Table 2 Outcome measuresa at baseline and post two blinded experimental sessions.

From: MDMA-assisted psychotherapy for treatment of anxiety and other psychological distress related to life-threatening illnesses: a randomized pilot study

 

Placebo (n = 5)

MDMA (n = 13)

p-value

Baseline

Post two experimental sessions

Changeb

Baseline

Post two experimental sessions

Changeb

 

Primary efficacy variable

STAI Trait, mean (SD)

57.4 (5.2)

48.6 (12.6)

− 8.8 (14.7)

62.5 (7.3)

38.9 (10.6)

− 23.5 (13.2)

0.06

Secondary efficacy variables

STAI state, mean (SD)

51.8 (5.3)

45.8 (12.5)

− 6.0 (15.8)

59.5 (11.9)

37.5 (13.6)

− 22.1 (17.9)

0.10

BDI-II, mean (SD)

30.0 (11.4)

15.4 (9.9)

− 14.6 (8.6)

30.2 (11.0)

9.3 (10.4)

− 20.9 (13.8)

0.36

PSQI, mean (SD)

7.0 (6.6)

6.8 (5.7)

− 0.2 (1.3)

10.9 (3.5)

7.3 (4.5)

− 3.6 (5.4)

0.05

PTGI, mean (SD)

64.0 (19.1)

61.4 (24.9)

− 2.6 (6.1)

58.1 (19.9)

71.0 (18.8)

12.9 (23.2)

0.04

MADRS, mean (SD)

19.2 (9.3)

12.2 (5.3)

− 7.0 (7.2)

19.5 (7.1)

9.0 (9.0)

− 10.5 (8.2)

0.41

GAF, mean (SD)

69.8 (13.4)

72.8 (7.7)

3.0 (12.5)

68.5 (5.4)

75.1 (9.9)

6.6 (9.7)

0.52

SCS, mean (SD)

2.8 (0.8)

2.7 (0.9)

− 0.04 (0.5)

2.8 (0.6)

3.3 (0.6)

0.4 (0.7)

0.21

FFMQ, mean (SD)

3.3 (0.4)

3.3 (0.4)

0 (0.2)

3.3 (0.4)

3.7 (0.5)

0.4 (0.6)

0.04

DAP, mean (SD)

 Fear of death

5.1 (1.1)

4.5 (0.7)

− 0.6 (1.0)

3.8 (1.6)

3.7 (1.4)

− 0.1 (0.6)

0.25

 Death avoidance

3.5 (1.9)

2.4 (0.9)

− 1.1 (1.8)

3.1 (1.7)

3.1 (1.6)

0 (0.8)

0.26

 Neutral acceptance

5.4 (1.0)

5.6 (0.5)

0.2 (0.6)

5.8 (0.5)

5.9 (0.7)

0.1 (0.6)

0.88

 Approach acceptance

3.2 (1.3)

3.0 (0.7)

− 0.1 (1.1)

3.2 (1.8)

3.5 (1.6)

0.3 (0.7)

0.32

 Escape acceptance

3.4 (1.3)

3.4 (1.3)

0 (0.9)

3.5 (1.4)

3.9 (1.0)

0.4 (1.0)

0.85

FACIT, mean (SD)c

 Physical well-being

19.8 (6.7)

21.4 (3.0)

2.8 (5.0)

21.6 (4.2)

23.0 (4.3)

1.4 (4.4)

0.61

 Social/family well-being

20.0 (9.7)

17.6 (6.3)

− 2.0 (2.9)

17.6 (2.9)

18.5 (3.8)

0.8 (3.4)

0.15

 Emotional well-being

14.0 (5.9)

15.0 (3.9)

1.0 (2.2)

14.7 (3.0)

16.3 (6.7)

1.6 (7.1)

0.87

 Functional well-being

19.5 (5.9)

18.8 (7.1)

1.0 (1.6)

14.5 (2.8)

19.3 (6.3)

4.8 (5.8)

0.22

 Additional concerns

24.8 (14.4)

24.2 (10.3)

− 0.3 (5.0)

24.0 (9.2)

28.5 (14.1)

4.5 (11.9)

0.45

  1. STAI State-Trait Anxiety Inventory, BDI-II beck depression inventory-II, PSQI Pittsburgh Sleep Quality Index, PTGI Post Traumatic Growth Inventory, MADRS, Montgomery-Asberg Depression Rating Scale, GAF, Global Assessment of Functioning, SCS Self-Compassion Scale, FFMQ Five-Facet Mindfulness Questionnaire, DAP Death Attitudes Profile, FACIT Functional Assessment of Chronic Illness Therapy Scale.
  2. aAll outcomes were based on an intent-to-treat set.
  3. bIndependent group t-test on change from baseline to post 2 experimental sessions.
  4. cMissing FACIT data at baseline for placebo group (n = 4).
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