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Table 3 Clinical characteristics of participants at baseline for all participants and changes over time for each arm separately at baseline, 12 months and 15 months follow-up and estimated pooled treatment effects (95% confidence intervals), p value of test and effect size Cohen’s d for continuous outcomes

From: Randomised control trial of the effectiveness of an integrated psychosocial health promotion intervention aimed at improving health and reducing substance use in established psychosis (IMPaCT)

Variable Combined Treatment as Usual (TAU) IMPACT Therapy (Health Promotion Intervention (HPI)) Mixed model results
  Baseline Baseline 12 months 15 months Baseline 12 months 15 months  
  N Mean(SD)/N(%) N Mean(SD)/N(%) N Mean(SD)/N(%) N Mean(SD)/N(%) N Mean(SD)/N(%) N Mean(SD)/N(%) N Mean(SD)/N(%) Treatment effect (95% C.I.) p value Cohen’s d
SF-36 PCS 406 48.03 (10.54) 193 48.68 (9.58) 132 49.01 (10.33) 114 48.88 (9.62) 213 47.44 (11.32) 127 46.51 (11.24) 117 47.54 (11.14) −1.40 (−3.20 to 0.41) 0.13 −0.13
SF-36 MCS 406 43.25 (13.02) 193 43.72 (12.22) 132 44.5 (13.47) 114 44.91 (13.42) 213 42.81 (13.73) 127 43.9 (12.97) 117 42.3 (13.42) −0.13 (−2.49 to 2.24) 0.92 0.01
BMI <100 only 380 31.17 (7.52) 177 31.79 (7.49) 124 32.29 (8.01) 102 33.6(9.61) 203 30.63 (7.52) 120 30.51 (7.38) 103 30.04 (7.67) −0.45 (−1.32 to 0.42) 0.31 −0.06
Waist (cm) 378 106.81 (17.94) 178 107.39 (16.38) 124 109.25 (16.52) 108 110.96 (16.62) 200 106.29 (19.24) 121 106.05 (16.44) 111 104.22 (16.21) −1.83 (−3.82 to 0.17) 0.07 −0.1
Smoker 405 253 (62.5%) 193 112 (58) 132 80 (62.1) 113 64 (56.6) 212 141 (66.5) 127 81 (63.8) 116 74 (63.8) 1.05 (0.37 to 3.03) 0.93 N/A
Cigarettes/day (if smoker) 244 18.30 (11.54) 108 18.27 (9,75) 80 18.06 (11.04) 61 17.31 (10.67) 136 18.32 (12.83) 81 19.79 (15.49) 71 18.97 (15.59) 0.1 (−0.33 to 0.53) 0.65 N/A
Cannabis user 405 50 (12.3) 193 26 (13.5) 158 21 (13.3) 148 12 (8.1) 212 24 (11.3) 160 21 (13.1) 153 21 (13.7) 1.40 (0.51 to 3.93) 0.50 N/A
Cocaine use 405 7 (1.7) 193 3 (1.5) 158 2 (1.3) 148 1 (0.7) 212 4 (1.9) 160 0 (0) 153 1 (0.9)
HBA1c (%) 303 40.49 (8.17) 148 40.93 (8.34) 91 41.77 (9.16) 85 40.79 (10.69) 155 40.06 (8) 80 38.6 (9.2) 86 39.28 (10.48) −0.32 (−1.49 to 0.86) 0.59 −0.04
Cholesterol 289 5.16 (1.46) 136 5.07 (1.11) 86 4.86 (1.12) 80 4.70 (1.32) 153 5.23 (1.72) 80 4.96 (1.02) 85 4.81 (1.00) 0.01 (−0.28 to 0.30) 0.93 0.01
HDL cholesterol 306 1.25 (0.43) 137 1.28 (0.35) 86 1.25 (0.34) 80 1.19 (0.34) 153 1.23 (0.5) 80 1.30 (0.30) 85 1.30 (0.35) 0.085 (0.007 to 0.16) 0.034 0.20
LDL cholesterol 290 3.06 (1.01) 137 3.03 (1) 86 2.77 (1.07) 80 2.73 (1.11) 153 3.08 (1.01) 80 2.9 (0.96) 85 2.75 (0.95) 0.06 (−0.11 to 0.24) 0.49 0.06
Triglycerides 307 2.08 (1.7) 150 2.12 (1.67) 91 2.23 (1.97) 86 2.03 (1.38) 157 2.04 (1.74) 82 1.82 (1.4) 90 2.09 (2.47) 0.01 (−0.37 to 0.4) 0.95 0.01
C-Reactive Protein (CRP) 238 5.65 (7.91) 124 5.46 (7.02) 24 6.59 (6.35) 17 4.98 (5.49) 114 5.85 (8.81) 20 4.55 (3.79) 11 4.2 (4.78) 0.76 (−1.25 to 2.77) 0.46 0.1
Hypertension 380 246 (64.7%) 178 110 (61.8%) 125 82 (65.6%) 106 67 (63.2%) 202 136 (67.3%) 120 76 (63.3%) 112 68 (60.7%) 0.71 (0.38 to 1.36) 0.31 N/A
DINE saturated fat score 393 31.69 (12.74) 186 31.88 (12.54) 125 32.47 (14.33) 110 31.76 (14.13) 207 31.52 (12.95) 123 31.83 (13.23) 110 31.19 (12.61) −0.19 (−2.82 to 2.44) 0.89 −0.01
Audit 270 5.8 (6.09) 127 5.4 (5.77) 79 5.05 (5.54) 68 4.76 (4.83) 143 6.15 (6.35) 84 6.98 (6.46) 77 7.43 (6.69) 0.19 (−0.02 to 0.39) 0.07 0.19
IPAQ 99 3197.74 (3701.23) 47 3472.78 (3841.4) 36 2543.28 (3554.38) 28 2011.84 (2738.3) 52 2949.14 (3589.07) 32 1540.72 (1563.33) 23 2695.74 (2764.05) −0.08 (−0.4 to 0.25) 0.65 −0.02
MADRS 403 10.99 (9.46) 193 11.05 (9.33) 132 10.23 (8.97) 114 9.92 (8.8) 210 10.93 (9.59) 127 10.87 (9.56) 115 12.03 (9.99) 0.49 (−1.23 to 2.22) 0.58 0.05
GAF 402 59.33 (13.19) 193 60.88 (13.38) 130 55.56 (12.64) 114 53.59 (11.01) 209 57.9 (12.87) 126 53.01 (11.03) 117 52.63 (11.42) −0.7 (−3.44 to 2.03) 0.62 −0.05
PANSS (total) 399 51.38 (14.14) 191 51.63 (14.46) 131 50.08 (12.74) 114 49.4 (14.8) 208 51.14 (13.86) 127 51.24 (13.44) 115 50.8 (13.77) 1.37 (−1.23 to 3.96) 0.3 0.1
  1. Presented descriptive statistics are mean (SD) for continuous variables and N (%) for categorical data. Statistics for changes over time within treatment arm and treatment effects are based on patients with follow-up data collected within defined time window
  2. Hypertension, smoking and cannabis use were binary variables (yes or no) and a logistic model was used. Treatment effects are odds ratios. Number of cocaine users was too small to fit a logistic model
  3. Number of cigarettes was modelled using a Poisson distribution. Treatment effects are incidence rate ratios. Only models with random intercept for care coordinators and id could be fitted for logistic and Poisson models. A model for saturated fat categories could not be estimated