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Table 2 Mixed model analyses of completers (a) and for completers and treatment non-completers taken together (intention to treat; b) for the four outcomes: ISI, Pain-7d, HADS-anxiety and HADS-depression

From: Is sleep disturbance in patients with chronic pain affected by physical exercise or ACT-based stress management? – A randomized controlled study

 

Exercise

Within grp

p-value

ACT-bsm

Within grp

p-value

CON

Within grp

p-value

Time vs T0

p-value

a) Completers

 ISI

  Time x group (p-value)

.037

       

   T0

13.48 ± 6.52

ref

14.23 ± 6.00

ref

12.76 ± 7.24

ref

   T1

12.14 ± 6.55

.020

13.25 ± 6.30

.071

13.15 ± 7.46

.234

   T2

11.64 ± 7.15

.002

13.24 ± 6.38

.215

11.53 ± 7.29

.122

   T3

11.19 ± 6.27

.001

12.22 ± 6.38

.009

12.59 ± 7.13

.851

 Pain-7d

  Time x group (p-value)

.003

       

   T0

5.91 ± 1.77

ref

5.78 ± 1.97

ref

5.73 ± 2.15

ref

   T1

4.58 ± 2.14

.001

5.45 ± 1.99

.142

5.67 ± 2.15

.930

   T2

5.14 ± 2.36

.015

5.59 ± 2.24

.315

5.02 ± 2.02

.010

   T3

5.09 ± 2.17

.011

5.47 ± 1.91

.169

5.04 ± 2.22

.025

 HADS-A

  Overall effect of time (p-value)

.003

 

.017

 

.276

  

  Overall effect of group (p-value)

.211

 

.916

 

ref

  

  Time x group (p-value)

.112

       

   T0

8.56 ± 4.42

ref

7.52 ± 4.14

ref

7.60 ± 4.10

ref

ref

   T1

7.08 ± 4.79

6.77 ± 3.77

7.42 ± 4.54

<.001

   T2

7.17 ± 4.26

6.59 ± 3.76

5.85 ± 4.45

<.001

   T3

7.30 ± 4.46

6.56 ± 3.90

7.27 ± 3.80

.001

 HADS-D

  Overall effect of time (p-value)

.137

 

.011

 

.487

  

  Overall effect of group (p-value)

.719

 

.260

 

ref

  

  Time x group (p-value)

.197

       

   T0

6.40 ± 3.65

ref

6.78 ± 3.37

ref

5.48 ± 3.94

ref

ref

   T1

5.41 ± 3.86

6.07 ± 3.80

5.42 ± 3.82

.002

   T2

5.52 ± 3.27

6.04 ± 3.61

4.87 ± 3.75

.005

   T3

5.67 ± 3.90

5.56 ± 3.75

5.49 ± 3.75

.037

b) Completers + treatment non-completers

 ISI

  Time x group (p-value)

.015

       

   T0

13.48 ± 6.49

ref

13.73 ± 6.16

ref

13.14 ± 7.31

ref

   T1

11.63 ± 6.50

.001

13.39 ± 6.47

.260

13.39 ± 7.45

.216

   T2

11.83 ± 7.29

.003

12.98 ± 6.16

.594

11.73 ± 7.27

.055

   T3

11.17 ± 6.22

.002

12.32 ± 6.19

.057

12.49 ± 7.01

.955

 Pain-7d

  Time x group (p-value)

.009

       

   T0

5.88 ± 1.78

ref

5.84 ± 1.96

ref

5.86 ± 2.11

ref

   T1

4.64 ± 2.29

.000

5.59 ± 1.99

.105

5.52 ± 2.13

.355

   T2

5.14 ± 2.28

.020

5.57 ± 2.31

.228

4.92 ± 2.05

.002

   T3

4.98 ± 2.30

.004

5.39 ± 2.03

.057

4.94 ± 2.25

.003

 HADS-A

  Overall effect of time (p-value)

.024

 

.021

 

.089

  

  Overall effect of group (p-value)

.784

 

.337

 

ref

  

  Time x group (p-value)

.103

       

   T0

8.22 ± 4.58

ref

7.41 ± 4.09

ref

8.01 ± 4.66

ref

ref

   T1

6.84 ± 4.79

.000

7.02 ± 3.91

.218

7.85 ± 4.82

.582

.001

   T2

7.09 ± 4.40

.002

6.64 ± 3.71

.033

6.15 ± 3.88

.000

<.001

   T3

7.21 ± 4.73

.021

6.63 ± 4.13

.036

7.17 ± 3.78

.475

.003

 HADS-D

  Overall effect of time (p-value)

.303

 

.065

 

.931

  

  Overall effect of group (p-value)

.355

 

.434

 

ref

  

  Time x group (p-value)

.494

       

   T0

6.32 ± 3.75

ref

6.20 ± 3.45

ref

5.75 ± 4.21

ref

ref

   T1

5.37 ± 3.90

.006

5.94 ± 3.75

.025

5.57 ± 3.69

.721

.002

   T2

5.58 ± 3.44

.058

5.81 ± 3.61

.198

5.08 ± 3.72

.396

.018

   T3

5.73 ± 3.99

.297

5.53 ± 3.75

.042

5.42 ± 3.73

.739

.096

  1. Exercise exercise intervention, ACT-bsm Stress Management Intervention, CON controls, ISI Insomnia Severity Index, Pain-7d pain intensity recent 7 days according to 11-graded numeric rating scale, HADS-A Hospital Anxiety and Depression Scale subscale Anxiety, HADS-D Hospital Anxiety and Depression Scale subscale depression, T0 baseline, T1 immediately after the intervention, T2 6-month follow-up, T3 12-month follow-up