Background
Method
Design
Participants
Procedure
Outcomes
Measures
Analysis plan
Results
Target symptoms
Anger (DSM) | Domineering (IIP) | Hostility (SCL-90) | |||||||||||||
Unadjusted observed mean (SD) | Unadjusted observed mean (SD) | Unadjusted observed mean (SD) | |||||||||||||
MBT | SCM |
t
| MBT (n = 21) | SCM (n = 19) |
t
| MBT (n = 21) | SCM (n = 19) |
t
| |||||||
Baseline | 2.76 (n = 21) | (0.62) | 2.68 (n = 19) | (0.75) | -0.36 | -0.12 | (0.77) | -0.33 | (0.40) | -0.10 | 1.73 | (1.20) | 2.04 | (1.04) | 0.88 |
6 months | -0.16 | (0.73) | -0.16 | (0.45) | -0.02 | 1.67 | (1.08) | 1.86 | (0.87) | 0.61 | |||||
12 months | -0.18 | (0.69) | -0.23 | (0.41) | -0.30 | 1.43 | (0.96) | 1.88 | (0.78) | 1.60 | |||||
18 months | 1.25 (n = 8) | (0.46) | 2.00 (n = 8) | (0.93) | 2.05* | -0.22 | (0.43) | -0.06 | (0.46) | 1.06 | 0.85 | (0.60) | 1.57 | (0.69) | 3.53*** |
Adjusted model coefficients (95 % CI)a | Adjusted model coefficients (95 % CI)b | Adjusted model coefficients (95 % CI)b | |||||||||||||
Model: Wald χ2 | 35.56*** (df = 3)a | 3.51 (df = 4) | 54.83*** (df = 5) | ||||||||||||
Linear change (both groups) | -0.23* | (-0.41, -0.04) | 0.07 | (-0.10, 0.24) | -0.48** | (-0.84, -0.12) | |||||||||
Quadratic change (both groups) | 0.00 | (-0.05, 0.05) | -0.17* | (-0.32, -0.02) | |||||||||||
Differential linear change (MBT) | -0.28* | (-0.54, -0.02)) | -0.11 | (-0.22, 0.05) | -0.27 | (-0.54, 0.01) | |||||||||
Group differences at 18 months | -0.75* | (-1.41, -0.09) | -0.13 | (-0.41, 0.16) | -0.60** | (-1.02, -0.18) | |||||||||
Paranoia (SCL-90) | Paranoid ideation (DSM) | ||||||||||||||
Unadjusted observed mean (SD) | Unadjusted observed mean (SD) | ||||||||||||||
MBT (n = 21) | SCM (n = 19) |
t
| MBT | SCM |
t
| ||||||||||
Baseline | 1.86 | (1.03) | 1.94 | (0.72) | 0.29 | 2.14 (n = 21) | (0.91) | 2.05 (n = 19) | (0.97) | -0.30 | |||||
6 months | 1.62 | (0.99) | 2.00 | (0.80) | 1.24 | ||||||||||
12 months | 1.52 | (1.00) | 1.81 | (0.78) | 1.02 | ||||||||||
18 months | 0.85 | (0.57) | 1.47 | (0.70) | 3.06** | 1.00 (n = 8) | (0.00) | 1.88 (n = 8) | (0.99) | 2.50** | |||||
Adjusted model coefficients (95 % CI)c | Adjusted model coefficients (95 % CI)d | ||||||||||||||
Model: Wald χ2 | 22.77*** (df = 3) | 22.77*** (df = 3) | |||||||||||||
Linear change (both groups) | -0.12 | (-0.29, -0.05) | -0.12 | (-.029, 0.05) | |||||||||||
Differential linear change (MBT) | -0.29* | (-0.53, -0.36) | -0.28* | (-0.53, –0.04) | |||||||||||
Group differences at 18 months | -0.75* | (-1.51, -0.01) | -0.75* | (-1.51, 0.01) |
Patients without severe clinical events | Patients who presented suicide attempts | Number of suicide attempts | |||||||||||||
n/N(%) | n/N(%) | Unadjusted observed mean (SD) | |||||||||||||
