Table 3.
Enrollment, intervention, and assessment schedule for primary outcomes, mediators, and predictors
| Screening | BL | Acute phase | Follow-up | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Timepoint (week) | −2 | 0 | 1 | 3 | 5 | 7 | 8 | 10 | 12 | 22 | 34 |
| Enrollment: | |||||||||||
| Eligibility confirmation | x | ||||||||||
| Informed consent | x | ||||||||||
| Allocation | x | ||||||||||
| Interventions: | |||||||||||
| Minimal-contact CBT (MC-CBT) | X | T | X | T | X | X | |||||
| UCPPS Education | X | T | X | T | X | X | |||||
| Assessments: | |||||||||||
| Primary outcome | |||||||||||
| Global symptom improvement (CGI-I) | x | x | x | x | x | x | x | ||||
| Secondary outcomes | |||||||||||
| Emotional distress (BSI-18) | x | x | x | x | |||||||
| Patient satisfaction (CSQ) | x | ||||||||||
| Comorbid COPCs (CMSI) | x | x | x | x | |||||||
| Pelvic pain severity (GUPI) | x | x | x | x | x | x | x | x | |||
| Urinary problem severity (ICPI) | x | x | x | x | x | x | x | x | |||
| Urinary symptom severity (ICSI) | x | x | x | x | x | x | x | x | |||
| Pain interference (PPI SF-6a) | x | x | x | x | |||||||
| Quality of life (SF-12 v2) | x | x | x | x | |||||||
| Mediators | |||||||||||
| Perspective broadening (CERQ-PB) | x | x | x | x | x | ||||||
| Self-distancing (EQ-D) | x | x | x | x | x | ||||||
| Perceived control (MAIA-2) | x | x | x | x | x | ||||||
| Repetitive thinking (PTQ) | x | x | x | x | x | ||||||
| Context sensitivity (CSI) | x | x | x | x | x | ||||||
| Coping flexibility (CFS-R) | x | x | x | x | x | ||||||
| Prescriptive predictors (moderators) | |||||||||||
| Trait self-regulation (BRIEF-A) | x | ||||||||||
| Prognostic predictors | |||||||||||
| Comorbidities: medical and psychiatric | x | x | x | x | |||||||
| Concomitant treatments | x | x | x | x | |||||||
| Demographics, chronicity, etc. | x | ||||||||||
BL baseline, CGI-I Clinical Global Impression-Improvement, BSI-18 Brief Symptom Inventory-18, CSQ Client Satisfaction Questionnaire, CMSI Complex Medical Symptoms Inventory, GUPI Genitourinary Pain Index, ICPI Interstitial Cystitis Problem Index, ICSI Interstitial Cystitis Symptom Index, PPI SF-6a PROMIS - Pain Interference SF-6a, SF-12 v2 Short Form-12 Health Survey v2, CERQ-PB Cognitive Emotion Regulation Questionnaire-Perspective Broadening, EQ-D Experiences Questionnaire-Decentering, MAIA-2 Multidimensional Assessment of Interoceptive Awareness-2 (Noticing, Non-Distracting, Not-Worrying and Attention Regulation scales), PTQ Perseverative Thinking Questionnaire, CSI Context Sensitivity Index, CFS-R Coping Flexibility Scale-Revised, BRIEF-A Behavior Rating Inventory of Executive Functioning-Adult. Bolded Capped X = clinic session (intervention); T = telephone check in (intervention)