Outcome | Intervention | Usual care | Diff in mean1 (95% CI) | P | Adjusted2 diff in mean (95% CI) | P | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Endpoint | Baseline | Endpoint | ||||||||||
N | Mean (sd) | N | Mean (sd) | n | Mean (sd) | n | Mean (sd) | ||||||
10 week analysis | |||||||||||||
Primary outcomes | |||||||||||||
EQ-5D-5L index score | 34 | 0.72 (0.19) | 34 | 0.69 (0.21) | 31 | 0.65 (0.25) | 28 | 0.65 (0.31) | -0.03 (-0.17,0.12) | 0.668 | -0.01 (-0.07,0.05) | 0.712 | |
EQ-VAS score | 34 | 62.2 (19.9) | 34 | 64.9 (15.4) | 31 | 61.2 (15.6) | 28 | 65.9 (18.2) | -1.4 (-8.8,6.0) | 0.676 | -1.4 (-9.1,6.2) | 0.671 | |
CES-D | 34 | 9.1 (9.1) | 34 | 9.3 (9.6) | 31 | 10.6 (9.1) | 28 | 8.5 (8.8) | 2.1 (-1.0,5.3) | 0.154 | 2.4 (-0.5,5.2) | 0.091 | |
Secondary outcomes | |||||||||||||
PACIC | 34 | 2.0 (0.5) | 34 | 2.1 (0.8) | 31 | 2.1 (0.7) | 28 | 1.8 (0.5) | 0.3 (-0.2,0.9) | 0.174 | 0.4 (-0.0,0.7) | 0.053 | |
KATZ Index | 34 | 5.4 (1.0) | 34 | 5.3 (0.8) | 31 | 5.1 (1.3) | 28 | 5.2 (1.1) | -0.1 (-0.4,0.1) | 0.168 | -0.2 (-0.5,0.1) | 0.105 | |
GAD-7 | 34 | 2.3 (3.2) | 34 | 2.6 (3.2) | 31 | 2.5 (2.8) | 28 | 2.4 (2.7) | 0.4 (-1.3,2.1) | 0.574 | 0.1 (-1.4,1.5) | 0.929 | |
MOS Social Support Score | 34 | 4.2 (0.8) | 34 | 4.5 (0.5) | 31 | 4.3 (0.8) | 28 | 4.2 (1.1) | 0.4 (-0.1,0.8) | 0.076 | 0.5 (-0.0,1.0) | 0.056 | |
6 month analysis | |||||||||||||
Primary outcomes | |||||||||||||
EQ-5D-5L index score | 34 | 0.72 (0.19) | 34 | 0.65 (0.27) | 31 | 0.65 (0.25) | 26 | 0.67 (0.28) | -0.07 (-0.22,0.08) | 0.316 | -0.07 (-0.16,0.03) | 0.139 | |
EQ-VAS score | 34 | 62.2 (19.9) | 34 | 63.1 (20.2) | 31 | 61.2 (15.6) | 26 | 66.9 (12.3) | -4.0 (-13.5,5.5) | 0.352 | -5.1 (-15.6,5.5) | 0.292 | |
CES-D | 34 | 9.1 (9.1) | 34 | 9.6 (7.1) | 31 | 10.6 (9.1) | 26 | 8.4 (7.7) | 1.6 (-2.1,5.3) | 0.341 | 1.2 (-1.2,3.6) | 0.29 | |
Secondary outcomes | |||||||||||||
PACIC | 34 | 2.0 (0.5) | 34 | 2.1 (0.9) | 31 | 2.1 (0.7) | 26 | 1.8 (0.8) | 0.5 (0.0,0.9) | 0.048 | 0.4 (0.0,0.8) | 0.049 | |
KATZ Index | 34 | 5.4 (1.0) | 34 | 5.3 (1.2) | 31 | 5.1 (1.3) | 26 | 5.2 (1.2) | -0.2 (-0.8,0.3) | 0.313 | -0.3 (-0.5,0.0) | 0.053 | |
GAD-7 | 34 | 2.3 (3.2) | 34 | 3.1 (3.5) | 31 | 2.5 (2.8) | 26 | 2.3 (3.3) | 0.8 (-0.6,2.3) | 0.227 | 0.3 (-1.2,1.9) | 0.637 | |
MOS Social Support Score | 34 | 4.2 (0.8) | 34 | 4.4 (0.7) | 31 | 4.3 (0.8) | 26 | 3.7 (1.1) | 0.7 (0.2,1.3) | 0.018 | 0.8 (0.4,1.2) | 0.001 |