MBT | SCM |
χ
2
| MBT | SCM |
χ
2
| MBT (n = 21) | SCM (n = 19) |
t
| |||||||
Baseline | 0/21 | 0.00 % | 0/19 | 0.00 % | 19/21 | 90.48 % | 15/19 | 78.95 % | 1.04 | 1.38 | (1.07) | 1.32 | (0.95) | -0.20 | |
6 months | 2/21 | 9.52 % | 1/19 | 5.26 % | 0.26 | 11/21 | 52.38 % | 11/19 | 57.89 % | 0.12 | 0.57 | (0.60) | 0.89 | (0.99) | 1.26 |
12 months | 6/21 | 28.57 % | 2/19 | 10.53 % | 2.03 | 8/21 | 38.10 % | 10/19 | 52.63 % | 0.85 | 0.43 | (0.60) | 0.79 | (1.03) | 1.37 |
18 months | 13/21 | 61.90 % | 4/19 | 21.05 % | 6.81** | 0/21 | 0.00 % | 4/19 | 21.05 % | 4.91* | 0.00 | (0.00) | 0.37 | (0.83) | 2.04* |
Modelled odds ratios (95 % CI) a | Modelled odd ratios (95 % CI) a | Adjusted model coefficients (95 % CI)b | |||||||||||||
Model: Wald χ2 | 12.48** (df = 3) | 23.67*** (df = 3) | 36.29*** | ||||||||||||
Linear change (both groups) | 8.42* | (1.18, 60.15) | 0.20** | (0.08, 0.51) | 0.70** | (0.55, 0.88) | |||||||||
Differential linear change (MBT) | 2.83 | (0.32, 24.79) | 0.34 | (0.10, 1.16) | 0.61* | (0.41, 0.91) | |||||||||
Group differences at 18 months | 61.45* | (1.17, 60.15) | 0.09 | (0.01, 1.35) | 0.25** | (0.09, 0.71) | |||||||||
Patients who self-harmed | Number of self-harm episodes | Number of hospital admissions | |||||||||||||
n/N(%) | Unadjusted observed mean (SD) | Unadjusted observed means (SD) | |||||||||||||
MBT | SCM |
χ
2
| MBT (n = 21) | SCM (n = 19) |
t
| MBT (n = 21) | SCM (n = 19) |
t
| |||||||
Baseline | 16/21 | 76.19 % | 14/19 | 73.68 % | 0.03 | 5.90 | (6.69) | 3.79 | (3.61) | -1.23 | 0.57 | (0.60) | 0.32 | (0.58) | -1.37 |
6 months | 17/21 | 80.95 % | 17/19 | 89.47 % | 0.57 | 3.14 | (3.02) | 3.11 | (3.57) | -0.04 | 0.24 | (0.44) | 0.21 | (0.42) | -0.20 |
12 months | 10/21 | 47.62 % | 15/19 | 78.95 % | 4.18* | 2.14 | (2.87) | 2.42 | (2.39) | 0.37 | 0.10 | (0.30) | 0.32 | (0.75) | 1.24 |
18 months | 8/21 | 38.10 % | 13/19 | 68.42 % | 3.68 | 0.62 | (0.97) | 2.63 | (3.65) | 2.43* | 0.00 | (0.00) | 0.16 | (0.37) | 1.93* |
Modelled odds ratios (95 % CI)a | Adjusted model coefficients (95 % CI)b | Adjusted model coefficients (95 % CI) b | |||||||||||||
Model: Wald χ2 | 13.34** (df = 3) | 98.73*** (df = 4) | 17.38** (df = 4) | ||||||||||||
Linear change (both groups) | 0.72 | (0.35, 1.49) | -0.12 | (-0.27, 0.35) | 0.89 | (0.46, 1.74) | |||||||||
Differential linear change (MBT) | 0.30* | (0.10, 0.91) | -0.29** | (-0.50, -0.08) | 0.28 | (0.06, 1.27) | |||||||||
Group differences at 18 months | 0.03* | (0.01, 0.63) | -0.66*** | (-0.98, -0.34) | 0.06* | (0.00, 0.81) |
Drivers of aggression
Anxiety (SCL-90) | Depression (BDI) | GSI (SCL-90) | |||||||||||||
Unadjusted observed mean (SD) | Unadjusted observed mean (SD) | Unadjusted observed mean (SD) | |||||||||||||
