Table 2.
Outcome measuresa at baseline and post two blinded experimental sessions.
| 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 |
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.
aAll outcomes were based on an intent-to-treat set.
bIndependent group t-test on change from baseline to post 2 experimental sessions.
cMissing FACIT data at baseline for placebo group (n = 4).