Table 3 Outcome measuresa at baseline, treatment exitb, 6-month follow-up, and 12-month follow-up—within-subject.

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

 

Placebo/MDMAc

(n = 5)

MDMAd

(n = 13)

Totale

(n = 17)

p-valuef

Primary efficacy variable

STAI trait score, mean (SD)

  Baseline

57.4 (5.2)

62.5 (7.3)

61.1 (7.0)

–

  Treatment exit

40.2 (11.3)

34.8 (8.6)

36.4 (9.5)

 < .0001

  6-month follow-up

39.2 (11.1)

31.3 (5.9)

33.6 (8.3)

 < .0001

  12-month follow-up

36.8 (8.7)

33.1 (11.0)

34.2 (10.3)

 < .0001

Secondary efficacy variables

STAI state score, mean (SD)

  Baseline

51.8 (5.3)

59.5 (11.9)

57.4 (10.9)

–

  Treatment exit

33.8 (10.2)

27.8 (6.5)

29.6 (8.0)

 < .0001

  6-month follow-up

33.0 (10.0)

29.2 (7.4)

30.3 (8.1)

 < .0001

  12-month follow-up

32.4 (8.6)

32.9 (12.4)

32.8 (11.1)

 < .0001

BDI-II, mean (SD)

  Baseline

30.0 (11.4)

30.2 (11.0)

30.2 (10.8)

–

  Treatment exit

3.8 (4.0)

2.7 (1.8)

3.0 (2.5)

 < .0001

  6-month follow-up

3.3 (2.5)

3.2 (3.3)

3.2 (3.1)

 < .0001

  12-month follow-up

6.8 (4.8)

3.3 (3.4)

4.3 (4.0)

 < .0001

PSQI, mean (SD)

  Baseline

7.0 (6.6)

10.9 (3.5)

9.8 (4.7)

–

  Treatment exit

6.2 (5.2)

5.7 (2.6)

5.8 (3.4)

0.0456

  6-month follow-up

6.6 (5.7)

5.6 (3.9)

5.9 (4.3)

0.0412

  12-month follow-up

5.2 (4.0)

6.3 (4.9)

5.9 (4.6)

0.0372

PTGI, mean (SD)

  Baseline

64.0 (19.1)

58.1 (19.9)

59.7 (19.3)

–

  Treatment exit

82.0 (10.7)

83.8 (13.1)

83.3 (12.2)

 < .0001

  6-month follow-up

81.4 (10.3)

92.3 (9.8)

89.1 (10.9)

 < .0001

  12-month follow-up

81.6 (9.9)

89.3 (13.8)

87.0 (13.0)

 < .0001

MADRS, mean (SD)

  Baseline

19.2 (9.3)

19.5 (7.1)

19.4 (7.5)

–

  Treatment exit

4.2 (3.6)

4.1 (4.9)

4.1 (4.4)

 < .0001

  6-month follow-up

5.0 (3.1)

3.1 (2.2)

3.6 (2.5)

 < .0001

  12-month follow-up

4.6 (2.5)

3.0 (3.5)

3.5 (3.2)

 < .0001

GAF, mean (SD)

  Baseline

69.8 (13.4)

68.5 (5.4)

68.8 (7.9)

–

  Treatment exit

82.8 (6.5)

81.7 (6.0)

82.0 (6.0)

 < .0001

  6-month follow-up

80.0 (6.1)

84.1 (5.5)

82.9 (5.8)

 < .0001

  12-month follow-up

81.2 (7.0)

84.6 (7.2)

83.6 (7.1)

 < .0001

SCS, mean (SD)g

  Baseline

2.8 (0.8)

2.8 (0.6)

2.8 (0.6)

–

  Treatment exit

3.5 (0.7)

3.6 (0.7)

3.6 (0.7)

0.0065

  6-month follow-up

3.3 (1.0)

3.8 (0.8)

3.7 (0.8)

0.0077

  12-month follow-up

3.4 (0.9)

3.8 (0.8)

3.7 (0.8)

0.0254

FFMQ, mean (SD)

  Baseline

3.3 (0.4)

3.3 (0.4)

3.3 (0.4)

–

  Treatment exit

3.7 (0.3)

3.9 (0.5)

3.9 (0.4)

 < .0001

  6-month follow-up

3.7 (0.4)

4.1 (0.5)

4.0 (0.5)

0.0002

  12-month follow-up

3.8 (0.4)

4.1 (0.4)

4.0 (0.4)

0.0023

DAP, mean (SD)

 Fear of Death

  Baseline

5.1 (1.1)

3.8 (1.6)

4.1 (1.5)

–

  Treatment exit

4.2 (1.3)

3.3 (1.6)

3.6 (1.5)

0.4540

  6-month follow-up

4.0 (1.4)

3.1 (1.5)

3.4 (1.5)

0.4258

  12-month follow-up

4.1 (1.6)

3.1 (1.5)