MBT (n = 21) | SCM (n = 19) |
t
| MBT (n = 21) | SCM (n = 19) |
t
| MBT (n = 21) | SCM (n = 19) |
t
| |||||||
Baseline | 1.83 | (0.91) | 2.18 | (0.82) | 1.30 | 27.51 | (11.42) | 30.58 | (7.51) | 0.99 | 1.75 | (0.74) | 2.01 | (0.55) | 1.25 |
6 months | 1.83 | (0.85) | 2.28 | (0.89) | 1.62 | 24.68 | (10.45) | 29.00 | (8.06) | 1.45 | 1.73 | (0.80) | 2.03 | (0.67) | 1.29 |
12 months | 1.59 | (1.02) | 2.05 | (0.80) | 1.61 | 19.19 | (11.18) | 26.56 | (8.71) | 2.31** | 1.52 | (0.87) | 2.00 | (0.66) | 1.91* |
18 months | 1.00 | (0.67) | 1.62 | (0.75) | 2.74** | 13.14 | (7.25) | 21.99 | (9.20) | 3.39*** | 0.96 | (0.52) | 1.57 | (0.63) | 3.37*** |
Adjusted model coefficients (95 % CI)a | Adjusted model coefficients (95 % CI) | Adjusted model coefficients (95 % CI) | |||||||||||||
Model: Wald χ2 | 54.07*** (df = 4) | 92.30*** (df = 3)a | 87.16*** (df = 5)b | ||||||||||||
Linear change (both groups) | -0.61*** | (-0.86, -0.36) | -2.82*** | (-4.05, -1.59) | -.060*** | (-0.90, -0.29) | |||||||||
Quadratic change (both groups) | -0.14*** | (-0.21, -0.07) | -0.18** | (-0.32, -0.05) | |||||||||||
Differential linear change (MBT) | -0.08 | (-0.24, -0.08) | -2.04* | (-4.74, -0.34) | -0.15 | (-0.34, 0.04) | |||||||||
Group differences at 18 months | -0.59* | (-1.07, -0.12) | -8.96*** | (-14.27, -3.65) | -0.47** | (-0.79, -0.15) |
Secondary consequences of aggression
GAF (DSM) | IIP total | SAS total | |||||||||||||
Unadjusted observed mean (SD) | Unadjusted observed mean (SD) | Unadjusted observed mean (SD) | |||||||||||||
MBT | SCM |
t
| MBT (n = 21) | SCM (n = 19) |
t
| MBT (n = 21) | SCM (n = 19) |
t
| |||||||
Baseline | 38.57 (n = 21) | (9.09) | 39.74 (n = 19) | (8.38) | 0.42 | 2.04 | (0.62) | 2.11 | (0.41) | 0.43 | 2.71 | (0.41) | 2.81 | (0.41) | 0.78 |
6 months | 1.87 | (0.58) | 2.03 | (0.40) | 1.04 | 2.53 | (0.62) | 2.72 | (0.49) | 1.06 | |||||
12 months | 1.66 | (0.51) | 2.01 | (0.56) | 2.06* | 2.05 | (0.41) | 2.63 | (0.44) | 4.31*** | |||||
18 months | 62.71 (n = 21) | (16.66) | 51.39 (n = 18) | (12.06) | -2.39** | 1.33 | (0.48) | 1.76 | (0.44) | 2.94** | 1.69 | (0.45) | 2.27 | (0.51) | 3.78*** |
Adjusted model coefficients (95 % CI) | Adjusted model coefficients (95 % CI) | Adjusted model coefficients (95 % CI) | |||||||||||||
Model: Wald χ2 | 107.57 (df = 3)b | 57.47*** (df = 3)b | 82.53*** (df = 4)a | ||||||||||||
Linear change (both groups) | 3.82*** | (2.01, 5.63) | -0.11** | (-0.18, -0.04) | -0.22*** | (-0.35, -0.10) | |||||||||
Quadratic change (both groups) | |||||||||||||||
Differential linear change (MBT) | 4.22** | (1.75, 6.70) | -0.13* | (-0.23, -0.03) | -0.19* | (-0.36 -0.02) | |||||||||
Group differences at 18 months | 11.51** | (4.13, 18.89) | -0.44** | (-0.73, -0.16) | -0.60*** | (-0.88, -0.33) |