Table 4.
Participant timeline (SPIRIT [Standard Protocol Items: Recommendations for Interventional Trials]) showing the schedule of enrollment, interventions, and assessments.
|
Study period | |||||||||||
|
Enrollment | Baseline and allocation | Postallocation | |||||||||
Time point | −12 to −1 week | −2 to −1 week | 0-9 weeks (intervention) | 9-week follow-up | 21-week follow-up | |||||||
Enrollment | ||||||||||||
|
Eligibility screening (online and phone) | ✓ |
|
|
|
|
||||||
|
Informed consent | ✓ |
|
|
|
|
||||||
|
Allocation |
|
✓ |
|
|
|
||||||
Interventions | ||||||||||||
|
iDBT-Paina |
|
✓ |
|
|
|||||||
|
Treatment as usual |
|
✓ |
|
|
|||||||
Assessments | ||||||||||||
|
Primary outcome measure | |||||||||||
|
|
Difficulties in Emotion Regulation Scale-18 |
|
✓ |
|
✓ | ✓ | |||||
|
Secondary outcome measures | |||||||||||
|
|
Numeric Rating Scale |
|
✓ |
|
✓ | ✓ | |||||
|
|
PROMISb Pain Interference Instrument |
|
✓ |
|
✓ | ✓ | |||||
|
|
State-Trait Anxiety Inventory |
|
✓ |
|
✓ | ✓ | |||||
|
|
Beck Depression Inventory |
|
✓ |
|
✓ | ✓ | |||||
|
|
NIHc Toolbox Perceived Stress |
|
✓ |
|
✓ | ✓ | |||||
|
|
PTSDd Checklist–Civilian Version |
|
✓ |
|
✓ | ✓ | |||||
|
|
The Awareness of Social Inference Test |
|
✓ |
|
✓ | ✓ | |||||
|
|
Medical Outcomes Study Sleep Scale |
|
✓ |
|
✓ | ✓ | |||||
|
|
Temperament & Character Inventory |
|
✓ |
|
✓ | ✓ | |||||
|
|
Satisfaction with Life Scale |
|
✓ |
|
✓ | ✓ | |||||
|
|
COMPAS-We Scale of Wellbeing |
|
✓ |
|
✓ | ✓ | |||||
|
|
Health Utilization Questionnaire |
|
✓ |
|
✓ | ✓ | |||||
|
|
Medication & Health Interventions |
|
✓ |
|
✓ | ✓ | |||||
|
Acceptability measures | |||||||||||
|
|
DBTf Ways of Coping Checklist |
|
✓ |
|
✓ | ✓ | |||||
|
|
Usefulness, Satisfaction & Ease of Use |
|
|
|
✓ | ✓ | |||||
|
|
Patient Global Impression of Change |
|
|
|
✓ | ✓ | |||||
|
|
Semistructured interview |
|
|
|
✓ |
|
|||||
|
|
Treatment adherence |
|
|
✓ | ✓ | ✓ |
aiDBT-Pain: internet-delivered DBT skills training for chronic pain.
bPROMIS: Patient-Reported Outcomes Measurement Information System.
cNIH: National Institutes of Health.
dPTSD: posttraumatic stress disorder.
eCOMPAS-W: Composure, Own-worth, Mastery, Positivity, Achievement, Satisfaction with Life–Well-being.
fDBT: dialectical behavioral therapy.