Table 3.
Outcome measuresa at baseline, treatment exitb, 6-month follow-up, and 12-month follow-up—within-subject.
| 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 |
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.
bTreatment Exit is defined as ‘after three MDMA sessions’ where MDMA group = End of Stage 1 and Placebo/MDMA group = End of Stage 2.
cParticipants in the blinded placebo group crossed-over and received three open-label MDMA sessions.
dParticipants in the blinded MDMA group had one MDMA session during open label.
eBaseline (n = 18), other endpoints (n = 17).
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.
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.