (incl. outliers). Outliers in number of intrusive memories were inspected per group separately, and were identified based on standard criteria (i.e., >3 SD51). For week 1 data, one statistical outlier was detected within the intervention group (reported 37 intrusions). This participant did not receive correct protocol delivery in ED. For completeness, the outlier is included in the descriptive analyses reported here. No outliers were detected for week 5 data.