Table 4. Schedule of enrollment, interventions, and assessments (SPIRIT [Standard Protocol Items: Recommendations for Interventional Trials] diagram).
| Description | Study phase | In-lab procedures | Follow-up post-treatment | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
|
Enrollment |
Baseline |
Allocation |
Week 1 |
Week 2 |
Week 3 |
Week 4 |
1-week |
1-month |
3-month |
|
| Time point | –T1a | T0b | T1c | T2d | T3e | |||||
| Enrollment | ||||||||||
| Eligibility form | ✓ | |||||||||
| Informed consent | ✓ | |||||||||
| MINIf | ✓ | |||||||||
| Randomization | ||||||||||
| Allocation | ✓ | |||||||||
| Study arm | ||||||||||
| MBg | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||
| MB+DPh | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||
| WLCi | ✓ | ✓ | ✓ | ✓ | ✓ | |||||
| Assessments | ||||||||||
| NADA-Sj | ✓ | ✓ | ||||||||
| EEGk | ✓ | ✓ | ||||||||
| fNIRSl | ✓ | ✓ | ||||||||
| MPoDm | ✓ | ✓ | ||||||||
| Acute pain intensity | ✓ | ✓ | ||||||||
| At-home mindfulness practice (MB and MB+DP only) | ✓ | ✓ | ✓ | ✓ | ||||||
| BPIn | ✓ | ✓ | ✓ | ✓ | ||||||
| Physical function | ✓ | ✓ | ✓ | ✓ | ||||||
| PCSo | ✓ | ✓ | ✓ | ✓ | ||||||
| PHQ-2p | ✓ | ✓ | ✓ | ✓ | ||||||
| GAD-2q | ✓ | ✓ | ✓ | ✓ | ||||||
| PROMISr sleep disturbance | ✓ | ✓ | ✓ | ✓ | ||||||
| Pain catastrophizing | ✓ | ✓ | ✓ | ✓ | ||||||
a
–T1: Enrollment activities
b
T0: 1-week pretreatment (baseline).
c
T1: 1-week posttreatment.
d
T2: 1-month posttreatment.
e
T3: 3-month posttreatment.
f
MINI: Mini-International Neuropsychiatric Interview.
g
MB: mindful breathing.
h
MB+DP: mindful breathing+direct pointing.
i
WLC: waitlist control.
j
NADA-S: Nondual Awareness Dimensional Assessment-State.
k
EEG: electroencephalogram.
l
fNIRS: functional near-infrared spectroscopy.
m
MPoD: Metacognitive Processes of Decentering.
n
BPI: Brief Pain Inventory.
o
PCS: Pain Catastrophizing Scale.
p
PHQ-2: Patient Health Questionnaire 2-item.
q
GAD-2: Generalized Anxiety Disorder 2-item.
r
PROMIS: Patient-Reported Outcomes Measurement Information System.