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Table 6 Potential effect on candidate clinical outcomes at 6-month follow-up

From: Trauma-specific mindfulness-based cognitive therapy for women with post-traumatic stress disorder and a history of domestic abuse: intervention refinement and a randomised feasibility trial (coMforT study)

Outcomes at 6-month follow-up

Intervention (n = 13)

Control (n = 3)

Mean or risk difference: intervention–control (95% CI)

N

Mean (SD) or n (%) if stated

N

Mean (SD) or n (%) if stated

 

Primary outcomes

 PTSD Checklist DSM-5 score

12

30.8 (18.0)

3

47.3 (20.8)

− 16.6 (− 42.3 , 9.1)

 PTSD Checklist DSM-5

n (%) above PTSD threshold

13

8 (61.5%)

3

2 (66.7%)

− 0.05 (− 0.65, 0.54)

 International Trauma Questionnaire–PTSD score

13

8.5 (6.8)

3

14.0 (3.6)

− 5.5 (− 14.4, 3.3)

 International Trauma Questionnaire–DSO score

12

9.9 (6.6)

3

17.3 (6.4)

− 7.4 (− 16.6, 1.7)

International Trauma Questionnaire

n (%) above threshold:

 - PTSD

13

1 (7.7%)

3

0 (0%)

0.08 (− 0.07, 0.22)

 - CPTSD

13

2 (15.4%)

3

0 (0%)

0.15 (− 0.04, 0.35)

Secondary outcomes

 Dissociative symptoms, DES-B

13

7.8 (5.3)

3

11.3 (6.7)

− 3.6 (− 11.2, 4.0)

 Depression, PHQ-9

13

9.2 (5.2)

2

21.5 (3.5)

− 12.3 (− 20.5, − 4.0)

 Anxiety, GAD-7

12

6.6 (3.8)

2

12.5 (7.8)

− 5.9 (− 13.0, 1.2)

 Self-compassion

13

3.0 (0.8)

3

2.3 (0.6)

0.8 (− 0.3, 1.8)

 Intimate partner violence score in past 6 months

12

3.6 (4.1)

2

10.5 (2.1)

− 6.9 (− 13.5 , -0.4)

Health economic outcomes

 Quality of life, women, EQ-5D-5L

13

0.57 (0.28)

3

0.31 (0.458)

0.26 (− 0.17, 0.69)

 Quality of life, index child, KIDSCREEN-10

4

53.8

0

–

–

  1. N completed questionnaire, SD Standard deviation, CI Confidence interval, PTSD Post-traumatic stress disorder, CPTSD Complex post-traumatic stress disorder, DSM-5 Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, PHQ-9 Patient Health Questionnaire, GAD-7 Generalised Anxiety Disorder questionnaire, EQ-5D-5L health-related quality of life states in adults questionnaire, KIDSCREEN-10 health-related quality of life questionnaire for children