3.4 (1.6)

0.6867

 Death avoidance

  Baseline

3.5 (1.9)

3.1 (1.7)

3.2 (1.7)

–

  Treatment exit

2.3 (1.1)

2.8 (1.8)

2.6 (1.6)

0.7914

  6-month follow-up

2.8 (1.6)

2.8 (1.8)

2.8 (1.7)

0.8806

  12-month follow-up

2.6 (1.3)

2.7 (1.9)

2.7 (1.7)

0.7336

 Neutral acceptance

  Baseline

5.4 (1.0)

5.8 (0.5)

5.7 (0.7)

–

  Treatment exit

5.6 (0.6)

5.9 (0.6)

5.8 (1.0)

0.3139

  6-month follow-up

5.9 (0.7)

6.3 (0.5)

6.2 (0.6)

0.1031

  12-month follow-up

5.8 (0.6)

6.2 (0.4)

6.0 (0.5)

0.9588

 Approach acceptance

  Baseline

3.2 (1.3)

3.2 (1.8)

3.2 (1.6)

–

  Treatment exit

3.3 (0.7)

4.1 (1.4)

3.8 (1.3)

0.6365

  6-month follow-up

3.4 (1.0)

4.0 (1.6)

3.8 (1.5)

0.5838

  12-month follow-up

3.6 (0.8)

3.9 (1.6)

3.8 (1.4)

0.5687

 Escape acceptance

  Baseline

3.4 (1.3)

3.5 (1.4)

3.5 (1.3)

–

  Treatment Exit

3.4 (0.7)

4.2 (0.9)

4.0 (0.9)

0.8424

  6-month follow-up

3.7 (0.8)

4.1 (1.5)

4.0 (1.3)

0.6101

  12-month follow-up

3.8 (0.7)

3.9 (1.4)

3.8 (1.2)

0.6463

FACIT, mean (SD)g

 Physical well-being

  Baseline

19.8 (6.7)

21.6 (4.2)

21.2 (4.7)

–

  Treatment exit

24.6 (3.4)

25.2 (3.5)

25.0 (3.4)

0.1204

  6-month follow-up

23.0 (3.7)

25.3 (2.5)

24.6 (3.0)

0.0610

  12-month follow-up

23.6 (4.0)

24.5 (4.9)

24.2 (4.5)

0.0320

 Social and family well-being

  Baseline

20.0 (9.7)

17.6 (2.9)

18.2 (5.0)

–

  Treatment exit

19.8 (6.1)

20.0 (3.8)

19.9 (4.4)

0.7207

  6-month follow-up

17.6 (8.0)

21.2 (3.8)

20.1 (5.4)

0.6570

  12-month follow-up

18.2 (7.1)

20.7 (3.6)

20.0 (4.8)

0.7207

 Emotional well-being

  Baseline

14.0 (5.9)

14.7 (3.0)

14.5 (3.7)

–

  Treatment exit

17.6 (3.4)

20.8 (2.0)

19.8 (2.8)

 < .0001

  6-month follow-up

19.0 (3.3)

20.6 (1.9)

20.1 (2.4)

 < .0001

  12-month follow-up

18.4 (2.7)

20.1 (3.1)

19.6 (3.0)

 < .0001

 Functional well-being

  Baseline

19.5 (5.9)

14.5 (2.8)

15.6 (4.1)

–

  Treatment exit

21.8 (5.4)

21.8 (5.5)

21.8 (5.3)

 < .0001

  6-month follow-up

21.8 (5.0)

22.1 (3.0)

22.0 (3.6)

0.0005

  12-month follow-up

21.4 (5.7)

23.5 (4.0)

22.9 (4.5)

0.0008

 Additional concerns

  Baseline

24.8 (14.4)

24.0 (9.2)

24.2 (10.1)

–

  Treatment exit

33.6 (8.9)

39.1 (7.6)

37.5 (8.1)

0.0002

  6-month follow-up

30.8 (10.1)

40.1 (7.2)

37.4 (9.0)

0.0003

  12-month follow-up

31.4 (8.9)

40.0 (6.3)

37.5 (8.0)

0.0002

  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. bTreatment Exit is defined as ‘after three MDMA sessions’ where MDMA group = End of Stage 1 and Placebo/MDMA group = End of Stage 2.
  4. cParticipants in the blinded placebo group crossed-over and received three open-label MDMA sessions.
  5. dParticipants in the blinded MDMA group had one MDMA session during open label.
  6. eBaseline (n = 18), other endpoints (n = 17).
  7. fRepeated measures ANOVA within subjects on time (p < 0.05); post-hoc contrasts between: Baseline to Treatment Exit; Baseline to 6-Month Follow-up; and Baseline to 12-Month Follow-up.
  8. gMissing data: one participant missing data on SCS at 12-month follow-up (n = 16); one participant in placebo group missing data on FACIT (n = 4) at baseline.
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